(7 days)
Hospira Vital Signs Wireless Monitoring System is indicated for use on patients requiring pressure monitoring. Hospira Vital Signs Wireless Monitoring System is intended to perform wireless transmission of pressure information to remote patient monitors from disposable pressure transducers.
The Hospira Vital Signs Wireless Monitoring System utilizes the Bluetooth® communications protocol. It will eliminate the multi-conductor, fixed length, shielded, reusable cable that typically acts as the interface between the patient's bedside monitor and the disposable transducer. The disposable transducer will simply plug into the system's remote transmitter unit, which will send its output signal to the system's receiver unit that is affixed to the bedside monitor. The wireless system is intended to operate at varying distances to accommodate typical layouts that exist within hospital operating rooms, critical care units, emergency rooms and catheterization lab suites.
The provided document, a 510(k) Summary for the Hospira Vital Signs Wireless Monitoring System, does not contain the specific information required to complete the detailed description of acceptance criteria and a study proving the device meets those criteria.
This document primarily focuses on establishing substantial equivalence to predicate devices for regulatory clearance. It outlines the device's technical characteristics, intended use, and similarities to previously cleared devices. It states that "The proposed modifications do not raise new issues of safety and/or effectiveness. Hospira Vital Signs Wireless Monitoring System meets the functional claims and intended use as described in product labeling and is as safe and effective in terms of substantial equivalence as the predicate devices described in the submission." However, it does not provide a table of acceptance criteria, specific reported device performance data against those criteria, or a detailed study plan/results.
Therefore, I cannot populate the table or answer the subsequent questions based solely on the provided text. The document asserts that the device meets functional claims, but those claims and the methods used to verify them are not elaborated upon here.
If a different document, such as a test report or a more detailed technical review, were available, it would likely contain the requested information.
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).