MILSCOPE FLOATING MASS STETHOSCOPE, MODEL 300-01

K091972 · Stethoscope Technologies, Inc. · DQD · Sep 23, 2009 · Cardiovascular

Device Facts

• Record ID: K091972
• Device Name: MILSCOPE FLOATING MASS STETHOSCOPE, MODEL 300-01
• Applicant: Stethoscope Technologies, Inc.
• Product Code: DQD · Cardiovascular
• Decision Date: Sep 23, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1875
• Device Class: Class 2

Intended Use

The Milscope Floating Mass Electronic Stethoscope, Model 300-01 is intended for medical diagnostic purposes only. It may be used for the detection and amplification of heart, lungs, arteries, veins, and other internal organs with the use of a selective frequency. It can be used on any person undergoing a physical assessment.

Device Story

Milscope Floating Mass Electronic Stethoscope (Model 300-01) functions as an electronic diagnostic tool for auscultation. Device captures acoustic signals from heart, lungs, arteries, veins, and internal organs; utilizes selective frequency amplification to enhance sound clarity. Operated by clinicians or users during physical assessments to facilitate diagnostic decision-making. Output provided as amplified audio for provider interpretation. Benefits include improved detection of physiological sounds compared to traditional acoustic stethoscopes.

Clinical Evidence

No clinical data provided. Substantial equivalence determination based on device description and intended use.

Technological Characteristics

Electronic stethoscope utilizing a floating mass transducer for sound detection. Features selective frequency amplification circuitry. Designed for physical assessment applications. Connectivity and specific material standards not detailed in provided documentation.

Indications for Use

Indicated for medical diagnostic purposes, specifically the detection and amplification of heart, lung, arterial, venous, and other internal organ sounds. Suitable for use on any person undergoing a physical assessment.

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

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

Stethoscope Technologies, Inc. c/o Mr. David Stark Stark-SMO 38 Miller Ave, PMB 170 Mill Valley, CA 94941

## SEP 2 8 2009

Re: K091972

Trade/Device Name: Milscope Floating Mass Electronic Stethoscope, Model 300-01 Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II (two) Product Code: DQD Dated: June 24, 2009 Received: July 1, 2009

Dear Mr. Stark:

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.

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Page 2 -- Mr. David Stark

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); labeling (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 (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.

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/MedicalDevices/Safety/ReportalProblem/default.htm 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

W.M.S.

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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## 1. Indications for Use Statement

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Stethoscope Technologies Inc., 890 Saratoga Ave. Suite 202, San Jose, CA 95129

510(k) Number (if known): Not assigned

Device Name: Milscope Floating Mass Stethoscope

## Indications for Use:

The Milscope Floating Mass Electronic Stethoscope, Model 300-01 is intended for medical diagnostic purposes only. It may be used for the detection and amplification of heart, lungs, arteries, veins, and other internal organs with the use of a selective frequency. It can be used on any person undergoing a physical assessment.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices

| 510(k) Number | K091972 |
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