POLYFIN EXTENSION SET, MODELS 126 AND 128
Device Facts
| Record ID | K965208 |
|---|---|
| Device Name | POLYFIN EXTENSION SET, MODELS 126 AND 128 |
| Applicant | Medtronic Minimed |
| Product Code | FPK · General Hospital |
| Decision Date | Feb 26, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5440 |
| Device Class | Class 2 |
| 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.
Indications for Use
Indicated for patients requiring medication delivery via external infusion pump; used as fluid delivery extension set connecting medication reservoir to infusion set, Y-site, or heparin lock.
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 infusion set (models 106, 107, 133)
Related Devices
- K020926 — EXTENSION SET, MODELS 1911-512 · Epimed International, Inc. · Jul 12, 2002
- K990777 — MED-RX EXTENSION SETS · Benlan, Inc. · Aug 25, 1999
- K230528 — Extension Set · Medcaptain Life Science Co., Ltd. · Dec 1, 2023
- K092172 — EXEL I.V. EXTENSION SET · Exelint Intl. Co. · Jan 4, 2010
- K993463 — INTRAVASCULAR ADMINISTRATION SET · Custom Assemblies, Inc. · Jan 4, 2000
