(342 days)
The ALN Optional Vena Cava Filter is indicated for the prevention of recurrent pulmonary embolism via placement in the vena cava 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; and
- Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.
The ALN optional filter may be removed according to the instructions supplied in the Instruction for Use of the ALN Extraction Kit.
Extraction kit: The ALN Optional Vena Cava Filter Extraction Kit has been designed for the removal of an implanted ALN Optional Vena Cava Filter in patients who no longer require a filter. The retrieval of the filter can be performed only by jugular approach.
The ALN Optional Vena Cava Filter and Extraction Kit consists of a 9 legs 316L stainless steel vena cava filter sold with a delivery kit, and an extraction kit with an 8 arms 316L stainless steel forceps. The filter is prepackaged in a filter holder designed to facilitate the insertion of the filter in the introducer catheter. The filter and the delivery kit are packaged together in Tyvek/film pouches and the extraction kit is packaged alone in the same type of pouches.
The ALN Optional Vena Cava Filter is designed to stop free thrombus in the vena cava in high risk patients. The insertion of the filter can be made by jugular, brachial or femoral approach and are very little traumatic, as the sheath has a 7F diameter. The extraction can be made only by jugular approach.
Here's an analysis of the provided text regarding the ALN Optional Vena Cava Filter and Extraction Kit, focusing on the acceptance criteria and the study used to demonstrate fulfillment:
I. Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of quantitative acceptance criteria with specific thresholds for the ALN Optional Vena Cava Filter and Extraction Kit. Instead, it describes a series of non-clinical tests and refers to clinical data. The acceptance is implied by successfully passing these tests and showing similar performance to predicate devices.
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| Non-Clinical Performance | |
| Simulated deployment | Passed all required tests. |
| Introducer / sheath suitability | Passed all required tests. |
| Clot trapping ability | Passed all required tests; filtering performances were assessed by a bench test in comparison with the predicate device, and results were similar for the two devices. |
| Filter fracture | Passed all required tests. |
| Caval perforation / filter migration | Passed all required tests. |
| Thrombogenicity | Passed all required tests. |
| MRI compatibility | Passed all required tests. |
| Clinical Performance | |
| Safety (complication rates) | Low rates of complication reported in the latest clinical study. 55 out of 220 filters were retrieved after a mean period of 51 days (range: 6 - 352 days) without any complication. |
| Effectiveness (prevention of PE) | "Clinical performances of ALN Optional Vena Cava Filter and Extraction Kit are similar to the clinical performances of the two predicates." The study included 220 patients who received the filter for prevention of venous thromboembolism, implying it serves this purpose effectively. |
| Retrievability | 55 filters retrieved without any complication, demonstrating successful retrievability. |
| Substantial Equivalence | The device was determined to be substantially equivalent to predicate devices based on design, material, components, fundamental technology, intended use, non-clinical, and clinical performances. |
II. Study Details for Demonstrating Acceptance Criteria
The document references both non-clinical (bench) testing and clinical data.
Non-Clinical Performance Studies:
- Sample Size: Not explicitly stated for each non-clinical test (simulated deployment, introducer/sheath suitability, filter fracture, caval perforation/migration, thrombogenicity, MRI compatibility). For "clot trapping ability," it involved a bench test comparison, but the number of tests or samples is not specified.
- Data Provenance: Implied to be laboratory/bench testing. No country of origin is mentioned for these specific non-clinical tests.
- Ground Truth: The "ground truth" for these non-clinical tests would be the established engineering/materials standards and performance metrics for such devices. Not applicable for expert review.
- Adjudication Method: Not applicable for non-clinical tests described.
- MRMC Comparative Effectiveness Study: Not applicable for non-clinical tests.
- Standalone Performance: Yes, the non-clinical tests evaluate the device's inherent performance characteristics independently.
- Type of Ground Truth: Engineering specifications, material properties, and established test methodologies (e.g., ISO standards for medical devices, although not explicitly named).
- Training Set Sample Size & Ground Truth: Not applicable; these are performance validation tests, not machine learning model training.
Clinical Performance Study:
- Study Description: The document states, "The safety and effectiveness of the ALN Optional Vena Cava Filter and Extraction Kit have been demonstrated via clinical data collected for 14 years." It then specifically mentions: "The last clinical study about ALN Optional Vena Cava Filter and Extraction Kit was published in chest in 2006. It includes 220 patients who receive an ALN Optional Vena Cava Filter for prevention of venous thromboembolism."
- Sample Size (Test Set): 220 patients.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). However, the publication in "Chest" in 2006 suggests it was a published, likely prospective, clinical trial. The long data collection period (14 years) implies either a series of studies or long-term follow-up from a prospective study.
- Number of Experts & Qualifications (Ground Truth): Not specified in the provided text. Clinical studies typically involve physicians (e.g., interventional radiologists, vascular surgeons) for patient selection, procedure performance, and outcome assessment, but the number and qualifications of those establishing study endpoints or ground truth directly are not detailed here.
- Adjudication Method: Not specified. Clinical trials often employ independent clinical event committees (CEC) or data safety monitoring boards (DSMB) for adjudication, but this detail is absent.
- MRMC Comparative Effectiveness Study: No, this was a study on the ALN filter itself, not a comparative effectiveness study involving human readers with/without AI assistance.
- Standalone Performance (Clinical): Yes, this clinical study assessed the standalone performance of the ALN Optional Vena Cava Filter in patients.
- Type of Ground Truth (Clinical): "Outcomes data." The study assessed clinical outcomes such as complication rates and successful retrieval. The fundamental "ground truth" for efficacy would be the absence of pulmonary embolism or the successful treatment of conditions leading to PE prevention.
- Training Set Sample Size & Ground Truth: Not applicable. This is a clinical trial evaluating device performance, not a machine learning model. The "training set" for the device's development would involve iterative design and bench testing, but not a dataset in the AI sense.
§ 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.”