Device |
peripheral intravenous (piv) infiltration monitor |
Regulation Description |
Infusion pump. |
Definition |
Peripheral catheter monitor (PIV) indicated for the detection of subcutaneous infiltrations and extravasations. |
Physical State |
The device consists of a monitor, a reusable optical sensor cable and a single-use sensor receptacle. |
Technical Method |
The peripheral intravenous (PIV) monitoring device that uses visible and near-infrared light to measure changes in the optical properties of the tissue near a PIV insertion site to determine if an infiltration of the peripheral catheter has occurred. |
Target Area |
peripherally-inserted IVs (PIVs), generally on the forearm or dorsal aspect of the hand. |
Regulation Medical Specialty |
General Hospital |
Review Panel |
General Hospital |
Product Code | PMS |
Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Drug Delivery and General Hospital Devices, and Human Factors
(DHT3C)
|
Submission Type |
510(k)
|
Regulation Number |
880.5725
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |