(22 days)
The SilverSpeed Hydrophilic Guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the peripheral, visceral and cerebral vasculature during diagnostic and/or therapeutic procedures.
The SilverSpeed™ Hydrophilic Guidewire is a 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 introducer to ease the introduction of the guidewire into the catheter hub and/or hemostasis valve.
The provided document is a 510(k) summary for a medical device (guidewire) and not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, and ground truth for an AI/ML device is not applicable and cannot be extracted from this document.
The document discusses:
- Device Description: The SilverSpeed™ Hydrophilic Guidewire is a stainless steel guidewire with a radiopaque platinum distal coil, hydrophilically coated.
- Intended Use: For general intravascular use to aid in selective placement of catheters in peripheral, visceral, and cerebral vasculature during diagnostic and/or therapeutic procedures.
- Testing:
- Biocompatibility: Verified in accordance with ISO 10993-1. Test results confirmed biocompatibility as an 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.