(56 days)
The MERIDIAN™ Filter System - Femoral Delivery Kit is indicated for use in the prevention of recurrent pulmonary embolism via permanent placement in the vena cava in the following situations:
- Pulmonary thromboembolism when anticoagulants are contraindicated. .
- Failure of anticoagulant therapy for thromboembolic disease. .
- . 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.
MERIDIAN™ Filter may be removed according to the instructions supplied under the section labeled: Optional Procedure for Filter Removal.
The MERIDIAN™ Filter consists of twelve electropolished shape-memory nitinol wires emanating from a central electropolished nitinol filter hook. These 12 wires form two levels of embolic filtration: the six legs provide the lower level of filtration and the six arms provide the upper level of filtration. The legs contain hooks and the arms contain anchors to resist filter movement. The MERIDIAN™ Filter is intended to be used in the inferior vena cava with diameters less than or equal to 28 mm.
The MERIDIAN™ Filter System - Femoral Delivery Kit consists of a 8 French inner diameter (I.D.) introducer sheath and dilator set, a storage tube preloaded with the MERIDIAN™ Filter and pusher system. The dilator is fitted with 2 radiopaque marker bands spaced 28 mm apart for caval sizing. The introducer sheath contains a radiopaque tip and hemostasis valve with a side port for injecting contrast medium via a syringe. The storage tube and pusher system attach to the introducer and allow for delivery and deployment of the MERIDIAN™ Filter.
Here's a breakdown of the acceptance criteria and study information for the MERIDIAN™ Filter System - Femoral Delivery Kit, based on the provided text:
Important Note: The provided document is a 510(k) Summary for a medical device. This type of document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving efficacy or safety through new clinical trials as would be the case for a novel device. Therefore, the "study" described here is primarily a series of in vitro and in vivo performance tests designed to show that the modified device performs comparably to the predicate. It does not involve human subjects as a traditional clinical trial would for evaluating primary outcomes.
Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" with quantitative thresholds against which "reported device performance" is directly compared for each test. Instead, it states that the results from the performance tests "demonstrate that the technological characteristics and performance of the MERIDIAN™ Filter System – Femoral Delivery Kit is comparable to the predicate devices and that the subject device can perform in a manner substantially equivalent to the predicates devices with the same intended use."
The document lists the following performance tests conducted:
In Vitro Delivery System Testing:
- Dimensional and Visual Inspection
- Tensile
- Torque
- Flushability
- Component compatibility
- Attachment/Detachment
- Filter Dislodgement
- Pushability
- Trackability
- Removability
- Filter Centering (Tilt)
- Arm and Leg Entanglement (Filter Configuration)
- Deployment Force
- Deployment Accuracy
- Liquid Leakage
- Leakage during power injection
- Burst
- Air Aspiration
- Biocompatibility per ISO 10993-1
In Vivo Delivery System Testing:
- Delivery System Trackability and Pushability
- Dilator and Introducer Sheath Trackability and Pushability
- Ease of Deployment (Deployment Force)
- Deployment Accuracy
- Filter Centering (Tilt)
- Arm and Leg Entanglement (Filter Configuration)
- Dilator Marker Band Visibility Under Fluoroscopy
- Introducer Sheath Tip Visibility Under Fluoroscopy
Summary of Reported Performance: The overall reported performance is that the device is "comparable to the predicate devices" and "substantially equivalent." Specific quantitative metrics for each test and their relation to defined acceptance criteria are not provided in this 510(k) summary. The FDA's clearance implies that the provided data (which likely included specific test reports and data that are not part of this public summary) met the agency's requirements for demonstrating substantial equivalence.
Study Details
Given this is a 510(k) summary focused on demonstrating substantial equivalence through performance testing of a modified device, many of the typical "study" parameters for clinical trials (like sample sizes for test sets, data provenance, expert ground truth, adjudication, MRMC studies) are not applicable or described in the same way.
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided summary. Performance tests typically involve a defined number of devices or components.
- Data Provenance: The tests were conducted "in vitro and in vivo." The "in vivo" testing would likely refer to animal models, not human subjects, given that this is a 510(k) for a modification (delivery kit components). The country of origin for the data is not specified but would typically be conducted by or for the manufacturer (Bard Peripheral Vascular, Inc. in Tempe, Arizona, USA). The study is prospective in the sense that these tests were performed specifically to support this 510(k) submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of device performance testing. Ground truth here is based on engineering specifications, material standards (e.g., ISO 10993-1 for biocompatibility), and comparison to the predicate device's established performance under those specifications.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as this is not a study requiring human expert assessment or consensus on clinical outcomes. Device performance tests are typically objective measurements.
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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:
- This is not an AI-assisted diagnostic device, but rather a medical implant delivery system. Therefore, an MRMC comparative effectiveness study is not applicable.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This is not an algorithm or AI device. The performance tests are of the physical device and its components.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" (or standard of comparison) for these performance tests is based on:
- Engineering specifications: Ensuring the components meet design tolerances and functional requirements (e.g., deployment force, trackability).
- Material standards: Conformance to established standards, such as ISO 10993-1 for biocompatibility.
- Predicate device performance: Demonstrating that the modified device performs comparably to the previously cleared predicate device in all relevant aspects.
- The "ground truth" (or standard of comparison) for these performance tests is based on:
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The sample size for the training set:
- This is not an AI/machine learning device; hence, there is no "training set." The device is evaluated based on its physical and mechanical properties.
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How the ground truth for the training set was established:
- Not applicable as there is no training set for an AI/ML model.
§ 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.”