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510(k) Data Aggregation
(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 (<24 hours), implying no unacceptable cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, hemolysis, complement activation, or thrombogenicity. | Passed all required biocompatibility tests (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Hemolysis, Complement Activation, Thrombogenicity). |
| Bench Performance | Device meets design specifications for physical and electrical properties, including dimensions, strength, friction, electrical continuity, and material integrity. | All listed tests (Dimensional Verification, Visual Inspection, Tensile Strength, Track Force, Guidewire Support Profile, Distal Flex Force, Shaft Friction Force, Electrode Size, Electrode Location, Device Continuity, Particulate Evaluation, Corrosion Resistance, Radiopacity) were performed and presumably met expectations for substantial equivalence. |
| Animal Performance | Similar performance to predicate devices in terms of adverse events, return to normal sinus rhythm post-pacing, and lack of histological differences. Ability to provide clinically significant blood pressure reduction, proper positioning, BAV device delivery, and connection to external pacing programmer. | Study 1: Performed similarly to control devices with regard to adverse events and animal health concerns. No sustained arrhythmia, all animals returned to normal sinus rhythm, no histological differences. Study 2: Similar performance and handling to control devices during simulated clinical use. Provided clinically significant BP reduction, proper positioning, successful BAV device delivery, and successful connection to external programmer. All animals returned to normal sinus rhythm and were free of concerning cardiac events post-procedure. |
| Clinical Performance | Predictable guidewire support, reliable bipolar pacing at low thresholds to allow safe transcatheter heart valve delivery. | The Wattson temporary pacing guidewire "offered predictable guidewire support with concomitant reliable bipolar pacing at low thresholds to allow safe transcatheter heart valve delivery." Performance indicates potential for a "more efficient procedure." |
2. Sample Size and Data Provenance
- Test Set (Clinical): 20 subjects.
- Data Provenance (Clinical): Single-center, prospective study. The country of origin is not explicitly stated, but the submission is to the U.S. FDA, suggesting a U.S. study or a study compliant with U.S. regulatory standards.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
This information is not provided in the document. The clinical study describes the outcomes observed in patients undergoing TAVR procedures but does not detail the process of establishing a "ground truth" through expert consensus for a test set, as might be typical for diagnostic AI devices. The assessment of performance appears to be based on the observed clinical outcomes and utility during the procedures.
4. Adjudication Method (Test Set)
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not conducted or reported. The document describes performance for the device itself, not an AI-assisted human reading scenario.
6. Standalone Performance Study
Yes, the studies described (bench, animal, and clinical) represent the standalone performance of the Wattson temporary pacing guidewire. There is no mention of human-in-the-loop performance; the device's efficacy is assessed directly.
7. Type of Ground Truth Used
- Biocompatibility & Bench Testing: Established by adherence to recognized international standards (ISO 10993-1) and internal design specifications/engineering measurements.
- Animal Studies: Established through direct observation of physiological responses, adverse events, histological findings, and procedural success in a porcine model, conducted under GLP. Comparison was made against predicate (control) devices.
- Clinical Study: Established by observed clinical outcomes during TAVR procedures, including aspects like guidewire support, pacing efficacy (reliable bipolar pacing at low thresholds), and safe transcatheter heart valve delivery.
8. Sample Size for the Training Set
This information is not applicable / not provided. The Wattson temporary pacing guidewire is a physical medical device, not an AI model requiring a training set in the conventional sense. The "training" of the device is through its design and manufacturing process, and its "performance" is evaluated through the validation studies described.
9. How the Ground Truth for the Training Set was Established
This information is not applicable / not provided for the same reasons as (8).
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