(5 days)
The Rex Medical Cleaner™ Rotational Thrombectomy System device permits mechanical declotting in synthetic dialysis grafts.
The Rex Medical Cleaner™ Rotational Thrombectomy System 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 thrombectomy. The Cleaner™ macerates clot into particulate size that is not harmful to the patient.
The provided document pertains to a 510(k) premarket notification for the Rex Medical Cleaner™ Rotational Thrombectomy System. This regulatory submission primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving device performance against specific acceptance criteria in a detailed study format typically seen for novel devices with extensive performance claims.
Based on the information provided, here's an analysis of the acceptance criteria and the study that indicates the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria that the device had to meet (e.g., "device must remove X% of clot"). Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices. The performance is reported in terms of comparative characteristics and qualitative success in non-clinical and in-vivo testing.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (Rex Medical Cleaner™) |
|---|---|
| Intended Use: Maceration of Clot | Macerates clot into particulate size that is not harmful to the patient. Proven to macerate clot formation in synthetic dialysis grafts. |
| Safety: Device operates without raising new safety questions | In-vivo (animal) test studies proven as safely as the predicate device. Bench testing showed no differences in technological characteristics that raise new safety questions. |
| Effectiveness: Achieve mechanical declotting | In-vivo (animal) test studies proven as effectively and efficiently as the predicate device. |
| Technological Characteristics Comparison | Substantially equivalent in attributes like catheter type, OD, length, drive wire, distal tip, activation, etc. |
| Energy Transmitted to Graft (6mm Id Graft) | 22.6J (Predicate: 31.1J). This difference was deemed not to raise new questions of safety or effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: The document states that statistical sampling rationale for choosing the number of devices tested was based on ISO 2859-1 sampling plans in accordance with projected lots (batch) size for non-clinical tests. However, the specific number of devices tested for non-clinical performance or the number of animals in the in-vivo study is not provided.
- Data Provenance:
- Non-Clinical/Bench Testing: The geographical origin of this data is not specified. It is likely internal testing conducted by Rex Medical or a contracted lab.
- In-Vivo (Animal) Testing: The document explicitly states "In-Vivo (animal) test studies." The geographical origin is not specified, but it would have been prospective testing.
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)
This type of information is not applicable and not provided for this 510(k) submission. The "ground truth" in this context is established by the physical and functional performance of the device itself (e.g., successful clot maceration, energy output, comparison of physical dimensions) and observed outcomes in animal models, not through expert interpretation of data like in an AI/imaging study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are typically used in clinical studies involving human interpretation or subjective endpoints, which is not the primary focus of the non-clinical and animal studies described here.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices, which is not what the Rex Medical Cleaner™ is. The device is a mechanical thrombectomy system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to a mechanical medical device like a thrombectomy system. There is no "algorithm only" performance separate from the physical device's operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance was established through:
- Objective measurements and engineering specifications for non-clinical testing (e.g., catheter dimensions, energy output).
- Direct observation of clot maceration and safety outcomes in in-vivo animal studies. This would effectively be a form of direct observation of the physiological effect of the device, akin to outcomes data in a controlled environment.
8. The sample size for the training set
This information is not applicable as there is no "training set" for a mechanical medical device like this, which does not employ machine learning or AI.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated in point 8.
§ 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).