The ConMed Deuce Polypectomy Snare is a sterile, single patient use, disposable device used in conjunction with an electrosurgical generator for the delivery of electrosurgical current through a flexible endoscope to a stainless steel wire snare at the operative site for endoscopic resection of a polypoid lesion.

The snare consists of a non-detachable handle with a sliding finger ring mechanism for retracting/extending the distal snare loop. An external sheath covers the snare loop cable and is attached to the distal portion of the snare handle. Within the handle, an electrode completes the circuit between the electrosurgical unit and the snare loop.

The polypectomy snares are manufactured in 230cm sheath lengths with a 2.3mm outer diameter in a variety of different loop configurations.

AI/ML Overview

The provided document describes the 510(k) premarket notification for the ConMed Deuce Polypectomy Snares. It states that "Bench testing has been performed to demonstrate equivalence of the ConMed Polypectomy Snares to their predicate devices. All testing passed the predetermined performance specifications." However, it does not provide details on the specific acceptance criteria, reported performance, sample sizes, ground truth establishment, or any advanced study designs such as MRMC comparative effectiveness or standalone performance studies.

Therefore, most of the requested information cannot be extracted from this document.

Here's a summary of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Predetermined performance specifications for equivalence to predicate devices.	All testing passed the predetermined performance specifications.

2. Sample size used for the test set and the data provenance: Not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned. (Bench testing typically does not involve expert ground truth in the same way clinical studies do.)

4. Adjudication method for the test set: Not applicable for bench testing as 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, this is a medical device (polypectomy snare), not an AI diagnostic tool. An MRMC study is not relevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is hardware. "Bench testing" can be considered a form of standalone performance measurement for the device itself.

7. The type of ground truth used: For bench testing, the "ground truth" would be the engineering specifications and performance standards of the predicate devices or general industry standards for such devices. The document implies comparison to predicate devices as the basis for equivalence.

8. The sample size for the training set: Not applicable, as this is a hardware device; there is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established: Not applicable.

Summary

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ConMed Endoscopic Technologies Deuce Polypectomy Snares

K091355
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Image /page/0/Picture/2 description: The image shows the logo for CONMED Endoscopic Technologies. The logo features a stylized swoosh shape on the left, followed by the word "CONMED" in bold, sans-serif font. Below the word "CONMED" is the phrase "ENDOSCOPIC TECHNOLOGIES" in a smaller font size.

JUL 2 2 2009

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510(k) Summary of Safety and Effectiveness

Sponsor Name: ConMed Endoscopic Technologies, Inc. One Executive Drive, Suite 101 Chelmsford, MA 01824 Telephone: 978-934-7832 Fax: 978-934-7854 Contact Individual: Karen Provencher Sr. Regulatory Affairs Specialist

ConMed Deuce Polypectomy Snare 2. Device Name:
Identification of Predicate or Legally Marketed Device: 3.

ConMed Beamer™ Snare Probe cleared under K081580 on June 20, 2008

Cook Sonnet™ Polypectomy Snare cleared under K050294 on March 31, 2005

Medi-Globe Polypectomy Snare cleared under K943935 on May 26, 1995 Polypectomy Snares cleared under K820430 on April 8, 1982

Device Description: 4.

The polypectomy snares are manufactured in 230cm sheath lengths with a 2.3mm outer diameter in a variety of different loop configurations.

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ConMed Endoscopic Technologies Deuce Polypectomy Snares

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5. Intended Use:

The ConMed Polypectorny Snares may be used in conjunction with an electrosurgical generator for endoscopic resection of a polypoid lesion.

Comparison of Technological Characteristics: 6.

The ConMed Polypectomy Snares are substantially equivalent to the predicate devices both in intended use, technological characteristics and materials.

Performance Testing: 7.

Bench testing has been performed to demonstrate equivalence of the ConMed Polypectorny Snares to their predicate devices. All testing passed the predetermined performance specifications.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure with three wing-like shapes extending from its body.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 222009

Ms. Karen Provencher Senior Regulatory Affairs Specialist ConMed Endoscopic Technologies One Executive Drive, Suite 101 CHELMSFORD MA 01824

Re: K091355

Trade/Device Name: ConMed Deuce Polypectomy Snares Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: FDI Dated: May 7, 2009 Received: May 8, 2009

Dear Ms. Provencher:

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. Iisting 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); medical device reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jarine M. Morris

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ConMed Endoscopic Technologies Deuce Polypactamy Snares

Image /page/4/Picture/1 description: The image shows the logo for CONMED Endoscopic Technologies. The logo features a stylized wave-like shape on the left, followed by the word "CONMED" in bold, sans-serif font. Below "CONMED" are the words "ENDOSCOPIC TECHNOLOGIES" in a smaller font size.

INDICATION FOR USE ்.

510(k) Number (if known) _K 09 1355

Device Name: ConMed Deuce Polypectomy Snare

Indication for Use:

May be used in conjunction with an electrosurgical generator for endoscopic resection of a polypoid lesion.

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

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY) Concurrence of CDRH, Office of Device Evaluation (ODE)

Lori White

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

510(k) Number

Page 1 of 1

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).