(127 days)
The MUSE Cardiology Information System is intended to store, access and manage cardiovascular information on adult and pediatric patients. The information consists of measurements, text, and digitized waveforms. The MUSE. Cardiology Information System provides the ability to review and edit electrocardiographic procedures on screen, through the use of reviewing, and editing tools including ECG serial comparison and interpretive 12-lead analysis. The MUSE Cardiology Information System is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or facility providing patient care. The MUSE Cardiology Information System is not intended for real-time patient monitoring. The MUSE Cardiology Information System is not intended for pediatric serial comparison.
The MUSE Cardiology Information System is a network PC- based system comprised of a client workstation/server configuration that manages adult and pediatric diagnostic cardiology data by providing centralized storage and ready access to a wide range of data/reports (e.g. Resting ECG, Stress, Holter, HiRes) from GE and non-GE diagnostic and monitoring equipment. The device provides the ability to: • Review and edit stored data consisting of measurements, text, and digitized waveforms on screen, through the use of reviewing, measuring, and editing tools including ECG serial comparison and interpretive 12-lead analysis. • Generate formatted management reports, ad-hoc database search reports and clinical patient reports on selected stored data.
The provided document, K110132, for the GE Healthcare MUSE Cardiology Information System, does not contain information about acceptance criteria or a study proving that the device meets those criteria, as it is a 510(k) Premarket Notification Submission based on substantial equivalence.
The summary explicitly states:
"The subject of this premarket submission, MUSE Cardiology Information System, did not require clinical studies to support substantial equivalence."
Therefore, I cannot provide the requested table or details about a study demonstrating the device meets acceptance criteria derived from this document. The submission relies on demonstrating that the new device employs the same functional and scientific technology as its predicate devices (MUSE Cardiology Information System K#072502 and MUSE Cardiology Information System w/ VMWare K#083639) and complies with voluntary standards and internal quality assurance measures.
§ 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).