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.
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K960001
MINIMED TECHNOLOGIES
12744 San Fernando Road
Sylmar, California 91342
Tel. (818) 362-5958 • (800) 933-3322
FAX: (818) 364-2246
MiniMed Technologies
Premarket Notification
MMT-507
# 510(k) Summary
This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990, and 21 CFR 807.92:
A. **Submitter**: MiniMed Technologies, 12744 San Fernando Road, Sylmar, California 91342. Contact: Terrance H. Gregg (818) 362-5958, ext. 2569. FAX: (818) 362-6928.
B. **Name of Device**: MiniMed MMT-507 (Insulin Infusion Pump).
C. **Predicate Device**: MiniMed MMT-506 (cleared: 510(k) K901588).
D. **Description of the Device**: The MMT-507 external insulin pump is a rate-programmable syringe infusion pump, designed for continuous delivery of insulin, at set and variable rates, as prescribed by the user's physician. The MMT-507 is restricted to sale by or on the order of a physician. It is not intended or indicated for the delivery of blood or blood products.
The MMT-507 consists of an external case, a microprocessor, a Liquid Crystal Display (LCD), a syringe compartment with a lead screw connecting to a motor. None of these components contact the fluid pathway.
E. **Intended Use of the New Device**: 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.
F. **Comparison of the Technological Features of the New Device and Predicate Device**: The principal differences between the new device and the predicate device include a back-light for the LCD display, software changes to allow link to a personal computer for in-house evaluations, a user self-test, the addition of audible tones, an increase in memory capacity relative to bolus programming and bolus recalls, the display of the 24 hour basal rate profile following programming, an increase in the temporary basal rate duration, and a time-delay feature for bolus delivery. These modifications do not negatively affect the safety or effectiveness of the device.
Signed,
Terrance H. Gregg
Vice President
Regulatory Affairs and Clinical Research
12/29/95
Date
CONFIDENTIAL
