POLYFIN INFUSION SET MMT-106/MMT-107/MMT-133

K961474 · Medtronic Minimed · FPA · May 6, 1996 · General Hospital

Device Facts

• Record ID: K961474
• Device Name: POLYFIN INFUSION SET MMT-106/MMT-107/MMT-133
• Applicant: Medtronic Minimed
• Product Code: FPA · General Hospital
• Decision Date: May 6, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the new device is subcutaneous infusion of medicine, including insulin, from an external pump, for up to 48 hours.

Device Story

Polyfin infusion set (Models MMT-106, MMT-107, MMT-133) facilitates subcutaneous delivery of medication, including insulin, from portable external pumps. Device connects to pump reservoir via Luer connection; delivers fluid to subcutaneous site. Intended for use up to 48 hours. Designed for MiniMed pumps; compatible with other pumps supporting Luer connections, provided prescriber ensures delivery accuracy. Used by patients or clinicians in home or clinical settings. Benefits include reliable, temporary subcutaneous access for medication administration.

Clinical Evidence

Bench testing only; biocompatibility testing performed per ISO 10993 standards.

Technological Characteristics

Subcutaneous infusion set with Luer connection. Materials tested for biocompatibility per ISO 10993. Designed for 48-hour use duration.

Indications for Use

Indicated for patients requiring subcutaneous infusion of medicine, including insulin, from an external pump for up to 48 hours.

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

• Pacesetter infusion set, model 124 and 142 (K838445A)
• Sof-set® Infusion Set, Models MMT-111 and MMT-112 (K861436)

Submission Summary (Full Text)

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K961474

MAY -6 1996

# Part H. Polyfin® Infusion Set 510(k) Summary

This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92:

A. Submitter: MiniMed®, Inc. 12744 San Fernando Road, Sylmar, California 91342. Contact: Don Selvey, Regulatory Affairs and Clinical Research [phone], Ext. 3011. FAX: [phone] (V/F).

B. Name of the device: Polyfin® infusion set, Models MMT-106, MMT-107, and MMT-133.

C. Predicate device: Pacesetter infusion set, model 124 and 142 (K838445A); Sof-set® Infusion Set, Models MMT-111 and MMT-112 (K861436).

D. Description of new device: This infusion set is intended for the administration of medicine, including insulin, from a portable, external pump to a subcutaneous infusion site, for up to 48 hours. The infusion set is designed to be used in conjunction with a MiniMed infusion pump, but may be used in other pumps capable of supporting a Luer connection to a reservoir; however, care must be exercised by the prescriber and user to ensure delivery accuracy if used with other devices.

Device materials have been successfully tested for biocompatibility. All components having contact with solutions being administered meet the ISO 10993 standard for medical devices of this type.

E. Intended use of the new device: The intended use of the new device is subcutaneous infusion of medicine, including insulin, from an external pump, for up to 48 hours.

F. Comparison of the technological features of the new device and predicate device: This device was initially introduced by Pacesetter as a subcutaneous infusion set, models 124 and 142. Several individually non-significant modifications have been made to this device since its initial introduction to the marketplace.

Signed,


Terrance H. Gregg, Executive Vice President Operations


MiniMed, Polyfin, and Sof-Set are Registered Trademarks of MiniMed, Inc.

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