ECG ELECTRODE (VARIOUS)

K991105 · Conmedcorp · DRX · Nov 26, 1999 · Cardiovascular

Device Facts

• Record ID: K991105
• Device Name: ECG ELECTRODE (VARIOUS)
• Applicant: Conmedcorp
• Product Code: DRX · Cardiovascular
• Decision Date: Nov 26, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2360
• Device Class: Class 2

Indications for Use

An electrical conductor applied to a patient's skin to transmit electrical signals at the body surface to a monitor for diagnosis of ailments by health professionals. The electrodes, without a lead wire or cable connected, are MR safe and not MRI compatible as a stand alone device.

Device Story

Device is an electrical conductor (ECG electrode) applied to patient skin; transmits electrical signals from body surface to external monitor for diagnostic use by health professionals. Device is passive; does not include lead wires or cables. Electrodes are MR safe but not MRI compatible as standalone units. Used in clinical settings for cardiac monitoring.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Passive electrical conductor for ECG signal transmission. MR safe (without lead wires/cables). Not MRI compatible. No active electronic components or software.

Indications for Use

Indicated for patients requiring ECG signal transmission from the skin surface to a monitor for diagnostic purposes by health professionals.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 26 1999

Mr. Ira D. Duesler, Jr. Quality Engineer ConMed Corporation 310 Broad Street Utica, NY 13501

Re: K991105 ECG Electrode (various) Requlatory Class: II (two) Product Code: DRX Dated: October 21, 1999 Received: October 25, 1999

Dear Mr. Duesler:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Ira D. Duesler, Jr.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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| 510(k) Number (if known): | K991105/S1 |
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Device Name:

Indications for Use:

An electrical conductor applied to a patient's skin to transmit electrical signals at the body surface to a monitor for diagnosis of ailments by health professionals. The electrodes, without a lead wire or cable connected, are MR safe and not MRI compatible as a stand alone device.

(Revised October 21, 1999)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

V. Carter Welch

(Division Sign-Off)
Division of Cardiovascular, Respiratory.
and Neurological Devices K991105
510(k) Number

Prescription Use (Per 21CFR 801.109

OR

Over-The-Counter