(128 days)
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Not Found
No
The summary does not mention AI, ML, or any related terms, and the described functions (amplification, filtering, heart rate measurement) are typical of traditional digital stethoscopes.
No
The device description states its intended use is "as a diagnostic aid in patient diagnosis" and that it amplifies body sounds for "physical assessment." It does not mention treating, preventing, or mitigating any disease or condition, which are characteristics of a therapeutic device.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is intended for use as a diagnostic aid in patient diagnosis."
Unknown
The provided text describes the intended use of a "Rhythm Digital Electronic Stethoscope" which amplifies and filters body sounds and measures heart rate. However, it lacks a "Device Description" section, which is crucial for determining if the device is purely software or includes hardware components (like a physical stethoscope head or sensor). Without this description, it's impossible to definitively classify it as software-only.
Based on the provided information, the "Rhythm Digital Electronic Stethoscope" is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a stethoscope used for the amplification and analysis of body sounds (heart, lung, etc.) and measuring heart rate based on these sounds. This is a non-invasive diagnostic tool that interacts directly with the patient's body, not with samples taken from the body.
Therefore, the "Rhythm Digital Electronic Stethoscope" falls under the category of a medical device used for physical assessment and diagnosis, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
DQD
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three wavy lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.
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