(29 days)
The PVS 1300 Synchro® 0.014" & 1600 Synchro® 0.010" Neuro Guidewire series of products are intended for general intravascular use, which includes peripheral and neurovascular use. The device can be used to selectively introduce and position catheters and other interventional devices within the peripheral & neurovasculature. The device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.
products having a 0.014" & 0.010" outside diameter respectively, being sterile, single use/disposable products, with shapeable tip which is used to gain intravascular access to and facilitate the positioning and exchange of interventional devices in small diameter, tortuous vasculature for peripheral, neuro diagnostic and interventional procedures. The guidewire can be torqued to facilitate navigation through the vasculature. A torque device, (Merit Medical Systems (K936032)) is supplied with the wire to facilitate deployment & positioning. A guidewire introducer (B. Braun (K760389)) is also supplied and may be used to aid introduction of the guidewire into the catheter hub and/or hemostasis valve and to gently shape the guidewire's distal flexible tip, if desired, according to standard practice. Neither the guidewire introducer or the torque device are intended to enter the body. The products are projected to be provided in a 180cm - 300cm length range, with 200cm being nominal. The Nitinol tip length is projected to be presented in a 25cm - 65cm range, with 35-45cm being nominal. A traditional range of flexibility profiles shall also be provided, ranging from support (stiff) to flex (soft). The device is coated on the outer diameter with a lubricious coating over the distal segment of the device. The marker coil is platinum wire at the distal tip of the device to aid visualization under fluoroscopy. The subject device has the ability to access distal, tortuous vasculature, with steerability and torque transmission properties.
The provided text describes a 510(k) submission for guidewires, which are physical medical devices, not software or AI-powered devices. Therefore, the questions related to AI/algorithm performance metrics, expert reviews, ground truth, and training sets are not applicable to this document. The submission focuses on demonstrating substantial equivalence to predicate guidewires through material properties and performance testing.
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1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | Verified in accordance with ISO 10993-1 (Biological Evaluation of Medical Devices - Part 1). Materials 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.