DISPOSABLE ESOPHAGEAL STETHOSCOPE

K973839 · Catheter Research, Inc. · BZT · Mar 19, 1998 · Anesthesiology

Device Facts

• Record ID: K973839
• Device Name: DISPOSABLE ESOPHAGEAL STETHOSCOPE
• Applicant: Catheter Research, Inc.
• Product Code: BZT · Anesthesiology
• Decision Date: Mar 19, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1920
• Device Class: Class 2

Indications for Use

Esophageal Stethoscope: Monitoring heart and breath sounds. Esophageal Stethoscope with Electrical Conductors: Monitoring heart and breath sounds, and core temperature.

Device Story

Disposable esophageal stethoscope; used for monitoring heart and breath sounds; models with electrical conductors also monitor core temperature. Device inserted into esophagus; used in clinical settings (e.g., OR) by physicians or trained personnel. Provides acoustic monitoring of cardiac/respiratory sounds; electrical temperature sensing. Output used by clinicians to assess patient status during procedures. Benefits include continuous, non-invasive monitoring of vital signs.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Disposable esophageal stethoscope; includes models with electrical conductors for temperature sensing. Form factor designed for esophageal insertion. Materials and sterilization methods not specified.

Indications for Use

Indicated for monitoring heart and breath sounds, and core temperature (for models with electrical conductors) in patients requiring esophageal monitoring.

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [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" (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 [phone] or [phone] 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<br>(to be assigned) |
|----------------|-----------------------------------------------------------------------------------------------------------------|
| Device Name: | Disposable Esophageal Stethoscope |
| Intended Use: | Esophageal Stethoscope: Monitoring heart and breath<br>sounds. |
| | Esophageal Stethoscope with Electrical Conductors:<br>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