The Intuitive Surgical* Endoscopic Instrument Control System (hereinafter referred to as the "da Vinci* System") is intended to assist in the accurate control of Intuitive Surgical* Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing during general laparoscopic surgical procedures, general noncardiovascular thoracoscopic surgical procedures, and thoracoscopically-assisted cardiotomy procedures. 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 Instructions for Use.

Device Description

The working ends and elements of the Intuitive Surgical® da Vinci™ Surgical System, Endoscopic Instruments and Accessories are essentially identical in function, size and shape to the predicate devices referenced. They represent standard embodiments of standard surgical tools, which have been modified for use with the Intuitive Surgical® da Vinci™ Surgical System.

AI/ML Overview

This 510(k) summary describes a traditional medical device (surgical instruments), not an AI/ML-driven device. Therefore, many of the requested categories related to AI/ML performance acceptance criteria, such as "Sample size used for the test set and the data provenance", "Number of experts used to establish the ground truth for the test set", "Adjudication method", "MRMC comparative effectiveness study", and "Sample size for the training set", are not applicable to this submission.

The acceptance criteria and evaluation method for this device are based on proving "substantial equivalence" to predicate devices through design analysis and in vitro testing, focusing on functional characteristics.

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Substantial equivalence in terms of shape, size, function, and tissue effect to predicate devices.	"The Intuitive Surgical® Instruments are essentially identical in terms of shape, size, function and tissue effect to the standard Class I and II endoscopic medical devices previously cited." "Design analysis and comparison as well as in vitro testing confirm that basic functional characteristics are substantially equivalent to the predicate devices cited."

Study Details

Sample size used for the test set and the data provenance: Not applicable. Performance was evaluated through design analysis and in vitro testing, not a clinical study with a "test set" in the context of AI/ML.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Performance claims are based on engineering analysis and in vitro testing, not expert consensus on a test set.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the conventional sense for AI/ML. The "ground truth" for substantial equivalence was based on predefined functional, size, and shape characteristics of existing predicate devices, against which the new device aspects were compared.
The sample size for the training set: Not applicable. This is not an AI/ML device.
How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

Summary

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NOV 1 3 2002

Section II

510(k) SUMMARY

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: K022574

Applicant Information:

Date Prepared:	November 8, 2002
Name:	Intuitive Surgical, Inc.
Address:	950 Kifer RoadSunnyvale, California 94086
Contact Person:	Usha Kreaden, M.S.
Phone Number:	(408) 523-2140
Facsimile Number:	(408) 523-1390
E-mail:	usha kreaden@intusurg.com

Device Information:

Classification/Name:	Class I/IEndoscope and Accessories (21 CFR §876.1500)Gynecologic Laparoscope and Accessories (21 CFR §884.1720)
Trade Name:	Intuitive Surgical® da Vinci™ Endoscopic InstrumentControl System and Endoscopic Instruments or da Vinci™Surgical System
Common Name:	Endoscopic Instruments, Control System and Accessories

Predicate Devices:

Substantial equivalence data for the Intuitive Surgical® da Vinci™ Surgical System and Endoscopic Instruments were provided in the original pre-market notifications (K011002, K002489, K990144, K965001).

Device Description:

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standard surgical tools, which have been modified for use with the Intuitive Surgical® da Vinci™ Surgical System.

Indications for Use:

The Intuitive Surgical® Endoscopic Instrument Control System (hereinafter referred to as the "da Vinci™ System") is intended to assist in the accurate control of Intuitive Surgical* Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing during general laparoscopic surgical procedures, general noncardiovascular thoracoscopic surgical procedures, and thoracoscopically-assisted cardiotomy procedures. 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 Instructions for Use.

Comparison to Predicate Device(s):

The Intuitive Surgical® Instruments are essentially identical in terms of shape, size, function and tissue effect to the standard Class I and II endoscopic medical devices previously cited.

In Vitro Test Data:

Design analysis and comparison as well as in vitro testing confirm that basic functional characteristics are substantially equivalent to the predicate devices cited.

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.

Intuitive® and Intuitive Surgical® is a registered trademark of Intuitive Surgical, Inc.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 2 2002

Ms. Usha S. Kreaden Director of Clinical and Regulatory Affairs Intuitive Surgical, Inc. 950 Kifer Road Sunnyvale, CA 94086

Re: K022574

Trade/Device Name: Intuitive Surgical Endoscope Instrument Regulation Number: 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: NAY Dated: November 5, 2002 Received: November 6, 2002

Dear Ms. Kreaden:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Usha S. Kreaden - - -

This letter will allow you to begin marketing your device as described in your Section 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 your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

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

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K022574

Intuitive Surgical® da Vinci™ Endoscopic Instrument Control System Device name: and Endoscopic Instruments

Indications for Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-the Counter Use

(per 21 CFR §801.109

(Optional Format 1-2-96)

Muriam C. Provet

(Division Sign-Off) (Division of General, Restorative Division of Neurological Devices

510(k) Number K022574

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.