(119 days)
The Cleaner™ Rotational Thrombectomy System is indicated for mechanical declotting of native vessel dialysis fistulae and synthetic dialysis access grafts.
The Cleaner "1" Rotational Thrombectomy System is a 7F percutaneous mechanical thrombectomy catheter. It is a sterile, single use disposable device. Its handle contains a battery operated motor that spins a flexible "S" shaped guidewire at approximately 4000rpm. The wall contacting rotational wire, with integrated soft distal tip, permits atraumatic mechanical declotting of native vessel dialysis fistulae and synthetic dialysis access grafts. The wire creates a fluid vortex as it spins that macerates clot and allows it to be aspirated through the introducer sheath.
The provided text describes a 510(k) summary for the Cleaner Rotational Thrombectomy System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel efficacy through detailed clinical studies with specific acceptance criteria and detailed performance metrics as one might find for a de novo or PMA submission.
Therefore, the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not explicitly present in the provided document. The document states that "bench testing and animal studies demonstrate Cleaner™ Rotational Thrombectomy System is as safe and effective as the legally marketed predicate device." It also mentions "Non-Clinical Performance Testing" derived from risk assessment and ISO standards, but does not provide specific details on the acceptance criteria or results.
Based on the provided text, here’s a breakdown of what can be inferred or is directly stated, and what cannot be answered:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states that "Test methodology and acceptance criteria were derived from within Rex Medical and from related ISO standards for evaluation of this device," but it does not specify these criteria or the reported performance metrics against them. The conclusion simply states the device is "substantially equivalent" to the predicate.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- No test set for clinical performance is mentioned. The testing described is "bench testing and animal studies," which are non-clinical. No sample sizes for these are provided, nor is their provenance or study design (retrospective/prospective) detailed.
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 / Cannot be provided. There's no mention of a clinical test set requiring expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Cannot be provided. There's no mention of a clinical test set requiring adjudication.
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
- No MRMC study was mentioned. This device is a mechanical thrombectomy system, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device's evaluation as described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical medical device, not a standalone algorithm. Its performance is inherent to its mechanical function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable for clinical ground truth. For the non-clinical "bench testing and animal studies," the ground truth would be physical measurements and observations of the device's mechanical performance in relevant models, but the specific types are not detailed.
8. The sample size for the training set
- Not applicable. This device does not use machine learning, so there is no training set in the typical sense.
9. How the ground truth for the training set was established
- Not applicable. As above, no machine learning training set is mentioned.
Summary of what the document does state:
- Device: Cleaner™ Rotational Thrombectomy System.
- Intended Use: Mechanical declotting of native vessel dialysis fistulae and synthetic dialysis access grafts.
- Predicate Devices: Cleaner™ Rotational Thrombectomy System (K091029 and K060904).
- Testing Conducted: "Bench testing and animal studies" to demonstrate safety and effectiveness, and "Non-Clinical Performance Testing" derived from risk assessment and ISO standards.
- Conclusion: The device is "substantially equivalent" to the predicate devices based on this testing and similarities in intended use, materials, technological characteristics, principle of operation, and design features.
§ 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).