ESOPHAGEAL STETHOSCOPE

K092716 · Truer Medical, Inc. · BZT · Sep 17, 2009 · Anesthesiology

Device Facts

• Record ID: K092716
• Device Name: ESOPHAGEAL STETHOSCOPE
• Applicant: Truer Medical, Inc.
• Product Code: BZT · Anesthesiology
• Decision Date: Sep 17, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1920
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

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 stathoscopes are provided "packaged clean" and are for "single use" only.

Device Story

Esophageal stethoscope; used during anesthesia to monitor heart and breath sounds; includes integrated 400 or 700 series thermistors for temperature monitoring; single-use device; provided packaged clean; operated by clinicians in surgical or clinical settings; provides acoustic monitoring and temperature data to assist in patient status assessment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Esophageal stethoscope with integrated 400 or 700 series thermistors for temperature sensing; single-use; packaged clean; non-sterile.

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)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is black. The background is white.

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 symbol that resembles three abstract shapes stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Truer Medical Incorporated C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street North West Buffalo, Minnesota 53313

Re: K092716

> Trade/Device Name: Esophageal Stethoscope Regulation Number: 21 CFR 868.1920 Regulation Name: Esophageal Stethoscope with Electrical Conductors Regulatory Class: II Product Code: BZT Dated: September 2, 2009 Received: September 3, 2009

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA), 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{1}------------------------------------------------

## Page 2 - Mr. Job

Enclosure

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); fabeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

for

Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

{2}------------------------------------------------

## Indications For Use Statement

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 stathoscopes are provided "packaged clean" and are for "single use" only.

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

Concurrences of GDRH, Office of Devise Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

...
... ... ... ... ... ... ... ... ... ... ... ..............................................................................................................................

(Optional Format 1-2-86)

L. Schulten

Section 3-2

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

4092716 510(k) Number: