(61 days)
The Polyfin extension set is intended for use as a fluid delivery set for medication from an external infusion pump.
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."
This document is a 510(k) summary for a medical device (Polyfin Infusion Extension Set Model 128). It describes the device, its intended use, and compares it to a predicate device. However, it does not contain the information required to answer your request about acceptance criteria and a study proving the device meets those criteria.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Information about sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods for any test or training set.
- Details about MRMC comparative effectiveness studies or standalone algorithm performance.
The document is purely a regulatory submission describing a device and its perceived equivalence to a predicate device, focusing on statements about safety and effectiveness without providing the underlying study data you are asking for.
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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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§ 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.