BLUE SENSOR, DISPOSABLE ECG ELECTRODES FOR ANAESTHESIA

K020382 · Medicotest A/S · DRX · Jun 28, 2002 · Cardiovascular

Device Facts

• Record ID: K020382
• Device Name: BLUE SENSOR, DISPOSABLE ECG ELECTRODES FOR ANAESTHESIA
• Applicant: Medicotest A/S
• Product Code: DRX · Cardiovascular
• Decision Date: Jun 28, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2360
• Device Class: Class 2

Intended Use

The ECG electrodes is applied to surface of the body to transmit the electrical signal at the body surface to a processor that produce an electrocardiogram or vectorcardiogram. For single patient use only. The electrode is designed for measuring ECG under Anaesthesia.

Device Story

ECG electrode for surface application; transmits body surface electrical signals to external processor for ECG/vectorcardiogram generation. Designed for use during anesthesia. Single-patient use. Physician/clinician-operated in clinical/OR settings. Provides raw signal transmission to monitoring equipment to facilitate cardiac rhythm assessment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Surface ECG electrode; single-patient use; passive signal transmission component. No active electronics, software, or energy source.

Indications for Use

Indicated for patients requiring ECG monitoring during anesthesia. For single patient use only.

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

JUN 2 8 2002

Medicotest, A/S c/o Ms. Emalee G. Murphy Kirkpatrick & Lockhart LLP 1800 Massachusetts Avenue, NW Suite 200 Washington, DC 20036-1221

Re: K020382

Trade Name: ECG Electrode for Anesthesia use Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph Electrode Regulatory Class: Class II (two) Product Code: DRX Dated: May 3, 2002 Received: May 6, 2002

Dear Ms. Murphy:

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.

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Page 2 - Ms. Emalee G. Murphy

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 and additionally 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Donna-Bea Tillman, Ph.D.
Acting Director
Division of Cardiovascular
and Respiratory Devices

and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## K020382

Page of ﻠﺴﻨﺎ 1

K020382 510 (k) Number (if known):

Device Name: ECG Electrode for Anaesthesia use

## Indications For Use:

The ECG electrodes is applied to surface of the body to transmit the electrical signal at the body surface to a processor that produce an electrocardiogram or vectorcardiogram. For single patient use only. The electrode is designed for measuring ECG under Anaesthesia.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|------------------------------------------------------------------------------|---------|
| (Division Sign-Off)<br>Division of Cardiovascular<br>and Respiratory Devices | |
| 510(k) Number | K020382 |

| Prescription Use<br>(Per 21 CFR 801.109) | X |
|------------------------------------------|---|
|------------------------------------------|---|

| OR |
|----|
|----|

| Over-The-Counter Use<br>(Optional format 1-2-96) | |
|--------------------------------------------------|--|
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