BIOLOGICAL SOUND MONITOR (BSM) SENSOR

K021389 · Andromed, Inc. · DQD · Oct 1, 2002 · Cardiovascular

Device Facts

• Record ID: K021389
• Device Name: BIOLOGICAL SOUND MONITOR (BSM) SENSOR
• Applicant: Andromed, Inc.
• Product Code: DQD · Cardiovascular
• Decision Date: Oct 1, 2002
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1875
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Biological Sound Monitor Sensor is intended for the purpose of capturing, detecting and transmitting biological sounds such as those produced by the heart, lungs, arteries and veins, and other internal organs and systems. The Biological Sound Monitor Sensor may be used with any compatible devices that may amplify biological sound signals for auscultation, display or further processing.

Device Story

Biological Sound Monitor (BSM) Sensor captures, detects, and transmits biological sounds (heart, lungs, arteries, veins, internal organs). Device functions as a transducer/sensor for use with compatible electronic stethoscopes or signal processing equipment. Operated by physicians or trained healthcare professionals in clinical or prescribed settings. Output consists of raw or amplified biological sound signals for auscultation or display. Clinical utility relies on professional interpretation of sound data to support physical examination. Benefits include enhanced sound acquisition for diagnostic assessment by clinicians.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Sensor for biological sound acquisition; compatible with electronic stethoscope systems for signal amplification/processing. Form factor designed for clinical auscultation. No specific materials or software algorithms described.

Indications for Use

Indicated for use with children and adults under the supervision of a physician or other trained health care professional. Used during routine exams in clinical or prescribed environments in conjunction with devices such as electronic stethoscopes. Not diagnostic; requires professional interpretation.

Regulatory Classification

Identification

Manual stethoscope: A mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs. Electronic stethoscope: An electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.

Special Controls

*Classification.* Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Submission Summary (Full Text)

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

#### Public Health Service

OCT 01 2002

Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850

ANDROMED, Inc. c/o Ms. Geneviève Hamel Director, Regulatory Affairs & Quality Assurance 4610 Bois-Franc Road Saint-Laurent, Quebec Canada H4S 1A7

K021389 Re:

> Device Name: Biological Sound Monitor (BSM) Sensor Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DOD Dated: August 16, 2002 Received: August 19, 2002

Dear Ms Hamel:

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. Iisting 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.

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

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### Page 2 - Ms. Geneviève Hamel

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); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR 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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

K. Donatelli

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Attachment A

## Indications for Use Statement

510(k) Number:

KO21389

Device Name:

Biological Sound Monitor Sensor

#### Indications for Use:

The Biological Sound Monitor Sensor is intended for the purpose of capturing, detecting and transmitting biological sounds such as those produced by the heart, lungs, arteries and veins, and other internal organs and systems. The Biological Sound Monitor Sensor may be used with any compatible devices that may amplify biological sound signals for auscultation, display or further processing.

The Biological Sound Monitor Sensor is indicated for use with children and adults under the supervision of a physician or other trained health care professional. It is indicated for use during routine exam in clinical or other suitably prescribed environment in conjunction with such devices as an electronic stethoscope.

In no way are any of the sensor functions represented as being in and of themselves diagnostic. Sound signals must be reviewed and interpreted by a physician or other trained health care professional who will exercise professional judgment in using this information.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K021389

Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use _