(24 days)
The AngioJet Ultra DVX Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from upper and lower extremity peripheral arteries ≥3 mm in diameter; break apart and remove thrombus from upper extremity and infra-inguinal lower extremity peripheral veins ≥3 mm in diameter; and for use with the AngioJet Ultra Power Pulse Kit for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system.
Each AngioJet Ultra DVX Thrombectomy Set is a sterile, single use, disposable set that includes the Thrombectomy Catheter and Pump in one combined unit. The AngioJet Ultra DVX Thrombectomy Set is used with the AngioJet Ultra Console.
This document is a 510(k) summary for the AngioJet Ultra DVX Thrombectomy Set, which is a medical device intended to remove thrombus from peripheral arteries and veins. However, it does not contain the specific information required to complete the table and answer all questions related to acceptance criteria and study details.
Here's a breakdown of what can and cannot be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. | "Representative samples of the devices underwent bench testing, including but not limited to mechanical testing, biocompatibility, sterility, comparative testing to demonstrate appropriate functional and performance characteristics." (No specific performance metrics are reported) |
2. Sample size used for the test set and data provenance:
- Sample size: Not specified. The document mentions "representative samples" for bench testing.
- Data provenance: Not specified. These are likely internal lab tests (bench testing) and not human clinical data.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
- Not applicable. The document describes bench testing, not a study involving ground truth established by experts.
4. Adjudication method for the test set:
- Not applicable. As above, this was bench testing, not a study requiring adjudication.
5. Multi-reader multi-case (MRMC) comparative effectiveness study:
- No. The document does not mention an MRMC comparative effectiveness study. It states "comparative testing to demonstrate appropriate functional and performance characteristics" but this refers to comparison with predicate devices, not human readers with and without AI assistance.
- Effect size: Not applicable, as no such study was performed.
6. Standalone (algorithm only without human-in-the-loop performance) study:
- The device is a physical thrombectomy set used in a medical procedure, not an AI algorithm. Therefore, a standalone (algorithm only) study is not applicable. The bench testing performed could be considered a form of standalone performance evaluation for the physical device.
7. Type of ground truth used:
- For the described bench testing, the "ground truth" would be established by the physical and chemical properties measured during mechanical, biocompatibility, and sterility tests. This is not "expert consensus, pathology, or outcomes data" in the typical sense for a diagnostic device.
8. Sample size for the training set:
- Not applicable. This is a physical medical device, not an AI model requiring 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.
In summary:
This 510(k) notification focuses on demonstrating substantial equivalence of the AngioJet Ultra DVX Thrombectomy Set to predicate devices based on functional design, materials, indications for use, and principles of operation, supported by bench testing. It does not provide the detailed information about acceptance criteria or a study with expert-adjudicated ground truth and clinical performance metrics that would be typically found for diagnostic AI devices.
§ 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).