MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712E

K053177 · Medtronic Minimed · LZG · Jan 31, 2006 · General Hospital

Device Facts

• Record ID: K053177
• Device Name: MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712E
• Applicant: Medtronic Minimed
• Product Code: LZG · General Hospital
• Decision Date: Jan 31, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medtronic MiniMed Paradigm Model 712E Insulin Pump is intended for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.

Device Story

External, portable insulin pump for continuous insulin delivery; manages diabetes mellitus. User programs basal rates (0.00–35.00 units/hr) and meal boluses (up to 25.00 units); step sizes 0.05 units/hr (basal) and 0.1 units (bolus). Uses proprietary 3.0 ml reservoir compatible with Paradigm infusion sets. Device simplifies user interface via software modifications to disable specific features compared to predicate. Operated by patient for self-management of insulin delivery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

External portable infusion pump; 3.0 ml reservoir; U100 insulin delivery. Mechanically identical to predicate. Software-controlled delivery rates. Battery-powered.

Indications for Use

Indicated for persons with diabetes mellitus requiring insulin therapy for continuous subcutaneous insulin delivery.

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

• Medtronic MiniMed Paradigm Model MMT-712 Insulin Pump (K053177)

Submission Summary (Full Text)

{0}------------------------------------------------

## JAN 3 1 2006

Kq53177

## SECTION D. 510(k) Summary

In accordance with the requirements of SMDA 1990, and 21 CFR 807.92, this 510(k) Summary is provided:

Submitter: Medtronic MiniMcd, 18000 Devonshire St., Northridge. CA 91325

Contact: Staci Ellis [phone].

Name of Device: Medtronic MiniMed Paradigm Model MMT-712E Insulin Pump

Predicate Device: Medtronic MiniMcd Paradigm Model MMT-712 Insulin Pump

Description of the Device: The Paradigm Model MMT-712E is an external, portable insulin pump, designed for continuous delivery of insulin. It is designed to deliver 000 to 35.00 units of U100 insulin per hour in basal rates and up to 25.00 units of U100 insults per meal bolus. The insulin programming step size allows users to program insulin delivery in steps of 0.1 units for boluses and 0.05 units/hour for basal dclivery.

The Model 712F accommodates a proprietary 3.0 ml reservoir. This reservoir mates with the existing and future Paradigm infusion sets.

Intended Use of the Device: The Medtronic MiniMed Paradigm Model 712E Insulin Pump is intended for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.

Comparison of the Technological Features of the New Device and Predicate Device: The new and predicate devices have identical materials and design. The new device, MMT 712E, is a derivative of the MMT-712. Both pumps are mechanically identical. Software modifications only were made to the MMT-712E to disable certain features therehy simplifying its use.

Mark Faillace

11/10/05
Date

Senior Director, Regulatory Affairs and Product Reporting Medtronic MiniMed

1 M Paradigm Model 712E insulin pump is a Trademark of Medtronic MiniMed

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, with flowing lines representing hair or clothing.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 3 1 2006

Ms. Staci Ellis Senior Regulatory Affairs Specialist Medtronic MiniMed 18000 Devonshire Street Northridge, California 91325

Re: K053177

Trade/Device Name: Medtronic MiniMed Paradigm Model MMT-712E Insulin Pump Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG Dated: November 14, 2005 Received: November 15, 2005

Dear Ms. Ellis:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{2}------------------------------------------------

Page 2 – Ms. Ellis

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

## Indications for Use

510(k) Number (if known):

Device Name:__________________________________________________________________________________________________________________________________________________________________ Medtronic MiniMed Paradigm Model MMT-712E Insulin Pump

Indications For Use: The Medtronic MiniMed Paradigm Model 712E Insulin Pump is intended for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

.. .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

For and in they, Caneral Houption, ი Control, Dental-LippigaSral Meastel, esobrad: Brund Devload

Page 1 of 1

.

K+S3177