(1002 days)
The AngioJet System, with the Catheter, is intended for breaking apart and removing thrombotic obstructions from infra-inguinal peripheral arteries ≥ 2.0 mm in diameter.
The AngioJet Rheolytic Thrombectomy System consists of a single-use Catheter, single-use Pump Set, and multi-use Drive Unit. The same Drive Unit and Pump Set are compatible with various Catheters with different design features.
The Catheter tracks and operates over a guide wire and is introduced through a guide catheter. It may be operated only in conjunction with the Pump Set and Drive Unit. Catheter components include a manifold, shaft, and tip segments. The manifold contains connections for the high pressure saline supply and effluent removal lines on the Pump Set, and a hemostasis valve for sealing around the guide wire. The Catheter shaft is dual lumen: one lumen provides high pressure saline delivered to the Catheter tip through a stainless steel hypodermic tube; the other larger lumen is used for evacuation of thrombotic debris and for guide wire passage. The Catheter tip is a stainless steel sub-assembly through which the stainless steel hypodermic tubing extends and terminates distally in a closed loop. The loop contains proximally directed jet orifices aimed at the evacuation lumen entrance.
Thrombectomy is accomplished with the introduction of a pressurized saline jet stream through the directed orifices in the Catheter distal tip. The jets generate a localized low pressure zone via the Bernoulli effect, which entrains and macerates thrombus. The same jets also provide the dynamic pressure to drive thrombotic debris down the exhaust lumen of the Catheter and out of the body for disposal.
Here's a breakdown of the acceptance criteria and the study information for the AngioJet Rheolytic Thrombectomy System, based on the provided documents:
1. Table of Acceptance Criteria and Reported Device Performance
The provided documents do not explicitly state predefined quantitative acceptance criteria for the device's performance in terms of specific metrics like sensitivity, specificity, or successful thrombus removal rates. Instead, the study's conclusions focus on comparative effectiveness and safety relative to a predicate device (urokinase).
However, based on the Summary of Clinical Results, the reported device performance can be summarized as:
| Metric | Reported Device Performance (AngioJet) |
|---|---|
| Primary Thrombus Removal | Higher reported effectiveness for complete thrombus removal not requiring additional intervention. |
| Distal Embolization Events | Lower percentage of patients experienced distal embolization events requiring additional thrombectomy aspiration or local thrombolytic intervention. |
| Vessel Injury (Dissection/Perforation) | Minor, without clinical sequelae. |
| Mortality | Dramatically fewer deaths (less than 50% of urokinase group). |
| Amputation-Free Survival | Higher at both six and twelve-month follow-up. |
| Primary Patency | Higher at both six and twelve-month follow-up. |
| Safety | No evidence to suggest higher frequency or severity of procedure-related complications compared to urokinase. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document states "a prospective non-randomized cohort of patients treated with AngioJet for peripheral arterial thrombus." The exact number of patients in this cohort is not specified.
- Data Provenance: The study was prospective and non-randomized. The country of origin of the data is not explicitly stated, but given the submission is to the U.S. FDA by a Minneapolis-based company, it is highly likely the study was conducted in the United States.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the given documents. The clinical results are reported directly (e.g., "higher reported effectiveness," "lower percentage of patients experienced"). There is no mention of independent experts establishing ground truth for the clinical outcomes.
4. Adjudication Method for the Test Set
This information is not provided in the given documents.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was one done? No. The study described is a comparison of the AngioJet device's clinical performance against an established therapy (urokinase) in a patient cohort, not an MRMC study comparing human readers with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
- Was one done? No. The AngioJet is an interventional medical device (mechanical thrombectomy catheter), not an AI algorithm. Therefore, a "standalone algorithm performance" study is not applicable. The study focuses on the device's performance in patients.
7. Type of Ground Truth Used
The ground truth for the clinical study was based on clinical outcomes data, including:
- Complete thrombus removal
- Occurrence of distal embolization events
- Vessel injury (dissection, perforation)
- Mortality
- Amputation-free survival
- Primary patency
These are direct patient outcomes observed during and after the procedure.
8. Sample Size for the Training Set
This question is not applicable as the AngioJet is a mechanical medical device, not an AI model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as the AngioJet is a mechanical medical device.
§ 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).