POLYFIN QR WITH WINGS INFUSION SETS, MODELS 365, 366, AND 367

K964456 · Medtronic Minimed · FPA · Jan 30, 1997 · General Hospital

Device Facts

• Record ID: K964456
• Device Name: POLYFIN QR WITH WINGS INFUSION SETS, MODELS 365, 366, AND 367
• Applicant: Medtronic Minimed
• Product Code: FPA · General Hospital
• Decision Date: Jan 30, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Polyfin QR with Wings infusion set is intended for use as an infusion administration set for delivery of appropriately labeled fluids or solutions from an external infusion pump or syringe.

Device Story

Infusion set for subcutaneous delivery of fluids/insulin from external pump to patient; consists of tubing and needle assembly with added wings for insertion ease and needle stability; connects via Luer fitting to pump reservoir; used in clinical or home settings by patients or caregivers; facilitates continuous or intermittent medication delivery; benefits include improved handling and secure site placement.

Clinical Evidence

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

Technological Characteristics

Subcutaneous infusion set; Luer connection; includes wings for stability; materials tested for biocompatibility per ISO 10993.

Indications for Use

Indicated for subcutaneous administration of medicine, including insulin, from a portable, external pump to a suitable infusion site in patients requiring infusion 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

• Polyfin QR infusion sets, Models 165, 166, and 167 (K961474)

Submission Summary (Full Text)

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K964456

JAN 30 1997

MiniMed

# Part II. Polyfin QR® with Wings 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 [phone], Ext. 3011. FAX: [phone] (V/F).

B. Name of the device: Polyfin QR® with Wings infusion set, Models 365, 366, and 367.

C. Predicate device: Polyfin QR infusion sets, Models 165, 166, and 167 (K961474).

D. Description of new device: This infusion set is intended for the subcutaneous administration of medicine, including insulin, from a portable, external pump to a suitable infusion site. 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 1.uer 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 Polyfin QR with Wings infusion set is intended for use as an infusion administration set for delivery of appropriately labeled fluids or solutions from an external infusion pump or syringe.

F. Comparison of the technological features of the new device and predicate device: The new device introduces no new technological features, compared to the predicate device. The only substantial difference in the devices is the addition of wings to make insertion easier by the user and to add stability to the needle in place. This modifications raises no new issues of safety or effectiveness.

Signed,


Terence H. Gregg.
President and Chief Operating Officer
MiniMed Inc.

20 Jan 97

©MiniMed and Polyfin are Registered Trademarks of MiniMed Inc. ™ Polyfin QR is a trademark of MiniMed Inc.

12744 San Fernando Road • Sylmar, CA 91342 • [phone] • [phone] • FAX [phone] • Web Site: http://www.minimed.com