MINIMED INSULIN PUMP, MODEL 505

K963948 · Medtronic Minimed · LZG · Apr 8, 1997 · General Hospital

Device Facts

• Record ID: K963948
• Device Name: MINIMED INSULIN PUMP, MODEL 505
• Applicant: Medtronic Minimed
• Product Code: LZG · General Hospital
• Decision Date: Apr 8, 1997
• Decision: ST
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 505 insulin pump is intended for continuous delivery of insulin for the management of diabetes mellitus in persons requiring exogenous insulin. It is not intended or indicated for the delivery of blood or blood products.

Device Story

MiniMed 505 insulin pump; rate-programmable syringe infusion pump for continuous insulin delivery. External device; consists of case, microprocessor, LCD, syringe compartment, motor, lead screw. No fluid pathway contact. User-programmed; delivers insulin as prescribed by physician. Simplified software compared to predicate; single rate profile; reduced memory capacity. Used for diabetes management; provides continuous insulin infusion.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological and functional comparison to predicate device.

Technological Characteristics

Rate-programmable syringe infusion pump. Components: external case, microprocessor, LCD, syringe compartment, motor, lead screw. Fluid path non-contacting. Software-controlled delivery.

Indications for Use

Indicated for continuous insulin delivery for management of diabetes mellitus in patients requiring exogenous insulin.

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 Insulin Pump, model 506 (K901588)

Submission Summary (Full Text)

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APR - 8 1997

MiniMed

1963948

Part I. 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 Inc. 12744 San Fernando Road, Sylmar, CA 91342
Contact: Don Selvey, Senior Regulatory Affairs Specialist 818 362-5958, ext. 3011 (v); 818 364-7947 (f); 520 527-0107 (v/f).

B. Name of Device: MiniMed Insulin Pump, model 505.

C. Predicate Device: MiniMed Insulin Pump, model 506 (cleared: 510(k) K901588).

D. Description of Device: The 505 insulin pump is a rate-programmable syringe infusion pump, designed for continuous delivery of insulin, as prescribed by the user's physician. The 506 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 505 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 505 insulin pump is intended for continuous delivery of insulin for the management of diabetes mellitus in persons requiring exogenous insulin. It is not intended or indicated for the delivery of blood or blood products.

F. Comparison of the Technological Features of the New Device and Predicate Device: The 505 insulin pump is identical to the 506 insulin pump in nearly every way, except that the software has been simplified, i.e., the new device has a single rate profile, instead of the six rates programmable with the predicate device, and the memory retains fewer values. Both devices use the same case and drive mechanism, same microprocessor, same reservoir and infusion sets, and are programmed the same way by the user. The indications, contraindications, warnings, precautions, and adverse reaction statements in the User's Guide are not substantially different, if at all. The intended use of the devices is nearly the same.

The modification described does not negatively affect the safety or effectiveness of the device.

Signed,


Terrance H. Gregg
Executive Vice President, Operations
MiniMed, Inc.

23 Sep 96
Date

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