0.014 INCH EXTRA LONG FLOPPY AND 0.014 EXTRA LONG INTERMEDIATE GUIDE WIRES WITH PHOSPHORYLCHOLINE (PC) POLYMER COATING

K962266 · Biocompatibles Cardiovascular, Inc. · DQX · Sep 10, 1996 · Cardiovascular

Device Facts

• Record ID: K962266
• Device Name: 0.014 INCH EXTRA LONG FLOPPY AND 0.014 EXTRA LONG INTERMEDIATE GUIDE WIRES WITH PHOSPHORYLCHOLINE (PC) POLYMER COATING
• Applicant: Biocompatibles Cardiovascular, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Sep 10, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Floppy and Intermediate Extra Long 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 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 facilitate placement of PTA/PTCA balloon dilatation catheters in peripheral or coronary vasculature. Device consists of 0.014-inch diameter wire, 300 cm length, with stainless steel core wire taper-ground for flexibility. Distal tip features platinum/tungsten alloy spring coil for radiopacity; entire length coated with phosphorylcholine (PC) polymer to enhance biocompatibility. Operated by physicians in clinical settings. Device provides mechanical support and trackability for balloon catheters; aids in navigating vascular anatomy. Benefits include safe, effective catheter delivery during interventional procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Performance relies on prior testing of predicate devices per FDA 1995 Coronary and Cerebrovascular Guidewire Guidance, including tensile strength, torque strength, torqueability, and tip flexibility. Biocompatibility profile established via Acute Systemic Toxicity, Skin Irritation, Skin Sensitization, Cytotoxicity, Hemolysis, and LAL Pyrogenicity testing.

Technological Characteristics

0.014" diameter guide wire, 300 cm length. Materials: stainless steel core wire, platinum/tungsten alloy distal spring coil, phosphorylcholine (PC) polymer coating. Sterilization: ethylene oxide. Packaging: lacquered paper and polyester-polypropylene pouch. Shelf life: 1 year (real-time aging).

Indications for Use

Indicated for patients requiring PTA or PTCA balloon dilatation catheter placement within peripheral or coronary vasculature. Contraindicated 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

• Biocompatibles 0.014" Floppy and Intermediate Guide Wires with Phosphorylcholine Polymer Coating (K955135)

Submission Summary (Full Text)

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K962266
SEP 10 1996

# 510(K) Summary

Submitter's Name: Biocompatibles Cardiovascular, Inc.
1049 Kiel Court
Sunnyvale, CA 94089
Tel: [phone]
Fax: [phone]

Contact Person: Mr. James Wood
Chief Engineer

510(k) Summary Date: June 12, 1996

Device Names:
1. 0.014" Floppy Extra Long Guide Wire with Phosphorylcholine (PC) Polymer Coating and 30 cm Radiopaque Tip
2. 0.014" Intermediate Extra Long Guide Wire with Phosphorylcholine (PC) Polymer Coating and 30 cm Radiopaque Tip
3. 0.014" Floppy Extra Long Guide Wire with Phosphorylcholine (PC) Polymer Coating and 4 cm Radiopaque Tip
4. 0.014" Floppy Extra Long Guide Wire with Phosphorylcholine Polymer Coating and 4 cm Radiopaque Tip

Common Name: Guide Wire -

Classification Name: Catheter Guide Wire (21 CFR 870.1330)

Predicate Devices: Biocompatibles 0.014" Floppy and Intermediate Guide Wires with Phosphorylcholine Polymer Coating (K955135 - SE Determination on April 9, 1996)

Device Description:

The Floppy (2) and Intermediate (2) Extra Long Guide Wires have a nominal outside diameter of 0.014 inch measured at the distal spring coil. The guide wires are 300 cm (nominal) in length and have a distally attached 30 cm composite spring coil. For the 30 cm radiopaque guide wires, the entire spring coil is made of platinum/tungsten alloy. The spring coil of the 4 cm radiopaque guide wires is proximally made of stainless steel wire (26 cm) and has a distal platinum/tungsten alloy spring coil for opacity. For all guide wires, the core wire and spring coils, up to and including the tip, are coated with phosphorylcholine polymer.

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Intended Use:

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

Comparison of Technological Characteristics:

The 0.014" Floppy and Intermediate Extra Long Guide Wires with PC polymer coating are similar to the predicate guide wires. The subject guide wires and predicate guide wires are manufactured by the same company. The 30 cm spring coils and coil assembly with the core wire are identical between the predicate devices and two subject guide wires. The only difference between these two groups of wires is the overall length (175 cm vs 300 cm).

The remaining two 0.014" Floppy and Intermediate Extra Long Guide Wires have a 4 cm radiopaque alloy distal spring coil brazed to a 26 cm proximal stainless steel spring coil. The 4 cm radiopaque guide wires have one more joint than the predicate guide wires. The 4 cm guide wire core wire specifications are identical to the predicate device, with the exception of the additional 125 cm of length.

The predicate and four extra long guide wires have a stainless steel core wire that is taper ground distally to improve flexibility. The guide wires each have a full length core wire extending to the tip. The distal tip section of each guide wire is flattened to increase tip section flexibility and facilitate shapeability. Differences in tip section flexibility are made possible by changing the amount of taper in the core wire, distally, and the length of the flattened section between the second to last joint and tip joint. The core wire and entire length of spring coil of the guide wires are coated with PC polymer.

Packaging and Sterilization

The predicate and subject guide wires are packaged in the same materials and ethylene oxide sterilized by the same contract sterilizer. The guide wires are individually packaged in a lacquered paper and polyester-polypropylene composite plastic heat sealable pouch. The shelf life of the guide wires is one year. The one year shelf life for the guide wires was established following real-time aging.

Safety and Effectiveness:

In vitro performance testing of the predicate devices was conducted according to the guidelines presented in FDA's January 1995 Coronary and Cerebrovascular

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Guidewire Guidance. 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 PC polymer-coated guide wires are non-toxic and biocompatible for short term use in the vascular system. Bench performance and biocompatibility testing was not performed on the subject guide wires; there is no reason to believe the subject guide wires would yield dissimilar results.

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