(59 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 pacing of the heart. The distal end of the device has an atraumatic pigtail shape. The shaft of the device has a hydrophilic coating. Pacing is achieved through a bipolar electrode configuration integrated in 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. Unshrouded adaptor pins are provided to ensure compatibility with all connecter cable terminals. The Wattson temporary pacing guidewire is sterilized with ethylene oxide.
This document is a 510(k) Summary for the Wattson Temporary Pacing Guidewire (Model 2250). It details the device's indications for use, its characteristics, and a comparison to a predicate device (K192454, also a Wattson temporary pacing guidewire). The summary also outlines the performance data gathered to support the claim of substantial equivalence.
Based on the provided text, the device is a medical guidewire used in cardiac procedures, specifically Transcatheter Aortic Valve Replacement (TAVR) and Balloon Aortic Valvuloplasty (BAV), which also has the capability to transmit an electrical signal for temporary cardiac pacing.
Here's an analysis of the acceptance criteria and study proving the device meets them, based solely on the provided text:
Important Note: The provided document is a 510(k) Summary, which is a regulatory submission for medical devices to demonstrate substantial equivalence to a legally marketed predicate device. It typically summarizes testing, but does not provide the full detailed study reports. Therefore, some information requested in your prompt (e.g., number of experts, specific effect sizes for MRMC studies, sample sizes for training sets for AI models) may not be present because this device is a traditional guidewire, not an AI/ML-driven diagnostic device. The questions you've asked are largely applicable to AI/ML device submissions, which is not what this document describes.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a submission for a physical medical device (guidewire) and not an AI/ML diagnostic tool, "acceptance criteria" are typically defined by engineering specifications, material biocompatibility, and functional performance benchmarks rather than diagnostic metrics like sensitivity/specificity. The document doesn't present a formal table of quantitative acceptance criteria and performance results in the way one would for an AI model.
However, the "Performance Data" section outlines the types of testing performed, which implicitly demonstrates "acceptance" based on successful completion of these tests.
| Category | Acceptance Criteria (Implicit from testing type) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meets ISO 10993-1 standards for an externally communicating device in contact with circulating blood and tissue for limited time ( |
§ 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.