(35 days)
The Del Mar Avionics Model 464 OmniCorder™ is intended for use as a Holter ECG cardiac-monitoring tool.
The Model 464 OmniCorder™ is a compact Holter ECG magnetic tape recorder utilizing standard C60 and C90 cassettes. The recorder may be used to record 2 channel ECG, 3 channel ECG, or 2 channel ECG + pseudo pacer pulses. A fourth track on the tape records a timing track for synchronized playback. Recording may be preset to a tape speed of .75 mm/sec, 1.0 mm/sec or 1.5 mm/sec. Amplitude may be preset to full or half gain. A patient event button records patient items of note on tape while maintaining the ECG signal.
The provided text is a 510(k) summary for the Del Mar Avionics Model 464 OmniCorder™, a Holter ECG magnetic tape recorder. It describes the device, its intended use, and compares it to a predicate device (Model 461 Pacercorder® 510(k) #K950020).
However, the document does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. The FDA letter also does not include this information, as its purpose is to acknowledge the 510(k) submission and confirm substantial equivalence.
Therefore, I cannot provide the requested table and study details based on the input text. The 510(k) summary focuses on device description and equivalence to a predicate device, not on detailed performance study results against specific acceptance criteria.
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).