(85 days)
MARS Holter Analysis Workstation is designed for acquisition, analysis, edit, review, report and storage of ambulatory ECG and multi-parameter data. Results of the automated analysis are intended to assist the physician in the interpretation of the recorded data. This information is not intended to serve as a substitute for the physician overread of the recorded ECG data. The MARS Holter Analysis Workstation is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner in a hospital or clinic environment. Patient population includes both adult and pediatric (greater than 10Kg) human patients. The MARS Holter Analysis Workstation provides the user arrhythmia studies and Holter analysis capabilities.
Data acquired may be used for the following indications:
- Evaluation of symptoms that may be caused by cardiac arrhythmia and/or conduction disturbances
- Evaluation of symptoms that may be due to myocardial ischemia
- Detection of ECG events that alter prognosis in certain forms of heart disease
- Detection and analysis of pacemaker function and failure
- Determination of cardiac response to lifestyle
- Evaluation of therapeutic interventions
- Investigations in epidemiology and clinical trials
The MARS Holter Analysis Workstation system is a software-system that runs on PC based hardware. The MARS Holter Analysis Workstation supports a number of software applications including analysis, user editing and final report processing. The MARS Holter Analysis Workstation analyzes ECG data, to detect and label beats, and then presents it in a variety of screens to the user for review and data editing purposes. The MARS Holter Analysis Workstation system stores and prints final reports and allows reports to be sent to the MUSE Cardiology Information Management System for long- term archive. The MARS Holter Analysis Workstation supports acquisition from ambulatory ECG Recorders and multi-parameter data from the CIC Pro Clinical Information Center. A variety of different final report formats can be stored and printed. The final report is used by trained medical personal to diagnose a patient's cardiac abnormalities.
The provided documentation indicates that the MARS Holter Analysis Workstation did not require clinical studies to support substantial equivalence. Therefore, there is no detailed information on acceptance criteria, a specific study proving device performance against those criteria, sample sizes, expert qualifications, or other clinical study specifics as requested.
The submission states:
"The subject of this premarket submission, MARS Holter Analysis Workstation, did not require clinical studies to support substantial equivalence."
Instead of clinical studies, the submission relies on non-clinical tests and compliance with voluntary standards and quality assurance measures during development. These measures include:
- Requirement Definition
- Risk Analysis
- Technical Review
- Formal Design Review
- Code Inspection
- Integration testing (Module and System verification)
- Final acceptance testing (Validation)
- Performance testing
- Safety testing
Since no clinical study was conducted as part of this submission, the requested information regarding acceptance criteria, reported performance, sample sizes, expert involvement, and ground truth establishment from a clinical trial perspective cannot be provided. The device was deemed substantially equivalent to predicate devices based on its fundamental scientific technology and non-clinical testing.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).