MINIMED SOF-SET ULTIMATE QR INFUSION SET MODELS 315 AND 316

K974163 · Medtronic Minimed · FPA · Feb 2, 1998 · General Hospital

Device Facts

• Record ID: K974163
• Device Name: MINIMED SOF-SET ULTIMATE QR INFUSION SET MODELS 315 AND 316
• Applicant: Medtronic Minimed
• Product Code: FPA · General Hospital
• Decision Date: Feb 2, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MiniMed Sof-set Ultimate QR is 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 or blood products.

Device Story

Infusion administration set for subcutaneous delivery of insulin/medication from external infusion pump; connects proximally to medicine reservoir via female Luer connector; inserts distally into subcutaneous tissue via 26-gauge stainless steel introducer needle; features 24-gauge FEP Teflon indwelling catheter. Hub includes winged configuration for handling/stability; incorporates antibacterial dressing and adhesive dressing for securement. Used in clinical or home settings by patients or caregivers. Modifications from predicate include flatter/smoother hub/wings, clear catheter, rotated adhesive tab for auto-inserter compatibility, IV 3000 adhesive tape, and higher-density polyethylene tubing liner. Higher-density liner increases sensitivity of pump occlusion alarms. Device facilitates continuous subcutaneous insulin infusion (CSII) therapy, improving patient convenience and alarm reliability.

Clinical Evidence

No clinical data. Substantial equivalence based on technological characteristics and design modifications.

Technological Characteristics

Indwelling catheter: FEP Teflon. Tubing: PVC with high-density polyolefin liner. Introducer needle: 304 stainless steel. Hub: Winged configuration. Adhesive: IV 3000. Connectivity: Mechanical Luer connection to external infusion pump reservoir. Sterilization: Not specified.

Indications for Use

Indicated for subcutaneous delivery of medicine, including insulin, from an external infusion pump to patients requiring such therapy.

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

• MiniMed Sof-set QR infusion sets, models 115 and 116

Submission Summary (Full Text)

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MiniMed Inc. Premarket Notification - 510(k) Sof-set Ultimate QR infusion set, models 315 and 316

## Part E. 510(k) Summary

Submitter: MiniMed® Inc. 12744 San Fernando Rd., Sylmar, California 91342.

Contact: Don Selvey, Regulatory Affairs [phone], 3011; [phone] (v/t).

Name of Device: MiniMed® Sof-set® Ultimate QR® infusion sets, models 315 and 316.

Predicate Device: MiniMed Sof-set QR infusion sets, models 115 and 116.

Description of the New Device: The MiniMed Sof-set Ultimate QR infusion sets, models 315 and 316, are infusion administration sets, connecting to a medicine reservoir proximally, and inserted in the subcutaneous tissue of a user distally by means of an introducer needle. The reservoir to which the infusion set attaches proximally is inserted into an external infusion pump, such as the MiniMed 507 insulin pump.

The administration set attaches to the reservoir syringe by means of a female Luer connector, and subcutaneously in the user through an indwelling catheter made of FEP Teflon. The tubing is made of polyvinyl chloride (PVC) with a polyolefin liner. This configuration of PVC and polyolefin has been trademarked by MiniMed as Polyfin.

The 24 gauge indwelling catheter is introduced into the subcutaneous tissue by a removable 26 gauge introducer needle made of 304 stainless steel. The needle, indwelling catheter, and tubing share a common hub. The hub incorporates a winged configuration to facilitate handling of the administration set during insertion and stability following insertion.

On the skin-contact side of the wings, around the Teflon catheter, is an antibacterial dressing. Additionally, an adhesive dressing covers the wings of the administration set, securing the subcutaneous catheter and infusion line to the user.

Intended Use of the New Device: The MiniMed Sof-set Ultimate QR is 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 or blood products.

®MiniMed, Sof-set, and QR are registered trademarks of MiniMed Inc.

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MiniMed Inc. Premarket Notification - 510(k) Sof-set Ultimate QR infusion set, models 315 and 316

Comparison of the Technological Features of the New Device and Predicate Device: The modified devices are substantially similar to the lawfully marketed predicate devices. Both are intended for subcutaneous delivery insulin or other appropriately labeled medicines from an infusion pump to the pump user. Both sets attach proximally to a reservoir by means of a Luer connector, and insert distally into the device user's subcutaneous tissues with a removable stainless steel needle and flexible catheter. Both devices are made of substantially similar materials.

Several differences exist between the new and predicate device:

1) changes in the shape/configuration of the hub and wings to be flatter and smoother;

2) the indwelling catheter is clear instead of white;

3) a change in the adhesive tab to be slightly longer and rotated 90°, facilitating tab removal prior to insertion and use with an auto inserter device;

4) a change in the adhesive tape: the infusion set will be secured with IV 3000, a product of Smith & Nephew;

5) a change in the polyethylene plastic in the inner layer of the tubing, from low density to a higher density. This has resulted in a more sensitive occlusion alarm, which will be promoted by MiniMed.

These modifications do not affect the safety or effectiveness of the device.

Signed,

Don Selvey 10-27-97
date

Regulatory Affairs MiniMed Inc.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized eagle emblem. The eagle is depicted with its head facing left and its wings spread, creating a sense of strength and protection. The overall design is simple and professional, reflecting the department's role in promoting the health and well-being of the nation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 1998

Mr. Don Selvey Requlatory Affairs MiniMed® Incorporated 12744 San Fernando Road Sylmar, California 91342

K974163 Re: MiniMed® Sof-set® Ultimate QR® infusion Trade Name: sets, models 315 and 316 Regulatory Class: II Product Code: FPA Dated: October 27, 1997 Received: November 5, 1997

Dear Mr. Selvey:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895 .... A ... ................................................................................................................... substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does

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Page 2 - Mr. Selvey

not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Directd Division of Dental, Infection Control and General Hospital Devices 10000000 Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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MiniMed Inc. Premarket Notification - 510(k) Sof-set Ultimate QR infusion set, models 315 and 316

## INDICATIONS FOR USE

510(k) Number:

MiniMed Sof-set Ultimate QR infusion sets, models 315 Device Name: and 316. Indications for Use: The MiniMed Sof-set Ultimate QR infusion set is indicated for the subcutaneous delivery of medicine, including insulin, from an external infusion pump.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patrick Cassinite

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number 的

Prescription Use (Per 21 CFR 801.109)

or

Over-the-Counter Use