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. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. 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

Here's an analysis of the provided text, focusing on the acceptance criteria and study information:

Device Acceptance and Study Information Summary

This 510(k) submission for the Intuitive Surgical® da Vinci™ Endoscopic Instrument Control System and Endoscopic Instruments focuses on demonstrating substantial equivalence to predicate devices, rather than establishing direct acceptance criteria through a specific performance study against defined metrics.

The primary method of demonstrating equivalence is through "Design analysis and comparison" and "in vitro testing." No specific reported device performance values are provided for quantitative acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) submission, formal acceptance criteria with numerical performance targets and reported device performance values are not explicitly stated. The core of the acceptance is based on demonstrating "substantial equivalence" to predicate devices.

Acceptance Criterion (Implicit)	Reported Device Performance
Substantial equivalence in function, size, shape, and tissue effect to predicate devices for endoscopic procedures.	Confirmed through design analysis, comparison, and in vitro testing.
Intended Use as outlined for general laparoscopic, non-cardiovascular thoracoscopic, and thoracoscopically-assisted cardiotomy procedures, including coronary anastomosis.	The device meets the intended use as specified in the submission.

2. Sample size used for the test set and the data provenance

The document states that "in vitro testing" was performed, but does not specify the sample size used for this testing. It also does not specify the data provenance in terms of country of origin or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The submission relies on "Design analysis and comparison" and "in vitro testing" rather than a clinical study requiring expert ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided. As the submission focuses on in vitro testing and design comparison, adjudication methods typically associated with human interpretation of results (e.g., in imaging studies) are not applicable or mentioned.

5. 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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done, nor is it applicable in this context. The device is a surgical control system and instruments, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The concept of "standalone" algorithm performance is not applicable to this device. The da Vinci™ System is an instrument control system intended to be used with human operators (trained physicians). It is not an autonomous algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Since the primary method of evaluation was "design analysis and comparison as well as in vitro testing," the "ground truth" would likely be based on:

Engineering specifications and performance standards: For the mechanical, electrical, and functional aspects validated during in vitro testing.
Comparison to predicate device characteristics: The known performance and characteristics of the cited predicate devices served as a baseline for "substantial equivalence."

There is no mention of expert consensus, pathology, or outcomes data being used to establish a ground truth for the "test set" in the context of this submission.

8. The sample size for the training set

This information is not applicable and not provided. The device is an instrument control system and instruments, not a machine learning or AI model that requires a "training set."

9. How the ground truth for the training set was established

This information is not applicable and not provided, as there is no "training set" for this type of device.

Summary

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JUL - 7 2004

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: K040237

Applicant Information:

Date Prepared:	January 28, 2004
Name:	Intuitive Surgical, Inc.
Address:	950 Kifer RoadSunnyvale, California 94086
Contact Person:	Usha Kreaden, M.Sc
Phone Number:	(408) 523-2140
Facsimile Number:	(408) 523-1390
E-mail:	usha.kreaden@intusurg.com

Device Information:

Classification/Name:	Class IIEndoscope 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 (K022574, K021036, 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:

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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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle faces right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

JUL - 7 2004

Re: K040237

Trade/Device Name: Intuitive Surgical Endoscopic Instrument Control System and Endoscopic Instruments Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscopes and accessories Regulatory Class: II Product Code: NAY Dated: June 9, 2004 Received: June 15, 2004

Dear Ms. Kreaden:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaused the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to commerce pror of they 2017 - 11:14 provisions of the Federal Food, Drug, de nees may na ve been resuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merelevy, mans of the Act include requirements for annual registration, listing of general voltarely pro revering 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 rryour device is classified (600 as 2010). Existing major regulations affecting your device can may be subject to back as a same as a ritle 21, Parts 800 to 898. In addition, FDA may be found in the Coursements 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 that + Dr has Intatutes and regulations administered by other Federal agencies. You must or any I cateral state and strequirements, 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) This lotter will anow your your e 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), please 11 you aton't the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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

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

510(k) Number (if known): K040237

Device Name: Intuitive Surgical® Endoscopic Instrument Control System and Endoscopic Instruments

Indications For Use:

The Intuitive Surgical® Endoscopic Instrument Control System (hereinafter referred to as the " I he Intented by Fred - Lassist in the accurate control of Intuitive Surgical® Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scalpels, mistraments moraing ngholders, endoscopic retractors, stabilizers, electrocautery and forcessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp accessories for endoooops, ligation, electrocautery and suturing during general laparoscopic ansoother, approminations andiovascular thoracoscopic surgical procedures and Surgically assisted cardiotomy procedures. The system can also be employed with നിഗ്രോട്‌സ് കാടിയായ varanetics) (
adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. It adjunctive meanability will be mained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

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

Page 1 of

510(k) Number_________________________________________________________________________________________________________________________________________________________________

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.