MEDTRONIC MINIMED PARADIGM INSULIN PUMPS

K120206 · Medtronic Minimed · LZG · Mar 29, 2012 · General Hospital

Device Facts

• Record ID: K120206
• Device Name: MEDTRONIC MINIMED PARADIGM INSULIN PUMPS
• Applicant: Medtronic Minimed
• Product Code: LZG · General Hospital
• Decision Date: Mar 29, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Paradigm Insulin Pump system is 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 Pump system provides continuous subcutaneous insulin infusion (CSII) for diabetes management. Device delivers insulin at set and variable rates to patients requiring insulin therapy. Operated by patients or caregivers in home or clinical settings. System functions as an infusion pump to automate insulin delivery, replacing manual injections. Healthcare providers program delivery parameters based on patient needs. Benefits include improved glycemic control through precise, continuous insulin administration.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Infusion pump system for continuous insulin delivery. Regulated under 21 CFR 880.5725 (Infusion Pump). Product codes LZG, MDS. Class II device.

Indications for Use

Indicated for persons with diabetes mellitus requiring insulin for the management of their condition via continuous 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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, with its wings spread and head facing to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Tamar Jaghasbanian Principle Regulatory Affairs Specialist Medtronic MiniMed 18000 Devonshire Street Northridge, California 91325

MAR 2 9 2012

Re: K120206

Trade/Device Name: Paradigm Insulin Pump System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG, MDS Dated: March 12, 2012 Received: March 14, 2012

Dear Ms. Jaghasbanian:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Jaghasbanian

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General 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)<br>Number | Device Name |
|------------------|---------------------------------------------------------------------------|
| | Medtronic MiniMed Paradigm Insulin Pumps (Model No. MMT-512) |
| | Medtronic MiniMed Paradigm Insulin Pumps (Model No. MMT-712) |
| | Medtronic MiniMed Paradigm Insulin Pumps (Model Nos. MMT-515,<br>MMT-715) |

## Indications for Use:

The Paradigm Insulin Pump system is indicated for the continuous delivery of insulin, at set and variable rates for the management of diabetes mellitus in persons requiring insulin.

Rijd U for RZC March 28, 2012
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:___________________

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)

## Concurrence of CDRH, Office of Device Evaluation (ODE)

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