(159 days)
The PowerAssert™ Radiofrequency Guidewire (PARG) is intended for use with a Stereotaxis Niobe Magnetic Navigation System for the recanalization of occluded peripheral vessels.
The PARG is a sterile, single use, magnetically steerable endovascular guidewire intended to create a channel through occlusive material in vessels using mechanical or radiofrequency energy. Once a channel is created this will allow the introduction of adjunct devices/therapies to more completely alleviate the occlusion.
This document describes a 510(k) premarket notification for the PowerAssert™ Radiofrequency Guidewire (PARG). The submission aims to demonstrate substantial equivalence to previously cleared predicate devices, not to establish new performance criteria through a standalone study. Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert ground truthing, and clinical study details (like MRMC or standalone performance) is not applicable or provided in this type of regulatory submission.
The document focuses on comparing the technological characteristics of the PARG to its predicates to assert substantial equivalence.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
This type of 510(k) summary does not typically include a table of formal acceptance criteria and reported device performance in the way one might expect from a clinical trial or algorithm validation study. Instead, substantial equivalence is claimed by demonstrating that the new device shares similar technological characteristics and intended use with legally marketed predicate devices, and that any differences do not raise new questions of safety or effectiveness.
The document implicitly treats the characteristics of the predicate devices as the "acceptance criteria" for demonstrating substantial equivalence. The "reported device performance" is the list of characteristics of the PARG itself.
| Device Characteristic | Proposed PARG (K080637) | Predicate Baylis RF Tunneler Wire (K051670) | Predicate Stereotaxis Cronus® & Assert™ Guidewires (K042854 & K043457) |
|---|---|---|---|
| Intended Use | Recanalization of occluded peripheral vessels with Stereotaxis Niobe Magnetic Navigation System | Create a channel in totally occluded peripheral vessels 3mm or greater | Introduce and position over-the-wire catheters and other over-the-wire therapeutic devices within coronary and peripheral vasculature during PTCA or other intravascular interventional procedures |
| RF Capable | Yes | Yes | No |
| Magnetic Navigation Capable | Yes | No | Yes |
| Wire Diameter | 0.018" | 0.035" | 0.014" |
| Wire Length(s) | 185 and 300 cm | 250 cm | 180, 210, 235 & 300 cm |
| Max. RF Power | 25 watts | 25 watts | NA |
| RF Dwell Time | 3 seconds | 99 seconds | NA |
| Sterilization Method | EtO | EtO | EtO |
| Single Use | Yes | Yes | Yes |
| Distal Tip Lubricious Coating | Hydrophilic | Hydrophilic | Hydrophilic |
| Energy Source | Baylis' RF Generator | Baylis' RF Generator | NA |
The "Performance" section explicitly states: "Based upon the objective evidence presented in this 510(k) it has been demonstrated that the PARG is substantially equivalent to the predicate data devices it has been compared to in this submission." This is the primary "proof" of meeting the implicit acceptance criteria (i.e., substantial equivalence).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This 510(k) summary does not describe a clinical study with a test set of patient data to validate an algorithm or device performance in that manner. The "test set" here refers to the engineering and design characteristics of the device being compared against predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is not an AI/algorithm validation study requiring expert ground truth. Ground truth for device characteristics is based on manufacturing specifications and testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/algorithm validation study.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a guidewire, not an AI diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a guidewire, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a device like this, the "ground truth" for demonstrating substantial equivalence is primarily based on:
- Engineering specifications and design: The physical and operational characteristics of the device.
- Bench testing: Laboratory tests to verify performance aspects like power output, dwell time, and coating properties.
- Comparison to predicate devices: The established safety and effectiveness of legally marketed predicate devices.
No clinical "ground truth" from patients or experts in the sense of diagnostic accuracy is discussed here.
8. The sample size for the training set
Not applicable. This is a medical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 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.