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The ZelanteDVT™ Thrombectomy System, which includes the ZelanteDVT™ Thrombectomy Set and the ClotHunter™ Helical Rotation Device, is intended for use with the AngioJet Ultra Console to break apart and remove thrombus, including deep vein thrombus (DVT), from:
· Iliofemoral and lower extremity veins ≥ 6.0 mm in diameter and
· Upper extremity peripheral veins ≥ 6.0 mm in diameter.
The ZelanteDVT Thrombectomy System is also intended for use with the AngioJet Ultra Power Pulse technique for the controlled and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system.

The AngioJet™ ZelanteDVT Thrombectomy System is a component of the AngioJet Ultra Thrombectomy System (AngioJet Ultra System or System). The ZelanteDVT Thrombectomy System can only be used in conjunction with the AngioJet Ultra Console. The AngioJet ZelanteDVT Thrombectomy System is comprised of the single-use ZelanteDVT Thrombectomy Set and the single-use ClotHunter Helical Rotation Device. Both components are packaged and sold separately. The ClotHunter Helical Rotation Device can only be used in conjunction with the ZelanteDVT Thrombectomy Set.

The Thrombectomy Set uses this pressurized, high-velocity saline to create a low-pressure zone at the Catheter tip. Thrombus is drawn into the Catheter where it is fragmented by the jets and evacuated from the body. The waste tubing transports the thrombus debris from the Catheter to the waste bag for ultimate disposal.

The ClotHunter Helical Rotation Device consists of a distal helical-shaped wire portion attached to a control handle that is used with the ZelanteDVT Thrombectomy Set. The Helical Rotation Device deflects the distal tip of the Catheter and improves clot removal due to increased luminal coverage. The ClotHunter Helical Rotation Device extends beyond the distal tip of the Catheter to provide a transition between the Catheter and the vessel wall.

The provided text describes a 510(k) premarket notification for the ZelanteDVT™ Thrombectomy System. This submission focuses on demonstrating substantial equivalence to a predicate device through bench, animal, and biocompatibility testing, rather than clinical studies involving human patients or complex AI-based performance metrics like sensitivity/specificity.

Therefore, the information requested in your prompt related to the acceptance criteria for an AI device, sample sizes for test/training sets, ground truth establishment by experts, MRMC studies, and human reader performance improvement is not applicable to this specific device submission as described in the provided document.

The document states:

• "Bench, animal, and biocompatibility testing were performed to support a determination of substantial equivalence."
• "No new safety or performance issues were raised during the testing."

This indicates that the acceptance criteria and study design for this device revolved around engineering performance, material compatibility, and biological safety, as opposed to diagnostic accuracy or AI algorithm performance typically seen with AI-powered medical devices.

Summary of what can be extracted and what is N/A:

1. A table of acceptance criteria and the reported device performance:

   • N/A. The document lists the types of tests performed (biocompatibility, in-vitro performance, GLP animal study), but it does not specify quantitative acceptance criteria or detailed numerical results for these tests. It broadly states that the results "provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use" and that "No new safety or performance issues were raised."

2. Sample sized used for the test set and the data provenance:

   • N/A (for human clinical data). The studies are described as "Bench, animal, and biocompatibility testing." There's no mention of a human test set in the context of device performance data, thus no data provenance or sample size for human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • N/A. Ground truth in the context of diagnostic accuracy established by human experts is not relevant here as the testing is not for diagnostic performance of an AI.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • N/A. Not applicable as there is no diagnostic 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:

   • N/A. This applies to AI-assisted diagnostic devices. The ZelanteDVT™ Thrombectomy System is a mechanical thrombectomy device, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • N/A. There is no algorithm to test standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • N/A. Not applicable in the context of a mechanical thrombectomy device's performance testing. The "ground truth" for this device would be established by direct measurement during bench testing (e.g., clot removal efficiency, wire whip force), and observations during animal studies.

8. The sample size for the training set:

   • N/A. No AI training set is mentioned or required for this type of device.

9. How the ground truth for the training set was established:

   • N/A. No AI training set.

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