Definition: The Device Is Adhered To The Body For Several Days For The Purpose Of Periodically Infusing An Insulin Bolus.
| Device Type ID | 2725 |
| Device Name | Pump, Infusion, Insulin Bolus |
| Physical State | The Device Is Worn Directly On The Body. It Is Constructed Of A Variety Of Polymeric Materials. Stainless Steel Is Used In Springs. |
| Technical Method | The Device Contains The Insulin In A Reservoir Attached To A Pumping Mechanism. The Pump Delivers A Discrete Bolus Volume To The Patient On Demand. There Are No Means Of Providing Continuous Infusion. |
| Target Area | Subcutaneous Tissue. The Device Is Generally Targeted For Use On The Abdomen, Buttocks, Or Other Location Acceptable For Insulin Delivery And Device Placement. |
| Regulation Description | Infusion Pump. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 880.5725 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OPP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 2725 |
| Device | Pump, Infusion, Insulin Bolus |
| Product Code | OPP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Infusion Pump. |
| CFR Regulation Number | 880.5725 [🔎] |
| Device Problems | |
|---|---|
Defective Component | 3 |
Loss Of Or Failure To Bond | 3 |
Human-Device Interface Problem | 2 |
Failure To Adhere Or Bond | 1 |
Contamination During Use | 1 |
Failure To Read Input Signal | 1 |
Device Dislodged Or Dislocated | 1 |
Detachment Of Device Component | 1 |
Leak / Splash | 1 |
Device Issue | 1 |
| Total Device Problems | 15 |