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The AngioJet DVX Rheolytic Thrombectomy Catheter is intended for use with the AngioJet System in breaking apart and removing thrombus from infra-inguinal peripheral arteries ≥ 3mm in diameter.

The AngioJet DVX Catheter is a 90 cm, 6 French, sterile, single-use catheter designed for removing thrombus from vascular conduits. High velocity saline jets directed back into the Catheter create a localized low-pressure zone at the distal tip (Bernoulli effect) that results in suction, break-up, and removal of thrombus through the exhaust lumen. The Catheter is designed to track over a 0.035" guide wire and through an 8 French high flow guide catheter (0.086 inch minimum internal diameter), which allows sufficient passage of the Catheter with adequate clearance for injection of standard contrast media, if desired.

This is a 510(k) summary for a medical device and typically does not contain detailed studies with acceptance criteria and performance data as it's primarily focused on demonstrating substantial equivalence to a predicate device. Therefore, much of the requested information cannot be extracted from this document.

However, I can extract information available and indicate what is not present.

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a table of acceptance criteria or specific quantitative performance metrics for the AngioJet DVX Rheolytic Thrombectomy Catheter. The submission aims to prove substantial equivalence to a predicate device rather than presenting detailed performance against specific criteria.

2. Sample Size Used for the Test Set and Data Provenance

Not available in this document. The 510(k) summary does not describe a test set or clinical study with sample sizes.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. No test set or ground truth establishment process is described.

4. Adjudication Method for the Test Set

Not applicable. No test set or adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This document is a 510(k) submission focused on substantial equivalence to a predicate device. It does not describe a comparative effectiveness study involving human readers with and without AI assistance. The device itself is a mechanical thrombectomy catheter, not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. The device is a physical medical instrument, not an AI algorithm.

7. Type of Ground Truth Used

Not applicable. No ground truth is described in this document as it's not a clinical trial report.

8. Sample Size for the Training Set

Not applicable. This document is for a medical device, not an AI model, so there is no training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Information that is available:

• Device Name: AngioJet® DVX™ Rheolytic™ Thrombectomy Catheter
• Intended Use: The AngioJet DVX Rheolytic Thrombectomy Catheter is indicated for use with the AngioJet System in breaking apart and removing thrombus from infra-inguinal peripheral arteries ≥ 3mm in diameter.
• Predicate Device: AngioJet XPEEDIOR® 120 Catheter (K040013, cleared 5/18/2004)
• Basis for Substantial Equivalence: Similarities in:
  • Indications for use
  • Operating principle
  • Basic design
  • Manufacturing environment
  • Sterilization process
  • Packaging configurations

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