LIFESOUND ESOPHAGEAL STETHOSCOPE

K062020 · Novamed, LLC · BZT · Sep 5, 2006 · Anesthesiology

Device Facts

• Record ID: K062020
• Device Name: LIFESOUND ESOPHAGEAL STETHOSCOPE
• Applicant: Novamed, LLC
• Product Code: BZT · Anesthesiology
• Decision Date: Sep 5, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1920
• Device Class: Class 2

Intended Use

For use as an esophageal stethoscope to listen to patient heart and breathe sounds while a patient is under anesthesia or sedation. Optionally it may be used as a temperature sensor to monitor patient temperature. The electrical conductors are YSI 400 or 700 series compatible. They can be provided "clean, non-sterile" or "sterile".

Device Story

Lifesound esophageal stethoscope is a long tube with distal side-wall and tip openings covered by a non-inflatable cuff to prevent secretion entry. Device functions as an acoustic conduit for heart and breath sounds; proximal end features a standard luer fitting for connection to earpieces or electronic stethoscopes. Optional integrated temperature sensor with internal wiring exits the proximal end for connection to standard YSI 400 or 700 series temperature monitors. Used in hospitals or sub-acute care settings by clinicians for patients under anesthesia or sedation. Provides real-time acoustic monitoring and temperature data to assist clinical decision-making during procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Device consists of a PVC tube with a non-inflatable cuff. Features a proximal luer fitting for acoustic output and electrical connectors for temperature monitoring. Compatible with YSI 400 or 700 series temperature monitors. Available in various lengths and diameters; provided clean, non-sterile, or sterile.

Indications for Use

Indicated for use as an esophageal stethoscope to monitor heart and breath sounds in patients under anesthesia or sedation. Optionally used as a temperature sensor. Compatible with YSI 400 or 700 series monitors.

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.

Predicate Devices

• Biomedical Concepts (NovaMed) (K864858)
• Shore Medical (K982193)

Reference Devices

• Lifesound electronic stethoscope (K844804)

Submission Summary (Full Text)

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

062020

### Non-Confidential Summary of Safety and Effectiveness

Page 1 of 2 29-Aug-06

| NovaMed LLC<br>4 Nursery Lane<br>Rye, NY 10580 | Tel - 914-967-3500<br>Fax - 914-967-3209 | | SEP - 5 2000 |
|------------------------------------------------|--------------------------------------------------------------------|--|--------------|
| Official Contact: | Peter Derrico - President | | |
| Proprietary or Trade Name: | Lifesound esophageal stethoscope and temperature sensor | | |
| Common/Usual Name: | Stethoscope, Esophageal with electrical conductors | | |
| Classification Name: | Stethoscope, Esophageal with electrical connectors | | |
| Device: | Lifesound esophageal stethoscope | | |
| Predicate Devices: | Biomedical Concepts (NovaMed) - K864858<br>Shore Medical – K982193 | | |
| Device Description: | | | |

The NovaMed esophageal stethoscopes are long tubes which at the distal end have openings in the side wall and tip end. These openings are covered by a thin non-inflatable cuff to prevent secretions from entering in the distal end.

.

A temperature sensor or electrical conductor can be placed inside the distal end with connecting wires running internally and exiting the proximal end of the stethoscope. The proximal end is fitted with a standard slip fit luer for connection to any standard earpiece or to the Lifesound electronic stethoscope (K844804). The insulated temperature sensor wires are terminated with standard connectors for fitting to standard cables which connect to the temperature monitor. They are available is various lengths, diameters (sizes), with or without temperature, and packaged clean, non-sterile and sterile.

| Indications for Use: | |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Indicated Use -- | For use as an esophageal stethoscope to listen to patient<br>heart and breathe sounds while a patient is under anesthesia or<br>sedation. |
| | Optionally it may be used as a temperature sensor to monitor<br>patient temperature. |
| | The electrical conductors are YSI 400 or 700 series compatible. |
| | They can be provided "clean, non-sterile" or "sterile". |

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## Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 29-Aug-06

Environment of Use --

Hospital, sub-acute care or any setting requiring the monitoring of breath sounds and / or temperature

Device Attributes:

| | NovaMed Esophageal Stethoscope |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Attributes | |
| Intended use<br>General | Monitor heart and breathe sounds<br>Optional configuration to monitor temperature |
| Intended use<br>Specific | Esophageal stethoscope<br>Monitor patient temperature |
| Environments of use | For patients under anesthesia or sedation.<br>Hospital, sub-acute care or any settings where monitoring<br>of breathe sounds and /or temperature is required |
| Prescription | Yes |
| Design | Inner tube with holes at distal end, covered with non-<br>inflating cuff with proximal end terminating in a luer<br>fitting. Electrical conductor / temperature sensor which<br>connects to standard monitors YSI 400 or 700 series<br>compatible. |
| Materials | |
| Components in air pathway | PVC |
| Performance | None applicable |

#### Differences between Other Legally Marketed Predicate Devices 12008 - 1

The NovaMed esophageal stethoscope is viewed as substantially equivalent to the following predicate devices - Biomedical Concepts (NovaMed) esophageal stethoscope -- K864858 and Shore Medical - K982193.

There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular fashion around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# SEP - 5 2006

NovaMed, LLC C/O Mr. Paul Dryden President ProMedic, Incorporated 3460 Pointe Creek Court, #102 Bonita Springs, Florida 34134-2015

Re: K062020

Trade/Device Name: Lifesound Esophageal Stethoscope and Temperature Sensor Regulation Number: 21 CFR 868.1920 Regulation Name: Esophageal Stethoscope with Electrical conductors Regulatory Class: II Product Code: BZT Dated: July 14, 2006 Received: July 17, 2006

Dear Mr. Dryden:

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 such 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.

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## Page 2 - Mr. Dryden

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. or me ret or any with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and if the (2 as set forth in the quality systems (QS) regulation (21 GFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

Syrite Y. Michael MD

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

Page 1 of 1

510(k) Number:

K062020 (To be assigned)

Device Name:

Lifesound Esophageal Stethoscope and Temperature Sensor

Indications for Use:

Indicated for use as an esophageal stethoscope to listen to patient heart and breathe sounds while a patient is under anesthesia or sedation.

Optionally it may be used as a temperature sensor to monitor patient temperature.

The electrical conductors are YSI 400 or 700 series compatible.

They can be provided "clean, non-sterile" or "sterile".

Prescription Use XX (Part 21 CFR 801 Subpart D) or

Over-the-counter use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Snette Y. Michie, Omd.

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Anesthesinlogy General Hospita Juon Control, Dental Device

) Number: K 06 2020