MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODELS MMT-515 AND MMT-715

K040676 · Medtronic Minimed · LZG · May 21, 2004 · General Hospital

Device Facts

• Record ID: K040676
• Device Name: MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODELS MMT-515 AND MMT-715
• Applicant: Medtronic Minimed
• Product Code: LZG · General Hospital
• Decision Date: May 21, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medtronic MiniMed Paradigm Model 515 and Model 715 Insulin Pumps are 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 pumps; deliver U100 insulin at set/variable basal rates (0.00-35.00 units/hr) and meal boluses (up to 25.00 units). MMT-515 uses 1.5 ml reservoir; MMT-715 uses 1.5 ml or 3.0 ml reservoirs. Operated by patients for diabetes management. Includes Bolus Wizard upgrades and user interface improvements. Provides continuous insulin infusion to maintain glycemic control.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and bench testing.

Technological Characteristics

External portable infusion pump; U100 insulin delivery; basal/bolus functionality. MMT-515 (1.5 ml reservoir) and MMT-715 (1.5/3.0 ml reservoirs). Software includes Bolus Wizard feature. Class II device (Product Code: LZG).

Indications for Use

Indicated for continuous insulin delivery for management of diabetes mellitus in persons requiring 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

• Medtronic MiniMed Paradigm Model 712 Insulin Pump

Submission Summary (Full Text)

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MAY 2 1 2004

## 510(k) Summary SECTION D.

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

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

Contact: Mirielle Mengotto [phone]

| Name of Device: | Medtronic MiniMed Paradigm Model 515 Insulin Pump |
|---------------------------------------------------|---------------------------------------------------|
| Medtronic MiniMed Paradigm Model 715 Insulin Pump | |

- Modtronic MiniMed Paradigm Model 512 Insulin Pump Predicate Device: Medtronic MiniMed Paradigm Model 712 Insulin Pump
Description of the Device: The Paradigm Model 515 and 715 are external, portable insulin purrips, designed for continuous delivery of insulin. They are designed to deliver 0.00 to 35.00 units of U100 insulin per hour in basal rates and up to 25.00) units of U100 insulin per meal bolus.

The difference between the MMT-515 and 715 pumps is the reservoir size. The MMT-515 will be compatible with a 1.5 ml reservoir and MMT-715 can be used with both the 3.0 and the 1.5 ml reservoirs.

Intended Use of the Device: The Medtronic MiniMed Paradigm Model 515 and Model 715 Insulin Pumps are 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 prodicate devices have similar materials and basic design. The new devices will have hardware as well as software modifications including the Bolus Wizard upgrades and other user improvements.

s software modifications including

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9/12 Date

Gerda Resch Manager, Regulatory Affairs Medtronic MiniMod

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 1 2004

Ms. Mirielle Mengotto Senior Regulatory Affairs Specialist Medtronic MiniMed 18000 Devonshire Street Northridge, California 91325-1219

Re: K040676

Trade/Device Name: Medtronic MiniMed Paradigm MMT-515/715 Insulin Pumps Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG Dated: March 11, 2004 Received: March 15, 2004

Dear Ms. Mengotto:

We have reviewed your Section 510(k) promarket 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.

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Page 2 - Ms. Mengotto

Please be advised that FDA's issuance of a substantial equivalence determination does not r lease to acribed that made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of all - Pourier and stills requirements, including, but not limited to: registration r od linest comply wart 807); labeling (21 CFR Part 801); good manufacturing practice alle listing (21 er reas on the quality systems (QS) regulation (21 CFR Part 820); and if requirements as bet form 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) This feter "hiffication. The FDA finding of substantial equivalence of your device to a premainer nemreans and 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), 11 you desire specific advise 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 may other 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/dsma/dsmamain.html

Sincerely yours,

Rreps

Chiu Lin, Ph.D Director Division of Anesthesiology, Gencral Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known):

Device Name:

Indications For Use:

Medtronic MiniMed Paradigm MMT-515/715 Insulin Pumps

The Medtronic MiniMed Paradigm Model MMT-515/715 Insulin Pumps are indicated for the continuous delivery of insulin, at set r anips are harvs, for the management of diabetes mellitus in persons requiring insulin.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRII, Office of Device Evaluation (ODE)

Kola Hubbard for Britton Watson
(Division-City or Town)

ision of Anesthesiolog y, General Hospital, Infection Control, Denta

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510(k) Number: K040676