(126 days)
The Dy Ansys, Inc. ANSiscope™ ECG Monitoring System and accessories, is intended to acquire, analyze, display and record electrocardiographic information and to measure-heart rate variability. These and other measurements are not intended for any specific clinical diagnosis. The clinical significance of HRV and other parameters must be determined by the physician.
The Portable ANSiscope™ is a device used for measuring heart rate variability (HRV). The device is designed to process raw ECG signals acquired from the patient in order to produce Heart Rate and other ancillary indices. The Portable ANSiscope™ includes an ECG Acquisition System that can digitize raw ECG signals, perform proprietary calculations from the HRV and then display the results utilizing a display unit.
The provided text does not contain specific acceptance criteria or a detailed study description with performance metrics for the Portable ANSiscope™. While it mentions that "The Portable ANSiscope™ was subjected to safety and performance tests against applicable recognized standards. Final testing for the product included various performance tests to confirm compliance with functional requirements and performance specifications," it does not elaborate on what these specific criteria were or the results of these tests.
Therefore, I cannot populate the requested table or provide information for points 1-9 based on the given document.
The document primarily focuses on:
- 510(k) Summary: Outlining the applicant information, device classification, trade name, predicate devices, and a general device description.
- Intended Use: Stating that the device acquires, analyzes, displays, and records electrocardiographic information and measures heart rate variability, but not for any specific clinical diagnosis.
- Comparison to Predicate Devices: Highlighting similarities and differences, noting that "the measurement technology and the technological characteristics are not the same as those of the legally marketed devices, the new characteristics do not affect the safety and effectiveness."
- FDA Clearance Letter: Confirming substantial equivalence to predicate devices based on the stated indications for use.
To fulfill the request, a more detailed study report or premarket submission document, which typically includes the detailed performance data and methodology, would be necessary.
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).