MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1

K052431 · Medtronic Minimed · FPK · Nov 29, 2005 · General Hospital

Device Facts

• Record ID: K052431
• Device Name: MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1
• Applicant: Medtronic Minimed
• Product Code: FPK · 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® Leapfrog II Infusion Sct, models MMT-801S1, MMT-801L1, MMT-801L2, MMT-801L2, MMT-803S1, MMT-803L1. MMT-80352, and MMT-803L2 are 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; connects to external infusion pump via female Luer connector; delivers medication through multi-layer tubing to indwelling FEP catheter. Catheter inserted into subcutaneous tissue using removable introducer needle; needle housed in plastic hub with guard. Base unit includes adhesive patch for skin securement; features modified attachment mechanism with multiple alignment/locking sites for connection/disconnection. Used by patients in home or clinical settings to facilitate insulin delivery; enables continuous subcutaneous infusion; provides secure, reliable site for medication administration.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Single-use infusion set; indwelling catheter made of Fluorinated Ethylene (FEP); multi-layer tubing; plastic base unit with integral adhesive patch; removable introducer needle with plastic hub and guard; female Luer connector. Features modified attachment mechanism with multiple alignment and locking sites.

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

• Unomedical A/S (formerly Maersk Medical) Contour Infusion Set (Quick-set®)
• Avail Medical Products Inc. Sof-Site™ Infusion Set (MMT-358S6, MMT-358M6, MMT-358L6, MMT-358S9, MMT-358M9, MMT-358L9)

Submission Summary (Full Text)

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52431/

## NOV 2 9 2005

Medtronic MiniMed Inc. Premarket Notification -- 510(k)

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Medronic MiniMed Leapfrog II Infusion Sets, Models MMT-80151, MMT-80152, MMT-801L2, MMT-801L2, MMT-803S1, MMT-803S1, MMT-803L1, MMT-803S2, and MMT-803L2

## SECTION C. 510(k) Summary

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: Jodic Rogers [phone]

Name of Device: Medtronic MiniMed® Leapfrog II Infusion Sct

Predicate Device: Unomedical A/S (formerly Maersk Medical), model Contour Infusion Set (Quick-set®), and Avail Medical Products Inc., Sof-Site™ Infusion Set, models MMT-358S6, MMT-358M6, MMT-358L6, MMT-358S9, MMT-358M9, and MMT-358L9.

Description of the New Device: The Medtronic MiniMed® Leapfrog II Infusion Sct. models MMT-801S1, MMT-801L1, MMT-801L2, MMT-801L2, MMT-803S1, MMT-803L1, MMT-803S2, and MMT-803L2, 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 female Luer connector and is inserted into the subcutancous 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 subcutaneous 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® Leapfrog II Infusion Sct, models MMT-801S1, MMT-801L1, MMT-801L2, MMT-801L2, MMT-803S1, MMT-803L1. MMT-80352, and MMT-803L2 are 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 Meduonic MiniMed IM Sof-site is a Trademark of Medtronic MiniMed

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Medtronic MiniMed Inc. Premarket Notification - 510(k) I Moducano MiniMed Leapfrog II Infusion Sets, Models MMT-801 St, MMT-801S2, MMT-801L2, MMT-801S2, MMT-801S2, MMT-803L1, MMT-803S2, and MMT-803L2

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.

ib Fullone

Mark Faillace, Sr. Director Regulatory Affairs and Product Reporting

^@MiniMed, and Quick-set, are Registerod Trademarks of Medtronic MiniMed ** Sof-site is a Trademark of Medtronic MiniMed

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its head facing left and three horizontal lines above it, representing the agency's commitment to health and human services. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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: K052431

Trade/Device Name: Medtronic MiniMed Leapfrog II Infusion Set, Models MMT-801S1, MT-801L1, MMT-801S2, MMT-801L2, MMT-803S1, MMT-803L1, MMT-803S2 and MMT-803L2 Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPK 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 vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), n Jase 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) Medronic MiniMed LeapIrog II Infusion Sets, Models MMT-801S1, MMT-801S2, MMT-801L2, MMT-801L2, MMT-803S1, MMT-803L1, MMT-803S2, and MMT-803L2

## INDICATIONS FOR USE

11052431 510(k) Number:

Medtronic MiniMed Leapfrog II Infusion Set, models MMT-Device Name: 801SI, MMT-801LI, MMT-801S2, MMT-801L2, MMT-803S1, MMT-803L1, MMT-803S2. and MMT-803L2

The Medtronic MiniMed Leapfrog II Infusion Set is Indications for Use: 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)

Ques

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Mision of Anesthesiciology, General Hospital,
Mision Oratcal, Dental Devices

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