(127 days)
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.
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.
The provided document (K170928) is a 510(k) clearance letter for the CADence System. While it states that the device is substantially equivalent to a predicate, it does not include the detailed acceptance criteria and study data that explicitly demonstrate the device meets those criteria. Such information is typically found in the full 510(k) submission, which is not provided here.
Therefore, I cannot provide the requested information based on the given text.
The document only contains:
- Device Name: CADence System
- Intended Use: A clinical decision support tool to aid analysis of normal/physiological and pathological heart murmurs after simultaneous recording of cardiac sounds and ECG. It is not intended to be a standalone diagnostic device.
- Regulatory Information: Class II device, regulation 21 CFR 870.1875 (Stethoscope).
- Statement of Substantial Equivalence: FDA has determined the device is substantially equivalent to legally marketed predicate devices.
To answer your request, I would need access to the actual 510(k) summary or the full submission, which would detail the performance studies and their results.
§ 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.