(141 days)
Use of the PF 5050 Pressure Unit is indicated for non-invasive Pulse Volume waveform Recordings (PVR) on extremities of patients with vascular diseases.
It is also intended to measure and control the pressure in a blood pressure cuff to simplify simultaneous measurements of perfusion and pressure when used in conjunction with a laser Doppler perfusion monitor.
The PF 5050 Pressure Unit is a modular unit that can be installed in the PeriFlux System 5000. The device provides Pulse Volume waveform Recordings (PVR) on various limb and digit extremities made possible through air plethysmography. The PF 5050 Pressure Unit includes a small display where the mean cuff pressure is displayed.
The PVR tracing is accomplished by attaching a standard blood pressure cuff on various areas of the extremities. To provide skin contact, atmospheric air is inflated to approximately 50 - 65 mmHg using the balloon pump supplied with a standard blood pressure gauge. A pressure transducer records the pressure change in the cuff (Pulse Volume waveforms) secondary to change in v the extremity segment under the cuff during repeated cardiac cycles.
The PeriFlux System 5000 is a multi-channel, multi-functional system capable of hosting one, two, three or four function units including for example a PF 5010 LDPM Unit for blood perfusion measurements. The PeriFlux 5001 Main Unit accommodates up to four different function units of the same type or of different types enabling simultaneous measurements of several parameters. There are three different function unit types available at the moment.
PF 5010 LDPM Unit for blood perfusion measurements.
PF 5020 Temp Unit for temperature measurements.
PF 5040 tcpO2 / pCO2 for measurements of transcutaneous O2 and CO2.
The provided text is a 510(k) summary for the PERIMED PF 5050 Pressure Unit, which describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, clinical studies, sample sizes, ground truth establishment, or expert adjudication methods.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is not present in the provided document. The 510(k) summary focuses on demonstrating equivalence to a predicate device rather than presenting detailed performance study results against specific acceptance criteria.
§ 870.2100 Cardiovascular blood flowmeter.
(a)
Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.(b)
Classification. Class II (performance standards).