CONMED® Surefit™ . Dual Dispersive Electrodes are designed for use with only those electrosurgical generators equipped with contact quality monitoring systems (i.e. REM™, ARM™, and NESSY, ™etc.) during electrosurgery and provides a path for, RF energy produced at the active electrode to return to the generator. The Surefit™ Dual Dispersive Electrode is for use with all patient populations providing there is sufficient surface area to ensure full contact of the electrode with the patient's skin.

Device Description

The CONMED® Surefit™ Dual Dispersive Electrode is a single use, non-sterile dispersive electrode with a pre-attached cord. The purpose of the return electrode is to complete the electrosurgical circuit between the generator, the active electrode, and the patient. The CONMED® Surefit™ Dual Dispersive Electrode is to be used on any patient where full skin contact and a suitable placement site can be obtained. The surface of the conductive area is covered with a soft, conformable hydro-gel conductive adhesive. The pad also has a non-conductive border adhesive surrounding the entire conductive area to isolated the conductive area from surgical fluids.

AI/ML Overview

The provided document is a 510(k) summary for the CONMED® Surefit™ Dual Dispersive Electrode. It describes the device, its intended use, and indicates that its technological characteristics are identical to a predicate device (K100047). The document refers to "Performance Testing" in section K, stating that specific testing performed was in conformance with the requirements of IEC 60601-2-2:2009 Edition 5.0, ISO 10993-5:1999, and ISO 10993-10:2002/Amd 1:2006.

However, the document does not describe acceptance criteria or the specific results of a study that proves the device meets those criteria. It only mentions the standards followed for performance testing and biocompatibility.

Therefore, many of the requested details cannot be extracted from this document, as they are not present.

Here's a breakdown of what can be inferred or what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: Not explicitly stated in terms of specific thresholds or pass/fail conditions for device performance. The document only lists the standards followed (IEC 60601-2-2, ISO 10993-5, ISO 10993-10). These standards contain general requirements and test methods for electrosurgical equipment and biological evaluation of medical devices, which would implicitly define acceptance criteria (e.g., no excessive heating, no cytotoxicity, no irritation). However, the specific "acceptance criteria" for the CONMED® Surefit™ Dual Dispersive Electrode as a device are not detailed in this summary.
Reported Device Performance: Not reported. The document states that testing was "in conformance with the requirements" of the listed standards, implying successful performance, but it does not provide any quantitative or qualitative results of these tests.

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

Not explicitly stated. The document refers to "specific testing performed" but does not give sample sizes for any tests.
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 applicable/Not mentioned. This document describes the testing of a medical device (electrode), not an AI algorithm or diagnostic tool where expert ground truth would typically be established. The "ground truth" for this device would be its physical and electrical performance against established standards.

4. Adjudication method for the test set

Not applicable/Not mentioned. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of data by multiple readers. This is not a clinical study of that nature described in this summary.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

No, this is not indicated. MRMC studies are relevant for diagnostic or AI-assisted interpretation, which is not the subject of this 510(k) summary.

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

Not applicable. This is a physical medical device (electrode), not an algorithm.

7. The type of ground truth used

For a device like this, the "ground truth" would be objective measurements against engineering specifications and international standards (e.g., electrical impedance, temperature rise, biocompatibility test results). The document states testing was "in conformance with the requirements of the following standards" (IEC 60601-2-2, ISO 10993-5, ISO 10993-10). The "ground truth" is therefore implicitly defined by the pass/fail criteria within these standards.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model that requires a training set.

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

Not applicable, for the same reason as above.

In summary, this 510(k) document is a regulatory submission for a medical device that details its equivalence to a predicate device and adherence to relevant standards for safety and performance (biocompatibility and electrical safety). It does not provide a detailed "study that proves the device meets the acceptance criteria" with specific performance metrics and sample sizes, as would be expected for a complex diagnostic AI device. Most of the requested information pertains to clinical or AI algorithm validation studies, which are not described here.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for CONMED Electrosurgery. The logo features a stylized crescent shape on the left, followed by the word "CONMED" in bold, sans-serif font. Below "CONMED" is the word "ELECTROSURGERY" in a smaller, sans-serif font, underlined by a thin line.

< 120322 AGE I OF 2

JUN 1 2 2012

510k Summary of Safety and Effectiveness

CONMED® Surefit™ Dual Dispersive Electrode

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92. ConMed Electrosurgery is hereby submitting the 510(s) Summary of Safety and Effectiveness for the 510(k) Number _______________________________________________________________________________________________________________________________

A. Submitter

ConMed Electrosurgery 14603 E. Fremont Ave. Centennial, Colorado 80112

B. Company Contact

Shawn Riedel Vice President, Quality Assurance and Regulatory Affairs 14603 E. Fremont Ave. Centennial, Colorado 80112

Phone: 303-269-8224 · Fax: 303-699-9854 e-mail: shawnriedel@conmed.com

C. Device Name

Trade Name:	CONMED® Surefit™ Dual Dispersive Electrode
Common Name:	Electrosurgical unit and accessories
Classification Name:	Electrosurgical Cutting and Coagulation Device and accessories
Regulation Number:	21 CFR 878.4400 Class II 79 GEI
Panel:	General and Plastic Surgery

D. Predicate Device Name

CONMED® Surefit™ Dual Dispersive Electrode ConMed Electrosurgery 510(k) K100047

E. Device Description

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contact and a suitable placement site can be obtained. Use of this product for unintended applications could lead to an unsafe condition.

The surface of the conductive area is covered with a soft, conformable hydro-gel conductive adhesive. The pad also has a non-conductive border adhesive surrounding the entire conductive area to isolated the conductive area from surgical fluids.

F. Intended Use

The CONMED® Surefit™ Dual Dispersive Electrode is intended for use in surgical procedures in which Electrosurgery equipment with contact quality monitoring system is used.

G. İndications for Use

CONMED® Surefit™ Dual Dispersive Electrodes are designed for use with only those electrosurgical generators equipped with contact quality monitoring systems (i.e. REM™, ARM™, and NESSY, ™etc.) during electrosurgery and provides a path for, RF energy produced at the active electrode to return to the generator. The CONMED® Surefit™ Dual Dispersive Electrode is for use with all patient populations providing there is sufficient surface area to ensure full contact of the electrode with the patient's skin

H. Technological Characteristics

The technological characteristics of the proposed device are identical to the predicate device.

-Safety Information

Questions of safety and effectiveness are the same for this device as they are for the predicated devices and other patient return electrodes on the market. There are no new technologies incorporated into the device.

J. Biocompatibility

The biological safety of selected components of the CONMED® Surefit ™ Dual Dispersive Electrode has been assured through the selection of materials which demonstrate appropriate levels of biocompatibility. These were selected on the basis of Part 1 of ISO 10993-1, "Biological Evaluation of Medical Devices."

K. Performance Testing

Where applicable, specific testing performed was in conformance with the requirements of the following standards:

IEC 60601-2-2:2009 Edition 5.0 2009-02, Medical Electrical Equipment Part 2-2 ISO 10993-5: 1999 Biological Evaluation of Medical Devices - Part 5 Tests for cytotoxicity, in vitro methods

ISO 10993-10: 2002/Amd 1:2006 Biological Evaluation of Medical Devices – Tests for Irritation and delayed-type hypersensitivity

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

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

JUN 1 2 2012

Conmed Corporation % Mr. Shawn Riedel VP, Quality Assurance and Regulatory Affairs 14603 East Fremont Avenue Centennial, Colorado 80112

Re: K120322

Trade Name: CONMED® Surefit™ Dual Dispersive Electrode Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI, JOS Dated: May 22, 2012 Received: May 25, 2012

Dear Mr. Riedel:

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. 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

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Page 2 -- Mr. Shawn Riedel

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/CDRH0ffices/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,
Mark N. Milliman

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative 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: CONMED® Surefit™ Dual Dispersive Electrode

Indications for Use:

Prescription Use × (Part 21 CFR 801 Subpart D)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

(Division Sign-Off) Division of Surgical, Ofthopedic, and Restorative Devices

Page of

510(k) Number K120322

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.