The EC Single Use, Polypectomy Snare is a disposable sterile device comprised of a snare loop, a snare tube, a mandrel, a slider and a plug. An electrical connection enables the snare loop to be connected to an electrosurgical generator. Tissue is resected by a combination of mechanical handling of the loop and electrosurgical current.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (EC Single Use, Polypectomy Snare) and does not contain the detailed information typically associated with acceptance criteria and a comprehensive study report for a novel AI/ML device.

Here's an analysis based on the provided text, highlighting what is present and what is missing:

Missing Information:
The document does not contain specific acceptance criteria or a study designed to "prove the device meets acceptance criteria" in the way one would expect for a new AI/ML product. This is a 510(k) for a relatively low-risk medical device (a polypectomy snare) which relies on substantial equivalence to an existing predicate device rather than novel performance claims from AI/ML. Therefore, many of the requested items related to AI/ML device validation are not applicable or not present in this type of submission.

Analysis based on available information:

A table of acceptance criteria and the reported device performance:
- Not Applicable/Not Present. The document states, "Results of the various tests indicate that the EC Single Use, Polypectomy Snare functions as intended." It does not provide a table of quantitative acceptance criteria typical of AI/ML device performance metrics (e.g., sensitivity, specificity, AUC) or the actual numerical results against such criteria. The "performance testing" mentioned is likely related to bench testing to ensure mechanical and electrical functionality, not clinical performance for diagnostic accuracy.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Present. No information about a "test set" in the context of AI/ML validation (e.g., patient data, images) is provided. This is a hardware device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable/Not Present. Ground truth establishment by experts is not relevant for this type of device submission as there's no diagnostic AI component.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable/Not Present. Adjudication methods are not relevant for this device.
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:
- Not Applicable/Not Present. This device is a surgical tool, not an AI-assisted diagnostic system.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable/Not Present. This is a physical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable/Not Present. Ground truth in the context of AI/ML is not relevant here. The "ground truth" for a polypectomy snare's performance would be its ability to safely and effectively resect tissue, verified through engineering tests and potentially animal or cadaver studies, none of which are detailed here in terms of "ground truth" establishment.
The sample size for the training set:
- Not Applicable/Not Present. There is no AI/ML component, so no training set is used.
How the ground truth for the training set was established:
- Not Applicable/Not Present. There is no AI/ML component, so no training set or its ground truth establishment is mentioned.

Summary of what is present:

Device Type: EC Single Use, Polypectomy Snare (a flexible snare for endoscopic tissue resection).
Intended Use: To endoscopically resect tissue from within the GI tract.
Predicate Device: Olympus SD Series Snares - K955650.
Technological Characteristics: Stated to be "virtually identical" to the predicate device.
Performance Testing: Mentioned that "Results of the various tests indicate that the EC Single Use, Polypectomy Snare functions as intended." This implies internal engineering and functional testing were conducted, but the specifics and results are not provided in this summary.
Conclusion: The device is substantially equivalent to its predicate device without raising new safety and/or effectiveness issues.

In conclusion, this 510(k) summary focuses on demonstrating substantial equivalence to a predicate device for a physical medical instrument, rather than providing the detailed AI/ML performance metrics and study design requested. The questions asked are highly relevant for AI/ML-driven medical devices, but the provided document is for a traditional surgical accessory.

Summary

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page 1 of 2

510(K) Summary

[as required by section 807.92(c)]

EC Single Use, Polypectomy Snare

510(k) Number K /23223

JAN 1 0 2013

Date Prepared:

October 10, 2012

Applicant's Name:

EndoChoice, Inc. 11800 Wills Road, Suite 100 Alpharetta, GA 30009 Phone: 678-534-6021 Fax: 770-962-6981

Contact Person:

Shoshana (Shosh) Friedman Regulatory Consultant Phone: (704) 899-0092 (704) 899-0098 FAX: shosh@pushmed.com

Trade Name:

EC Single Use, Polypectomy Snare

Classification Name:

Flexible Snare

Classification:

FDA has classified Flexible Snare devices for as class II devices (product code FDI) and they are reviewed by the Gastroenterology/Urology.

`Predicate Devices:

Olympus SD Series Snares - K955650

Device Description:

Intended Use:

The EC Single Use, Polypectomy Snare is indicated to endoscopically resect tissue from within the GI tract.

EC Single Use, Polypectomy Snare - Page 5-2

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Technological Characteristics:

The technological characteristics of the EC Single Use, Polypectomy Snare are virtually identical to those of the Olympus SD Series Snares cleared under K955650.

Performance Testing:

Results of the various tests indicate that the EC Single Use, Polypectomy Snare functions as intended.

Conclusion:

EndoChoice Inc. believes that, based on the information provided in this submission, EC Single Use, Polypectomy Snare is substantially equivalent to its predicate device without raising any new safety and/or effectiveness issue.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 10, 2013

EndoChoice, Inc. % Ms. Shoshana Friedman Regulatory Consultant Push-Med LLC 1914 J.N. Pease Place CHARLOTTE NC 28262

Re: K123223

Trade/Device Name: EC Single Use, Polypectomy Snare Regulation Number: 21 CFR§ 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: FDI Dated: December 10, 2012 Received: December 11, 2012

Dear Ms. Friedman:

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. 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.

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Page 2 – Ms. Shoshana Friedman

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 (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Herbert B. Lerner

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K /a3223

EC Single Use, Polypectomy Snare Device Name:

Indications for Use:

The EC Single Use, Polypectomy Snare is indicated to endoscopically resect tissue from within the GI tract.

Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert P. Lerner

Gastro-Renal, and

EC Single Use, Polypectomy Snare - Page 4-2

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).