IVT 0.014 TRACK OR IVT 0.014 ACCUTRACK

K954622 · Boston Scientific /International Technologies · DQX · Apr 29, 1996 · Cardiovascular

Device Facts

• Record ID: K954622
• Device Name: IVT 0.014 TRACK OR IVT 0.014 ACCUTRACK
• Applicant: Boston Scientific /International Technologies
• Product Code: DQX · Cardiovascular
• Decision Date: Apr 29, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The IVT 0.014" TRACK is intended to facilitate the navigation and placement of angioplasty and interventional devices through tortuous peripheral and coronary vessels.

Device Story

Guidewire used to navigate tortuous peripheral and coronary vessels; facilitates placement of interventional devices. Operator (physician) shapes distal tip; rotates proximal end to transmit torque along core axis; allows vessel selection or avoidance of branches. Device input: manual manipulation by physician. Device output: mechanical guidance of interventional equipment. Benefits: improved navigation in complex vascular anatomy; reduced vessel trauma via flexible distal tip.

Clinical Evidence

Bench testing only; biocompatibility and physical performance testing demonstrated safety and effectiveness.

Technological Characteristics

Aermet 100 steel core wire; gold alloy radiopaque coil; parylene coating. Distal tip plasma arc brazed to form gold alloy sphere; proximal coil secured with silver alloy solder. Diameter 0.0136"; lengths 100-300 cm. Mechanical steering via torque transmission.

Indications for Use

Indicated for patients requiring navigation and placement of angioplasty and interventional devices through tortuous peripheral and coronary vessels.

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

• IVT 0.014" Guidewire (K895903)
• IVT 0.014" Peripheral Guidewire (K882804)
• ACS 0.014" High Torque Floppy
• Cook Family of Guidewires

Submission Summary (Full Text)

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k954622

# 9. SUMMARY OF SAFETY AND EFFECTIVENESS DATA

SUBMITTER: InterVentional Technologies Inc. (IVT)

DATE: October 4, 1995

DEVICE NAME: Guidewire

PROPRIETARY NAME: IVT 0.014" TRACK or IVT 0.014" ACCUTRACK

CONTACT: Michael E. Klicpera, Esq.
Corporate Counsel

CLASSIFICATION: Guidewires classified under 21 CFR 870.1330

PREDICATED DEVICES:

IVT is claiming substantial equivalence to the following predicate medical devices:

1. IVT 0.014" Guidewire (K895903)
2. IVT 0.014" Peripheral Guidewire (K882804)
3. ACS 0.014" High Torque Floppy
4. Cook Family of Guidewires

## 1. DEVICE DESCRIPTION:

The IVT 0.014" TRACK is constructed from Aermet 100 steel core wire that is distally tapered and fitted with a gold alloy coil. To minimize blood vessel trauma and to facilitate maneuverability, the distal tip is extremely flexible.

The core is nominally 0.0136" in diameter. The coil, approximately 1.2" in length with a nominal diameter of 0.0136", is made from a single continuous radiopaque gold alloy wire that has two different wind spacings. Both the core and coil are single continuous pieces that are secured together at two points. The core is inserted into the coil lumen and attached at the distal end utilizing a plasma arc technology that brazes the end of the gold alloy coil to the cylindrical bulb. This special process results in the formation of a gold alloy sphere. The proximal end of the coil is secured to the stainless steel core using a silver alloy solder.

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The IVT 0.014" TRACK will be manufactured in various lengths ranging from 100 to 300 cms. All IVT 0.014" TRACKs will receive a final parylene (poly-para-xylyene) coating prior to packaging and sterilization.

Steering or guidance of the wire is achieved by shaping the tip and rotating the proximal end of the wire, thereby transmitting torque along the axis of the core to the flexible tip. This redirects the shaped tip of the IVT 0.014" TRACK allowing selection or avoidance of branch vessels, thus facilitating navigation in tortuous vessels.

## 2. INTENDED USE:

The IVT 0.014" TRACK is intended to facilitate the navigation and placement of angioplasty and interventional devices through tortuous peripheral and coronary vessels.

## 3. SUBSTANTIAL EQUIVALENCE:

The intended use of the IVT 0.014" TRACK is the same as that for other predicate guidewire devices. The materials and design of the IVT 0.014" TRACK are similar to these previously FDA cleared guidewires. The technical characteristics of the IVT 0.014" TRACK do not introduce new questions regarding safety or effectiveness of cardiovascular guidewires. The labeling associated with the IVT 0.014" TRACK provides similar information as the predicate devices.

Biocompatibility and physical performance testing demonstrates the IVT 0.014" TRACK product to be safe and effective. Information provided in the 510(k) submission supports the determination of substantial equivalence.

In summary IVT has provided evidence that shows the IVT 0.014" TRACK device to be safe and effective. This guidewire is considered to be substantially equivalent to similar marketed devices.

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