(79 days)
The G2 EXPRESS™ Filter System - Femoral and 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.
- G2 EXPRESS™ Filter may be removed according to the instructions supplied . under the section labeled: Optional Procedure for Filter Removal.
The G2 EXPRESS™ Filter consists of 12 shape-memory nitinol wires emanating from a central nitinol sleeve with a snare tip. These 12 wires form two levels of emboli filtration: the legs provide the lower level of filtration and the arms provide the upper level of filtration. The G2 EXPRESS™ Filter is intended to be used in the inferior vena cava with diameters less than or equal to 28 mm.
The G2 EXPRESS™ Filter System – Jugular/Subclavian Delivery Kit consists of a 10 Fr I.D. introducer sheath and dilator set and a delivery device preloaded with the G2 EXPRESS™ Filter. The introducer sheath and dilator are used to gain access to the inferior vena cava via a jugular approach. The delivery device fits within the introducer sheath and consists of a delivery mechanism to deploy the G2 EXPRESS™ Filter.
The G2® EXPRESS™ Filter System - Femoral Delivery Kit consists of a 7 Fr I.D. introducer catheter and dilator set and a storage tube preloaded with the G2 EXPRESS™ Filter and delivery device. The introducer sheath and dilator are used to gain access to the inferior vena cava via a femoral approach. The delivery device fits within the introducer sheath and consists of a delivery mechanism to deploy the G2 EXPRESS™ Filter.
I am sorry, but the provided text does not contain the detailed information necessary to complete all sections of your request regarding acceptance criteria and study details for the KOR2305 G2 EXPRESS™ Filter System.
Specifically, the document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed report of specific performance studies and their acceptance criteria. While it states that the device "met all predetermined acceptance criteria of design verification and validation," it does not list those criteria or describe the studies that proved they were met.
Therefore, I cannot provide information on:
- A table of acceptance criteria and the reported device performance: This information is not present.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size: Not mentioned, and generally not a requirement for 510(k) clearances unless specifically requested due to novel AI aspects (which this device pre-dates).
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device, not an AI algorithm.
- The type of ground truth used: Not mentioned.
- The sample size for the training set: Not applicable as this is a physical medical device, not an AI algorithm.
- How the ground truth for the training set was established: Not applicable as this is a physical medical device, not an AI algorithm.
The document primarily states:
"The G2 EXPRESS™ Filter System – Femoral and Jugular/Subclavian Delivery Kits met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs."
This is a general statement of compliance, but the specifics of what those criteria and studies were are not elaborated within this 510(k) summary.
§ 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.”