(357 days)
The MERIDIAN™ Filter System -Jugular/Subclavian Delivery Kits are 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 subject MERIDIAN™ Filter System - Jugular/Subclavian Delivery Kit consists of a 10 French I.D. introducer sheath and dilator set and a delivery device preloaded with the MERIDIAN™ Filter. The introducer sheath and dilator are used to gain access to the inferior vena cava via a jugular approach using the Seldinger technique. The dilator accepts a 0.038" guidewire, enables a contrast medium power injection up to 800 psi maximum pressure, and is fitted with two radiopaque marker bands spaced 28 mm apart for caval sizing. The introducer sheath contains a radiopaque tip for identification of the distal end of the sheath and a hemostasis valve with a side port for injecting contrast medium via a syringe. The delivery device fits within the introducer sheath and delivery mechanism to deploy the MERIDIAN™ Filter.
The provided text is a 510(k) summary for the MERIDIAN™ Filter System - Jugular/Subclavian Delivery Kit. It focuses on demonstrating substantial equivalence to a predicate device through various performance tests rather than presenting a standalone study with acceptance criteria and reported device performance in the way a diagnostic AI device might.
Therefore, many of the requested categories for AI device studies (like sample size, ground truth establishment, expert qualifications, MRMC studies, and training set details) are not applicable to this submission.
Here's an attempt to answer the questions based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative "acceptance criteria" and "reported device performance" in a tabular format as would be expected for a diagnostic AI device. Instead, it lists various types of in vitro and in vivo tests conducted to demonstrate substantial equivalence to the predicate device. The conclusion states that the "results from these tests demonstrate that the technological characteristics and performance criteria of the MERIDIAN™ Filter System - Jugular/Subclavian Delivery Kit is comparable to the predicate device and that the subject device can perform in a manner substantially equivalent to devices currently on the market for the same intended use."
The tests performed are:
| Test Type | In Vitro Tests | In Vivo Tests |
|---|---|---|
| Mechanical/Physical | - Fatigue Resistance | - Retrievability |
| - Anchor Weld Tensile Strength | - Fatigue Resistance | |
| - Cephalad Migration Resistance | - Cephalad Migration Resistance | |
| - Caudal Migration Resistance | - Caudal Migration Resistance | |
| - Removal Force | - Penetration Resistance | |
| - Delivery System Trackability | - Perforation | |
| - Delivery System Pushability | - Caval Patency | |
| - Deployment Accuracy | - Caval Damage | |
| - Filter Centering (Tilt) | - Caval Narrowing | |
| - Arm/Leg Entanglement (Configuration) | - Delivery System Trackability | |
| - Delivery System Pushability | ||
| - Ease of Deployment (Deployment Force) | ||
| - Deployment Accuracy | ||
| - Filter Centering (Tilt) | ||
| - Arm/Leg Entanglement (Configuration) | ||
| Material/Visibility | - MRI Compatibility | - Filter Visibility Under Fluoroscopy |
| - Biocompatibility | - Delivery System Visibility Under Fluoroscopy | |
| - Corrosion Resistance |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes for the in vitro or in vivo tests. It only lists the types of tests performed. The provenance of the data (country of origin, retrospective/prospective) is also not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the submission describes physical and material performance testing of a medical device, not a diagnostic AI system requiring expert-established ground truth from imaging data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a physical device performance study.
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
Not applicable. This is not an AI device or an imaging interpretation study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a physical medical device, "ground truth" would refer to established engineering standards, material specifications, and biological responses. The tests performed (e.g., fatigue, migration, biocompatibility, perforation) implicitly rely on these standards and established clinical outcomes for similar devices, rather than expert consensus on interpretive data.
8. The sample size for the training set
Not applicable, as this is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.”