THERMOGARD DISPERSIVE ELECTRODES, THERMOGARD PLUS ABC DISPERSIVE ELECTRODES

K140658 · Conmed Corporation · GEI · Jul 10, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K140658
• Device Name: THERMOGARD DISPERSIVE ELECTRODES, THERMOGARD PLUS ABC DISPERSIVE ELECTRODES
• Applicant: Conmed Corporation
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jul 10, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ConMed ThermoGard® and ThermoGard® Plus ABC Dispersive Electrodes are used for the dispersion and return to the electrosurgical generator of therapeutic (RF) energy introduced to the active electrode during electrosurgical procedures.

Device Story

Single-use, non-sterile dispersive electrode; pre-attached cord. Functions as return path for electrosurgical circuit between generator, active electrode, and patient. Designed for use with electrosurgical generators featuring continuity monitors or contact quality monitoring systems. Composed of conductive gel area surrounded by non-conductive border adhesive to ensure skin contact. Used in clinical electrosurgical procedures; operated by surgical staff. Benefits patient by safely returning RF energy, preventing thermal injury at return site.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1:2009. Compliance with AAMI/ANSI ES60601-1:2005/(R)2012 and IEC 60601-2-2 Edition 5.0:2009 verified.

Technological Characteristics

Single-use dispersive electrode with pre-attached cord. Conductive gel with non-conductive adhesive border. Complies with AAMI/ANSI ES60601-1 and IEC 60601-2-2. Biocompatible materials per ISO 10993-1. Compatible with electrosurgical generators using continuity or contact quality monitoring.

Indications for Use

Indicated for use as a return electrode to disperse and return therapeutic RF energy to an electrosurgical generator during electrosurgical procedures. Patient population not specified.

Regulatory Classification

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.

Predicate Devices

• ThermoGard® and ThermoGard® Plus ABC Dispersive Electrodes (K972628)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for CONMED Corporation. The logo consists of a stylized "C" shape on the left, followed by the word "CONMED" in bold, sans-serif font. Below the word "CONMED" is the word "CORPORATION" in a smaller, thinner font. A horizontal line underlines the word "CONMED".

K140658 Page 1 of 4

JUL 1 0 2014

#### 510{k) Summary of Safety and Effectiveness

### ConMed ThermoGard® and ThermoGard® Plus ABC Dispersive Electrodes

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92. ConMed Corporation is hereby submitting the 510(k) Summary for 510(k) number as of March 11, 2014

#### A. Submitter

ConMed Corporation 525 French Road Utica, N.Y. 13502 Registration Number: 1320894

#### B. Company Contact

Sandy LeClair Regulatory Affairs Specialist ConMed Corporation 525 French Road Utica, N.Y. 13502 Phone: [phone] Fax: [phone] Email: [e-mail]

Alternate Contact

Lisa Anderson Regulatory Affairs Manager ConMed Corporation 525 French Road Utica, N.Y. 13502 Phone: [phone] Fax: [phone] Email: [e-mail]

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Image /page/1/Picture/0 description: The image shows the logo for CONMED Corporation. The logo consists of a stylized "C" shape on the left, followed by the word "CONMED" in bold, sans-serif font. Below the word "CONMED" is the word "CORPORATION" in a smaller, sans-serif font. The logo is black and white.

#### C. Device Name

| Trade Name: | The ConMed ThermoGard® and ThermoGard® Plus AB<br>Dispersive Electrodes |
|----------------------|-------------------------------------------------------------------------|
| Common Name: | Dispersive Electrodes |
| Classification Name: | Electrosurgical cutting and coagulation device and<br>accessories |
| Regulation Number: | 21 CFR 878.4400 |
| Class: | II |
| Product Code: | GEI |
| Panel: | General and Plastic Surgery |

#### D. Predicate Device

ThermoGard® and ThermoGard® Plus ABC Dispersive Electrodes ConMed Corporation 510(k) # K972628 Product Code: GEI Regulation Number: 878.4400

#### E. Device Description

The ConMed ThermoGard® and ThermoGard® Plus ABC 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 ThermoGard® and ThermoGard® Plus ABC Dispersive Electrode is designed for use with electrosurgical generators equipped with either continuity monitors or contact quality monitoring systems. The ConMed ThermoGard® and ThermoGard® Plus ABC Dispersive Electrode is composed of a non-conductive border adhesive surrounding the entire conductive gel area to ensure full contact with the patient's skin, and a pre-attached cordset.

#### F. Intended Use of Device

Both the proposed and predicate devices have the same intended use. The ConMed ThermoGard® and ThermoGard® Plus ABC Dispersive Electrode is used for the dispersion and return to the electrosurgical generator of therapeutic energy

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Image /page/2/Picture/0 description: The image shows the logo for CONMED Corporation. The logo consists of a stylized graphic on the left, resembling a curved shape within a square. To the right of the graphic is the word "CONMED" in bold, sans-serif font. Below "CONMED" is the word "CORPORATION" in a smaller, sans-serif font.

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(RF) introduced to the patient at the active electrode during electrosurgical procedures.

#### G. Technological Characteristics

The proposed devices are equivalent to the predicate devices in their technological characteristics and performance. Both are designed for use with electrosurgical generators equipped with either continuity monitors or contact quality monitoring systems.

Both devices are designed to disperse and return therapeutic (RF) energy from the patient back to the electrosurgical generator during electrosurgical procedures.

Both devices demonstrate compliance with applicable sections of AAMI / ANSI ES60601-1:2005/(R) 2012 and C1:2009/(R)2012 A2:2010/(R)2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance and IEC 60601-2-2 Edition 5.0: 2009 Medical electrical equipment -Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories. Materials analysis demonstrates the ConMed ThermoGard® and ThermoGard® Plus ABC Dispersive Electrode materials comply with the requirements of ISO 10993-1:2009 Biological Evaluation of Medical Devices Evaluation and Testing within a Risk Management Process.

The proposed devices differ from the predicates with minor design changes affecting dimensions, construction, and patient contacting materials.

#### H. Non-Clinical Testing

Design testing was performed to verify that none of the changed features would affect equivalence. New patient contacting materials were tested per ISO 10993 and verified to be biocompatible.

#### I. Substantial Equivalence

The differences between the predicate device and the proposed device do not raise any new issues of safety or efficacy. Supporting documentation per this premarket submission confirms that the proposed ConMed ThermoGard® and ThermoGard® Plus ABC Dispersive Electrodes are substantially equivalent in design, manufacturing materials, intended use, and technical characteristics to the

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K140658 Page 4 of 4 Plus ABC Dispersive predicate ConMed ThermoGard and ThermoGard Electrodes.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure with outstretched arms.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 10, 2014

ConMed Corporation Ms. Sandy LeClair Regulatory Affairs Specialist 525 French Road Utica, New York 13502

Re: K140658

Trade/Device Name: Thermogard & Thermogard Plus ABC dispersive electrodes Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: April 15, 2014 Received: April 21, 2014

Dear Ms. LeClair:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Sandy LeClair

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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

## David Krause -S

for

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement befow.

510(k) Number (if known)

K40658

Davice Name ConMed ThermoGard® and ThermoGard® Plus ABC Dispersive Electrodes

Indications for Use (Describe)

The ConMed ThermoGard® and ThermoGard® Plus ABC Dispersive Electrodes are used for the dispersion and return to the electrosurgical generator of therapeutic (RF) energy introduced to the scrive electrode during elecrosurgical procedures.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

Concurrence of Center for Devices and Radiological Health (CDRH) (Signeture)

# Joshua C. Nipper -S

This section applies only to requirements of the Paperwork Reduction Act of 1995.

'DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gether and maintain the data needed and complete and review the collection of Information. Send commonts regarding this burden estimate of ony other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Offica of Chief Information Officer Pagenvork Reduction Act (PRA) Staff PRAStaffanta.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (1/14)

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PSC Publicition Sunties (10 |} +13490