(156 days)
The Crux VCF System is indicated for the prevention of recurrent pulmonary embolism via percutaneous placement in the inferior vena cava (IVC) in the following situations:
- Pulmonary thromboembolism when anticoagulants are contraindicated .
- Failure of anticoagulant therapy in thromboembolic diseases .
- Emergency treatment following massive pulmonary embolism where anticipated . benefits of conventional therapy are reduced
- Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or . is contraindicated
The Crux VCF may be removed according to the instructions contained in the Instructions for Use section "Optional Retrieval of the Crux VCF" in patients who no longer require a vena cava filter. Retrieval of the filter can be performed by femoral or jugular approach.
The Crux VCF System is an endovascular medical device used in the prevention of recurrent pulmonary embolism (PE). The system consists of a self-expanding Nitinol filter delivered from a single-use, disposable 9Fr catheter, which can be used percutaneously to deploy the filter. The filter wireforms are composed of two opposing self-expanding Nitinol spiral elements connected at each end with Nitinol crimps. One end of each wireform is formed into a sinusoidal shaped retrieval tail to aid in retrieval of the filter using a snare. Each retrieval tail has an atraumatic plasma ball and a radiopaque tantalum marker band to facilitate visualization. There are five tissue anchors attached to the wireforms elements with Nitinol tubing. The filter is designed to treat IVC diameters of 17 to 28mm.
The delivery catheter for the Crux VCF is a disposable, 9Fr introducer-sheathcompatible, single-use delivery catheter. The filter is provided loaded in the Crux VCF System for jugular or femoral approach delivery. The delivery catheter is an over-thewire system, 0.035" guidewire-compatible, and consists of a polycarbonate inner shaft and a nylon outer shaft. The inner shaft consists of the guidewire lumen and a flexible, radiopaque tracking tip. The outer shaft has a radiopaque distal marker band, a Touhy-Borst hemostasis valve and a one-way checkvalve for flushing.
The filter can be retrieved with commercially available snares and sheaths via either the jugular or femoral approach.
Here's a breakdown of the acceptance criteria and study information for the Crux Vena Cava Filter System, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Defined as "Primary Endpoint of Clinical Success") | Reported Device Performance |
|---|---|
| Technical success of deployment | 98% (123/125) |
| Freedom from PE (Pulmonary Embolism) | 2.4% recurrent PE |
| Freedom from filter migration | 0 cases of migration |
| Freedom from device related adverse events requiring intervention | Not explicitly quantified, but overall Clinical Success was 96% |
| Overall Clinical Success: Expected to exceed 80% (91.8% lower one-sided 95% CL) | 96% (91.8% lower one-sided 95% CL) |
| Retrieval success (Secondary Endpoint) | 98% (53/54) |
Note: The document explicitly states, "Clinical Success was 96% (91.8% lower one-sided 95% CL exceeding the 80)." This indicates that the acceptance criterion for overall clinical success was likely a lower bound of 80% with a 95% confidence interval.
Study Details
2. Sample size used for the test set and the data provenance:
- Test set sample size: 125 subjects (for clinical trial)
- Data provenance: Prospective, single-arm, multinational clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not explicitly provided in the given text. Clinical trials often involve multiple clinicians for assessment, but the number and qualifications of experts specifically for establishing "ground truth" (e.g., confirming PE diagnoses, migration, etc.) are not detailed.
4. Adjudication method for the test set:
- This information is not explicitly provided in the given text.
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:
- No, an MRMC comparative effectiveness study involving AI assistance for human readers was not performed. This document describes a clinical trial for a physical medical device (vena cava filter), not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this refers to a physical medical device, not an algorithm. Therefore, no standalone algorithm performance was assessed.
7. The type of ground truth used:
- The ground truth was established through clinical outcomes observed in the prospective clinical trial. This includes:
- Technical success of deployment (observed during procedure)
- Occurrence of recurrent PE (diagnosed clinically)
- Filter migration (diagnosed clinically/radiographically)
- Device-related adverse events requiring intervention (diagnosed clinically)
- Retrieval success (observed during removal procedure)
- Radiographic anomalies (e.g., IVC thrombus).
8. The sample size for the training set:
- This information is not applicable as this describes a physical medical device and its clinical trial, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established:
- This information is not applicable for the same reasons as above.
§ 870.3375 Cardiovascular intravascular filter.
(a)
Identification. A cardiovascular intravascular filter is an implant that is placed in the inferior vena cava for the purpose of preventing pulmonary thromboemboli (blood clots generated in the lower limbs and broken loose into the blood stream) from flowing into the right side of the heart and the pulmonary circulation.(b)
Classification. Class II. The special controls for this device are:(1) “Use of International Standards Organization's ISO 10993 ‘Biological Evaluation of Medical Devices Part I: Evaluation and Testing,’ ” and
(2) FDA's:
(i) “510(k) Sterility Review Guidance and Revision of 2/12/90 (K90-1)” and
(ii) “Guidance for Cardiovascular Intravascular Filter 510(k) Submissions.”