The Intuitive Surgical™ Stereo View Endoscopic System is intended for endoscopic vicwing of internal surgical sites during minimally invasive surgery in the peritoneal cavity, thoracic cavity, and peritoneum. It is designed to be used with the Intuitive Surgical™ Endoscopic Instrument Control System during thoracoscopic and laparoscopic surgical procedures

Device Description

The Intuitive Surgical™ Stereo View System consists of an Intuitive Surgical endoscope, an Intuitive Surgical camera, and a commercially available light source. The endoscope is essentially identical in size and shape to the predicate devices referenced above, with minor modifications so that it can be attached to the Intuitive Surgical™ Endoscopic Instrument Control System. The camera and illumination sources attach to the endoscope and are essentially identical in function to those incorporated with the predicate Olympus System.

AI/ML Overview

The provided text does not contain information about specific acceptance criteria or a detailed study proving the device meets them. Instead, it is a 510(k) summary for a medical device (Intuitive Surgical™ Stereo View Endoscopic System) seeking substantial equivalence to predicate devices.

The document indicates that the device's approval is based on a comparison to existing devices rather than a performance study against specific acceptance criteria.

Here's an analysis of the provided information based on your requested points, highlighting what is present and what is absent:

1. A table of acceptance criteria and the reported device performance

Not present. The document does not define specific acceptance criteria (e.g., in terms of resolution, field of view, illumination intensity, or accuracy metrics) or provide a table reporting the device's performance against such criteria. The submission is focused on demonstrating "substantial equivalence" to predicate devices rather than meeting pre-defined performance thresholds.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable / Not present. The document states, "Design analysis and comparison confirm that basic functional characteristics are substantially equivalent to the predicate devices cited." This indicates that the evaluation was likely based on engineering design analysis and direct comparison of specifications and functional descriptions, rather than a clinical "test set" of patient data or samples. Therefore, information on sample size, data provenance, retrospective/prospective nature is not provided.

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

Not applicable / Not present. As there is no described test set involving clinical data or human evaluation to establish ground truth, this information is not relevant or provided.

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

Not applicable / Not present. Since no test set or human evaluation for ground truth is described, there is no mention of an adjudication method.

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

Not present. This document predates widespread AI integration in medical devices and does not describe any MRMC study or AI assistance. The device is an endoscopic system, not an AI diagnostic tool.

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

Not applicable / Not present. This is not an AI algorithm. The device is a physical endoscopic system; therefore, a standalone algorithm performance study is not relevant.

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

Not applicable / Not present. The submission relies on "Design analysis and comparison" to predicate devices, not on establishing ground truth for diagnostic accuracy. The substantial equivalence argument is based on the device's physical and functional characteristics being similar to already approved devices.

8. The sample size for the training set

Not applicable / Not present. This is not an AI/machine learning device that would require a training set.

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

Not applicable / Not present. As there is no training set for an AI model, this information is not relevant or provided.

Summary of the Study Proving Device Meets Acceptance Criteria (as described in the document):

The "study" or justification for approval is primarily a comparison to predicate devices. The document states:

"Design analysis and comparison confirm that basic functional characteristics are substantially equivalent to the predicate devices cited."
"The Intuitive Surgical™ Stereo View Endoscopic System endoscopes are essentially identical in terms of shape, size, materials, and function to the standard endoscopes cited. The stereo view feature of the camera is essentially identical to the 3D feature of the predicate Olympus System. The illumination source is identical to the one in the predicate Olympus system."

This means the device's acceptability is proven by demonstrating its similarity in design, materials, function, and intended use to devices already cleared for market, rather than through independent performance testing against pre-defined acceptance criteria. The FDA's clearance letter confirms "substantial equivalence."

Summary

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4/1/99

510(k) SUMMARY

K990188

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: TBD

Applicant Information:

Date Prepared:	January 1, 1999
Name:	Intuitive Surgical, Inc.
Address:	1340 W. Middlefield RoadMountain View, California 94043650-237-7000
Contact Person:	John N. Zorich, Jr.
Phone Number:	(650) 237-7195
Facsimile Number:	(650) 526-2060

Device Information:

Classification:	Class II	Gynecologic Laparoscope and AccessoriesRigid EndoscopeEndoscope and Accessories
Trade Name:	Intuitive Surgical™ Instruments / Accessories: EndoscopicInstruments including: Stereo Endoscope and accessories for usewith: The Intuitive Surgical™, Endoscopic Instrument ControlSystem
Common Name:	3D Endoscope and Accessories
Classification Name:	Endoscope and AccessoriesRigid EndoscopeGynecologic laparoscope and Accessories,	21 CFR 876.150021 CFR 876.150021 CFR 884.1720

Predicate Devices:

The Intuitive Surgical™ Endoscope is substantially equivalent in intended use and/or method of operation to the following predicate devices:

Olympus 3D Surgical Endoscopy System ( Premarket Notification # K943305) Origin/Medsystems 5mm Endoscope (Premarket Notification # K960637)

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Device Description:

Intended Use:

The Intuitive Surgical™ Stereo View Endoscopic System is intended for endoscopic viewing of internal surgical sites during minimally invasive surgery in the peritoneal cavity, thoracic cavity, and peritoneum. It is designed to be used with the Intuitive Surgical™ Endoscopic Instrument Control System during thoracoscopic and laparoscopic surgical procedures.

Comparison to Predicate Devices:

The Intuitive Surgical™ Stereo View Endoscopic System endoscopes are essentially identical in terms of shape, size, materials, and function to the standard endoscopes cited. The stereo view feature of the camera is essentially identical to the 3D feature of the predicate Olympus System. The illumination source is identical to the one in the predicate Olympus system.

Test Data:

Design analysis and comparison 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 Stereo View Endoscopic 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

1 1999 APR

Mr. John N. Zorich, Jr. Manager, Quality Systems and Regulatory Compliance Intuitive Surgical, Inc. 1340 West Middlefield Road Mountain View, California 94043

Re: K990188 Trade Name: Intuitive Surgical™ Stereo View Endoscopic System Regulatory Class: II Product Code: GCJ Dated: January 19, 1999 Received: January 20, 1999

Dear Mr. Zorich:

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.

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 requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such 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.

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Page 2 - Mr. John N. Zorich, Jr.

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 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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,

Celia M. Witten. Ph.D., M.D.

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

Enclosure

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K 990188 510(k) Number (if known): TBD

Intuitive Surgical™ Stereo View Endoscopic System Device Name:

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

colees

Restorative Devices

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Over-The-Counter Use

page 9

(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.