(87 days)
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.
Not Found
This document is a 510(k) premarket notification letter from the FDA regarding the "Blue Sensor SUPtab ECG Electrode." It indicates that the device has been found substantially equivalent to a legally marketed predicate device.
However, the provided text DOES NOT contain specific information about acceptance criteria or a study proving the device meets acceptance criteria.
The document primarily focuses on:
- The FDA's determination of substantial equivalence (K983689).
- The regulatory classification of the device (Class II).
- The general controls provisions of the Act that apply.
- The allowed indications for use (transmitting electrical signals for ECG/vectorcardiogram, for single patient use, designed for resting ECG).
- Contact information for further regulatory advice.
Therefore, I cannot extract the requested information (acceptance criteria, device performance, study details, sample sizes, expert qualifications, etc.) from this document. This kind of detail would typically be found in the 510(k) submission itself, which is not provided here.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with three parallel lines above them.
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
{1}------------------------------------------------
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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
{2}------------------------------------------------
ENCLOSURE NO. 8
1 Page 1 of
510 (k) Number (if known):
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) | |
|---|---|
| (Division Sign-Off) | |
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K983689 |
| Prescription Use (Per 21 CFR 801.109) | X |
|---|---|
| --------------------------------------- | --------------------------------------------------- |
OR
| Over-The-Counter Use | _________________ |
|---|---|
| ---------------------- | ------------------- |
(Optional format 1-2-96)
§ 870.2360 Electrocardiograph electrode.
(a)
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.(b)
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.