(127 days)
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Not Found
Unknown
The summary mentions "automated analysis of cardiac sounds" but does not explicitly state that AI or ML is used for this analysis. The lack of information on training/test sets and performance metrics further suggests that AI/ML may not be the core technology, or at least not explicitly disclosed in this summary.
No
The CADence system is described as a clinical decision support tool intended to aid a clinician's analysis of heart murmurs and heart sounds, not to provide therapy or treatment.
No
The input explicitly states, "The CADence System is not intended to be a stand-alone diagnostic device."
No
The device description explicitly states that the CADence System is comprised of a digital stethoscope with integrated sensors, a single-use Patient Booklet, and the CADence Software application, indicating it includes hardware components.
Based on the provided information, the CADence System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The CADence System records cardiac sounds and electrical activity directly from the patient's body using a stethoscope and ECG sensors. It does not analyze blood, urine, tissue, or other samples taken out of the body.
- The intended use describes a clinical decision support tool. While it aids in the analysis of heart murmurs, it does so by processing signals recorded directly from the patient, not by analyzing biological samples.
- The device description confirms direct patient contact. The components are a digital stethoscope and integrated ECG sensors, both of which are applied to the patient's body.
Therefore, the CADence System falls under the category of a medical device that interacts directly with the patient, rather than an IVD which analyzes samples.
N/A
Intended Use / Indications for Use
The CADence System is comprised of a digital stethoscope used to record cardiac (heart) sounds, with integrated sensors used to record electrical activity of the heart (ECG), a single-use Patient Booklet, and the CADence Software application.
CADence Software is a clinical decision support tool intended to aid a qualified clinician's analysis of normal/ physiological and pathological heart murmurs after simultaneous recording of cardiac sounds and ECG.
The device must be used in a clinical setting by trained personnel. The automated analysis of cardiac sounds by the CADence System are only significant when used in conjunction with physician oversight as well as consideration of all other relevant patient information. All relevant patient information must be taken into consideration before making a diagnosis. The CADence System is not intended to be a stand-alone diagnostic device. It does not supersede the judgment of the clinician.
Product codes
DOD, DOC
Device Description
The CADence System is comprised of a digital stethoscope used to record cardiac (heart) sounds, with integrated sensors used to record electrical activity of the heart (ECG), a single-use Patient Booklet, and the CADence Software application.
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
Heart / Cardiac
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified clinician, trained personnel / clinical setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
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.
0
Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is simple and recognizable, and it is used to represent the U.S. Department of Health & Human Services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 3, 2017
AUM Cardiovascular, Inc. Marie Johnson CEO 1405 Heritage Dr., Suite 100 Northfield, Minnesota 55057
Re: K170928
Trade/Device Name: CADence System Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DOD, DOC Dated: June 30, 2017 Received: Julv 6, 2017
Dear Marie Johnson:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
M.A. Willemen
for
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name CADence System
Indications for Use (Describe)
The CADence System is comprised of a digital stethoscope used to record cardiac (heart) sounds, with integrated sensors used to record electrical activity of the heart (ECG), a single-use Patient Booklet, and the CADence Software application.
CADence Software is a clinical decision support tool intended to aid a qualified clinician's analysis of normal/ physiological and pathological heart murmurs after simultaneous recording of cardiac sounds and ECG.
The device must be used in a clinical setting by trained personnel. The automated analysis of cardiac sounds by the CADence System are only significant when used in conjunction with physician oversight as well as consideration of all other relevant patient information. All relevant patient information must be taken into consideration before making a diagnosis. The CADence System is not intended to be a stand-alone diagnostic device. It does not supersede the judgment of the clinician.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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