(28 days)
The Retraction Aspirator is intended to be used with the FlowTriever Retrieval/Aspiration System to facilitate the simultaneous aspiration and withdrawal of the FlowTriever Catheter into the Guide Catheter.
The Retraction Aspirator facilitates the simultaneous aspiration and withdrawal of the FlowTriever Catheter into the Guide Catheter. The hand-lever operated Retraction Aspirator, with its integrated clutch, is fitted with a vacuum syringe and collection container. Operating the Retraction Aspirator lever simultaneously retracts the FlowTriever Catheter into the Guide Catheter and aspirates fluid.
The provided text is a 510(k) summary for the Inari Medical Retraction Aspirator, stating that it is substantially equivalent to a previously cleared device (K143563) and that no changes have been made to the device, its design, technology, materials, or manufacturing processes. Therefore, no new performance data or acceptance criteria are presented for this specific 510(k) (K152097). Instead, it refers back to the non-clinical test results submitted for K143563.
Based on the provided document, the following information can be extracted regarding the device and its assessment:
1. A table of acceptance criteria and the reported device performance:
Since the current submission (K152097) explicitly states "No changes have been made to the Retraction Aspirator since the original clearance on February 3, 2015 (K143563). The device design, technology, materials, processes, etc. have not been changed with this application," and "Non-clinical test results for the Retraction Aspirator were submitted in premarket notification K143563. No changes have been made to the device therefore additional testing was not necessary," no new acceptance criteria or reported performance is included in this document. The assessment relies on the prior clearance.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this document due to reliance on prior clearance (K143563). | Not specified in this document due to reliance on prior clearance (K143563). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not specified in this document. The document refers to non-clinical test results from the original clearance (K143563).
- Data Provenance: Not specified in this document. The document refers to non-clinical test results from the original clearance (K143563).
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/Not specified. The assessment for this device relies on non-clinical testing rather than expert-based ground truth from clinical studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. The assessment for this device relies on non-clinical testing.
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 an embolectomy catheter, a physical medical device, not an AI-powered diagnostic or assistive tool for human readers. "Clinical testing was not required for the determination of substantial equivalence."
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 an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical testing referenced from K143563, the ground truth would typically be based on established engineering and material science metrics, such as mechanical strength, fluid dynamics, biocompatibility, and manufacturing quality control. Specific types are not detailed in this document.
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is a physical medical device, not an AI model.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).