RADIFOCUS GLIDEWIRE FOR CORONARY USE WITH PLATINUM (OR GOLD) COIL

K961445 · Terumo Medical Corp. · DQX · Jul 9, 1996 · Cardiovascular

Device Facts

• Record ID: K961445
• Device Name: RADIFOCUS GLIDEWIRE FOR CORONARY USE WITH PLATINUM (OR GOLD) COIL
• Applicant: Terumo Medical Corp.
• Product Code: DQX · Cardiovascular
• Decision Date: Jul 9, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The RADIFOCUS Glidewires for coronary use with platinum (or gold) coil are used to facilitate the placement of balloon dilatation catheters for percutaneous transluminal coronary angioplasty (PTCA) and/or percutaneous transluminal angioplasty (PTA).

Device Story

RADIFOCUS Glidewire is a manual guide wire used by clinicians during PTCA/PTA procedures to facilitate balloon dilatation catheter placement. Device consists of a nickel-titanium core coated with polyurethane and hydrogel; features a distal radiopaque marker coil (platinum/iridium or gold). Available in 180cm and 300cm lengths; 0.014", 0.016", and 0.018" diameters. Distal portion is tapered for flexibility. Operated manually by physician to navigate coronary vasculature. Radiopaque tip allows visualization under fluoroscopy. Higher pushing resistance compared to predicate improves crossability. Benefits include reliable navigation and catheter support during angioplasty.

Clinical Evidence

Bench testing only. Performance evaluated via tensile strength, torque transmission, torque failure, memory retention, flexibility, radiopacity, and pushing resistance tests. Biocompatibility testing performed per ISO-10993 and Tripartite Guidance for blood-contacting devices (short-term/prolonged). Sterilization validated to SAL 10^-6.

Technological Characteristics

Nickel-titanium core; polyurethane and hydrogel exterior coating; platinum/iridium or gold radiopaque marker coil. Dimensions: 180cm/300cm length; 0.014"-0.018" diameter. Manual operation. Sterilized via ethylene oxide.

Indications for Use

Indicated for patients undergoing percutaneous transluminal coronary angioplasty (PTCA) or percutaneous transluminal angioplasty (PTA) requiring guide wire assistance for balloon dilatation catheter placement.

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

• Terumo RADIFOCUS Glidewires for coronary use with platinum (or gold) coil (K953533)

Reference Devices

• Terumo guide wires (K863138)
• Terumo guide wires (K913074B)
• Terumo guide wires (K925852A)

Submission Summary (Full Text)

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JUL 9 1996
K961445
SECTION II Summary and Certification

# SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION PERTAINING TO SUBSTANTIAL EQUIVALENCE

Proprietary Device Name: RADIFOCUS® Glidewire® for coronary use with platinum (or gold) coil*
*These wires may also be called by a proprietary name of just CROSSWIRE®.

Classification Name: Wire, Guide, Catheter

## INTENDED USE

The RADIFOCUS Glidewires for coronary use with platinum (or gold) coil are used to facilitate the placement of balloon dilatation catheters for percutaneous transluminal coronary angioplasty (PTCA) and/or percutaneous transluminal angioplasty (PTA).

Note: This is the same intended use as the Terumo Coronary Guide Wires cleared under 510(k) K953533.

## DESCRIPTION

The RADIFOCUS Glidewires for coronary use with platinum (or gold) coil have a core of titanium nickel alloy coated with polyurethane which is second coated with a hydrogel. The wires are 180cm and 300cm in length and come in 0.014", 0.016" and 0.018" diameters respectively. The platinum coil wire, 300cm length, is used exclusively for exchange purposes. The wires also possess a radiopaque marker at the tip of the wire. This coil is made of an amalgam of platinum and iridium or gold. The coil is entirely coated with polyurethane with tungsten. The distal portion of the wire is gradually tapered from 10 to 30 cm in length providing increasing flexibility at the distal portion of the wire.

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SECTION II Summary and Certification

# SUBSTANTIAL EQUIVALENCE

The Terumo RADIFOCUS® Glidewires® for coronary use with platinum (or gold) coil submitted in this 510(k) are substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared Terumo RADIFOCUS Glidewires for coronary use with platinum (or gold) coil K953533.

# PRINCIPLE OF OPERATION/TECHNOLOGY

The RADIFOCUS Glidewires for coronary use with platinum (or gold) coil are operated manually or by a manual process.

# DESIGN/MATERIALS

| Parts | Terumo PTCA Wire | Cleared Terumo PTCA Wire K953533 |
| --- | --- | --- |
| Wire | Nickel-Titanium core coated with polyurethane | Nickel-Titanium core coated with polyurethane |
| Core Wire | Single Taper | Single Taper |
| Radiopaque Marker | Platinum or Gold | Platinum or Gold |
| Radiopaque Length | 3-3.5cm | 2cm |
| Exterior Coating | Hydrogel | Hydrogel |

# SPECIFICATIONS

| Parts | Terumo PTCA Wire | Cleared Terumo PTCA Wire K953533 |
| --- | --- | --- |
| Wire diameter | .014, .016, .018 | .014, .016, .018 |
| Wire length | 180cm & 300cm | 180cm & 300cm |
| Tip configuration | Straight | Straight |

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SECTION II Summary and Certification

# PERFORMANCE

The Terumo PTCA guide wires (represented in this submission) tested are substantially equivalent to the cleared Terumo RADIFOCUS® Glidewires® for coronary use with platinum (or gold) coil K953533. The Terumo PTCA guide wires represented in this submission exhibit a higher pushing resistance that can be associated with the higher crossability. For all other physical characteristics the Terumo PTCA guide wires represented in this submission were found to be equivalent to the cleared Terumo RADIFOCUS Glidewires for coronary use with platinum (or gold) coil K953533.

The following tests were performed demonstrating the substantial equivalence of the Terumo RADIFOCUS Glidewires for coronary use with platinum (or gold) coil submitted in this 510(k) to the cleared Terumo RADIFOCUS Glidewires for coronary use with platinum (or gold) coil K953533.

- Tensile Strength Test
- Torque Transmission Test
- Torque Failure Test
- Memory Retention Test
- Flexibility Test
- Radiopacity Test
- Pushing Resistance Test

PLEASE NOTE: A coating Adherence Strength Test and Coating Flake Test (SEM) was not performed again for purposes of this submission as none of the coating features of the Terumo PTCA guide wires represented in this submission are different from the cleared Terumo PTCA guide wires K953533.

# ADDITIONAL SAFETY INFORMATION

Sterilization conditions have been validated according to the AAMI guidelines to provide a Sterility Assurance Level (SAL) of 10 to the negative sixth.

Ethylene oxide residuals will not exceed the maximum residue limits proposed for Part 821 of Title 21 in the Federal register of June 23, 1978 (or as finalized or amended).

Manufacturing control test methods include: functional, extraction and sterility tests.

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SECTION II Summary and Certification

Blood contacting materials were tested in accordance with the tests recommended in the Tripartite Biocompatibility Guidance for Medical Devices for biocompatibility testing of a device classified as Externally Communicating Devices, Blood Path Direct, Short-term (5 minutes-29 days). These tests were also in accordance with the tests recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing." [External Communicating Devices, Circulating Blood, Prolonged (24 hours-30 days) contact duration]. The blood contacting materials were found to be biocompatible.

The expiration dating for the RADIFOCUS® Glidewires® for coronary use with platinum (or gold) coil will be 24 months. This dating period is adopted from legally marketed Terumo guide wires cleared under K863138, K913074B and K925852A. The sterilization process and packaging materials are the same for these products. Verification testing of aged product consists of package permeability, sterility and shelf life functional testing.

## CONCLUSION

The Terumo RADIFOCUS Glidewires for coronary use with platinum (or gold) coil submitted in this 510(k) are substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared Terumo RADIFOCUS Glidewires for coronary use with platinum (or gold) coil K953533. Differences between the devices cited in this section do not raise any new issues of safety or effectiveness.

Date Prepared April 11, 1996

Prepared by Keith M. Smith
Submissions Specialist
Regulatory Affairs

Prepared for Terumo Medical Corporation
125 Blue Ball Road
Elkton, MD 21921
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