PARADIGM INSULIN INFUSION PUMP, MODELS MMT-512, MMT-712, MMT-515 AND MMT-715

K073356 · Medtronic Minimed · LZG · Apr 25, 2008 · General Hospital

Device Facts

• Record ID: K073356
• Device Name: PARADIGM INSULIN INFUSION PUMP, MODELS MMT-512, MMT-712, MMT-515 AND MMT-715
• Applicant: Medtronic Minimed
• Product Code: LZG · General Hospital
• Decision Date: Apr 25, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medtronic MiniMed Paradigm Model MMT-512, MMT-712, MMT-515 and MMT-715 insulin infusion pumps are indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.

Device Story

Paradigm insulin infusion pumps (MMT-512, MMT-712, MMT-515, MMT-715) provide continuous subcutaneous insulin delivery for diabetes management. Devices operate via user-programmed basal rates and bolus doses to manage blood glucose levels. Pumps are worn by patients; settings are adjusted by patients or caregivers based on clinical guidance. Output is insulin delivery; device provides therapeutic benefit by automating insulin administration, replacing manual injections. No specific AI/ML algorithms described; device functions as an electromechanical infusion system.

Clinical Evidence

No clinical data provided; substantial equivalence established through bench testing and comparison to predicate devices.

Technological Characteristics

Electromechanical insulin infusion pump; battery-powered; user-programmable basal/bolus delivery; subcutaneous infusion set interface. Software-controlled delivery rates.

Indications for Use

Indicated for continuous insulin delivery at set/variable rates 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 MMT-512 (K030531)
• Medtronic MiniMed Paradigm Model MMT-712 (K031390)
• Medtronic MiniMed Paradigm Model MMT-515/MMT-715 (K040676)

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Mark J. Faillace Senior Director, Regulatory Affairs and Product Reporting Medtronic MiniMed, Incorporated 18000 Devonshire Street Northridge, California 91325

APR 2 5 2008

Re: K073356

Trade/Device Name: Medtronic-MiniMed Paradigm Model: MMT-512, MMT-712, MMT-515 and MMT-715 Insulin Infusion Pumps

Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG Dated: April 1, 2008 Received: April 2, 2008

Dear Mr. Faillace:

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.

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

Page 2 - Mr. Faillace

Please be advised that FDA's issuance of a substantial equivalence determination docs 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,

Smythe y. Nickens MD.

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

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

## INDICATIONS FOR USE

| 510(k) Numbers: | K030531 (MMT-512) K031390 (MMT-712) K040676 (MMT-515/MMT-715) |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Names: | Medtronic MiniMed Paradigm Model MMT-512, MMT- 712, MMT-515 and MMT-715 insulin infusion pumps |
| Indications for Use: | The Medtronic MiniMed Paradigm Model MMT-512, MMT-712, MMT-515 and MMT-715 insulin infusion pumps are indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. |

Prescription Use _ X (Per 21 CFR 80 Subpart D)

AND/OR

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

Concurrence of CDRH, Office of Device Evaluation (ODE)

Charle Bady for Alw

(Division Sign-Off) Division of Anesthesiology, General Hospital intection Control, Dental Devices

510(k) Number: k673356