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510(k) Data Aggregation
(146 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-sheath-compatible, 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-the-wire system, 0.035" guidewire-compatible, and consists of a polycarbonate inner shaft and a nylon outer shaft. The polyimide inner shaft consists of the guidewire lumen and a flexible, radiopaque tracking tip and a radiopaque marker band. The outer shaft has a radiopaque marker band, a Touhy-Borst hemostasis valve and a one-way check-valve for flushing.
The filter can be retrieved with commercially available snares and sheaths via either the jugular or femoral approach.
This document outlines the performance data for the Crux Vena Cava Filter System, as presented in its 510(k) submission.
Device: Crux Vena Cava Filter System
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly met by demonstrating "substantial equivalence" to a predicate device through bench testing. The document states that "Bench test results demonstrate that the device meets the established specifications and is comparable to the predicate device supporting substantial equivalence." Specific performance metrics and criteria are not explicitly detailed in the provided text, but the tests conducted were:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device meets established specifications. | "Bench test results demonstrate that the device meets the established specifications." |
| Device is comparable to the predicate device. | "Bench test results demonstrate that the... device is comparable to the predicate device supporting substantial equivalence." and "The results also are comparable to the established predicate device supporting substantial equivalence." |
| No adverse impact on safety and effectiveness compared to the predicate device due to design updates. | "Based on the design verification results, the updates in Delivery Catheter do not have an adverse impact on the safety and effectiveness of the VCF when compared to the predicate device." |
| Performance of the updated delivery catheter is not adversely affected compared to the predicate device. | "As demonstrated in the results of the bench testing, these differences in design do not adversely affect the performance when compared to the predicate device and the devices are substantially equivalent." |
2. Sample Size for Test Set and Data Provenance
The provided text does not specify the sample sizes used for the in-vitro bench tests (Dimensional and Visual Inspection, Deployment Trackability, Bond Strength). The data provenance is assumed to be from Crux Biomedical, Inc.'s internal testing, as it's part of a 510(k) submission to the FDA. The testing is in-vitro, meaning it was conducted in a lab setting, not on human or animal subjects, so country of origin isn't relevant in the same way as clinical data.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. The study involved bench testing (in-vitro testing) of the device's physical properties and performance. There was no ground truth established by experts in a clinical context for a diagnostic output.
4. Adjudication Method for the Test Set
Not applicable, as this was bench testing, not a clinical study with subjective assessments requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document describes a 510(k) submission based on bench testing to demonstrate substantial equivalence of a medical device to a predicate device, not a comparative effectiveness study involving human readers or AI.
6. Standalone Performance Study (Algorithm Only)
No. This device is a physical medical device (vena cava filter system), not an algorithm or AI system. Therefore, standalone algorithm performance is not applicable.
7. Type of Ground Truth Used
The "ground truth" for this submission is based on established engineering specifications and performance benchmarks derived from the predicate device. The tests are designed to verify that the updated device components (specifically the delivery catheter) meet these physical and mechanical requirements and perform comparably to the predicate.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical device, not an AI or machine learning system that requires a "training set" of data.
9. How Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device submission.
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