| Device |
pump, infusion, insulin bolus |
| Regulation Description |
Infusion pump. |
| Definition |
The device is adhered to the body for several days for the purpose of periodically infusing an 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 Medical Specialty |
General Hospital |
| Review Panel |
Clinical Chemistry |
|---|
| Product Code | OPP |
|---|
| Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Chemistry and Toxicology Devices
(DCTD)
|
| 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 |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Recognized Consensus Standards
|
| Guidance Document
|
| Third Party Review |
Not Third Party Eligible |
