TRANSEND GUIDEWIRE

K964611 · Boston Scientific Corp · DQX · Jan 28, 1997 · Cardiovascular

Device Facts

• Record ID: K964611
• Device Name: TRANSEND GUIDEWIRE
• Applicant: Boston Scientific Corp
• Product Code: DQX · Cardiovascular
• Decision Date: Jan 28, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The BSC Transend Steerable Guidewire with hydrophilic coating and accessories are intended for general intravascular use including the peripheral and neurovasculature. The devices will be provided sterile, and are intended for one procedure use only.

Device Story

Steerable guidewire for intravascular navigation; peripheral and neurovascular applications. Device features hydrophilic coating to enhance lubricity. Used by physicians during interventional procedures to facilitate catheter placement. Single-use, sterile device. Performance relies on mechanical properties: tip flexibility, torque strength, and torque response. Clinical benefit derived from navigation through complex vascular anatomy.

Clinical Evidence

Bench testing included tip tensile strength, tip flexibility, torque strength, torque response, coating adherence, coating extraction, and lubricity testing. Biocompatibility and in vivo testing performed. No clinical trial data provided.

Technological Characteristics

Steerable guidewire; hydrophilic coating. Materials evaluated for biocompatibility. Performance specifications: tip tensile, tip flexibility, torque strength, torque response, coating adherence, lubricity. Sterile, single-use.

Indications for Use

Indicated for general intravascular use in peripheral and neurovasculature procedures.

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

• BSC Transend Guidewire (K964611)
• Target Therapeutics Dasher-10 Guidewire
• Target Therapeutics Seeker-Lite Guidewire
• Terumo Corporation Glidewire Gold Guidewire
• Micro Interventional Systems Quicksilver Guidewire

Submission Summary (Full Text)

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JAN 28 99
K964611
510(k) Premarket Notification
BSC Transend Guidewire
November 15, 1996

# ATTACHMENT K

## SUMMARY OF SAFETY AND EFFECTIVENESS

Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation is required to submit with this Premarket Notification either an "...adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Boston Scientific Corporation choose to submit a summary of information respecting safety and effectiveness. According to §513(i)(3)(B), "Any summary under subparagraph (A) respecting a device shall contain detailed information regarding data concerning adverse health effects..."

The summary regarding the adverse health effects of the proposed Transend Guidewire is as follows:

| Trade Name: | Transend Guidewire |
| --- | --- |
| Manufacturer: | BSC/SciMed Life Systems, Inc.
6655 Wedgwood Road
Maplegrove, MN 55311-3636 |
| Device Generic Name: | Guidewire |
| Classification: | According to Section 513 of the Federal Food, Drug and Cosmetic Act, the device classification is Class II, Performance Standards (CFR 870.1330). |
| Predicate Devices: | BSC Transend Guidewire
Target Therapeutics Dasher-10 and Seeker-Lite Guidewires
Terumo Corporation’s Glidewire Gold Guidewire
Micro Interventional Systems Quicksilver Guidewire |

## Product Description:

The BSC Transend Steerable Guidewire with hydrophilic coating and accessories are intended for general intravascular use including the peripheral and neurovasculature. The devices will be provided sterile, and are intended for one procedure use only. Testing and evaluation included tip tensile, tip flexibility, torque strength, torque response, coating adherence, coating extraction, lubricity testing, biocompatibility and in vivo testing.

## Conclusion:

Based on the Indication for Use, technological characteristics and safety and performance testing, the Transend Guidewire has been shown to be safe and effective for its intended use.

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