RHYTHM DIGITAL ELECTRONIC STETHOSCOPE

K032230 · Thinklabs, Inc. · DQD · Nov 26, 2003 · Cardiovascular

Device Facts

• Record ID: K032230
• Device Name: RHYTHM DIGITAL ELECTRONIC STETHOSCOPE
• Applicant: Thinklabs, Inc.
• Product Code: DQD · Cardiovascular
• Decision Date: Nov 26, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1875
• Device Class: Class 2

Intended Use

The "Rhythm Digital Electronic Stethoscope" is intended for use as a diagnostic aid in patient diagnosis. It can be used for the amplification of heart, lung, and other body sounds with selective frequency filtering and can be used on any patient undergoing physical assessment. The device can also be used to measure heart rate, based on measurement of heart sound signals.

Device Story

The Rhythm Digital Electronic Stethoscope is a diagnostic aid used by clinicians during physical examinations. It captures acoustic body sounds (heart, lung, and other body sounds) via a sensor, amplifies these signals, and applies selective frequency filtering to enhance auscultation. The device also processes heart sound signals to calculate and display heart rate. It functions as an electronic stethoscope, providing clinicians with improved sound clarity and objective heart rate data to assist in patient diagnosis. The device is intended for use in clinical settings where traditional stethoscopes are employed.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electronic stethoscope; utilizes acoustic sensors for sound capture; includes signal amplification and frequency filtering circuitry; provides heart rate measurement based on acoustic signal processing; handheld form factor.

Indications for Use

Indicated for use as a diagnostic aid for patients of all ages undergoing physical assessment to amplify heart, lung, and body sounds and to measure heart rate.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 26 2003

Thinklabs, Inc. c/o Mr. Richard C. Lanzillotto Authorized Agent NATS Corp. 30 Northport Rd. Sound Beach, NY 11789

Re: K032230

Trade Name: Rhythm Digital Electronic Stethoscope Regulation Number: 21 CFR §870.1875 Regulation Name: Electronic Stethoscope Regulatory Class: Class II (two) Product Code: DQD Dated: October 28, 2003 Received: October 30, 2003

Dear Mr. Lanzillotto:

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. Richard C. Lanzillotto

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); 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. 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]. 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) you may obtain. 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.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Tomá Reischer for

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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Thinklabs Inc. Rhythm Digital Electronic Stethoscope 510K Notification

## INDICATIONS FOR USE

510(k) Number (if known):

Thinklabs Inc. "Rhythm Digital Electronic Stethoscope" Device Name: The "Rhythm Digital Electronic Stethoscope" is intended for use as a Indications for Use: diagnostic aid in patient diagnosis. It can be used for the amplification of heart, lung, and other body sounds with selective frequency filtering and can be used on any patient undergoing physical assessment. The device can also be used to measure heart rate, based on measurement of heart sound signals.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

Dwa Seexluu

510(k) Number K032230