(128 days)
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.
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The provided text is a 510(k) premarket notification approval letter for the "Rhythm Digital Electronic Stethoscope." It confirms the device's substantial equivalence to predicate devices but does not contain information about acceptance criteria, specific performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to AI/ML device performance evaluation.
Therefore, I cannot populate the requested table and answer the study-related questions based on this document. The information typically required for these questions (e.g., performance metrics like sensitivity, specificity, or AUC; details of clinical trials; characteristics of the test set) is not present in this regulatory approval letter.
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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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
§ 870.1875 Stethoscope.
(a)
Manual stethoscope —(1)Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.(b)
Electronic stethoscope —(1)Identification. An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
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.