(30 days)
The G2™ 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.
The G2™ Filter System – Femoral Delivery Kit consists of a 7 French inner diameter (1.D.) introducer catheter and dilator set (Kit A) and a storage tube preloaded with the G2™ Filter and pusher system (Kit B). Kit A (introducer catheter and dilator) is used to gain access to the inferior vena cava using the Seldinger technique. The dilator accepts a 0.038" guidewire and the introducer catheter has 2 radiopaque marker bands on distal end to assist in filter delivery. The pusher system (Kit B), designed to pass through the introducer catheter, consists a grooved segment designed to hold and properly orient the filter legs and a flexible nitinol wire with a pad at the end that pushes on the filter apex.
The provided text [0-6] is a 510(k) summary for the G2™ Filter System - Femoral Delivery Kit. It does not contain details of a study that proves the device meets specific acceptance criteria with quantifiable metrics.
Instead, it states a general conclusion:
- Conclusion: "The G2™ Filter System – Femoral Delivery Kit met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs." (Page 2)
This document is a regulatory submission focused on demonstrating substantial equivalence to a predicate device (K050558). It outlines the device description, intended use, and technological comparison, asserting that the subject device has the same intended use, indications for use, application, user population, basic design, fundamental scientific technology, performance, and sterilization method as the predicate device.
Therefore, I cannot provide the specific tables and study details requested, as that information is not present in the provided text. The document indicates that design verification and validation were performed according to specified standards and protocols, but it does not present the results or methodology of those tests in this summary.
In summary, based only on the provided text:
- 1. A table of acceptance criteria and the reported device performance: Not provided. The text states criteria were met but doesn't list them or performance metrics.
- 2. Sample size used for the test set and the data provenance: Not provided.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no human-expert-validated test set is described.
- 4. Adjudication method for the test set: Not applicable.
- 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 a medical device (vena cava filter), not an AI diagnostic tool involving human readers.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
- 7. The type of ground truth used: Not explicitly stated beyond "applicable standards, guidance, test protocols and/or customer inputs."
- 8. The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
- 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.”