The Intuitive Surgical Seal is Indicated for use in general, abdominal, gynecological, and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments

Device Description

The Intuitive Surgical Seal is assembled with an Intuitive Surgical cannula and used with a previously approved obturator. The assembly is placed over an incision made through the skin, large enough to accept the tip of the trocar. The trocar assembly is then advanced through the remaining layers of tissue. The obturator is then removed leaving the Intuitive Surgical Seal and Intuitive Cannula in place to allow access to the surgical site for endoscopic instruments while maintaining pneumopertoneum.

AI/ML Overview

The provided document is a 510(k) summary for the Intuitive Surgical Seal, a medical device. It describes the device's intended use and includes a summary of performance data. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria, specific study designs, sample sizes, or expert qualifications.

Based on the provided text, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Inflation	The performance and functional testing demonstrated that the Intuitive Surgical Seal is substantially equivalent to its predicate device [Applied Medical Modular Trocar (K932995)].
Leakage	The performance and functional testing demonstrated that the Intuitive Surgical Seal is substantially equivalent to its predicate device [Applied Medical Modular Trocar (K932995)].

Note: The document states that the performance and functional testing "included tests to verify the inflation and leakage as compared to its predicate device." It then concludes that these tests "demonstrated that the Intuitive Surgical Seal is substantially equivalent to its predicate device and it introduces no new safety and effectiveness issues when used as instructed." However, the specific numerical acceptance criteria (e.g., maximum leakage rate, pressure thresholds for inflation) and the actual measured performance values are not provided in this summary. The "reported device performance" is a qualitative statement of substantial equivalence rather than specific quantitative results.

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature of data). It only mentions "performance and functional testing."

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 type of testing described (inflation and leakage) suggests direct physical device testing rather than human expert assessment of a test set.

4. Adjudication method for the test set

This information is not applicable as the testing described is direct physical device performance, not evaluation of a test set requiring adjudication.

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

An MRMC study is not applicable here. The device is a surgical seal, not an AI-assisted diagnostic tool.

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

This concept is not applicable to this type of medical device (surgical seal). The testing described is inherent to the device's physical function.

7. The type of ground truth used

For the performance testing mentioned (inflation and leakage), the "ground truth" would likely be defined by established engineering standards and specifications for surgical trocars/seals, and comparison against the predicate device's known performance characteristics. The document does not explicitly state the type of ground truth, but it implies a direct comparison to the predicate device's performance.

8. The sample size for the training set

This information is not provided and is likely not relevant as 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

This information is not provided and is likely not relevant for the reasons stated in point 8.

Summary

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MAR 1 3 2006

510(k) SUMMARY

510(k) NUMBER: PENDING

SUBMITTED BY: Applied Medical Resources Corporation 22872 Avenida Empresa Rancho Santa Margarita, CA-92688 (949) 713-8000

CONTACT PERSON: Cheryl Blake Vice President, Regulatory Affairs and Quality Systems
DATE OF PREPARATION: January 20, 2006

NAME OF DEVICE: Intuitive Surgical Seal

CLASSIFICATION NAME:Laparoscope, General & Plastic Surgery (21CFR 876.1500)

TRADE NAME:	Intuitve Surgical Seal
PREDICATE DEVICE:	Applied Medical Modular Trocar (K932995)Applied Medical, Rancho Santa Margarita, CA

INTENDED USE: DESCRIPTION/INDICATIONS:

DEVICE DESCRIPTION: The Intuitive Surgical Seal is assembled with an Intuitive Surgical cannula and used with a previously approved obturator. The assembly is placed over an incision made through the skin, large enough to accept the tip of the trocar. The trocar assembly is then advanced through the remaining layers of tissue. The obturator is then removed leaving the Intuitive Surgical Seal and Intuitive Cannula in place to allow access to the surgical site for endoscopic instruments while maintaining pneumopertoneum.

PERFORMANCE DATA SUMMARY: The performance and functional testing of the Intuitive Surgical Seal included tests to verify the inflation and leakage as compared to its predicate device. The performance and functional testing demonstrated that the Intuitive Surgical Seal is substantially equivalent to its predicate device and it introduces no new safety and effectiveness issues when used as instructed.

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Image /page/1/Picture/2 description: The image is a seal for the Department of Health and Human Services, USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. In the center of the seal is an emblem of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans. The eagle is stylized with flowing lines, giving it a sense of movement and dynamism. The overall design is simple and elegant, conveying a sense of authority and trustworthiness.

MAR 1 3 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Applied Medical Resources Corporation c/o Underwriters Laboratories, Inc. Mr. Morten Simon Christensen Staff Engineer & FDA Office Coordinator 455 East Trimble Road San Jose, California 95131-1230

Re: K060534

Trade/Device Name: Intuitive Surgical Seal Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: February 27, 2006 Received: February 28, 2006

Dear Mr. Christensen:

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 sct

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Page 2 - Mr. Morten Simon Christenscn

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. 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), please contact the Office of Compliance at (240) 276-0120. 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,

Mark N. Melk Acting 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): ____________________________________________________________________________________________________________________________________________________

Device Name: Intuitive Surgical Seal

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

el.moll

Division of General, Restorative. and Neurological Devices

KOGOE34 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.