(238 days)
The ReavillMED product is combination product containing a pressure monitoring system and a peripherally inserted central catheter. The pressure monitoring system is intended for continuous measurement of blood pressures or other physiological pressures. The catheter is intended for short term peripheral access to the central venous system.
The ReavillMED pressure monitoring device is a combination product consisting of the following components within a single device:
- . Blood pressure monitoring line and end cap
- . Disposable pressure transducer
- Single lumen polyurethane reverse taper catheter .
- . Catheter hub with suture wing tabs and slip tip cap
The single lumen catheter is packaged within a pressure monitoring line to maintain a sterile environment. A transducer is attached to the distal end of the monitoring line.
The product is sold sterile, single use, and non-pyrogenic.
The ReavillMED Pressure Monitoring System is a combination product consisting of a blood pressure monitoring line with an end cap, a disposable pressure transducer, a single lumen polyurethane reverse taper catheter, and a catheter hub with suture wing tabs and a slip tip cap. It is intended for continuous measurement of blood pressure or other physiological pressures, and the catheter is for short-term peripheral access to the central venous system.
1. Table of acceptance criteria and the reported device performance
| Testing Performed | Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Sensor Testing | ANSI/AAMI BP-22, 1994 | Operating Pressure Range: -50 mmHg to +300 mmHg | Meets Requirements |
| Sensitivity: 5µV/V/mmHg, +/- 2% (typically 500 hours | Meets Requirements | ||
| Storage Temperature: -25 C to +65 C | Meets Requirements | ||
| Defibrillation Withstand: 5 discharges/5 minutes of 360 joules @ 50 Ω load | Meets Requirements | ||
| Natural Frequency: > 20 Hz in saline | Meets Requirements | ||
| Phase Shift: |
§ 870.2850 Extravascular blood pressure transducer.
(a)
Identification. An extravascular blood pressure transducer is a device used to measure blood pressure by changes in the mechanical or electrical properties of the device. The proximal end of the transducer is connected to a pressure monitor that produces an analog or digital electrical signal related to the electrical or mechanical changes produced in the transducer.(b)
Classification. Class II (performance standards).