(207 days)
The IVT 0.014" TRACK is intended to facilitate the navigation and placement of angioplasty and interventional devices through tortuous peripheral and coronary vessels.
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. 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. 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.
This document concerns a medical device (guidewire) and does not contain information about an AI/ML powered device, a study that uses a test set, or human/expert evaluations. Therefore, I cannot provide the requested information about acceptance criteria and study details.
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954622
SUMMARY OF SAFETY AND EFFECTIVENESS DATA ਰ .
| 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 |
Guidewires classified under 21 CFR 870.1330 CLASSIFICATION:
PREDICATED DEVICES:
IVT is claiming substantial equivalence to the following predicate medical devices:
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IVT 0.014" Guidewire (K895903)
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IVT 0.014" Peripheral Guidewire (K882804)
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ACS 0.014" High Torque Floppy
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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 Both the core and coil are single continuous pieces that are spacings. The core is inserted into the coil lumen secured together at two points. 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.
ਕੇ ਹ
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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.
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থ 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 510 (k) submission supports determination the the 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.
§ 870.1330 Catheter guide wire.
(a)
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.(b)
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.