The Universal Seal (5-12 mm), as part of the da Vinci Trocar system, supports a port of entry for endoscopes, instruments, and accessories. It is intended to be used with a compatible da Vinci cannula to provide a seal within a port of entry for endoscopes, instruments, and accessories. It is intended to provide an attachment for gas insufflation while minimizing gas leakage.

Device Description

The Universal Seal (5-12 mm) is a sterile, single-use device. It provides a seal within a port of entry for endoscopes, instruments, and accessories with a diameter range between 5 mm and 12 mm. It also provides an attachment for insufflation accessories and allows for air flow in or out of the body cavity while minimizing gas leakage.

AI/ML Overview

The provided text is a 510(k) summary for the "Universal Seal (5-12 mm)" device. The document states that the device is "substantially equivalent" to a predicate device and details the performance testing conducted to demonstrate this equivalence. However, it does not describe a study involving an AI algorithm or human readers, but rather engineering-focused performance testing of a physical medical device (a cannula seal).

Therefore, I cannot provide a direct answer to your request as it pertains to AI algorithm performance evaluation. The document describes a traditional medical device submission, not an AI/ML medical device where acceptance criteria would involve metrics like accuracy, sensitivity, specificity, and human reader performance.

However, I can interpret the acceptance criteria and "proof" provided for this specific physical device based on the information given.

Based on the provided document for the "Universal Seal (5-12 mm)", here's a breakdown of the acceptance criteria and study that proves the device meets them:

Crucial Note: This document pertains to a physical medical device (a trocar seal), not an AI algorithm. Therefore, the "study" described is a series of engineering and biocompatibility tests, not a clinical trial or algorithm performance study with human readers. Many of the requested details (like ground truth establishment for AI, human expert involvement for AI interpretation, MRMC studies) are not applicable to this type of device submission.

Acceptance Criteria and Reported Device Performance (Non-AI Device)

The acceptance criteria for this physical device are implied by the "Design Verification" and "Design Validation" sections, which ensure the device functions as intended and meets user needs.

Acceptance Criteria Category	Specific Criteria (Implied)	Reported Device Performance
Functional Performance	- Leakage: Minimal gas leakage, provides seal	- Bench testing performed for "Leakage".- "Successfully meets design inputs and user needs." (Implied)
	- Torque Limits: (Within specified operational range)	- Bench testing performed for "Torque limits".- "Successfully meets design inputs and user needs." (Implied)
	- Force Limits: (Withstands expected operational forces)	- Bench testing performed for "Force limits".- "Successfully meets design inputs and user needs." (Implied)
	- Reliability: (Consistent performance over time/use)	- Bench testing performed for "Reliability".- "Successfully meets design inputs and user needs." (Implied), Reliability testing also mentioned separately.
Clinical Use Simulation	- Product Specifications meet user's needs & intended use	- "Simulated clinical use testing was performed with a porcine model to validate that the product specifications continued to meet the user's needs and intended use." (Successful completion implied by overall conclusion of substantial equivalence)
Biocompatibility	- Meets recognized standards for biocompatibility	- "Determined that the subject device met the requirements of the recognized standards for biocompatibility for its intended clinical use." (ISO 10993-1:2018 and FDA Guidance)
Shelf-Life	- Maintain a shelf-life of two years	- "Shelf-life testing was performed through an accelerated aging study to verify that the product can maintain a shelf-life of two years." (Successful verification implied)
Packaging/Transit	- Withstands shipping conditions	- "Transit testing was performed in accordance with ASTM D4169-16, Standard Practice for Performance Testing of Shipping Containers and Systems." (Successful completion implied)

Details of the "Study" (Performance Testing)

Given that this is a physical medical device (a cannula seal) and not an AI algorithm, many of the typical questions for AI studies are not applicable (N/A).

Sample size used for the test set and the data provenance:
- Test Set (Device Performance): The document refers to "a series of tests" and "bench testing." It does not specify sample sizes (e.g., number of seals tested for leakage, torque, etc.).
- Data Provenance: N/A for country/retrospective/prospective as this refers to engineering and laboratory testing of a product. The testing was performed internally by the manufacturer, Intuitive Surgical, Inc.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For this physical device, "ground truth" is established by engineering specifications, validated performance metrics via testing equipment, and adherence to recognized standards (e.g., ISO, ASTM, FDA guidance). There are no human experts interpreting data to establish a diagnostic "ground truth" in the way one would for an AI algorithm in medical imaging.
Adjudication method for the test set:
- Not Applicable. Test results are quantitative measurements against predefined engineering specifications. There is no human interpretative "adjudication."
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:
- No. This type of study is specifically for AI-assisted diagnostic devices involving human readers. This device is a physical surgical seal.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an AI algorithm. Its performance is evaluated through bench testing and simulated use, not standalone algorithm metrics.
The type of ground truth used:
- Engineering Specifications and Standard Compliance: The "ground truth" for this device's performance is adherence to its design inputs, functional specifications, and relevant industry standards (e.g., ISO 10993 for biocompatibility, ASTM D4169-16 for transit testing). For clinical utility, it's validated in a porcine model to confirm it meets user needs and intended use, but this is a validation against expected clinical function, not a diagnostic ground truth.
The sample size for the training set:
- Not Applicable. This is not an AI algorithm; therefore, there is no "training set."
How the ground truth for the training set was established:
- Not Applicable. As there's no training set for an AI algorithm, this question is irrelevant.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

July 5, 2023

Intuitive Surgical, Inc. Emily Hovick Sr. Regulatory Affairs Specialist 1266 Kifer Road Sunnyvale, California 94086

Re: K231358

Trade/Device Name: Universal Seal (5-12 mm) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ Dated: May 9, 2023 Received: May 10, 2023

Dear Emily Hovick:

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.

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

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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-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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,

Image /page/1/Picture/5 description: The image shows a digital signature. The signature is from Mark Trumbore. The date of the signature is 2023.07.05, and the time is 14:03:36 -04'00'.

Mark Trumbore, Ph.D. Assistant Director THT4A1: Robotically-Assisted Surgical Devices Team DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

Device Name

Universal Seal (5-12 mm)

Indications for Use (Describe)

The da Vinci Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.

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.

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

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510(k) Summary

510(k) Owner: Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale, CA 94086

Contact Person: Emily Hovick Sr. Regulatory Affairs Specialist Phone: 314-359-8534 Email: Emily.hovick@intusurg.com

Date Summary Prepared: May 09, 2023

I. SUBJECT DEVICE

Trade Name: Universal Seal (5-12mm) Common Name: Cannula Seal Classification: Class II, Endoscope and Accessories (21 CFR 876.1500) Product Code: GCJ

PREDICATE DEVICE II.

Intuitive Surgical, Inc, Universal Cannula Seal (5-12 mm), K181395

III. DEVICE DESCRIPTION

IV. INTENDED USE/INDICATION FOR USE

V. TECHNOLOGICAL CHARACTERISTICS

The subject Universal Seal (5-12 mm) is very similar to its predicate device cleared under K181395. It has the same intended use, same indication for use, same fundamental scientific technology, and similar technological characteristics as the predicate device. The modification to the device consists of indirect patient contacting material changes. Results from performance data

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indicate that the Universal Seal (5-12 mm) is substantially equivalent to the predicate Universal Cannula Seal (5-12 mm).

VI. PERFORMANCE DATA

The subject Universal Seal (5-12 mm) underwent a series of tests to evaluate the impact of the modification to the predicate device. Testing was performed with a compatible da Vinci surgical system. Testing included design verification, reliability testing, design validation, biocompatibility, packaging, shelf-life, and transit testing. The successful completion of testing demonstrated that the subject Universal Seal (5-12 mm) design outputs continue to meet design inputs.

Design Verification

Bench testing was performed to verify functional design outputs met the functional design inputs. The design verification in this section addressed the following:

. Leakage
Torque limits
Force limits ●
Reliability ●

Design Validation

Simulated clinical use testing was performed with a porcine model to validate that the product specifications continued to meet the user's needs and intended use.

Biocompatibility

Biocompatibility testing was completed in accordance with the following standards and guidance documents:

FDA Guidance: Use of International Standard ISO-10993, "Biological Evaluation of ● Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process", issued September 2020
ISO 10993-1:2018 Biological evaluation of medical devices

Based on the biological safety assessment and biocompatibility testing, it was determined that the subject device met the requirements of the recognized standards for biocompatibility for its intended clinical use.

Shelf-Life

Shelf-life testing was performed through an accelerated aging study to verify that the product can maintain a shelf-life of two years.

Transit Testing

Transit testing was performed in accordance with ASTM D4169-16, Standard Practice for Performance Testing of Shipping Containers and Systems

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VII. CONCLUSIONS

Based on the intended use, indications for use, technological characteristics, and performance data,
the subject Universal Seal (5-12 mm) is substantially equivalent to the p

IN

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.