(56 days)
The Bard Hydrophilic Coated Angiography Guide Wires are indicated for percutaneous entry into a vessel using the Seldinger technique.
The Bard Hydrophilic Coated Angioplasty (PTCA) Guide Wires are steerable guide wires that are used for the introduction and placement of diagnostic or interventional devices in the coronary or peripheral vasculature and may be used to reach and cross a target lesion.
The Bard Hydrophilic Coated Guide Wire is a guide wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel. They may be used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion.
The provided text does not contain detailed acceptance criteria or a specific study proving the device meets acceptance criteria in the manner requested. The document is a 510(k) summary for the Bard Hydrophilic Coated Guide Wires, focusing on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with explicit acceptance criteria.
The "Performance Data" section states: "Safety and performance testing was performed to demonstrate that the Bard Hydrophilic Coated Guide Wire is substantially equivalent to the predicate devices. This testing supports the guide wires covered under this 510(k) as they are of the same design and materials of construction. No changes have been made that would warrant additional testing."
This statement indicates that testing was done, but it does not detail the acceptance criteria, the specific performance metrics, the results, or the methodology of those tests. It relies on the concept of "substantial equivalence" to predicate devices (Bard Preamendment Angiographic Guide Wires, Bard PTCA Steerable Standard Guide Wire, Bard Silk Guide Wire, and Terumo Glidewire) rather than presenting new performance data against pre-defined criteria for this specific device.
Therefore, I cannot populate the requested table and sections with information directly from the provided text because these specific details are not available. The document suggests that the device's performance is deemed acceptable because it is substantially equivalent to already approved devices, implying it would meet their implicit performance standards without requiring new, explicit acceptance criteria to be established or proven in this submission.
§ 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.