MINIMED INFUSION PUMP, MODEL MMT-507
Device Facts
| Record ID | K960001 |
|---|---|
| Device Name | MINIMED INFUSION PUMP, MODEL MMT-507 |
| Applicant | Medtronic Minimed |
| Product Code | LZG · General Hospital |
| Decision Date | Apr 30, 1996 |
| Decision | ST |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5725 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The MMT-507 is intended for continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
Device Story
External rate-programmable syringe infusion pump; delivers insulin at set/variable rates. Components: external case, microprocessor, LCD, syringe compartment, lead screw, motor. Operated by patient/caregiver in home/clinic settings. User programs basal rates and bolus delivery via interface. Device provides audible tones, LCD back-light, and bolus recall memory. Software allows PC link for in-house evaluations. Benefits: continuous insulin delivery for diabetes management; improved programming flexibility via temporary basal rates and bolus time-delay features.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Rate-programmable syringe infusion pump. Microprocessor-controlled motor drive. Features: LCD with back-light, audible alarm tones, increased memory capacity. Connectivity: PC link for in-house evaluation. Software-based programming for basal/bolus delivery.
Indications for Use
Indicated for management of diabetes mellitus in persons requiring insulin therapy. Restricted to sale by or on the order of a physician. Not for delivery of blood or blood products.
Regulatory Classification
Identification
An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.
Predicate Devices
- MiniMed MMT-506 (K901588)
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