(118 days)
Not Found
No
The document describes a standard dispersive electrode for electrosurgery and explicitly states "Mentions AI, DNN, or ML: Not Found".
No
Explanation: The device is described as a "dispersive electrode" used for the "dispersion and return to the electrosurgical generator of therapeutic (RF) energy," not for applying therapeutic energy itself. Its purpose is to complete the electrosurgical circuit, not to directly treat a medical condition.
No
The device is a dispersive electrode used to complete an electrosurgical circuit, not to diagnose medical conditions or diseases.
No
The device description clearly states it is a physical electrode with adhesive, conductive gel, and a pre-attached cord, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used for the "dispersion and return to the electrosurgical generator of therapeutic (RF) energy introduced to the active electrode during electrosurgical procedures." This describes a device used during a medical procedure on a patient, not a device used to examine specimens in vitro (outside of the body).
- Device Description: The description details a "dispersive electrode" that completes an "electrosurgical circuit" with a patient's skin. This further reinforces its use in a surgical setting on a living patient.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in specimens
- Providing information for diagnosis, monitoring, or screening of diseases
Therefore, the ConMed ThermoGard® and ThermoGard® Plus ABC Dispersive Electrodes are medical devices used in electrosurgical procedures, but they do not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
GEI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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: 315-624-3435 Fax: 315-624-3225 Email: sandyleclair@conmed.com
Alternate Contact
Lisa Anderson Regulatory Affairs Manager ConMed Corporation 525 French Road Utica, N.Y. 13502 Phone: 315-624-3371 Fax: 315-624-3225 Email: lisaanderson@conmed.com
1
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
Dispersive Electrodes |
|----------------------|-------------------------------------------------------------------------|
| Common Name: | Dispersive Electrodes |
| Classification Name: | Electrosurgical cutting and coagulation device and
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
2
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.
K140658 Page 3 of ਜੋ
(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
3
K140658 Page 4 of 4 Plus ABC Dispersive predicate ConMed ThermoGard and ThermoGard Electrodes.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4
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
5
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
6
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:
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"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)
Page 1 of 1
PSC Publicition Sunties (10 |} +13490