HANNIBAL GUIDEWIRE

K970494 · Schneider (Europe) GmbH · DQX · May 9, 1997 · Cardiovascular

Device Facts

• Record ID: K970494
• Device Name: HANNIBAL GUIDEWIRE
• Applicant: Schneider (Europe) GmbH
• Product Code: DQX · Cardiovascular
• Decision Date: May 9, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The HANNIBAL™ steerable guide wires are designed to reach and cross stenotic lesions prior to the insertion on a coronary balloon dilatation catheter. Schneider steerable stent support guide wires are also designed to reach and cross stenotic lesions prior to the insertion of a coronary balloon dilatation catheter with mounted expandable stent, or of a stent delivery device. Any use other than that intended is not recommended.

Device Story

HANNIBAL™ Guidewire; 0.014" diameter; 185-315 cm length. Stainless steel construction; PTFE-coated proximal shaft; radiopaque tungsten spring coil distal tip. Used by physicians in interventional cardiology to navigate coronary vasculature; reach/cross stenotic lesions; provide support for balloon catheters or stent delivery systems. Manual operation; provides tactile feedback to clinician for vessel navigation. Benefits include improved lesion access and device delivery during percutaneous coronary intervention.

Clinical Evidence

Bench testing only. Testing included bond strength, tip flexibility, coating adhesion, torque, and compatibility with interventional devices. Biocompatibility testing included hemolysis and cytotoxicity assays.

Technological Characteristics

0.014" diameter guidewire; 185-315 cm length. Materials: stainless steel, PTFE coating, radiopaque tungsten spring coil. Distal tip is flexible and shapeable. Manual operation; no energy source. Sterilization and packaging consistent with predicate C-Thru guidewire.

Indications for Use

Indicated for patients requiring coronary artery intervention; used to reach and cross stenotic lesions to facilitate placement of coronary balloon dilatation catheters, stent delivery devices, or balloon catheters with mounted expandable stents.

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

• ACS Hi-Torque Extra S'port™ Guidewire
• C-Thru Coronary Guidewire

Submission Summary (Full Text)

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510(k) Summary for HANNIBAL™ Guidewire
MAY - 9 1997

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92. The assigned 510(k) number is K970494

Date prepared: February 4, 1997

Sponsor: Schneider (Europe) AG
Ackerstrasse 6
PO Box CH-6180
Bulach, Switzerland

Contact: Rudolf Ott
V.P. Clinical and Regulatory Affairs
Phone: [phone]

Trade/Proprietary Name: HANNIBAL™ Guidewire
Classification: Class II
Equivalent Devices: ACS Hi-Torque Extra S'port™ Guidewire (performance)
C-Thru Coronary Guidewire (materials, sterilization, packaging)

Device Description
The HANNIBAL™ Guidewire is a 0.014" guidewire manufactured in lengths of 185-315 cm. The guidewire is made of stainless steel, PTFE coated proximal shaft, which tapers down to a flexible distal tip. The tip area consists of a radiopaque tungsten spring coil, which is attached to the distal flexible shaft port and soldered to the proximal taper of the shaft. The distal part of the coil is very flexible and shapeable.

Intended Use
- The HANNIBAL™ steerable guide wires are designed to reach and cross stenotic lesions prior to the insertion on a coronary balloon dilatation catheter.
- Schneider steerable stent support guide wires are also designed to reach and cross stenotic lesions prior to the insertion of a coronary balloon dilatation catheter with mounted expandable stent, or of a stent delivery device.
- Any use other than that intended is not recommended.

Technological characteristics
Equivalence in technological characteristics was substantiated by comparative performance testing including bond strength, tip flexibility, coating adhesion, torque and compatibility with interventional devices. Because materials used were the same as those used in other Schneider guidewires, a reduced biocompatibility battery, consisting of hemolysis and cytotoxicity, was conducted.
The results of all testing indicated that the HANNIBAL™ guidewire is equivalent to the ACS Hi-Torque Extra S'port™ guidewire and is, therefore, safe for the intended use.