Question

how to perform testing of succesful project of robot surgery in a healthcare setting. explain the step for demonstration and testing .

Answer 1

QUESTION:

1.how to perform testing of succesful project of robot surgery in a healthcare setting. explain the step for demonstration and testing .

ANSWER:

DEMONSTRATION AND TESTING OF SUCCESFUL PROJECT OF ROBOT SURGERY IN A HEALTHCARE SETTING.

Introduction

The first documented use of a robot-assisted surgical procedure occurred in 1985 when the PUMA 560 robotic surgical arm was used in a delicate neurosurgical biopsy, a non-laparoscopic surgery. The robotic system allowed for a successful robotic surgery and the potential for greater precision when used in minimally invasive surgeries, such as laparoscopies which typically utilize flexible fiber optic cameras. The 1985 robotic surgery lead to the first laparoscopic procedure involving a robotic system, a cholecystectomy, in 1987. The following year the same PUMA system was used to perform a robotic surgery transurethral resection. In 1990 the AESOP system produced by Computer Motion became the first system approved by the Food and Drug Administration (FDA) for its endoscopic surgical procedure.In 2000, the da Vinci Surgery System broke new ground by becoming the first robotic surgery system approved by the FDA for general laparoscopic surgery. This was the first time the FDA approved an all-encompassing system of surgical instruments and camera/scopic utensils. Its predecessors relied upon the use of endoscopes and numerous surgical assistants to perform surgery. The da Vinci robotic surgery system’s three-dimensional magnification screen allows the surgeon to view the operative area with the clarity of high resolution. The one-centimeter diameter surgical arms represent a significant advancement in robotic surgery from the early, large-armed systems such as the PUMA 560. With such miniaturized operating arms, the da Vinci robotic surgery system removes the need to leverage the sides of the incision walls. This advancement allows for less contact between exposed interior tissue and the surgical device, greatly reducing the risk of infection. The “Endo-wrist” features of the operating arms precisely replicate the skilled movements of the surgeon at the controls, improving accuracy in small operating spaces.The da Vinci system has been approved by the FDA for use in both adult and pediatric robotic surgery procedures in the following areas:

• Urological surgeries
• General laparoscopic surgeries
• General non-cardiovascular thoracoscopic surgeries
• Thoracoscopically-assisted cardiotomy procedures

Computer-Assisted Surgical Systems

• Different types of computer-assisted surgical systems can be used for pre-operative planning, surgical navigation and to assist in performing surgical procedures. Robotically-assisted surgical (RAS) devices are one type of computer-assisted surgical system. Sometimes referred to as robotic surgery, RAS devices enable the surgeon to use computer and software technology to control and move surgical instruments through one or more tiny incisions in the patient’s body (minimally invasive) for a variety of surgical procedures.The benefits of a RAS device may include its ability to facilitate minimally invasive surgery and assist with complex tasks in confined areas of the body. The device is not actually a robot because it cannot perform surgery without direct human control.
• RAS devices generally have several components, which may include:
  • A console, where the surgeon sits during surgery. The console is the control center of the device and allows the surgeon to view the surgical field through a 3D endoscope and control movement of the surgical instruments;
  • The bedside cart that includes three or four hinged mechanical arms, camera (endoscope) and surgical instruments that the surgeon controls during surgical procedures; and
  • A separate cart that contains supporting hardware and software components, such as an electrosurgical unit (ESU), suction/irrigation pumps, and light source for the endoscope.
• Most surgeons use multiple surgical instruments and accessories with the RAS device, such as scalpels, forceps, graspers, dissectors, cautery, scissors, retractors and suction irrigators.

Applications for Robotic Surgery

• Because robotic surgery is at the cutting edge of precision and miniaturization in the realm of surgery, the possible applications are as extensive as the uses of minimally invasive surgery. Robotic surgery has already become a successful option in neurological, urological, gynecological, cardiothoracic, and numerous general surgical procedures. Intuitive Surgical, makers of the da Vinci robotic surgery system, have released upgrades in the number of operating arms, eliminating the need for one surgical assistant, which may expand its clinical applications.

Common uses of Robotically-Assisted Surgical (RAS) Devices

• The FDA has cleared RAS devices for use by trained physicians in an operating room environment for laparoscopic surgical procedures in general surgery cardiac, colorectal, gynecologic, head and neck, thoracic and urologic surgical procedures. Some common procedures that may involve RAS devices are gall-bladder removal, hysterectomy and prostatectomy (removal of the prostate).

Recommendations for Patients and Health Care Providers about Robotically-Assisted Surgery:

Health Care Providers:

• Robotically-assisted surgery is an important treatment option that is safe and effective when used appropriately and with proper training. The FDA does not regulate the practice of medicine and therefore does not supervise or provide accreditation for physician training nor does it oversee training and education related to legally marketed medical devices. Instead, training development and implementation is the responsibility of the manufacturer, physicians, and health care facilities. In some cases, professional societies and specialty board certification organizations may also develop and support training for their specialty physicians. Specialty boards also maintain certification status of their specialty physicians.
• Physicians, hospitals and facilities that use RAS devices should ensure that proper training is completed and that surgeons have appropriate credentials to perform surgical procedures with these devices. Device users should ensure they maintain their credentialing. Hospitals and facilities should also ensure that other surgical staff that use these devices complete proper training.
• Users of the device should realize that there are several different models of robotically-assisted surgical devices. Each model may operate differently and may not have the same functions. Users should know the differences between the models and make sure to get appropriate training on each model.
• If there is a problem or complications associated with the use of RAS devices, the FDA encourages filing a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.

Patients:

• Robotically-assisted surgery is an important treatment option but may not be appropriate in all situations. Talk to your physician about the risks and benefits of robotically-assisted surgeries, as well as the risks and benefits of other treatment options.
• Patients who are considering treatment with robotically-assisted surgeries should discuss the options for these devices with their health care provider, and feel free to inquire about their surgeon’s training and experience with these devices.

FDA Activities:

• The FDA is aware of an increase in the number of medical device reports (MDRs) related to robotically-assisted surgical devices. The majority of the medical device reports the FDA received were of device malfunctions, such as component breakage, mechanical problems and image/display issues. However, the FDA has also received reports of injuries and deaths related to the device. This increase in reports may be due to a number of factors, including an increase in the number of devices being used or surgeries being conducted, better awareness of how to report device issues to the FDA, increased publicity resulting from product recalls, media coverage, and litigation, as well as other influences. In addition, because reports submitted to the FDA can contain incomplete, inaccurate, duplicative, and unverified information, confirming whether a device actually caused a specific event can be difficult based solely on information provided in a given report. For these reasons, the FDA also evaluates other information to make decisions about a device’s safety and effectiveness, relying on a variety of postmarket surveillance data sources to monitor the safety and effectiveness of medical devices. MDRs of suspected device-associated deaths, serious injuries and malfunctions are one of these sources, but submission of a report to FDA does not necessarily indicate a faulty or defective medical device.
• To obtain additional information, the FDA conducted a small sample Medical Product Safety Network (MedSun) survey of experienced surgeons who use robotically-assisted surgical devices in a variety of procedures. The goal was to better understand the user’s perspectives and the different challenges identified when using this type of system to perform surgery compared to conventional surgical procedures.
• The FDA is working with professional societies to encourage training and education associated with the use of these devices.
• The FDA routinely monitors postmarket performance of marketed devices and inspects manufacturing facilities that make the medical devices, and will continue to collect and analyze all available information regarding robotically-assisted surgical devices to better understand the risks and benefits. The FDA will keep the public informed if new information becomes available.
• The FDA’s CDRH classifies all medical devices based on the risks associated with the device. Devices are classified into one of three categories: Class I, Class II, or Class III.
• Class I devices are deemed to be low-risk and are therefore subject to the least regulatory controls. Class II devices are moderate risk devices, and Class III devices are life sustaining and/or the highest risk devices and are therefore subject to the highest level of regulatory control.
• 13 Regulatory pathways used for medical devices include the premarket notification [510(k)], Premarket Approval Application (PMA), and the de novo classification process. RASD are currently regulated as Class II 510(k) devices, under the “Endoscope and accessories” regulation (21 CFR 876.1500).
• Therefore, in order for a new or modified RASD to obtain FDA clearance, the new or modified device must be demonstrated to be “substantially equivalent” to a “predicate” (legally marketed) device.
• To find a new device substantially equivalent to a predicate device, FDA must find that the two devices have the “same intended use.” FDA must then determine that the two devices have “the same technological characteristics,” or that any differences in technological characteristics do not raise different questions of safety and effectiveness and that the new device is as safe and effective as the predicate device.
• Originally, RASD were found substantially equivalent to laparoscope holding devices, and were therefore placed in the “endoscope and accessories” regulation. These initial clearances were made by considering RASD as surgical tools (i.e., demonstrated ability to grasp, cut, dissect, retract tissues and coagulate bleeding, etc.).
• Therefore, RASD have been cleared for general surgical indications such as urological surgeries, general laparoscopic surgeries, gynecological laparoscopic surgeries, etc. with the premarket testing demonstrating the capability of performing “representative” tasks or procedures. In this context, such general claims for device use in a specialty have not typically assessed every procedure performed by that specialty.
• FDA has published guidance on the general principles that are considered in determining when a specific indication for use is reasonably included within a general indication for use of a medical device for purposes of determining substantial equivalence.
• Generally, FDA has considered new, specific indications for use for RASD to fall within the scope of the cleared general “intended use” for RASD. Specific indications for use are typically supported by additional data, which may include pre-clinical, animal, literature, or clinical data.

Guidance for Industry on General/Specific Intended Use

This guidancedocument identifies the general principles that will be considered by the Food and Drug Administration (FDA) in determining when a specific indication for use is reasonably included within a general indication for use of a medical device for purposes of determining substantial equivalence under Section 513(f) or Section 520(l) of the Federal Food, Drug and Cosmetic Act (the Act). This guidance is issued in accordance with new Section 513(i)(1)(F) of the Act, which was added by Section 206 of the Food and Drug Administration Modernization Act of 1997 (FDAMA).There are a number of reasons medical device manufacturers may seek to add a specific indication for use to a general use of a legally marketed predicate device. In some cases, technology may drive a manufacturer’s decision to request the addition of a specific indication for use; "minor" technological changes to a device may make it more applicable to one specific indication for use and less applicable to other uses. Alternatively, a new competing device may enter the market with a specific claim resulting in a potential loss of market share for the device without that claim. Sometimes the identification of a specific intended use is the result of the evolution of medical practice once a device is marketed. When the medical community adopts a specific indication for use as routine practice, manufacturers and physicians want that specific indication for use to appear on the labeling for both liability and reimbursement purposes.

Purpose

• The purpose of this document is to help medical device manufacturers understand the principles used by FDA to determine whether the addition of a specific indication for use to a medical device cleared for marketing with a general indication for use could trigger the need for a PMA. The guidance is intended to help manufacturers answer the following questions: Under what circumstances is a device with a new, specific indication for use likely to be found to be substantially equivalent to a device legally marketed for a general indication for use? Conversely, when does a specific indication for use become a new intended use that requires submission of a PMA to establish the safety and effectiveness of the device?
• This guidance does not offer a bright line rule to answer these questions. The agency believes it could not formulate such a rule without compromising the ability of FDA reviewers to factor in the important public health and regulatory considerations that are essential to making appropriate classification determinations. Thus, the purpose of this guidance is to describe that decision-making process and its basis in the law and in agency practice.
• Nor does this guidance construct a new or separate SE/NSE decision-making process. That process is addressed in other agency guidance (see Blue Book Memorandum #K86-3, "510(k) Substantial Equivalence Decision-Making Process"). Instead, this document provides guidance to sponsors by describing the criteria that FDA considers in deciding whether the addition of a specific indication for use alters the intended use of a product that is already marketed with a general indication for use, requiring approval of a PMA.
• Item #4 of the 510(k) flowchart (K86-3), which FDA reviewers have used for years in 510(k) evaluations, asks "Do the differences [ in indications ] alter the intended therapeutic/diagnostic effect" and directs FDA reviewers to "consider impact on safety and effectiveness ." This general/specific guidance, therefore, does not add a new level of scrutiny to the review process; rather, it articulates the factors which are currently used by FDA in assessing the impact of a change from general to specific use on safety and effectiveness.

Definitions

For the purpose of this guidance, the definitions for "general to specific" and "level of specificity" listed below are used.

General to Specific

A change from a general to a specific indication for use is defined as: Any proposed increase in the level of specificity of the indication for use of a medical device. A change in a device’s indication for use from general to specific usually results in an indication for use that is narrower than the approved or cleared general use. Such a change or additional indication generally will narrow the indication for use with respect to function, target population, organ or organ system, tissue type, disease entity, or analyse.

Levels of Specificity

The level of specificity is defined as: a qualitative ranking of the proposed indications for use of a medical device. Levels of specificity for diagnostic and therapeutic devices in order of increasing specificity from general to specific can be categorized as follows:

Levels of Specificity for diagnostic medical devices:

1. Identification or measurement of a physical parameter (e.g., image, heart rate) or biochemical parameter (e.g., analyte)
2. Identification of a new or specific target population (e.g., women, children of a certain age range) or anatomical location (e.g., MR of the brain)
3. Identification of the clinical use of the measurement (e.g., diagnosis, screening)
4. Identification of or implication of an effect on the clinical outcome (e.g., screening mammography reduces breast cancer mortality)

Levels of Specificity for therapeutic (including preventive) medical devices:

1. Identification of function (e.g., cut)
2. Identification of tissue type (e.g., soft tissues)
3. Identification of an organ system (e.g., GI tract ) or
   Identification of a specific organ (e.g. liver)
4. Identification of a particular disease entity (e.g., resection of hepatic metastases) or target population
5. Identification of an effect on clinical outcome (e.g., use of medical device improves the rate of durable complete remissions with chemotherapy)

Regulatory Background

• For products not requiring a Premarket Approval that are not exempt from premarket notification ( 510(k) ), a 510(k) submission is required whenever a medical device is introduced into commercial distribution in the United States (21 CFR 807.81). In addition, a 510(k) is required when a legally marketed device is to be significantly modified in design, components, method of manufacture, or intended use ( 21 CFR 807.81(a)(3) ). In either situation, review of the 510(k) submission is how the agency’s experts determine whether the device is substantially equivalent (SE) to the predicate device to which it is being compared.
• The 510(k) review process requires the agency to determine the proper classification for a medical device. Devices that are determined to be substantially equivalent to legally marketed devices that are not Class III devices subject to premarket approval, are placed in the same regulatory class as the predicate and may go to market upon receiving clearance from FDA. Devices determined to be substantially equivalent to a Class III device subject to premarket approval requirements, as well as devices determined to be not substantially equivalent (NSE) to a predicate device, are placed in Class III. Unless reclassified into Class I or Class II, these devices cannot go to market without an approved PMA or a completed product development protocol. Under new 513(f)(2) of the act, sponsors of devices declared NSE may seek FDA evaluation of their devices’ automatic Class III designation.
• FDA has issued guidance documents that describe the process by which substantial equivalence decisions are rendered. Guidance about the Agency’s 510(k) decision making process is contained in Blue Book memorandum #K86-3. Guidance about Agency decisions with respect to the requirement for 510(k) clearance when modifications are made to legally marketed devices are contained in Blue Book memorandum #K97-1. While these guidance documents provide information relevant to FDA’s decision-making processes with respect to general/specific use, Congress indicated through FDAMA § 206 that FDA should provide additional guidance on the approach that the agency takes when evaluating whether a new indication for use, which appears to fall within the scope of the intended use of a legally marketed predicate device, is a new intended use that would require a PMA.
• Blue Book memorandum #K86-3 further states that the Center assesses any differences in indications for use in terms of the safety and effectiveness questions those differences may raise. This guidance also indicates that some modifications in indications will be considered a new use, "even though the intended effect of the new device is very similar to that of the predicate device." The Blue Book memorandum notes that slight modifications in indications for use can significantly change the intended use of the predicate device.
• It should also be noted that the agency has received previous Congressional guidance which bears directly on the issue of substantial equivalence in the Report of the Committee on Interstate and Foreign Commerce on the Medical Device Amendments of 1976 (Senate Report):

FDAMA

• The Senate committee report which preceded the final FDAMA bill stated that "this clarification [with respect to general/specific use] is important because FDA has not established a consistent pattern upon which persons who submit premarket notifications may rely. Two specific examples may help us to understand the need to address the general/specific use issue.
• The first example, cited in the same 1997 Senate report, relates to a substantial equivalence determination made for condoms, using the general indication for use of prevention of sexually transmitted disease as a predicate for condoms labeled to prevent the transmission of HIV. This was a situation where an overriding potential public health benefit, an established safety profile, and an identical mechanism of action were weighed against concerns regarding the level of available effectiveness data in deciding that 510(k) was the appropriate regulatory pathway for this indication for use. The Senate report concluded that, "[T]his determination made perfect public health sense, despite the fact that the general use labeling pre-dated the ‘Medical Device Amendments of 1976’ and HIV was unknown at that time.
• A second example, cited in Blue Book Memorandum #K86-3, relates to powered suction-aspiration devices, which were initially cleared to remove tissue and fluid from the body during surgery. New versions of these devices were presented to the agency to be cleared for use in "suction lipectomy" for body contouring. In this instance, FDA determined that this was a new intended use requiring submission of a PMA. Key factors that led the agency to this decision included:

1. The aspiration process performed by the device became the surgical outcome for which the device was intended to be used, rather than the device being intended to aid the physician in performing surgery. This surgical outcome, which would affect large numbers of "well" patients desiring enhanced body image, had never been validated through controlled clinical trials.
2. The removal of large quantities of body fat raised questions of safety and effectiveness not posed by the labelling of pre-Amendments aspirators, e.g., possible metabolic changes, and permanent bagging of the skin resulting when the fat removed from the area exceed the ability of the skin to contract.

• These major differences in risk, benefit, and clinical endpoints led FDA to conclude that submission of a PMA was necessary to establish whether there was reasonable assurance that the device was safe and effective for this intended use.

Decision-Making Criteria

The criteria that follow are provided as guidance on the Agency’s decision-making process for determining substantial equivalence or non-equivalence for general/specific uses. The list of criteria should not be considered to be all-inclusive. Nor should the list be viewed as a scale which can be used to calculate a particular outcome. Rather, these criteria should be seen as important contributing factors, which, when used appropriately, can help the agency consistently arrive at reasonable regulatory decisions that relate to the safety and effectiveness of medical devices. These criteria should be evaluated in connection with the Levels of Specificitydescribed earlier in this document.

1. Risk- Does a specific use introduce new risks not normally associated with the general use of the device?
2. Public Health Impact- Does a specific use impact public health to a significantly greater degree than the general use of the device? Differences in public health impact can result from changes in target population. These changes may have quantitative dimensions, but routinely will also affect safety and effectiveness because of major qualitative differences in how the device is to be used (e.g. diagnosis vs. screening, cutting soft tissue vs. treating breast cancer).
3. Knowledge base- Is there a body of evidence available to the agency regarding a proposed specific use that reflects existing understanding by the medical community that the more specific use is a subset of the general use, rather than a new intended use? That evidence can be derived from such sources as the medical literature and practice guidelines.
4. Endpoints- To what degree can the performance or clinical endpoints (e.g., ability to ablate tissue; prevention of STDs) used to evaluate the general use be applied to the specific use?
5. Tool or treatment? - To what degree is the device used by the physician intended to perform a task (e.g., a scalpel) as opposed to "being" the treatment (e.g., extra corporeal shock wave lithotripter)?
6. Adjunctive therapy- To what degree does another product not routinely needed for the general use need to be used in conjunction with the device to achieve the specific use safely and effectively?
7. Design changes- To what extent does a modification to a medical device to facilitate the specific use render it less applicable to the other aspects of the general use?

Specific uses that ordinarily fall within a general use for the purpose of determining that the device with the specific indication for use is substantially equivalent to the general use device include:

• Those indications for use that specify a sub-specialty of a particular clinical discipline where the types of treatments or procedures are similar.
• Those indications for use that specify a particular anatomic site or tissue type that does not imply diagnosis or therapy of a specific disease entity.
• Those indications for use that specify a narrow target population within a broader population and,
• Those indications for use for which a considerable body of knowledge or experience exists to demonstrate that the specific use falls within accepted parameters for the general use of the device, as defined by the clinical community
• Specific indications for use that ordinarily fall outside a general use for the purpose of determining substantial equivalence include:

• Those indications for use that involve the diagnosis, therapy, or prevention of a particular disease entity or entities, especially where such entity carries clinical implications not normally associated with other general uses of the device
• Those specific indications for use that presume a specific clinical outcome, especially when that outcome could influence patient management outside standard practice

· Those indications for use that provide a new type of diagnostic information or therapeutic option that significantly impacts patient management

CONCLUSION:

The future of robotic surgery is nearly as promising as the human will to invent better ways of accomplishing delicate medical procedures. It is reasonable to assume that the current advantages of robotic surgery systems will be expanded upon in the next generation of medical robotics. Removing human contact during surgery may be taken to the next level with robotic surgery systems capable of functioning at greater distances between surgeons control console and the patient side table robotics. This would allow robotic surgery to be conducted with patients in a nearby “clean room,” reducing or eliminating the intraoperative infection. It is possible for next-generation medical robotics and robotic surgery to conduct surgical prep work remotely as well.Advancements in making robotic surgery systems more capable of replicating the tactile feel and sensation a surgeon experiences during more invasive traditional procedures would give the surgeon the best of both worlds. The surgeon would gain the precision and advantages of minimally invasive procedures without losing the sensory information helpful in making judgment calls during robotic surgery.