(105 days)
The Ivy Biomedical Model 7600 Cardiac Trigger Monitor is a simple to use instrument for monitoring the ECG and Heart Rate. It is designed for use in the ICU, CCU and operating room conditions. It can sound an alarm when the HR falls outside of preset limits. It provides an output pulse, synchronized to the R-wave for use in applications requiring precision R-wave synchronization. The Model 7600 is limited to use by trained and qualified medical professionals. This product is not intended for home care monitoring.
The Ivy Biomedical Model 7600 Cardiac Trigger Monitor is a simple to use instrument for monitoring the ECG and Heart Rate. It is designed for use in the ICU, CCU and operating room conditions. It can sound an alarm when the HR falls outside of preset limits. It provides an output pulse, synchronized to the R-wave for use in applications requiring precision R-wave synchronization.
Based on the provided text, the document is a 510(k) clearance letter for the Ivy Biomedical Model 7600 Cardiac Trigger Monitor. It confirms the device's substantial equivalence to a predicate device but does not contain information regarding detailed acceptance criteria, performance studies, or technical specifications of the device's performance.
Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment. The document focuses on regulatory clearance, not the technical validation of the device's performance against specific metrics.
§ 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).