(182 days)
CareAware Event Management™ is a software application intended to provide healthcare professionals with supplemental information about events and alarms originating from medical devices, or other event or alarm producing systems within a clinical setting. This device can route notifications including all or a subset of the event or alarm information along with related contextual information to selected end points such as but not limited to mobile phones, or other computing or communications end points.
Receipt of notifications by the end point is not confirmed, and delivery to the end point is not guaranteed. The primary alarm notification is the device or system producing the alarm or event. This device is not intended to provide real-time information, nor is it a source of patient alarms, nor is it a replacement for alarming devices.
CareAware Event Management™ is not intended to directly monitor, diagnose or treat patients or to be used in the prevention of a disease or condition, nor does CareAware Event Management™ come into direct contact with patients.
CareAware Event Management™ is a software application intended to provide healthcare professionals with supplemental information about events and alarms originating from medical devices, or other event or alarm producing systems within a clinical setting. This device can route notifications including all or a subset of the event or alarm information along with related contextual information to selected end points such as but not limited to mobile phones, or other computing or communications end points.
This document is an FDA 510(k) clearance letter for the Cerner CareAware Event Management™ device. It does not contain information about a study proving the device meets acceptance criteria.
The letter explicitly states:
- "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices..."
- "Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies."
The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a predicate device, rather than requiring a detailed study proving performance against specific acceptance criteria for the new device as would be seen in a clinical trial.
Therefore, I cannot provide the requested information because the provided document does not contain a description of a study with acceptance criteria and reported device performance.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).