(163 days)
The NH-301 Ambulatory ECG Analysis Software is intended for patients requiring ambulatory (Holter) monitoring from 1 to 168 hours. Such monitoring is most frequently used for the following indications:
- Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.
- Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients.
- Evaluation of patients for ST segment changes.
- Evaluation of patient's response after resuming occupational or recreational activities, (e.g., after M.I. or cardiac surgery.)
- Clinical and epidemiological research studies.
- Norav Holter Systems containing Heart Rate Variability (HRV) software have been tested to measure Heart Rate Variability within 4 ms tolerance. The clinical significance of Heart Rate Variability measures should be determined by a physician.
- Evaluation of patients with pacemakers
The NH-301 Ambulatory ECG Analysis Software is designed to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value.
The Software uploads long term ECG data from compatible ambulatory ECG recorders, analyzes via an algorithm and then displays it on the color monitor, in a manner that allows the analyses to be edited and reported. Several parameters are adjustable in the set-up of the analysis system.
The Software has an open architecture designed to operate on various IBM PC or compatible. It uses r his convalion printer. Instead of designing a computer inside a medical instrument, the instrument is delivered as a software and interface assembly to be used with an off the shelf computer system. This technique enhances the system cost effectiveness and reliability.
Acquired data is stored, and subsequently transferred to the PC for display. Up to 12 channels of real time ECG display are possible. The available commands, calculation of results and status messages are also displayed. All commands are initiated via keyboard.
The provided text describes the Norav NH-301 Ambulatory ECG Analysis Software and its 510(k) summary, but it does not contain any information about specific acceptance criteria, a study proving the device meets those criteria, or performance metrics like sensitivity, specificity, or accuracy based on a test set.
Therefore, I cannot populate the requested table or provide details about sample sizes, ground truth establishment, or expert involvement for a performance study.
The document primarily focuses on establishing substantial equivalence to a predicate device (Norav's NH-300 Holter Analysis System) based on structural and functional identity, intended use, and indications for use. The key difference highlighted is the monitoring duration capability (NH-300 up to 48 hours, NH-301 up to 168 hours).
The only performance-related statement is:
- "Norav Holter Systems containing Heart Rate Variability (HRV) software have been tested to measure Heart Rate Variability within 4 ms tolerance." This is not presented as an acceptance criterion within a formal study, but rather a characteristic of the HRV software. It does not refer to the overall ECG analysis software.
Therefore, I am unable to generate the requested table and information based on the provided text.
§ 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).