MEDTRONIC MINIMED PARADIGM MODEL 511 INSULIN PUMP

K041318 · Medtronic Minimed · LZG · Jul 19, 2004 · General Hospital

Device Facts

• Record ID: K041318
• Device Name: MEDTRONIC MINIMED PARADIGM MODEL 511 INSULIN PUMP
• Applicant: Medtronic Minimed
• Product Code: LZG · General Hospital
• Decision Date: Jul 19, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medtronic MiniMed Paradigm Model 511 Insulin Pump 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

Medtronic MiniMed Paradigm Model 511 is an external infusion pump for continuous subcutaneous insulin delivery. Device manages diabetes mellitus by delivering insulin at set and variable rates. Operated by patient or caregiver; provides basal and bolus insulin delivery to maintain glycemic control. Device functions as a portable infusion system; replaces manual injections. Healthcare providers program delivery parameters based on patient needs. Benefits include improved glycemic management through precise, continuous insulin administration.

Clinical Evidence

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

Technological Characteristics

External infusion pump; continuous subcutaneous insulin delivery; battery-powered; portable form factor; software-controlled delivery rates.

Indications for Use

Indicated for continuous insulin delivery in patients with diabetes mellitus requiring insulin therapy.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized representation of a caduceus, a symbol often associated with healthcare. The caduceus consists of a staff with two snakes coiled around it and wings at the top.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 9 2004

Ms. Gerda P. Resch, MT, RAC Manager, Regulatory Affairs Medtronic MiniMed 18000 Devonshire Street Northridge, California 91325-1219

Re: K041318

Trade/Device Name: Medtronic MiniMed Paradigm Model 511 Insulin Pump Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG Dated: July 8, 2004 Received: July 12, 2004

Dear Ms. Resch:

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.

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Page 2 - Ms. Resch

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 vour 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/dsma/dsmamain.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

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## INDICATIONS FOR USE

## 510(k) Numbers:

| Device Names: | Medtronic MiniMed Paradigm Model 511 Insulin Pump |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: | The Medtronic MiniMed Paradigm Model 511 Insulin Pump<br>is indicated for the continuous delivery of insulin, at set and<br>variable rates, for the management of diabetes mellitus in<br>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)

Ar Vm

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

510(k) Number: _ Kuy 13/8

Confidential 10