ESOPHAGEAL STETHOSCOPE

K982193 · Shore Medical, Inc. · BZT · Sep 1, 1998 · Anesthesiology

Device Facts

• Record ID: K982193
• Device Name: ESOPHAGEAL STETHOSCOPE
• Applicant: Shore Medical, Inc.
• Product Code: BZT · Anesthesiology
• Decision Date: Sep 1, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1920
• Device Class: Class 2

Intended Use

The intended use of the esophageal stethoscope is to listen to heart and breath sounds while a patient is under anesthesia. Additionally, patient temperature can be monitored using the stethoscopes with 400 or 700 series thermistors. The stethoscopes are provided "packaged clean" and are for "single use" only.

Device Story

Esophageal stethoscope; used during anesthesia; enables auscultation of heart and breath sounds; optional integrated 400 or 700 series thermistors for temperature monitoring; single-use; packaged clean; operated by clinicians in surgical or clinical settings; provides auditory feedback to provider; facilitates patient monitoring during anesthesia.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Esophageal stethoscope; includes optional 400 or 700 series thermistors for temperature sensing; single-use; packaged clean.

Indications for Use

Indicated for patients under anesthesia to monitor heart and breath sounds and patient temperature.

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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three heads facing to the right. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" written around it.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

1 1698 SFP

Mr. Mark Richardson Shore Medical, Inc. 2037 Oak Glen Drive Vista, CA 92083

K982193 Re: Esophaqeal Stethoscope Requlatory Class: II (two) Product Code: 73 BZT Dated: Undated Received: August 24, 1998

Dear Mr. Richardson:

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 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 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 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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## Page 2 - Mr. Mark Richardson

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 requlation (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/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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510(k) Number (if known): not assigned

Device Name: Esophageal Stethoscope

Indications for Use:

The intended use of the esophageal stethoscope is to listen to heart and breath sounds while a patient is under anesthesia. Additionally, patient temperature can be monitored using the stethoscopes with 400 or 700 series thermistors. The stethoscopes are provided "packaged clean" and are for "single use" only.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Marla Krame

(Division Sign-C Division of Cardiovas and Neurological Devi 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)