MEDTRONIC MINIMED PARADIGM LEAPFROG II INFUSION SET, MODELS MMT-802S1, MMT-802L1, MMT-802S2, MMT-802L2

K052432 · Medtronic Minimed · FPA · Nov 29, 2005 · General Hospital

Device Facts

• Record ID: K052432
• Device Name: MEDTRONIC MINIMED PARADIGM LEAPFROG II INFUSION SET, MODELS MMT-802S1, MMT-802L1, MMT-802S2, MMT-802L2
• Applicant: Medtronic Minimed
• Product Code: FPA · General Hospital
• Decision Date: Nov 29, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medtronic MiniMed® Paradigm™ Leapfrog II Infusion Set, models MMT-802S1, MMT-802L1, MMT-802S2, MMT-802L2, MMT-804S1, MMT-804L1, MMT-804S2, and MMT-804L2 arc intended for the subcutaneous infusion of medicine, including insulin, from an external infusion pump. The set is not intended nor indicated for use with blood.

Device Story

Single-use infusion administration set for subcutaneous delivery of medication (e.g., insulin) from external infusion pump. Device consists of multi-layer tubing, proprietary proximal connector, and distal indwelling FEP catheter. Catheter inserted into subcutaneous tissue via removable introducer needle housed in plastic hub with guard. Base unit includes integral adhesive patch for skin securement and connection/disconnection site. Modified attachment mechanism provides multiple alignment and locking sites. Used by patients or clinicians in clinical or home settings. Output is continuous or bolus medication delivery; device facilitates therapy by providing reliable fluid path between pump and patient.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Fluorinated Ethylene (FEP) catheter, plastic needle hub/guard, plastic base unit. Energy source: None (passive fluid delivery). Form factor: Multi-layer tubing with proprietary connector and adhesive base. Connectivity: Mechanical interface to external infusion pump. Sterilization: Not specified.

Indications for Use

Indicated for subcutaneous infusion of medicine, including insulin, from a Medtronic MiniMed infusion pump. Not indicated 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

• Paradigm™ Quick-set® Infusion Sets (MMT-396, MMT-397, MMT-398, MMT-399)
• Paradigm™ Sof-Site™ Infusion Set (MMT-359S6, MMT-359M6, MMT-359L6, MMT-359S9, MMT-359M9, MMT-359L9)

Submission Summary (Full Text)

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## NOV 2 9 2005

Premarket Notification 510(k) Medronic MiniMed Paradigm Leapfrog II Infusion Sets, Models MMT-802L1, MMT-802L1, MMT-8021 2, MMT-80151 MMT-804LI. MMT-804S2, MMT-804L2

## SECTION C. 510(k) Summary

Medtronic MiniMed Inc.

In accordance with the requirements of SMDA 1990, and CFR 807.92, the 510(k) Summary is provided.

Submitter: Medtronic MiniMed 18000 Devonshire St. Northridge, CA 91325

Contact: Jodie Rogers [phone]

Name of Device: Medtronic MiniMed® Paradigm™ Leapfrog II Infusion Set

Predicate Device: Unomedical A/S (formerly Maersk Medical), Paradigm™ Quick-set® Infusion Sets, models MMT-396, MMT-397, MMT-398, and MMT-399, and the Avail Medical Products Inc., Paradigm™ Sof-Site™ Infusion Set, models MMT-359S6, MMT-359M6, MMT-359L6. MMT-359S9, MMT-359M9, and MMT-359L9.

Description of the New Device: The Medtronic MiniMed® Paradigm™ Leapfrog II Infusion Set, models MMT-802S1, MMT-802L1. MMT-802S2, MMT-802L2, MMT-804S1, MMT-804L1, MMT-804S2, and MMT-804L2, are single use infusion administration sets intended for use with an external infusion pump, such as the Medtronic MiniMed® infusion pump.

The infusion administration set attaches proximally to a medication reservoir by means of a proprietary connector and is inserted into the subcutaneous tissue of the user distally through an indwelling catheter made of Fluorinated Ethylene (FEP). Fluid is administered through multi-layer tubing to an indwelling catheter. The indwelling catheter is introduced into the subcutancous tissue by means of a removable introducer needle. The introducer needle is housed in a plastic needle hub and protected by a plastic needle guard. The needle guard is removed before insertion.

The indwelling catheter is affixed to a plastic base unit. The plastic base unit functions as a site for connection and disconnection. The adhesive patch is integral to the base and is used to secure the unit to the user.

Intended Use of the New Device: The Medtronic MiniMed® Paradigm™™ Leapfrog II Infusion Set, models MMT-802S1, MMT-802L1, MMT-802S2, MMT-802L2, MMT-804S1, MMT-804L1, MMT-804S2, and MMT-804L2 arc intended for the subcutaneous infusion of medicine, including insulin, from an external infusion pump. The set is not intended nor indicated for use with blood.

^@MiniMed and Quick-set are Registered Trademarks of Medtronic MiniMed

TM Paradigm and Sof-site are Trademarks of Medtronic MiniMed

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Medtronic MiniMed Inc. Premarket Notification 510(k) Mcdronic MiniMed Paradigm Leapfrog II Infusion Sets, Models MMT-802S1, MMT-802S2, MMT-802L2, MMT-8021, MMT-804L1, MMT-804S2, MMT-804L2

Comparison of the Technological Features of the New Device and Predicate Devices The modified device and the lawfully marketed predicate devices contain similar materials of construction. Features of the modified device are comparable to those of the predicate devices with the exception of the modified attachment mechanism that offers multiple alignments and locking sites for the attachment to the site connection. This modification does not affect the safety or effectiveness of the device.

Signed.

uld Follon

Mark Faillace, Sr. Director Regulatory Affairs and Product Reporting

^@MiniMed and Quick-set are Registered Trademarks of Medironic MiniMed TM Paradigm and Sof-site are Trademarks of Medtronic MiniMed

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, with three curved lines above them.

NOV 2 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Jodie Rogers, B.S. Regulatory Affairs Specialist Medtronic MiniMed 18000 Devonshire Street Northridge, California 91325-1219

Re: K052432

Trade/Device Name: Medtronic MiniMed Paradigm Leapfrog II Infusion Set, Models MMT-802S1, MMT-802L1, MMT-802S2, MMT-802L2, MMT-804S1, MMT-804L1, MMT-804S2, and MMT-804L2 Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: September 2, 2005 Received: September 6, 2005

Dear Ms. Rogers:

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. Rogers

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 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,

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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Medtronic MiniMed Inc. Premarket Notification - 510(k) Modronic MiniMod Paradigm Leapfrog II Infusion Sets, Moxicls MMT-802L1, MMT-802S2, MMT-802L2, MMT-802L2, MMT-802L2, MMT-804S1, MMT-804L1, MMT-804S2, MMT-804L2

## INDICATIONS FOR USE

510(k) Number:

| Device Name: | Medtronic MiniMed Paradigm Leapfrog II Infusion Set, models MMT-802S1, MMT-802L1, MMT-802S2, MMT-802L2, MMT-804S1, MMT-804L1, MMT-804S2, and MMT-804L2 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: | The Medtronic MiniMed Paradigm Leapfrog II Infusion Set is indicated for the subcutaneous infusion of medicine, including insulin, from a Medtronic MiniMed infusion pump. |

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH Office of Device Evaluation (ODE)

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

K052432

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