The PERIscope Optical Dissector is intended for dissection of connective tissue and the creation of an operative cavity in the extraperitoneal spaces and subcutaneous areas. The instrument has application in various general surgical procedures, such as laparoscopic hernia repair.

Device Description

The PERIscope Optical Dissector consists of a handle, a scope retainer clip, a cannula and a dissecting tip. The dissecting tip dissects tissue and creates a cavity that allows instrument passage. The dissecting tip allows visualization during insertion, tunneling, and dissection. The device is designed to be used with a trocar. The instrument is compatible with a 0° rigid endoscope that has a maximum diameter of 5.5 mm and is 290 mm to 300 mm in length.

AI/ML Overview

This document provides limited information regarding acceptance criteria and studies. Based on the provided text, here’s a breakdown of the available information:

No specific acceptance criteria: The document does not explicitly state quantitative acceptance criteria for device performance (e.g., minimum dissection depth, maximum tissue damage).
No detailed study results: The document mentions "Preclinical testing" and "Animal testing" but does not provide specific performance data, statistical results, or a comparison table against any predefined criteria.

However, I can extract information related to the general performance assessment:

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

Acceptance Criteria	Reported Device Performance
No explicit criteria mentioned in the document.	Animal testing demonstrated satisfactory performance according to the requirements for an Optical Dissector during laparoscopic surgical procedures.

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

Sample size: Not specified. The document only mentions "Animal testing."
Data provenance: Not specified beyond "Animal testing." It does not mention country of origin, nor whether the study 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. The document does not describe a process for establishing ground truth using experts.

4. Adjudication method for the test set

This information is not provided. 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

This information is not provided. The PERIscope Optical Dissector is a surgical instrument, not an AI-assisted diagnostic device, so an MRMC study with human readers improving with AI assistance would not be applicable.

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

This information is not provided. The PERIscope Optical Dissector is a physical surgical instrument, not an algorithm. Standalone algorithm performance is not applicable.

7. The type of ground truth used

The document implies that the ground truth for performance was established by observing "satisfactory performance according to the requirements for an Optical Dissector during laparoscopic surgical procedures" in animal models. This suggests a functional/procedural ground truth based on the successful execution of intended surgical tasks. It is not explicitly stated if this involved pathology, expert consensus on outcomes, or other specific metrics.

8. The sample size for the training set

This information is not provided, and the concept of a "training set" typically applies to machine learning algorithms, which is not relevant for this device.

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

This information is not provided, as it is not applicable to the type of device described.

Summary

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PERIscope™ 510(k) Summary of Safety and Effectiveness

JAN 2 5 2002

Company:

Ethicon Endo-Surgery, Inc. 4545 Creek Rd. Cincinnati, OH 45242

Contact:

Name: Doug Kentz Title: Regulatory Affairs Associate II

Date Prepared:

October 26, 2001

Name of Device:

Trade Name: PERIscope Optical Dissector Classification Name: Laparoscope, General and Plastic Surgery

Predicate Device:

Cardiovations™ ClearGlide™ Optical Vessel Dissector, cleared under K973139 on November 13, 1997.

Device Description:

Intended Use:

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Technological Characteristics:

The PERIscope Optical Dissector is similar to the predicate device with respect to design and intended use. Both devices are also sterile, single patient use devices.

Performance Data

Preclinical testing was performed to ensure the device performs as intended when used according to the instructions for use. Animal testing demonstrated satisfactory according to the mourblems for asso a Dissector during laparoscopic surgical procedures.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. The text is written in all capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 5 2002

Mr. Doug Kentz Regulatory Affairs Associate II Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242

Re: K013576

Trade/Device Name: PERIscope Optical Dissector Regulation Number: 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: October 26, 2001 Received: October 29, 2001

Dear Mr. Kentz:

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 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 - Mr. Doug Kentz

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 V. Milliman

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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Page of of

510(k) Number (if known): KO1 357 b

Device Name: PERIscope Optical Dissector

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

for Mark A. Milliken
(Division Sign-Off)

Division of General, Restorative and Neurological Devices

510(k) Number K013576

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.