“Cardiac Monitor Guidance (including Cardiotachometer and Rate Alarm)”
This doument was issued on November 5, 1998. This guidance is for preperation of 510(k) submissions for devices regulated under 21CFR 870.2300. In the scope section of this guidance it states that if the processing at the central station is for generating heart rate alarms then the device will be considered of regulatory class II. However, if the processing at the central station involves real time anrithria detection and alarams, then the device is in class III and is not covered by this guidance document. It also states that this guidance does not address issues specific to central monitoring stations, network devices, or devices that use telemetry or transtelphonic communications
Section II.A item five requires at a minimum indentification of all components and accessories that can be used with the monitor and gives examples of persoal computers, printers, and database management software.
Section II.D.2 references the current FDA software submission guidance and states that these cardiac monitors can be considered to have level of concern from minor to moderate depending on their exact intended use and function.
This guidance document also has a section that provides a suggested format and contents for test reports inculding test protocols, data results, and analysis. Although not specifically identifiying its use for software testing the information provided can be assumed to apply for the device overall including software functional testing and is fairly specific about the requirements for information to be included in these test reports.