(51 days)
The WIRION™ is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/ debris) while performing atherectomy in calcified lesions of the lower extremities. The diameter of the vessel at the site of filter basket placement should be between 3.5mm to 6.0mm. WIRION™ may be used with commercially available 0.014" guide wires.
WIRION™ is a temporary Embolic Protection System (EPS), filtering distal to the intervention site. The system is a rapid exchange, pre-crimped filter that can be used with any commercially available 0.014" guide wires.
This document is for an embolic protection system (WIRION™), a medical device, and not an AI/ML powered device. Therefore, many of the requested criteria (e.g., acceptance criteria for an AI algorithm, expert ground truth establishment, MRMC study, training/test set sample sizes, data provenance) are not applicable to this 510(k) submission.
The core of this 510(k) submission is that the WIRION™ device is identical to a previously cleared predicate device (K180023). This means the manufacturer is asserting substantial equivalence based on the device being literally the same as one already on the market, rather than needing to prove performance through new clinical or algorithm-specific studies.
Here's how to address the request based on the provided document:
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence claim based on identity to a predicate device, there are no specific performance acceptance criteria or reported performance data for this specific submission. The acceptance is predicated on the prior clearance of the identical device.
| Acceptance Criteria (Not explicitly stated for new testing, but implied by identity to predicate) | Reported Device Performance (Implied by identity to predicate) |
|---|---|
| Device is identical to K180023 WIRION™ | Device is identical to K180023 WIRION™ and thus is expected to perform as previously demonstrated by the predicate. |
| Meets Indications for Use: "contain and remove embolic material (thrombus/debris) while performing atherectomy in calcified lesions of the lower extremities... vessel at the site of filter basket placement should be between 3.5mm to 6.0mm. WIRION™ may be used with commercially available 0.014" guide wires." | Expected to contain and remove embolic material in calcified lower extremity lesions with specified vessel and guidewire parameters, as demonstrated by the predicate device. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. No new test set or data provenance details are provided because the device is stated to be identical to a previously cleared predicate.
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. No ground truth establishment by experts for a test set was required for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No adjudication method for a test set was required for this submission.
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 is not an AI/ML device, and no MRMC comparative effectiveness study was performed or required.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm, so no standalone performance evaluation was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No new ground truth types were used or established for this submission, as it relies on the predicate device's prior clearance. The previous clearance would have relied on data and performance demonstrations appropriate for a mechanical medical device, likely including preclinical testing and/or clinical data that established safety and effectiveness.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. No ground truth for a "training set" was established.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).