(162 days)
Esophageal Stethoscope: Monitoring heart and breath sounds.
Esophageal Stethoscope with Electrical Conductors: Monitoring heart and breath sounds, and core temperature.
Disposable Esophageal Stethoscope
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a Disposable Esophageal Stethoscope, dated March 19, 1998. This document does not contain information about acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement for a device's performance evaluation as would be required to answer your request.
The letter simply states that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices for its stated indications for use (monitoring heart and breath sounds, and core temperature for models with electrical conductors). It does not include a performance study summary or the details of how the substantial equivalence was demonstrated in terms of specific performance metrics.
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MAR 1 9 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
John A. Steen, Ph.D. President and CEO Catheter Research, Inc. 6131 West 80th Street Indianapolis, IN 46278
Re: K973839 Disposable Esohageal Stethoscopes Regulatory Class: II (two) Product Code: 74 BTZ Dated: January 23, 1998 Received: January 26, 1998
Dear Dr. Steen:
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 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 reqistration, 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 requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. 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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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, "Misbranding by reference to premarket notification" (21 CFR 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/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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Section #3
Indications for Use
| 510(k) Number: | K973839(to be assigned) |
|---|---|
| Device Name: | Disposable Esophageal Stethoscope |
| Intended Use: | Esophageal Stethoscope: Monitoring heart and breathsounds. |
| Esophageal Stethoscope with Electrical Conductors:Monitoring heart and breath sounds, and core temperature. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
N. Dougls Tiller
(Division Sk Division of Cars and Neurological D 510(k) Numbe
Prescription Use (Per CFR 801.109) OR
Over-the-counter use
§ 868.1920 Esophageal stethoscope with electrical conductors.
(a)
Identification. An esophageal stethoscope with electrical conductors is a device that is inserted into the esophagus to listen to a patient's heart and breath sounds and to monitor electrophysiological signals. The device may also incorporate a thermistor for temperature measurement.(b)
Classification. Class II (performance standards).