CONMED ECG MONITORING ELECTRODES , MODEL 1700 ( INCLUDING 2500), 1750, 2700, 2710, 1800, SERIES

K091856 · Conmed Corporation · DRX · Aug 7, 2009 · Cardiovascular

Device Facts

• Record ID: K091856
• Device Name: CONMED ECG MONITORING ELECTRODES , MODEL 1700 ( INCLUDING 2500), 1750, 2700, 2710, 1800, SERIES
• Applicant: Conmed Corporation
• Product Code: DRX · Cardiovascular
• Decision Date: Aug 7, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2360
• Device Class: Class 2

Intended Use

The ConMed" ECG Monitoring Electrodes are pre-gelled, single patient use, disposable electrocardiographic electrodes for use as an accessory to ECG equipment for long term or short term monitoring and diagnostic procedures with regular or diaphoretic adhesives.

Device Story

ConMed ECG Monitoring Electrodes are pre-gelled, disposable, single-patient-use electrodes. They function as an interface between the patient's skin and ECG monitoring equipment to capture electrical signals for diagnostic or monitoring purposes. Electrodes are applied to the patient's skin by clinical staff in a hospital or clinical setting. The device facilitates the transmission of cardiac electrical activity to the ECG monitor, allowing healthcare providers to visualize heart rhythms and make clinical decisions regarding patient cardiac status. The disposable nature of the electrodes helps prevent cross-contamination between patients.

Clinical Evidence

Bench testing only.

Technological Characteristics

Pre-gelled, disposable, single-patient-use electrocardiographic electrodes. Features regular or diaphoretic adhesives for skin attachment. Passive sensing component for ECG signal acquisition. No electronic or software components.

Indications for Use

Indicated for patients requiring short or long-term ECG monitoring or diagnostic procedures. Used as an accessory to ECG equipment. No specific age or gender contraindications provided.

Regulatory Classification

Identification

An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.

Predicate Devices

• ConMed 2710 CLEARTRACE 2LT Monitoring ECG Electrode (K954388)
• 2700 Cleartrace Radiotranslucent Monitoring ECG Electrode (K944849)
• ECG Electrode (K944655)
• 1800 Monitoring ECG Electrode and 1870 Diaphoretic Monitoring ECG Electrodes (K945836)
• 1700 Monitoring ECG Electrode (K946273)

Submission Summary (Full Text)

{0}------------------------------------------------

K09/856
P 1/2

## 510(k) Summary of Safety and Effectiveness

# ConMed™ ECG Monitoring Electrodes

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

#### A. Submitter

ConMed Corporation 525 French Road Utica, NY 13502 Registration Number: 1320894

AUG 0 7 2009

### B. Company Contact

Sandy Coveleski Regulatory Affairs Specialist ConMed Corporation 525 French Road Utica, NY 13502

Phone: [phone] Fax: [phone] e-mail: [e-mail]

#### C. Device Name

| Trade Name: | ConMed" ECG Monitoring Electrodes |
|------------------------|-----------------------------------|
| Common Name: | Electrocardiograph Electrode |
| CLASSIFICATION NAME: | Cardiovascular Devices |
| Proposed Class/Device: | Class II |
| Product Code: | DRX |
| Regulation Number: | 21 CFR 870.2360 |
| Panel: | 870 Cardiovascular |

{1}------------------------------------------------

K09/856
P2/2

#### D. Predicate Devices

ConMed 2710 CLEARTRACE 2LT Monitoring ECG Electrode ConMed Corporation 510(k) # K954388

2700 Cleartrace Radiotranslucent Monitoring ECG Electrode ConMed Andover Medical, Inc 510(k) # K944849

ECG Electrode ConMed Andover Medical, Inc 510(k) # K944655

1800 Monitoring ECG Electrode And 1870 Diaphoretic Monitoring ECG Electrodes ConMed Andover Medical, Inc 510(k) # K945836

1700 Monitoring ECG Electrode ConMed Andover Medical, Inc 510(k) # K946273

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002

AUG 0 7 2009

ConMed Corporation c/o Ms. Sandra Coveleski Regulatory Affairs Specialist 525 French Road Utica, NY 13502

Re: K091856

> Trade/Device Name: ConMed ECG Monitoring Electrode Regulatory Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph Electrode Regulatory Class: Class II (Two) Product Code: DRX Dated: July 14, 2009 Received: July 15, 2009

Dear Ms. Coveleski:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

{3}------------------------------------------------

## Page 2 - Ms. Sandra Coveleski

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

una R. Vachner

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

K091856

## Indications For Use

K691856 510(k) Number (if known)

ConMed" ECG Monitoring Electrodes Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for use:

The ConMed" ECG Monitoring Electrodes are pre-gelled, single patient use, disposable electrocardiographic electrodes for use as an accessory to ECG equipment for long term or short term monitoring and diagnostic procedures with regular or diaphoretic adhesives.

Prescription Use X (Part 21 CFR 801 Subpart D) and/or

Over-the-counter Use (Part 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)

Nina R. Larios
(Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number Ko 9185