(33 days)
The Modified Omniwave Endovascular System is indicated for use in the infusion of physician specified fluids, including thrombolytics, into the peripheral vasculature and for removal of thrombi from the peripheral vasculature.
The Modified Omniwave Endovascular System is comprised of two major components: (1) the sterile, single use Kit, and (2) the multi-use Generator.
The provided text is a 510(k) premarket notification summary for the Modified Omniwave Endovascular System. This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria based on performance studies.
Therefore, the document does not contain the detailed information requested regarding:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone (algorithm only) performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
Instead, the document states:
- Substantial Equivalence: The Modified Omniwave Endovascular System is substantially equivalent to the predicate device, Omniwave Endovascular System (K071762), in terms of device classifications, intended use, indications for use, target population, product design, materials, packaging, labeling, sterilization, and product performance.
- Support of Substantial Equivalence: "Product testing has demonstrated that the applicant device is substantially equivalent to the predicate devices." This implies that testing was conducted to show the new device performs similarly to the predicate, but the specific acceptance criteria and results are not detailed in this summary.
Conclusion:
Based on the provided document, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them because this information is not present in the 510(k) summary, which focuses on demonstrating substantial equivalence rather than reporting detailed performance study outcomes against a predefined set of acceptance criteria.
§ 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).