← Product Code [FPK](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPK) · K965208

# POLYFIN EXTENSION SET, MODELS 126 AND 128 (K965208)

_Medtronic Minimed · FPK · Feb 26, 1997 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPK/K965208

## Device Facts

- **Applicant:** Medtronic Minimed
- **Product Code:** [FPK](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPK.md)
- **Decision Date:** Feb 26, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.5440
- **Device Class:** Class 2
- **Review Panel:** General Hospital
- **Attributes:** Therapeutic

## Indications for Use

The Polyfin extension set is intended for use as a fluid delivery set for medication from an external infusion pump.

## Device Story

Polyfin extension set (models 126, 128) consists of 42-inch or 60-inch tubing with Luer connectors at both ends; connects medication reservoir to infusion set, Y-site, or heparin lock; facilitates fluid delivery from external infusion pump; used in clinical or home settings; operated by patients or healthcare providers; extends reach of existing infusion systems.

## Clinical Evidence

No clinical data; bench testing only.

## Technological Characteristics

Fluid delivery tubing; 42 or 60-inch length; Luer connectors at proximal and distal ends; compatible with external infusion pumps and standard Y-site/heparin lock interfaces.

## Regulatory 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 infusion set (models 106, 107, 133)

## Submission Summary (Full Text)

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K 965208

MiniMed™

MiniMed Inc.
Premarket Notification - 510(k)
Polyfin Infusion Extension Set
Model 128

FEB 26 1997

# Part I. 510(k) Summary

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

Contact: Don Selvey, Senior Regulatory Affairs Specialist (818) 362-5958, ext. 3011; or (520) 527-0107 (v/f)

Name of Device: Polyfin extension set, models 126 and 128

Predicate Device: Polyfin infusion set, models 106, 107, 133

Description of the New Device: The new device is a 42 inch or 60 inch length of Polyfin® tubing with Luer connectors at each end. The device attaches at the proximal end to a medication reservoir, such as the MiniMed reservoir, model 103, and at the distal end to an infusion set such as the Polyfin infusion set, model 106. The Polyfin extension set may also be used to administer drugs labeled for intravenous administration from an external pump by attaching the distal end to a “Y-site” or “Heparin lock.”

Intended Use of the New Device: The Polyfin extension set is intended for use as a fluid delivery set for medication from an external infusion pump.

Comparison of the Technological Features of the New Device and Predicate Device: The differences between the subject device and the predicate device are limited to the distal connector and the intended use. The subject device is intended for use as an extension set, i.e., to extend the length of an infusion set such as the predicate device, or to connect the reservoir/infusion pump to a “Y” site or heparin lock.

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

Signed,

![img-0.jpeg](img-0.jpeg)

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

00022

1000000000000000000000000000000000000000000000000000

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