MEDTRONIC MINIMED PARADIGM POLYFIN QR, MODEL MMT 312L AND 312S

K031917 · Medtronic Minimed · FPA · Aug 19, 2003 · General Hospital

Device Facts

• Record ID: K031917
• Device Name: MEDTRONIC MINIMED PARADIGM POLYFIN QR, MODEL MMT 312L AND 312S
• Applicant: Medtronic Minimed
• Product Code: FPA · General Hospital
• Decision Date: Aug 19, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medtronic MiniMed Paradigm Polyfin QR MMT-312L and MMT-312S are intended for the subcutaneous infusion of medicine, including insulin, from a Medtronic MiniMed Paradigm infusion pump. The set is not intended for use with blood.

Device Story

Disposable, single-use infusion set; connects to Medtronic MiniMed Paradigm external microinfusion pumps for subcutaneous delivery of medicine, including insulin. Device features proprietary connector for Paradigm reservoir interface; replaces standard luer connection found in predicate. Used in clinical or home settings by patients or caregivers to facilitate continuous or bolus medication delivery. Output is physical delivery of medication to subcutaneous tissue; enables automated pump-driven therapy. Not intended for blood infusion.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Disposable, single-use subcutaneous infusion set. Features proprietary connector for Paradigm reservoir interface. Materials and basic design consistent with predicate. Non-electronic, mechanical device.

Indications for Use

Indicated for subcutaneous infusion of medicine, including insulin, via Medtronic MiniMed Paradigm infusion pump. Not for use with blood.

Regulatory Classification

Identification

An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

Special Controls

*Classification.* Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.

Predicate Devices

• Polyfin™ QR® with Wings Infusion set, Model MMT-365 and MMT-366

Submission Summary (Full Text)

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## AUG 1 9 2003

K031917

Medtronic MiniMed Inc. Premarket Notification-510 (k) Medtronic MiniMed Paradigm Polyfin QR Model MMT-312L/ 312S Infusion set

#### SECTION C. 510(k) Summary

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™ Polyfin® QR® Infusion set, Model MMT-312L and MMT-312S

Predicate Device: Polyfin™ QR® with Wings Infusion set, Model MMT-365 and MMT-366

Description of the Device: The Paradigm Polyfin QR MMT-312L and MMT-312S are disposable single-use infusion set intended for use with Medtronic MiniMed external microinfusion pumps.

Intended Use of the Device: The Medtronic MiniMed Paradigm Polyfin QR MMT-312L and MMT-312S are intended for the subcutaneous infusion of medicine, including insulin, from a Medtronic MiniMed Paradigm infusion pump. The set is not intended for use with blood.

Comparison of the Technological Features of the New Device and Predicate Device: The new and predicate devices have similar materials and basic design. The new devices include a proprietary connector for connection to a Paradigm reservoir whereas the predicate devices use a standard luer connection.

Amor

Gerda Resch Manager, Regulatory Affairs Medtronic MiniMed

8/13/03

Date

R nd QR are Registered Trademarks of Medtronic MiniMed

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Image /page/1/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the border of the circle. In the center of the seal is an abstract image of an eagle.

AUG 1 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K031917

Trade/Device Name: Medtronic MiniMed Paradigm™ Polyfin® QR ® Model MMT-312L and MMT-312S Infusion Set Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: June 20, 2003 Received: June 24, 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 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/dsma/dsmamain.html

Sincerely vours.

Susan Runne

Susan Runner, DDDS, 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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K031917

# INDICATIONS FOR USE

### 510(k) Number:

Medtronic MiniMed Paradigm™ Polyfin® QR® Model Device Name: MMT-312L and MMT-312S Infusion set

The Medtronic MiniMed Paradigm Polyfin QR MMT-312L Indications for Use: and MMT-312S are intended for the subcutaneous infusion of medicine, including insulin, from a Medtronic MiniMed Paradigm infusion pump. The set is not intended for use with blood.

Patricia Crescent

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

510(k) Number: KD31917

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use**
(Per 21 CFR 801.109)

or

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________