The Intuitive Surgical Endoscopic Instrument Control System is intended for accurate control of selected endoscopic instruments including, rigid endoscopes, blunt endoscopic dissectors and endoscopic retractors during thoracoscopic and laparoscopic surgical procedures. It is intended to be used by professionals in operating room environments.

Device Description

The Intuitive Surgical Endoscopic Instrument Control System is an electro-mechanical device consisting of a Surgical Console including "Master Manipulators", articulated Instrument Control Arms or "Slave Manipulators" and Limited Reuse Tools or end effectors.

AI/ML Overview

The provided text describes the 510(k) summary for the Intuitive Surgical Endoscopic Instrument Control System (K965001). However, it does not contain the specific details required to complete all sections of your request, particularly regarding detailed acceptance criteria, specific reported device performance metrics against those criteria, and granular information about the study design (e.g., sample sizes for test and training sets, expert qualifications, ground truth establishment methods for training data).

Here's an analysis based on the available information and what is missing:

Acceptance Criteria and Study for Intuitive Surgical Endoscopic Instrument Control System (K965001)

The submission focuses on establishing substantial equivalence to predicate devices rather than demonstrating performance against predefined, quantitative acceptance criteria via a comprehensive clinical study as might be seen for novel devices.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific quantitative acceptance criteria and corresponding reported device performance metrics are NOT explicitly stated. The document refers to "internal specification requirements" and "external standard requirements and predicate performance expectations" but does not detail what these are.

Acceptance Criteria (Quantitative/Qualitative)	Reported Device Performance
Reproducibility	"All data fell within... internal specification requirements as well as external standard requirements and predicate performance expectations."
Hysteresis	"All data fell within... internal specification requirements as well as external standard requirements and predicate performance expectations."
Functional Adequacy	"All data fell within... internal specification requirements as well as external standard requirements and predicate performance expectations."
Substantial Equivalence to Predicates	Confirmed through "Design analysis and in vitro data" and comparison of intended use, basic functionality, and tissue effects.
Capability of precisely moving and controlling endoscopic tools	"The Intuitive system is substantially equivalent to both the Computer Motion and Andronic devices in terms of the capability of precisely moving and controlling endoscopic tools."
Tissue Effects	"The Intuitive system is substantially equivalent to the cited predicates in terms of the tissue effects."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (Test Set): Not specified. The document mentions "in vitro test data" and "design analysis" but does not give a number of tests or samples.
Data Provenance: The tests are described as "in vitro data," suggesting laboratory or bench testing. No information on country of origin or whether it was retrospective or prospective human clinical data is provided, as it appears to be primarily bench/pre-clinical testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Number of Experts: Not specified.
Qualifications of Experts: Not specified. It's likely that internal engineers or subject matter experts evaluated the in vitro test results against specifications, but this is not detailed.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified. Given the nature of "in vitro test data," it's more likely that direct measurements were taken and compared against pre-defined specifications rather than requiring expert adjudication in the traditional sense of clinical imaging studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No. The provided information does not describe any MRMC study comparing human readers with and without AI assistance. This device is an electromechanical control system for surgical instruments, not an AI-powered diagnostic or assistive tool in the context of interpretation.

6. Standalone (Algorithm Only) Performance Study

Standalone Performance Study: Yes, in a sense. The "in vitro test data" and "design analysis" would represent the "standalone" performance of the device's functional characteristics (reproducibility, hysteresis, functional adequacy) in a controlled environment. However, it's not an "algorithm only" study in the typical AI sense, but rather a performance study of the electromechanical system.

7. Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for the in vitro tests would be the pre-defined engineering specifications and performance expectations for reproducibility, hysteresis, and functional adequacy. These would likely be based on established engineering principles, predicate device performance, and clinical needs for precise instrument control.

8. Sample Size for the Training Set

Sample Size (Training Set): Not applicable in the context of machine learning. This device is an electromechanical system, not an AI/ML algorithm that requires a training set. Its design and validation rely on engineering principles, material science, and control systems, not data-driven machine learning models.

9. How the Ground Truth for the Training Set Was Established

Ground Truth (Training Set): Not applicable, as there is no training set for this type of device.

Summary

{0}------------------------------------------------

JUL 31 1997

510(k) SUMMARY

K965001

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

510(k) Number: K965001

Applicant Information:

Date Prepared:	June 20, 1997
Name	Intuitive Surgical, Inc.
Address:	1340 W. Middlefield RoadMountain View, California 94043 415-237-7036
Contact Person:	Michael A. Daniel
Phone Number:	(415) 237-7036
Facsimile Number:	(415) 526-2060

Device Information:

Classification:	Class I / II	Surgical Table and AccessoriesEndoscope and AccessoriesGynecologic Laparoscope and Accessories
Trade Name:	Intuitive Surgical, Endoscopic Instrument Control SystemAccessories: "Resposable" (limited reuse) Instruments consistingof Retractors and Blunt Dissectors
Common Name:	Endoscopic Instrument Control SystemEndoscope and Accessories for Minimally Invasive Surgery
Classification Name:	Surgical Table and Accessories,	21 CFR 878.4960
	Endoscope and Accessories,	21 CFR 876.1500
	Gynecologic laparoscope and acces.	21 CFR 884.1720

Predicate Devices:

The Innuive Surgical Endoscopic Instrument Control System and Tools are substantially equivalent in intended use and/or method of operation to a combination of the following predicate devices:

Computer Motion AESOP Laparoscope Positioning and Control System ﻟﺴﻨﺔ
Adronic Devices Endex (originally "Adept") Instrument Positioning Accessory (IPA) ు
And various atraumatic Class I Exempt surgical instruments including the US Surgical 3 Auto Suture Endoscopic Fan Retractor (K914190), Inman Medical Corp. Endoscopic Blunt Dissector (K933169) and Medical Perspectives Corp. Kittner Dissector (K953059)

{1}------------------------------------------------

510(k) SUMMARY

(Continued)

Device Description:

Intended Use:

The Intuitive Surgical Endoscopic Instrument Control System is intended for precise and accurate control of selected tracoscopic and laparoscopic instruments including, rigid laparoscopes, blunt endoscopic dissectors, and endoscopic retractors, during thoracoscopic and laparoscopic surgical procedures. It is intended to be used by trained professionals in operating room environments

Comparison to Predicate Device(s):

The Intuitive Surgical Endoscopic Instrument Control System and Resposable Tools are substantially equivalent to a combination of the Computer Motion AESOP Laparoscope Posstoning and Control System, the Adept/Andronic Laparoscopic Positioning and Manipulation System and various other Class I Exempt endoscopic instruments in terms of intended use and basic functionality. The Intuitive System is substantially equivalent to both the Computer Motion and Andronic devices in terms of the capability of precisely moving and controlling endoscopic tools. The Intuitive system is substantially equivalent to the cited predicates in terms of the tissue effects.

In Vitro Test Data:

Design analysis and in virro data confirm that basic functional characteristics are substantially equivalent to the predicate devices sited. Testing included evaluation of reproducibility, hysteresis, and functional adequacy. All data fell within both internal specification requirements as well as external standard requirements and predicate performance expectations.

Summary:

Based upon the product technical information provided, intended use, and performance Information provided in this pre-market notification, the Intuitive Surgical Endoscopic Instrument Control System has been shown to be substantially equivalent to currently marketed predicate devices.

{2}------------------------------------------------

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Michael A. Daniel Vice President, Regulatory/Clinical. Affairs &. Quality Assurance. ........... Intuitive Surgical, Inc. 1340 W. Middlefield Road Mountain View. California 94304

JUL 3 1 1997

Re: K965001

Trade Name: Intuitive Surgical Endoscopic Instrument Control System Regulatory Class: II Product Code: GCJ Dated: June 30, 1997 Received: July 1, 1997

Dear Mr. Daniel:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. The substantial equivalence determination for the Intuitive Surgical Endoscopic Instrument Control System includes use with rigid endoscopes and the following manual surgical instruments only: (1) the Intuitive™ Retractor, (2) the Intuitive™ Blunt Dissector, (3) the Intuitive™ Kitner, and (4) the Intuitive™ Stablizer manual instrument tips.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such

{3}------------------------------------------------

Page 2 - Mr. Michael A. Daniel

assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. . . . . . . . . . . . . . .

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

a M. Witten, M.D., Ph.D. Director, Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

510(k) Number (if known): K965001

Intuitive Surgical Endoscopic Instrument Control System Device Name:

Indications For Use ... . .

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number kg65001

ption Use
OR
Over-The-Counter Use

Prese : phon Use (Pat 21 ChR 801 109) OR

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.