0.014 FLOPPY & 0.014 INTERMEDIATE GUIDE WIRES W/PHOSPHORYLCHOLINE POLYMER COATING & 4CM RADIOPAQUE TIP

K961232 · Biocompatibles , Ltd. · DQX · Jun 26, 1996 · Cardiovascular

Device Facts

• Record ID: K961232
• Device Name: 0.014 FLOPPY & 0.014 INTERMEDIATE GUIDE WIRES W/PHOSPHORYLCHOLINE POLYMER COATING & 4CM RADIOPAQUE TIP
• Applicant: Biocompatibles , Ltd.
• Product Code: DQX · Cardiovascular
• Decision Date: Jun 26, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Floppy and Intermediate guide wires and predicate devices 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 designed for safe use with appropriately sized balloon catheters. The guide wires are not intended for use in the cerebral vasculature.

Device Story

Guide wires (0.014 inch diameter, 176 cm length) facilitate placement of PTA/PTCA balloon catheters in peripheral or coronary vasculature. Device features stainless steel core wire, composite spring coil with 4 cm radiopaque platinum/tungsten tip, and Phosphorylcholine Polymer (PCP) coating. Used by clinicians in interventional procedures. PCP coating provides surface modification. Performance verified via bench testing (tensile/torque strength, flexibility) and biocompatibility assessment (toxicity, irritation, sensitization, cytotoxicity, hemolysis, pyrogenicity).

Clinical Evidence

Bench testing only. Comparison of tensile strength, torque strength, torqueability, and tip flexibility against predicate devices. Biocompatibility testing included Acute Systemic Toxicity, Skin Irritation, Skin Sensitization, Cytotoxicity, Hemolysis, and LAL Pyrogenicity. Results confirm non-toxicity and biocompatibility for short-term vascular use.

Technological Characteristics

0.014" diameter, 176 cm length. Materials: stainless steel core wire, platinum/tungsten radiopaque tip, Phosphorylcholine Polymer (PCP) coating. Distal 30 cm composite spring coil. Sterilization: ethylene oxide gas. Packaging: lacquered paper/polyester-polypropylene pouch. Shelf life: 1 year.

Indications for Use

Indicated for patients requiring PTA or PTCA balloon dilatation catheter placement within peripheral or coronary vasculature. Not for use in cerebral vasculature.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Advanced Cardiovascular Systems, Inc. 0.014" Hi-Torque Floppy II® Guide Wire
• Advanced Cardiovascular Systems, Inc. 0.014" Hi-Torque Intermediate® Guide Wire

Submission Summary (Full Text)

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JUN 26 1996
K961232

# 510(K) Summary

Submitter's Name:
Biocompatibles Limited
Brunel Science Park
Kingston Lane
Uxbridge
Middlesex UB8 3PQ
England
Tel. [phone]

Contact Person:
Mr. Neil McLachlan
Regulatory Affairs Manager

510(k) Summary Date:
March 29, 1996

Device Names:
0.014" Floppy Guide Wire with Phosphorylcholine Polymer (PCP) Coating and 4 cm Radiopaque Tip and 0.014" Intermediate Guide Wire with Phosphorylcholine Polymer (PCP) Coating and 4 cm Radiopaque Tip

Common Name:
Guide Wire

Classification Name:
Catheter Guide Wire (21 CFR 870.1330)

Predicate Devices:
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 measured at the distal spring coil. The guide wires are 176 cm long (nominal) and have a distally attached 30 cm composite spring coil. The most distal 4 cm of the spring coil is radiopaque. The core wire and spring coils, up to and including the tip, are coated with PCP.

Intended Use:
The Floppy and Intermediate guide wires and predicate devices 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 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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Comparison of Technological Characteristics:

The 0.014" Floppy and Intermediate Guide Wires with PCP Coating and 4 cm Radiopaque Tip have similar technological characteristics as the predicate devices. The BCP and ACS guide wires are similar in design, materials, intended use, and sterilization.

The BCP and ACS 0.014" guide wires have a stainless steel core wire that is taper ground distally to improve flexibility. The two BCP guide wires and the ACS Intermediate guide wire have a full length core wire. The distal tip section of each style BCP guide wire is flattened to increase tip section flexibility. The ACS Intermediate guide wire has a round core wire passing into the middle joint and continuing on to the tip. The ACS Floppy guide wire core terminates just past the middle joint. A stainless steel flat ribbon connects the middle joint and stainless steel tip.

A 30 cm (nominal) composite spring coil is concentrically positioned over the distal core wire or shaping ribbon of each guide wire. The proximal 26 cm (nominal) of BCP and ACS spring coils are made of stainless steel spring wire. Each manufacture has made the distal 3 - 4 cm of spring coil radiopaque through the use of platinum/tungsten spring coils. The BCP spring coil is formed at a joint proximal to the traditional middle joint and the spring coils are not attached to the core wire at this point. For both BCP and ACS guide wires, the spring coils are brazed (BCP) or soldered (ACS) to the central core wire at a joint proximal to the tip. For all guide wires, the tip section is shapeable.

The core wire and entire length of spring coil of the BCP guide wires are coated with PCP. The ACS guide wires have a Teflon coated core wire. The ACS spring coil proximal to the middle joint is coated with a silicone-based material (Microglide®) and the coil distal to the middle joint is uncoated.

Packaging and Sterilization

The BCP guide wires are individually packaged in a lacquered paper and polyester-polypropylene composite plastic heat sealable pouch. The ACS product is packaged in Tyvek/Mylar heat sealable pouch. Both guide wire providers sterilize the product with ethylene oxide gas. The shelf life of the BCP guide wires is one year. The one year shelf life for the BCP guide wires was established following real-time aging. The shelf life of the ACS products is two years.

Safety and Effectiveness:

In vitro performance testing was conducted according to the guidelines presented in FDA's January 1995 Coronary and Cerebrovascular Guidewire Guidance. The performance of BCP Floppy and Intermediate guide wires and ACS guide wires was

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compared by bench testing. The BCP Floppy and Intermediate guide wires were found to have adequate tensile strength, torque strength, torqueability, and tip flexibility. The biocompatibility tests conducted included Acute Systemic Toxicity, Skin Irritation, Skin Sensitization, Cytotoxicity, Hemolysis, and LAL Pyrogenicity. The PCP-coated guide wires are non-toxic and biocompatible for short term use in the vascular system.

Based on the indications for use, design and construction, and results of the bench and biocompatibility testing, the Biocompatibles 0.014" Floppy and Intermediate Guide Wires with PCP Coating and 4 cm Radiopaque Tip are safe and effective for their intended use.

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