(178 days)
TherOx Infusion Guidewires are intended for use in facilitating the placement of interventional devices in the cardiovascular and neurovascular system. TherOx Infusion Guidewires are designed for small vessel use.
TherOx Infusion Guidewires are also intended to be used for the controlled selective infusion of physician-specified fluid agents before, during or after interventional procedures in the cardiovascular or neurovascular system.
TherOx Infusion Guidewires are not intended for delivery of contrast agents. Fluid agents utilized with TherOx Infusion Guidewires should be fully prepared and used according to their manufacturer's instructions for use.
TherOx Infusion Guidewires are intended for use in facilitating the placement of interventional devices in the cardiovascular and neurovascular system. TherOx Infusion Guidewires are designed for small vessel use.
TherOx Infusion Guidewires are also intended to be used for the controlled selective infusion of physician-specified fluid agents before, during or after interventional procedures in the cardiovascular or neurovascular system.
TherOx Infusion Guidewires are not intended for delivery of contrast agents. Filuid agents utilized with TherOx Infusion Guidewires should be fully prepared and used according to their manufacturer's instructions for use.
TherOx Infusion Guidewires are not intended for neonatal or pediatric use.
The TherOx Infusion Guidewire has an outside diameter of .014 in. and is available 180 cm and 300 cm in length, and is intended to pass freely thru standard catheters that have a thru lumen of 016 in. or larger.
The 300 cm TherOx Exchange Guidewire differs only in its overall length from the 180 cm TherOx Infusion Guidewire. The distal 180 cm of the TherOx Exchange Guidewire is identical to the 180 cm TherOx Infusion Guidewire. Only the proximal hypotube has been extended by 120 cm to achieve the 300 cm length. This extended proximal portion always remains outside the body and facilitates the replacement of one interventional device for another.
A proximal fluid connection is secured by connecting the proximal open end to a simple Tuohy-Borst connection. The infusion guidewire may be torqued by rotation of the torquing knob to direct the orientation of the distal tip.
Here's a breakdown of the acceptance criteria and the study information for the TherOx Infusion Guidewires, based on the provided text:
Acceptance Criteria and Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format. Instead, it describes various tests performed and concludes that the device meets its functional specifications and is safe for its intended use, or performed comparably to predicate devices.
However, we can infer the acceptance criteria from the "Summary of Studies" section and present the reported performance against these implicit criteria:
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| In Vitro Tests: | |
| Functionality and Durability | Met or exceeded functional specification, safe for intended use. |
| Tensile Strength | Not explicitly detailed, but implied to meet functional specifications. |
| Guidewire Torque Response | Not explicitly detailed, but implied to meet functional specifications. |
| Tip Deflection and Strength | Not explicitly detailed, but implied to meet functional specifications. |
| Joint Integrity and Strength | Not explicitly detailed, but implied to meet functional specifications. |
| Handling Characteristics | Not explicitly detailed, but implied to meet functional specifications. |
| Fluid Infusion Characteristics | Not explicitly detailed, but implied to meet functional specifications. |
| Product Failure Modes | Not explicitly detailed, but implied to meet functional specifications. |
| Dimensional Conformance (Length, O.D., joint sizes, etc.) | All dimensions were within the design specifications. |
| Radiopacity | Demonstrated adequate radiopacity when compared with commercially available guidewires and vascular catheters. |
| Biocompatibility (for short-term vascular use, |
§ 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.