(152 days)
The Floppy and Intermediate guide wires are intended for use to facilitate the placement of PTA and/or PTCA balloon dilatation catheters within the peripheral or coronary vasculature. The guide wires are a 0.014 inch size and designed for safe use with appropriately sized balloon catheters. The guide wires are not intended for use in the cerebral vasculature.
The Floppy and Intermediate guide wires have a nominal outside diameter of 0.014 inch. The guide wires are 175 cm long (nominal) and have a 30 cm radiopaque spring coil joined distally to a central stainless steel core wire. The core wire and spring coils are coated with a hydrophilic phosphorvicholine polymer.
This document is a 510(k) summary for a medical device (guide wires), not a study report. Therefore, it does not contain the information requested about acceptance criteria, study design, or performance metrics typically found in clinical studies or validation reports.
Specifically, the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, and training set details) is absent from this 510(k) summary.
This document describes the device, its intended use, and identifies a predicate device for substantial equivalence, which is a regulatory filing requirement, not a detailed performance study.
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510(k) Summary
APR - 9 1996
Submitter's Name:
Contact Person:
510(k) Summary Date:
Device Names:
Classification Name:
Predicate Device:
Biocompatibles Limited
Brunel Science Park
Kingston Lane
Uxbridge
Middlesex UB8 3PQ
England
Tel. +44 1895 274481
Mr. Neil McLacian
Regulatory Affairs Manager
November 9, 1995
0.014" Floppy Guide Wire with
Phosphorylcholine Polymer (PCP) Coating and
0.014" Intermediate Guide Wire with Phosphorylcholine
Polymer (PCP) Coating
Catheter Guide Wire (21 CFR 870.1330)
Advanced Cardiovascular Systems, Inc. 0.014" Hi-Torque
Floppy II® Guide Wire and 0.014" Hi-Torque Intermediate®
Guide Wire
Device Description:
The Floppy and Intermediate guide wires have a nominal outside diameter of 0.014 inch. The guide wires are 175 cm long (nominal) and have a 30 cm radiopaque spring coil joined distally to a central stainless steel core wire. The core wire and spring coils are coated with a hydrophilic phosphorvicholine polymer.
Intended Use:
The Floppy and Intermediate guide wires are intended for use to facilitate the placement of PTA and/or PTCA balloon dilatation catheters within the peripheral or coronary vasculature. The guide wires are a 0.014 inch size and designed for safe use with appropriately sized balloon catheters. The guide wires are not intended for use in the cerebral vasculature.
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§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.