K Number
K965208
Device Name
POLYFIN EXTENSION SET, MODELS 126 AND 128
Manufacturer
Date Cleared
1997-02-26

(61 days)

Product Code
Regulation Number
880.5440
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Polyfin extension set is intended for use as a fluid delivery set for medication from an external infusion pump.
Device Description
The new device is a 42 inch or 60 inch length of Polyfin® with Luer connectors at each end. The device 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."
More Information

K106, K107, K133

Not Found

No
The 510(k) summary describes a simple fluid delivery extension set and contains no mention of AI or ML technology.

No.
The device is an extension set for fluid delivery, not a device that directly treats a condition or disease.

No

Explanation: The device is described as an extension set for fluid delivery, specifically for medication administration from an external infusion pump. Its function is to transport fluids, not to detect, diagnose, or monitor a medical condition.

No

The device description clearly states it is a physical extension set made of Polyfin with Luer connectors, indicating it is a hardware device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is "as a fluid delivery set for medication from an external infusion pump." This describes a device used to administer substances into the body, not to test samples outside the body.
  • Device Description: The description details a tube with connectors for delivering fluids. This aligns with a medical device for infusion, not a diagnostic test.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health status. This device's function is purely for delivering medication.

N/A

Intended Use / Indications for Use

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

Product codes

Not Found

Device Description

The new device is a 42 inch or 60 inch length of Polyfin® with Luer connectors at each end. The device 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."

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Polyfin infusion set, models 106, 107, 133

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 880.5440 Intravascular administration set.

(a)
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.(b)
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.

0

K 965208

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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® with Luer connectors at each end. The device 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 influsion 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.

date

Signed,

12/23/94

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

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