(22 days)
The Cleaner ™ Rotational Thrombectomy System Kit is designed for mechanical declotting in synthetic dialysis access grafts.
The Rex Medical Cleaner™ Rotational Thrombectomy System Kit is a battery operated, hand held, wall contacting, rotational thrombectomy device which provides an effective means to restore patency to occluded synthetic dialysis grafts. The rotational wire, with integrated soft distal tip, provides an atraumatic approach to mechanical thrombectorny. The Cleaner™ macerates clot into particulate size that is not harmful to the patient.
This document is a 510(k) summary for the Rex Medical Cleaner™ Rotational Thrombectomy System Kit, which is a medical device. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving performance against specific acceptance criteria through a clinical study.
Therefore, the input does not contain information on acceptance criteria, reported device performance, sample sizes for test sets, data provenance, number of experts or their qualifications for ground truth, adjudication methods, MRMC studies, standalone performance, or details on training sets.
The relevant sections are:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the document as performance metrics. The focus is on demonstrating that modifications do not adversely affect safety and effectiveness compared to predicate devices.
- Reported Device Performance:
- The original Cleaner™ Rotational Thrombectomy System had a specified rotational velocity of 4000 ± 500 RPM.
- The Cleaner™ Rotational Thrombectomy System Kit has a rotational velocity specified as 3000 - 4500 RPM.
- "Testing proved that there is no effect on the safety and efficacy of the Cleaner™ Rotational Thrombectomy System Kit with the additions and modification noted above."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not specified. The document mentions "Verification testing was performed" but does not detail the sample size or data provenance.
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 device submission is about verifying manufacturing and design changes, not evaluating diagnostic performance against ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This type of adjudication is for studies involving multiple readers evaluating a test set against ground truth, which is not the nature of 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 device is a mechanical thrombectomy system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a mechanical thrombectomy system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the context of diagnostic ground truth. The "ground truth" here is the established safety and effectiveness of the predicate device, against which the modified device is compared to ensure no adverse effects.
8. The sample size for the training set
- Not applicable. This device does not involve a training set as it is not an AI/machine learning product.
9. How the ground truth for the training set was established
- Not applicable.
§ 870.4875 Intraluminal artery stripper.
(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).