MEDTRONIC MINIMED PARADIGM RESERVOIR, MODEL MMT-332

K032005 · Medtronic Minimed · FRN · Aug 22, 2003 · General Hospital

Device Facts

• Record ID: K032005
• Device Name: MEDTRONIC MINIMED PARADIGM RESERVOIR, MODEL MMT-332
• Applicant: Medtronic Minimed
• Product Code: FRN · General Hospital
• Decision Date: Aug 22, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medtronic MiniMed Paradigm Reservoir MMT-332 is indicated for the subcutaneous infusion of medication, including insulin, from the Paradigm family of infusion pumps and infusion sets. The reservoir is not indicated for use with blood.

Device Story

Medtronic MiniMed Paradigm Reservoir MMT-332 is a disposable, single-use medication container; designed for use with Paradigm family external micro infusion pumps. Reservoir includes plunger rod and transfer guard for filling from medication vials. Device facilitates subcutaneous delivery of insulin; not for use with blood. Used in clinical or home settings by patients or caregivers. Output is the contained medication delivered via pump mechanism. Benefits include safe, controlled medication storage and delivery interface for infusion therapy.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Disposable, single-use medication reservoir. Includes plunger rod and transfer guard. Designed for integration with Paradigm family infusion pumps. Materials and specific technical standards not disclosed in provided text.

Indications for Use

Indicated for subcutaneous infusion of medication, including insulin, via Paradigm family infusion pumps and sets. Not indicated for use with blood.

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™ Reservoir Model MMT-326

Submission Summary (Full Text)

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K032005

Modtronic MiniMod Premarket Notification - 510(k) Paradigm™ Reservoir MMT-332 AUG 2 2 2003

## Section C. 510(k) Summary

In accordance with the requirements of SMDA 1990, and 21 CFR 807.92, a 510(k) Summary follows:

Submitter: Medironic MiniMed 18000 Devonsbire Street Northridge California 9132.5

Contact: Mirielle Mengotto [phone]

Name of Device: Mcdtronic MiniMed Paradigm™ Reservoir Model MMT-332

Predicate Device: Medtronic MiniMed Paradigm™ Reservoir Model MMT-326

Description of the Device: The Medtronic MiniMed Paradigm Reservoir Model MMT-332 is a disposable, single use medication container intended for use with the Mediconic MiniMed external micro infusion pumps. The reservoir shall be packaged together with a plunger rod and a transfer guard for use in filling the reservoir from a medication vial.

The modifications which are the subject of this premarker notification have no untoward effect on the safety and offectiveness of the device.

Intended Use of the Device: The Meditoric MiniMed Paradigm Reservoir MMT-332 is indicated for the subcutaneous infusion of medication, insulin, from the Paradigm family of infusion pumps and infusion sets. The reservoir is not indicated for use with blood

Comparison of the Technological Features of the New and Predicate Devices: The new device is substantially equivalent to the lawfully marketed predicate device. They differ in volume, filling mechanism, and infusion set connector.

1 Or

Gerda Resch Manager Regulatory Affairs Medtronic MiniMed

Date

CONFIDENTIAL

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Image /page/1/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 a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 2 2003

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

Re: K032005

Trade/Device Name: Medtronic MiniMed Paradigm Reservoir MMT-332 Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: June 26, 2003 Received: June 30, 2003

Dear Ms. Mengotto:

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. Mengotto

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 (OS) 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 mr rketed 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/dsma/dsmamain.html

Sincerely yours,

Susan Runner

Susan Runner, DDS, MA Interim 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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K032005

Medtronic MiniMed Premarket Notification - 510(k) Paradigm™ Reservoir MMT-332

## INDICATIONS FOR USE

510(k) Number:

Device Name:

Medtronic MiniMed Paradigm Reservoir MMT-332

Indications for Use:

The Medtronic MiniMed Paradigm Reservoir MMT-332 is indicated for the subcutaneous infusion of medication, including insulin, from the Paradigm family of infusion pumps and infusion sets. The reservoir is not indicated for use with blood.

Patricia Cascente

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

510(k) Number:_

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

Prescription Use (Per 21 CFR 801.109)

or

Over-the-Counter Use