| 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 |
