(72 days)
The proposed Günther Tulip® Vena Cava Filter is intended for the prevention of recurrent pulmonary embolism via placement in the vena cava in the following situations: Pulmonary thromboembolism when anticoagulant therapy is 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 Günther Tulip® Vena Cava Filter may be retrieved according to the instructions supplied in the section labeled: Optional Retrieval Procedure.
Günther Tulip® Vena Cava Filter: The Günther Tulip Vena Cava Filter is available in femoral vein and jugular vein access versions. A universal set is also available, which contains the components necessary for both the jugular and femoral filter delivery approach. The femoral set is introduced through the femoral vein, while the jugular set is introduced through the jugular vein. The device consists of a pre-loaded filter, a coaxial introducer sheath system, a hydrophilic coated dilator, and a three-way stopcock. The filter is introduced and placed via a 7.0 French coaxial introducer sheath system. The introducer dilator is a 7.0 French power iniectable dilator that is 75 centimeters long. The Günther Tulip Vena Cava Filter is constructed from conichrome. The basic design of the filter is conical with four primary legs. The end of each leg is hooked outward. The hooks are designed to secure the filter to the wall of the inferior vena cava. "Webbed" wires (like tulip petals) between the legs are bent secondary legs which maintain the shape of the filter by pressing outward toward the vein walls. These webs also increase the area into which emboli can be trapped.
Cook® Celect® Vena Cava Filter: The Cook® Celect® Vena Cava Filter is available in femoral vein and jugular vein access versions. A universal set is also available, which contains the components necessary for both the jugular and femoral filter delivery approach. The femoral set is introduced through the femoral vein, while the jugular set is introduced through the jugular vein. The device consists of a pre-loaded filter, a coaxial introducer sheath system, a hydrophilic coated dilator, and a three-way stopcock. The filter is introduced and placed via a 7.0 French coaxial introducer sheath system. The introducer dilator is a 7.0 French power injectable dilator that is 75 centimeters long. The filter is compatible with placement in vena cavae with diameters between 15 and 30 mm and is constructed from conichrome. The design of the Cook® Celect® Vena Cava Filter allows the filter to anchor to the vena cava walls by means of the hooks at the ends of the primary legs. The secondary legs promote centering of the filter within the vena cava, and assist in caval filtering of sizeable thrombi in the bloodstream.
This document describes a Special 510(k) submission for modifications to the Günther Tulip® Vena Cava Filter and the Cook® Celect® Vena Cava Filter. It focuses on demonstrating that the modified devices are substantially equivalent to their predicate devices, rather than on proving performance against specific acceptance criteria for a new device. Therefore, much of the requested information regarding study design, ground truth, and expert evaluation is not present in this type of submission.
Here's an analysis of the provided text based on your request:
1. Table of acceptance criteria and reported device performance:
The document doesn't present specific acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) because it's a submission for device modifications, not a new device seeking initial clearance based on clinical performance. Instead, the acceptance criteria are inherent in demonstrating that the modified devices continue to meet the requirements for their intended use through various engineering and material tests, ensuring the modifications do not negatively impact safety or effectiveness.
| Test Performed | Reported Device Performance / Outcome |
|---|---|
| Tensile Testing | The results of these tests provide reasonable assurance that the devices have been designed and tested to assure conformance to the requirements for their intended use. |
| Flow Rate Testing | The results of these tests provide reasonable assurance that the devices have been designed and tested to assure conformance to the requirements for their intended use. |
| Static Burst Testing | The results of these tests provide reasonable assurance that the devices have been designed and tested to assure conformance to the requirements for their intended use. |
| Diameter Retention Testing | The results of these tests provide reasonable assurance that the devices have been designed and tested to assure conformance to the requirements for their intended use. |
| Leak Testing | The results of these tests provide reasonable assurance that the devices have been designed and tested to assure conformance to the requirements for their intended use. |
| Biocompatibility Testing | The results of these tests provide reasonable assurance that the devices have been designed and tested to assure conformance to the requirements for their intended use. |
| Deployment Testing | The results of these tests provide reasonable assurance that the devices have been designed and tested to assure conformance to the requirements for their intended use. |
| Shipping Testing | The results of these tests provide reasonable assurance that the devices have been designed and tested to assure conformance to the requirements for their intended use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document details engineering and material tests rather than clinical or performance studies with patient data. Therefore, concepts like "sample size for the test set" and "data provenance" in the context of clinical data are not applicable here. The "test set" refers to the modified devices themselves undergoing various physical and chemical evaluations.
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)
Not applicable. Ground truth, in the sense of expert evaluation of medical images or patient outcomes, is not part of this type of submission. The "ground truth" for these tests would be the established engineering and material standards and specifications that the devices are required to meet.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for subjective assessments, typically in clinical studies or expert reviews of data. These are objective engineering tests.
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 a study involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document is about medical devices (vena cava filters), not an algorithm or AI system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the tests performed (Tensile Testing, Flow Rate Testing, etc.) would be the established engineering specifications, material standards, and performance requirements for vena cava filters. These are objective, measurable parameters rather than subjective expert consensus or clinical outcomes.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of device modification testing by engineering methods.
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
§ 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.”