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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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(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.
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