(143 days)
The SilverSpeed guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the mural, visceral and cerebral vasculature during diagnostic and/or therapeutic procedures.
The SilverSpeed™ Hydrophilic Guidewire is a .010" diameter stainless steel guidewire with a radiopaque, platinum distal coil. The guidewire is hydrophilically coated from the shapeable platinum coil up to the proximal 30cm of the guidewire. Included within the sterile pouch is a torque device to assist in guidewire manipulation and a guidewire introduction of the guidewire into the catheter hub and or hemostasis valve.
The provided text describes the regulatory submission for the "SilverSpeed™ Hydrophilic Guidewire" and focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria and proving performance against them through extensive clinical studies.
Therefore, many of the requested categories are not applicable to this type of submission. However, I can extract the information that is present.
Acceptance Criteria and Device Performance Study for SilverSpeed™ Hydrophilic Guidewire
This submission focuses on demonstrating substantial equivalence to predicate devices rather than setting and proving new acceptance criteria through a large-scale clinical study with specific performance metrics. The testing performed aimed to show that the new device performs as well as or similarly to existing legally marketed devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly based on Predicate Devices) | Reported Device Performance (Summary) |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1 for external communicating, blood contact, short duration ( |
§ 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.