The da Vinci Handheld Camera is intended for endoscopic viewing of internal surgery sites during minimally invasive surgery. It is designed for use with compatible da Vinci Surgical Systems.

Device Description

The da Vinci Handheld Camera is a lightweight handheld 2D Camera which can be connected to any third party 5 mm to 10 mm laparoscope to view images on the da Vinci Xi Vision cart. The da Vinci Handheld Camera consists of the camera head, the light guide, camera connector and the light guide adaptor.

The da Vinci Handheld Camera leverages the illuminator, video processor, monitor and video outputs on the do Vinci Xi Vision Cart to provide common functions of a laparoscopic video tower. The da Vinci Xi Handheld Camera connects to the vision cart in the same way an endoscope does through the endoscope controller. The da Vinci Handheld Camera consists of the camera head, endocoupler, cable assembly, light guide, and an adapter. The da Vinci Handheld Camera Head Sterilization Tray is intended for use to encase and protect da Vinci Handheld Camera Head during sterilization.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the da Vinci Handheld Camera, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Bench Testing	Physical Specifications	Met (demonstrated in testing)
	Mechanical Requirements	Met (demonstrated in testing)
	Electrical Requirements	Met (demonstrated in testing)
	User Interface Requirements	Met (demonstrated in testing)
	Equipment Interface Requirements	Met (demonstrated in testing)
Animal Validations	Performance in simulated clinical models	Evaluated and determined to meet requirements.
Human Factors Evaluation	Safety for intended users, uses, and use environments	Found to be safe and effective.

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

The document does not explicitly state specific sample sizes for each test set. It mentions "simulated clinical models (animal)" for animal validation and "Human factors evaluation" for usability, suggesting the use of a finite number of animals and human participants. The data provenance is not explicitly mentioned (e.g., country of origin).

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

This information is not provided in the document. The studies mentioned (bench, animal, human factors) are likely conducted by engineers, researchers, and usability specialists, but their specific roles in establishing "ground truth" and their qualifications are not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the document. The document describes various tests but doesn't mention any adjudication process for conflicting results or inter-reviewer variability.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not mentioned in the document. The device is a handheld camera for endoscopic viewing, not an AI-assisted diagnostic tool.

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

This question is not applicable as the da Vinci Handheld Camera is a physical imaging device and not an AI algorithm. Its performance is intrinsically tied to human usage and interpretation of the live video feed.

7. The Type of Ground Truth Used

The ground truth for the various tests seems to be established through:

Engineering specifications and standards for bench testing (e.g., physical, mechanical, electrical requirements).
Physiological and anatomical observations in animal models for performance evaluation.
Usability metrics and safety assessments in human factors evaluation.

8. The Sample Size for the Training Set

This information is not applicable as the da Vinci Handheld Camera is a hardware device, not an AI model that requires a training set.

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

This information is not applicable for the same reason as above (not an AI model).

Summary

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

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 6, 2019

Intuitive Surgical, Inc. Mr. Manjunath Bisalehalli Regulatory Affairs Engineer 1266 Kifer Road Sunnyvale, California 94086

Re: K191043

Trade/Device Name: da Vinci Handheld Camera Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: April 17, 2019 Received: April 19, 2019

Dear Mr. Bisalehalli:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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

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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-

combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for

Jennifer R. Stevenson Acting Division Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation & Quality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K191043

Device Name da Vinci Handheld Camera

Indications for Use (Describe)

The da Vinci Handheld Camera is intended for endoscopic viewing of internal surgery sites during minimally invasive surgery. It is designed for use with compatible da Vinci Surgical Systems.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

510(k) Summary 7

510(k) Owner:	Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086
Contact:	Manjunath BisalehalliRegulatory Affairs EngineerPhone Number: 408-523-7089Fax Number: 408-523-8907Email: Manjun.Bisalehalli@intusurg.com
Date Summary Prepared:	April 17, 2019
Trade Name:	da Vinci Handheld Camera
Common Name:	Endoscope and accessories
Classification:	Class II21 CFR 876.1500, Endoscope and Accessories
Product Codes:	GCJ (Endoscope and accessories)
Classification AdvisoryCommittee:
Committee:	General and Plastic Surgery
Predicate Device:	Intuitive Surgical Stereo View Endoscopic System(K080155)

Device Description

Image /page/3/Picture/8 description: The image contains the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a light gray color. Below that, the word "SURGICAL" is in a smaller font and also in a light gray color, with the registered trademark symbol to the right of it.

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

Intended Use

The da Vinci Handheld Camera is intended for endoscopic viewing of internal surgery sites during minimally invasive surgery. It is designed for use with compatible do Vinci Surgical Systems.

Technological Characteristics

The subject device, do Vinci Handheld Camera, is technologically very similar to the predicate device, Intuitive Surgical Stereo View Endoscopic System (cleared under K080155). The subject device has the same architecture design, as the predicate except it is a handheld camera.

Performance Data

Performance data (bench and animal testing) demonstrate that the subject device is substantially equivalent to the predicate device and that the design outputs meet the design requirements. The testing includes dimensional measurements, mechanical and functional verification, simulated use in animal model (porcine), and human factors evaluation.

Bench Testing

The subject device, da Vinci Handheld Camera, was subjected to a series of bench tests to evaluate the performance and to demonstrate that the design outputs meet the input requirements. The design verification testing assessed the following:

. Physical Specifications
Mechanical Requirements
Electrical Requirements
User Interface Requirements
Equipment Interface Requirements

Animal Validations

A series of tests were performed using simulated clinical models (animal) to evaluate the performance of the subject device, da Vinci Handheld Camera.

Human Factors Evaluation

As part of the Usability Engineering Process for the da Vinci Handheld Camera, the Usability Risk Analysis was updated to identify any new usability characteristics related to safety, as well as foreseeable hazards and hazardous situations. Human factors

Image /page/4/Picture/19 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a light gray color. Below that, the word "SURGICAL" is in a smaller font and also in a light gray color, with the registered trademark symbol to the right of it.

{5}------------------------------------------------

evaluation was conducted on the da Vinci Handheld Camera. Based on the results of those studies, the da Vinci Handheld Camera is found to be safe and effective for the intended users, uses, and use environments.

Summary

Based on the intended use, indications for use, technological characteristics, and performance data, the subject device, da Vinci Handheld Camera is substantially equivalent to the predicate device, Intuitive Surgical Stereo View Endoscopic System.

Image /page/5/Picture/6 description: The image contains the logo for Intuitive Surgical. The word "INTUITIVE" is in a larger, sans-serif font, and is placed above the word "SURGICAL", which is in a smaller font. There is a yellow dot above the "I" in "INTUITIVE".

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.