BLUE SENSOR SUPATAB,DISPOSABLE ECG ELECTRODES

K983689 · Medicotest A/S · DRX · Jan 15, 1999 · Cardiovascular

Device Facts

• Record ID: K983689
• Device Name: BLUE SENSOR SUPATAB,DISPOSABLE ECG ELECTRODES
• Applicant: Medicotest A/S
• Product Code: DRX · Cardiovascular
• Decision Date: Jan 15, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2360
• Device Class: Class 2

Intended Use

The ECG electrode is applied to the 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 resting ECG.

Device Story

Blue Sensor SUPAtab is a disposable ECG electrode; applied to body surface to capture electrical signals; transmits signals to external processor for generation of electrocardiogram or vectorcardiogram. Designed for resting ECG applications. Intended for single patient use. Used in clinical settings by healthcare professionals to facilitate cardiac monitoring.

Clinical Evidence

Bench testing only.

Technological Characteristics

Disposable ECG electrode; designed for resting ECG; single patient use; surface-applied sensor for electrical signal transmission.

Indications for Use

Indicated for patients requiring resting electrocardiogram (ECG) or vectorcardiogram monitoring. 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

JAN 1 5 1999

Ms. Emalee G. Murphy McKenna & Cuneo, L.L.P. 1900 K. Street, NW Washington, DC 20006-1108

Re: K983689 Blue Sensor SUPtab ECG Electrode Regulatory Class: II (two) Product Code: DRX Dated: October 16, 1998 Received: October 20, 1998

Dear Ms. Murphy:

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 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). 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 Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. 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 Reqister. 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

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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, 2Misbranding 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,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## ENCLOSURE NO. 8

1 Page 1 of

510 (k) Number (if known):

K983689

Blue Sensor SUPAtab, Disposable ECG electrodes Device Name:

## Indications For Use:

The ECG electrode is applied to the 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 resting ECG.

## 'LEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| | |
| (Division Sign-Off) | |
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K983689 |

| Prescription Use (Per 21 CFR 801.109) | <span style="text-decoration: overline;">X</span> |
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OR

| Over-The-Counter Use | _________________ |
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