(128 days)
The Wattson™ temporary pacing guidewire is intended to introduce and position catheters and other interventional devices within the chambers of the heart, including those used within transcatheter aortic valve replacement (TAVR) procedures and balloon aortic valvuloplasty (BAV), while transmitting an electrical signal from an external pulse generator to the heart. The temporary pacing guidewire is not intended to remain in place following the clinical procedure.
The Wattson temporary pacing guidewire is a dual-purpose 0.035" guidewire designed for the delivery of devices and for temporary rapid pacing of the heart. The distal end of the device has an atraumatic pigtail shape. The shaft of the device has a silicone lubricant applied to the outer surface. Rapid pacing is achieved through a bipolar electrode configuration integrated in the shaft of the guidewire. The electrodes terminate in a single positive electrode at the distal tip of the device and three discrete negative electrodes located proximal to the tip within the pigtail section. The entire device is visible using standard fluoroscopic methods. The device is packaged with a proprietary adapter that locks on to the proximal end of the guidewire and converts it to discrete positive and negative terminal pins. The terminal pins of the adapter are compatible with standard external pulse generators. The Wattson temporary pacing guidewire is sterilized with ethylene oxide.
The provided document describes the Wattson™ temporary pacing guidewire and its substantial equivalence to predicate devices, but it does not explicitly state specific quantifiable acceptance criteria for the device performance or present a table comparing such criteria with reported performance values.
Instead, the document focuses on demonstrating substantial equivalence through various types of testing. I will extract information related to the closest aspects of 'acceptance criteria' and 'reported device performance' based on the safety and effectiveness testing conducted.
Here's an attempt to answer your request based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
As specific quantifiable acceptance criteria are not provided in the document, this table will summarize the types of tests and the outcomes as described for demonstrating substantial equivalence.
| Test Category | Acceptance Criteria (Inferred/Qualitative) | Reported Device Performance (Qualitative Summaries) |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1 for an externally communicating device in contact with circulating blood and tissue for limited 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.