MEDTRONIC MINIMED SOF-SITE INFUSION SET, MODELS MMT-358S6, MMT-358M6, MMT-358L6, MMT-358S9, MMT-358M9, AND MMT-358L9

K030137 · Avail Medical Products, Inc. · FPA · Feb 19, 2003 · General Hospital

Device Facts

• Record ID: K030137
• Device Name: MEDTRONIC MINIMED SOF-SITE INFUSION SET, MODELS MMT-358S6, MMT-358M6, MMT-358L6, MMT-358S9, MMT-358M9, AND MMT-358L9
• Applicant: Avail Medical Products, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Feb 19, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medtronic MiniMed Sof-site infusion sets, models MMT-358S6, MMT-358M6, MMT-358L6, MMT-358S9, MMT-358M9, and MMT-358L9, are intended for the subcutaneous infusion of medicine, including insulin, from a external infusion pump. The set is not intended nor indicated for use with blood.

Device Story

Infusion administration set connecting to Medtronic MiniMed medication reservoir via female Luer connector; delivers fluid through multi-layer tubing to indwelling catheter. Catheter introduced into subcutaneous tissue using removable introducer needle housed in plastic hub with needle guard. Base unit includes integral adhesive patch for skin securement; provides site for connection/disconnection. Device allows subcutaneous medication delivery from external infusion pump. Modification from predicate includes at-site connection mechanism requiring no specific alignment. Used by patients or clinicians for insulin/medication delivery.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Infusion set with multi-layer tubing, indwelling catheter, introducer needle, and plastic base unit with adhesive patch. Connects to medication reservoir via female Luer connector. Non-electronic, mechanical device.

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

• Maersk Medical Quick-set (model Contour)
• Medtronic MiniMed Sof-set Ultimate OR infusion sets (models MMT-315 and MMT-316)

Submission Summary (Full Text)

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Avail Medical Products, Inc., Premarket Notification - 510(k), Sof-site Infusion Set, Models MMT-358S6, MMT-358M6, MMT-358L6, MMT-358S9, MMT-358M9, MMT-358L9 KO30137 Page 10 of 173

### Section C. 510(k) Summary

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

FEB 1 9 2003

Contact: Courtland Imel [phone]

Name of Device: Medtronic® MiniMed® Sof-site

Predicate Device: Maersk Medical Quick-set®, model Contour, and Medtronic® MiniMed® Sof-set® Ultimate® OR® infusion sets, models MMT-315 and MMT-316.

Description of the New Device: The Medtronic MiniMed Sof-site infusion sets, models MMT-358S6. MMT-358M6. MMT-358L6. MMT-358S9. MMT-358M9. and MMT-358L9, are infusion administration sets that connect to a Medtronic MiniMed medication reservoir.

The infusion sets attach to the medication reservoir by means of a female Luer connector. 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 Sof-site infusion sets, models MMT-358S6, MMT-358M6, MMT-358L6, MMT-358S9, MMT-358M9, and MMT-358L9, are intended for the subcutaneous infusion of medicine, including insulin, from a external 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 at-site connection mechanism. The modified mechanism does not require specific alignment for attachment 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

Manager, Quality Avail Medical Products, Inc.

^@MiniMed, Quick-setter, Quick-set, Soft-set Ultimate QR, Soft-set, and QR are Registered Trademarks of Medtronic MiniMed TMParadigm, Quick Release, Ultimate, and Sof-site are Trademarks of Medtronic MiniMed Inc.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## FEB 1 9 2003

Mr. Courtland Imel Quality Manager Avail Medical Products 8300 Esters Road, Suite 930 Irving, Texas 75063

Re: K030137

Trade/Device Name: Medtronic MiniMed Sof-site Infusion Sets, Models MMT-358S6, MMT-358M6, MMT-358L6, MMT-358S9, MMT-358M9, and MMT-358L9 Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: January 13, 2003 Received: January 14, 2003

Dear Mr. Imel:

:

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 - Mr. Imel

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 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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Avail Medical Products, Inc., Premarket Notification - 510(k), Sof-site Infusion Set, Models MMT-358S6, MMT-358M6, MMT-358L6, MMT-358S9, MMT-358M9, MMT-358L9 Page 12 of 173

# INDICATIONS FOR USE

#### 510(k) Number:

Device Name: Medtronic MiniMed Sof-site infusion sets, models MMT-358S6, MMT-358M6, MMT-358L6, MMT-358S9, MMT-358M9, and MMT-358L9 The Medtronic MiniMed Sof-site infusion sets are indicated Indications for Use:

for the subcutaneous infusion of medicine, including insulin, from a Medtronic MiniMed infusion pump.

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

or

Over-the-Counter Use

Tatian Cuciente

ivision of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number. K030137