These devices are intended to endoscopically transect polyps in the gastrointestinal tract (sessile or perdunctuated) using electrocautery. During the same maneuver the polyp is captured, retrieved and submitted for pathological analysis.

Device Description

This disposable product consists of a handle equipped with a male plug for connection to a standard ESU, a flexible sheath and a cable to which a snare loop fitted with a net is attached distally. Upon resection, the device and scope is removed from the patient and the polyp removed from the net together in a continuous retrograde motion. The Snare II version is disposed after one use. The Snare III version may be reused with the same patient. The device is available with different loop sizes and the sheath/cable lengths to accommodate different polyp sizes and endoscope types.

AI/ML Overview

The provided document is a 510(k) summary for the Nakao Snare II and Nakao Snare III. This type of regulatory submission is for demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific performance criteria through extensive clinical studies.

Therefore, the document does not contain the detailed information requested regarding acceptance criteria, specific device performance metrics, study designs (sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance), or training set details.

Here's what can be inferred and what is explicitly missing:

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

Acceptance Criteria: Not explicitly stated in terms of measurable performance metrics (e.g., success rates, safety profiles, specific dimensional tolerances beyond typical design).
Reported Device Performance: Not explicitly reported as an outcome of a specific study against acceptance criteria.

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

Sample Size (Test Set): Not mentioned.
Data Provenance (Country of Origin, Retrospective/Prospective): Not mentioned.

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

This type of detail is not provided as there is no indication of a clinical validation study using expert ground truth in this document.

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

Not applicable/Not mentioned, as no such test set or adjudication process is described.

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:

No, an MRMC study was not done. This device is a medical instrument (polypectomy snare), not an AI-driven diagnostic or assistive technology for human readers.

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

No, a standalone performance study was not done. This is a physical medical device, not an algorithm.

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

Not applicable/Not mentioned, as no explicit study using ground truth is described. The intended use states "the polyp is captured, retrieved and submitted for pathological analysis," implying pathology as a definitive diagnostic outcome for the resected tissue, but this isn't described as the ground truth for a device performance study.

8. The sample size for the training set:

Not applicable/Not mentioned. There is no mention of a "training set" as this is not an AI/machine learning device.

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

Not applicable/Not mentioned.

Summary from the 510(k) document:

The basis for market clearance is substantial equivalence to a predicate device (K926103 - U. S. Endoscopy Group Inc.). The document states:

"The subject device has the same technological characteristics, is composed of the same type of materials and is of a similar design to the predicate device."

This means that the device's safety and effectiveness were established by arguing its similarity to an already legally marketed device, not by performing new detailed performance studies against specific acceptance criteria. The regulatory approval is based on this comparison, implying that if the predicate device was safe and effective, the substantially equivalent subject device will also be.

Summary

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JUN 1 7 2002

KO20891
Page 1 of 1

510(k) Summary of Safety and Effectiveness for the Nakao Snare II and Nakao Snare III:

Granit Medical Innovations, Inc. 1.) Submitter: 992 Fifth Avenue New York City, NY 10028
Naomi L. Nakao, MD 2). Contact Person:
3.) Summary Preparation Date: March 15, 2002
Snare, Flexible 4.) Classification Name:
Monopolar Polypectomy Snare Net Device 5.) Common Name:
Nakao Snare II and Nakao Snare III 6.) Proprietary Name:
7.) Substantially Equivalent Device:

K926103 - U. S. Endoscopy Group Inc.

8.) Description of Subject Device:
This disposable product consists of a handle equipped with a male plug for connection to a standard ESU, a flexible sheath and a cable to which a snare loop fitted with a net is attached distally. Upon resection, the device and scope is removed from the patient and the polyp removed from the net together in a continuous retrograde motion. The Snare II version is disposed after one use. The Snare III version may be reused with the same patient. The device is available with different loop sizes and the sheath/cable lengths to accommodate different polyp sizes and endoscope types.
9.) Intended Use:
These devices are intended to endoscopically transect polyps in the gastrointestinal tract (sessile or perdunctuated) using electrocautery. During the same maneuver the polyp is captured, retrieved and submitted for pathological analysis.
10.) Technological Characteristics:
The subject device has the same technological characteristics, is composed of the same type of materials and is of a similar design to the predicate device.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three parallel lines forming its wings and body.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 7 2002

Naomi L. Nakao, M.D. President Granit Medical Innovations, Inc. 992 Fifth Avenue NEW YORK CITY NY 10028

Re: K020891

Trade/Device Name: Nakao Snare II and Nakao Snare III Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories

Regulatory Class: II Product Code: 78 FDI Dated: March 15, 2002 Received: March 19, 2002

Dear Dr. Nakao

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 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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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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 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,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K020891
Page 1 of 1

K020891

Nakao Snare II and Nakao Snare III Proprietary Name:

Monopolar Polypectomy Snare Net Device Common Name:

Indication(s) for Use:

These devices are intended to endoscopically transect polyps in the These "devilose" and "internated) using electrocautery. During the gastromitootiful tract (coosn's captured, retrieved and submitted for pathological analysis.

Sarid G. Lynn

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

prescr-iption weker/

Regulation Number and Section

§ 876.4300 Endoscopic electrosurgical unit and accessories.

(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).