MEDTRONIC MINIMED SOF-SITE INFUSION SET, MODELS MMT-359S6, MMT-359M6, MMT-359L6, MMT-359S9, MMT-359M9, AND MMT-359L9

K030149 · Avail Medical Products, Inc. · FPA · Mar 20, 2003 · General Hospital

Device Facts

• Record ID: K030149
• Device Name: MEDTRONIC MINIMED SOF-SITE INFUSION SET, MODELS MMT-359S6, MMT-359M6, MMT-359L6, MMT-359S9, MMT-359M9, AND MMT-359L9
• Applicant: Avail Medical Products, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Mar 20, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medtronic MiniMed Paradigm Sof-site, model: MMT-359S6, MMT-359M6, MMT-359L6, MMT-359S9, MMT-359M9, and MMT-359L9, are intended for the subcutaneous infusion of medicine, including insulin, from a Medtronic MiniMed infusion pump. The set is not intended nor indicated for use with blood.

Device Story

Infusion administration set connecting to Medtronic MiniMed medication reservoir; proprietary connector; multi-layer tubing; indwelling catheter; removable introducer needle; plastic needle hub; plastic needle guard; adhesive patch. Introducer needle inserts catheter into subcutaneous tissue; needle guard removed prior to insertion; base unit secures to skin via adhesive. Used for insulin delivery from infusion pump. No electronic or software components.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Infusion set consisting of multi-layer tubing, indwelling catheter, plastic base unit, and adhesive patch. Includes removable introducer needle with plastic hub and guard. Proprietary connector for medication reservoir. Mechanical device; no energy source or software.

Indications for Use

Indicated for subcutaneous infusion of medicine, including insulin, from a Medtronic MiniMed 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

• Medtronic MiniMed Paradigm Quick-set (MMT-396, MMT-397, MMT-398, MMT-399)
• Medtronic MiniMed Paradigm Sof-set Ultimate QR (MMT-317, MMT-318)

Submission Summary (Full Text)

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Avail Medical Products, Inc., Premarket Notification - 510(k), Paradigm Set, Models MMT-359S6, MMT-359M6, MMT-359L6, MMT-359S9, MMT-359M9, MMT-359L9 Page 10 of 177

K030149

Section C. 510(k) Summary

Submitter: Avail Medical Products, Inc. 201 Main Street. Suite 1600 Fort Worth, Texas 76102

Contact: Courtland Imel [phone]

Name of Device: Medtronic® MiniMed® Paradigm® Sof-site

Predicate Device: Medtronic® MiniMed® Paradigm™ Quick-set™, models MMT-396, MMT-397, MMT-398, and MMT-399 and Medtronic® MiniMed® Paradigm™ Sof-set™ ! . ! timate™ QR® infusion sets, models MMT-317 and MMT-318

Description of the New Device: The Medtronic MiniMed Paradigm Sof-site infusion sets, models MMT-359S6, MMT-359M6, MMT-359L6, MMT-359S9, MMT-359M9, and MMT-359L9, are infusion administration sets that connect to a Medtronic MiniMed medication reservoir.

The infusion sets attach to the medication reservoir by means of a proprietary connecter. Fluid is administered through multi-layer tubing to an indwelling catheter. The indwelling catheter is introduced into the subcutaneous tissue of the user 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. 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 Sof-site, model: MMT-359S6, MMT-359M6, MMT-359L6, MMT-359S9, MMT-359M9, and MMT-359L9, are intended for the subcutaneous infusion of medicine, including insulin, from a Medtronic MiniMed infusion pump. The set is not intended nor indicated for use with blood.

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 distal connect mechanism. The modified mechanism does not require specific alignment to the site as is currently required in the predicate devices. This modification does not affect the safety or effectiveness of the device.

Signed.

Courtland Imel

Courtland Imel Manager, Quality Avail Medical Products, Inc.

@MiniMed, Quick-setter, Quick-set, Soft-set Utimate QR, Soft-set, and OR are Registered Trademarks of Meduronic MiniMed TMParadigm, Ouick Release, Ultimate, and Sof-site are Trademarks of Medtronic MiniMed.

MAR 2 0 2003

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 three profiles facing right, resembling a bird or a symbol of human connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 0 2003

Ms. Carroll Councilman Avail Medical Products, Incorporated 1900 Carnegie Avenue Santa Ana, California 92705

Re: K030149

Trade/Device Name: Medtronic MiniMed Paradigm Sof-site Infusion Sets, Models MMT359S6, MMT359M6, MMT359L6, MMT359S9, MMT359M9 and MMT359L9 Regulation Number: 880.5440 Regulation Name: Intravascular Administrative Set Regulatory Class: II Product Code: FPA Dated: January 14, 2003 Received: January 15, 2003

Dear Ms. Councilman:

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 mav, 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. Councilman

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/dsma/dsmamain.html

Sincerely vours.

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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Avail Medical Products, Inc., Premarket Notification - 510(k), Paradigm Set, Models MMT-359S6, MMT-359M6, MMT-359L6, MMT-359S9, MMT-359M9, MMT-359L9 Page 12 of 177

K030/49

## INDICATIONS FOR USE

510(k) Number:

| Device Name: | Medtronic MiniMed Paradigm Sof-site infusion sets, models<br>MMT359S6, MMT359M6, MMT359L6, MMT359S9,<br>MMT359M9, and MMT359L9 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: | The Medtronic MiniMed Paradigm Sof-site infusion sets are<br>indicated for the subcutaneous infusion of medicine,<br>including insulin, from a Medtronic MiniMed infusion<br>pump. |

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

or

Over-the-Counter Use __________

Patrice Crescent

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

CONFIDENTIAL

510(k) Number. 6030

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