(20 days)
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS5000) shall assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures and general thoracoscopic surgical procedures. The system is indicated for adult use.
It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
Contraindication:
Use of the force feedback needle driver is contraindicated in hysterectomy and myomectomy due to the risk of vaginal bleeding requiring hospital readmission and/or the need for additional procedures. The use of non-force feedback needle drivers is recommended for suturing in these procedures.
The da Vinci Force Feedback Instruments are 8 mm, multi-use, endoscopic instruments intended for use with the da Vinci Surgical System, Model IS5000. These instruments have been designed with an articulating wrist that gives surgeons natural dexterity and range of motion, and have the ability to render forces measured at the instrument tip to the hand controls at the system Console.
The basis for this submission is a modification to the reprocessing instructions, in addition to an increase in the number of surgical uses (lives) and reprocessing cycles for the da Vinci Force Feedback Instrument family as listed in Table 1, which Intuitive intends to introduce into interstate commerce in accordance with 21 CFR Section 807.81.
The provided document is an FDA 510(k) summary for a medical device. It focuses on demonstrating substantial equivalence to predicate devices, particularly regarding changes to reprocessing instructions and increasing the number of surgical uses (lives) and reprocessing cycles for the da Vinci Force Feedback Instruments.
Here's an analysis of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes performance testing conducted to support the changes. While it doesn't explicitly state "acceptance criteria" with numerical thresholds, it details the types of tests performed and implies that passing these tests demonstrates acceptable performance. The "reported device performance" is generally stated as "All testing passed and supports the subject device changes."
| Performance Test Category | Implied Acceptance Criteria (Based on document) | Reported Device Performance |
|---|---|---|
| Cleaning Validation | Efficacy of manual cleaning process in accordance with ANSI/AAMI ST98, AAMI TIR12, ASTM F3208, and FDA Guidance. | Passed |
| Reliability (Life) Verification | Instrument mechanical and sensor performance maintained after sufficient reprocessing and simulated surgical use cycles (simulating design life). | Passed (benchtop measurements, visual inspection, functional performance) |
| Dielectric Strength Testing | Compliance with IEC 60601-2-2:2017 and FDA Guidance for Electrosurgical Devices, after instruments have undergone design life cycles. | Passed |
| Jaw Force to Failure Verification | Verification of jaw force to failure after instruments have undergone design life cycles, in compliance with FDA Guidance for Electrosurgical Devices. | Passed |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample sizes used for each of the performance tests (Cleaning Validation, Reliability Verification, Dielectric Strength Testing, Jaw Force to Failure Verification). It generally refers to "instruments" being subjected to tests.
The data provenance (country of origin, retrospective/prospective) is not explicitly stated. The testing appears to be internal validation performed by the manufacturer, Intuitive Surgical, Inc., located in Sunnyvale, California.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document describes engineering-based performance testing rather than studies involving human interpretation or expert ground truth establishment in the traditional sense (e.g., for diagnostic algorithms). The "ground truth" for these tests would be the established engineering specifications and regulatory standards. Therefore, the concept of a "number of experts" establishing ground truth in this context is not directly applicable. The experts involved would be the engineers and regulatory specialists who designed and conducted the tests and interpreted the results against established standards.
4. Adjudication Method for the Test Set:
Not applicable, as this is engineering performance testing, not a study requiring expert adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The document describes benchtop and laboratory testing of the instruments' physical and functional performance, not a study evaluating human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. The device, the da Vinci Force Feedback Instruments, is a physical surgical instrument that assists a human surgeon. It is not an AI algorithm in the standalone sense. The performance tests are for the instruments themselves, not an algorithm's output.
7. The Type of Ground Truth Used:
The "ground truth" for the performance tests is based on engineering specifications, regulatory standards, and established industry guidelines. For example:
- Cleaning validation against ANSI/AAMI ST98.
- Dielectric strength testing against IEC 60601-2-2.
- Jaw force to failure verification against FDA guidance.
- Reliability (life) verification against internal design life specifications.
8. The Sample Size for the Training Set:
Not applicable. This document is about a physical medical device (surgical instruments) undergoing performance validation, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no machine learning model or training set involved.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.