(380 days)
The Option* Vena Cava Filter is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following conditions:
- Pulmonary thromboembolism when anticoagulant therapy is contraindicated; .
- Failure of anticoagulant therapy in thromboembolic diseases; ●
- Emergency treatment following massive pulmonary embolism when anticipated . benefits of conventional therapy are reduced;
- Chronic, recurrent pulmonary embolism when anticoagulant therapy has failed or is contraindicated
The filter may be retrieved according to the instructions supplied in section entitled "Optional Procedure for Filter Retrieval" in patients who no longer require a filter. Retrieval of the filter can be performed only by jugular approach.
The Rex Medical Option Vena Cava Filter System consists of a self-centering vena cava filter made from nickel-titanium alloy (Nitinol). The filter consists of shape memory nitinol struts emanating from a central location and designed for clot capture. Retention anchors are located at the caudal portion of the filter. These anchors are intended for filter fixation into the cava wall. The Option Filter is intended for use in cava diameters up to 30mm.
The delivery system consists of the filter preloaded in a filter cartridge, a 5French catheter sheath introducer, an openended angiographic vessel dilator which may be used for infusion of contrast solution during placement and a pusher with deployment marker.
The provided text describes the Rex Medical Option Vena Cava Filter System. Here's an analysis of the acceptance criteria and supporting studies based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list quantitative acceptance criteria in a table format with corresponding reported device performance metrics for the device itself. Instead, it states that "Substantial equivalence is based upon not only descriptive characteristics of the various devices but also upon the safety and performance testing completed."
However, it does mention that the device underwent certain types of testing and adhered to specific standards and guidance documents. These implicitly serve as acceptance criteria for regulatory clearance.
| Acceptance Criteria Category | Specific Criteria (Implicit from Document) | Reported Device Performance (Summary from Document) |
|---|---|---|
| Biocompatibility | Adherence to ISO-10993 Biological Evaluation of Medical Devices Part I: Evaluation and Testing | "Testing was also performed in accordance with... ISO-10993 Biological Evaluation of Medical Devices Part I: Evaluation and Testing" (Implies successful completion) |
| Sterility | Adherence to FDA's Updated 510(k) Sterility Review Guidance (K90-1); Final Guidance for Industry and FDA, August 30, 2002 | "Testing was also performed in accordance with... FDA's Updated 510(k) Sterility Review Guidance" (Implies successful completion) |
| Functional/Mechanical Performance | Adherence to FDA's Guidance for Cardiovascular Intravascular Filter 510(k) Submissions. (Implicitly includes design and performance of filter for clot capture, fixation, and retrieval) | "Mechanical bench testing, in vivo animal testing and clinical testing were performed." "The Option Filter is intended for use in cava diameters up to 30mm." "Substantial equivalence... upon the safety and performance testing completed." (Implies successful performance against these criteria to demonstrate substantial equivalence to predicate devices). |
| Intended Use | Prevention of recurrent pulmonary embolism (PE) in specified conditions (e.g., contraindication to anticoagulation, failure of anticoagulant therapy, emergency treatment, chronic/recurrent PE). | The device is indicated for these uses. (Implies the testing supported these indications). |
| Retrieval Capability | Ability to be retrieved by jugular approach according to instructions. | "The filter may be retrieved according to the instructions supplied in section entitled 'Optional Procedure for Filter Retrieval' in patients who no longer require a filter. Retrieval of the filter can be performed only by jugular approach." (Implies successful demonstration of retrieval capabilities). |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Mechanical bench testing, in vivo animal testing and clinical testing were performed." However, it does not specify the sample sizes for the test sets used in these studies, nor does it provide details on the data provenance (e.g., country of origin, retrospective or prospective nature) for clinical or animal studies.
It does mention that "In some instances, legally marketed vena cava filters were tested as control devices for the purpose of comparison with the Option Vena Cava Filter System," which suggests a comparative study design.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide any information regarding the number of experts, their qualifications, or their role in establishing ground truth for any test set.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method used for a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
The document does not mention any MRMC comparative effectiveness study involving human readers with or without AI assistance. The device is a physical medical implant, not an AI-powered diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable as the device is a physical vena cava filter, not an algorithm or AI. The performance discussed is the device's functional and safety performance, not algorithmic performance.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
For the mechanical bench testing and in vivo animal testing, the "ground truth" would likely be derived from:
- Mechanical measurements: e.g., filter strength, deployment accuracy, clot capture efficiency, migration resistance, retrieval force.
- Physiological observations (animal studies): e.g., absence of organ damage, successful deployment and retrieval, lack of significant adverse events, patency of the vena cava.
- Histopathology (animal studies): Tissue response around the filter.
- Clinical outcomes (clinical testing): Successful prevention of PE, successful deployment, no significant adverse events, successful retrieval.
However, the document does not explicitly detail the specific ground truth methodologies for the clinical or animal studies, beyond broadly stating "safety and performance testing."
8. The Sample Size for the Training Set
The document does not mention a training set as this information is relevant for machine learning algorithms, which is not the type of device being described.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as the device is not an AI/ML algorithm.
§ 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.”