(35 days)
The ECLIPSE™ 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.
ECLIPSE™ Filter may be removed according to the instructions supplied under the section labeled: Optional Procedure for Filter Removal.
The ECLIPSE™ 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 legs provide the lower level of filtration and the arms provide the upper level of filtration. The ECLIPSE™ Filter is intended to be used in the inferior vena cava with diameters less than or equal to 28 mm.
The ECLIPSE™ Filter System - Femoral Delivery Kit consists of a 7 French inner diameter (I.D.) introducer catheter and dilator set and a storage tube preloaded with the ECLIPSE™ 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 ECLIPSE™ Filter.
The ECLIPSE™ Filter System – Jugular/Subclavian Delivery Kit consists of a 10 French I.D. introducer catheter and dilator set and a delivery device preloaded with the ECLIPSE™ Filter. 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 delivery device fits within the introducer sheath and has a delivery mechanism to deploy the ECLIPSE™ Filter.
The provided text describes the ECLIPSE™ Filter System, an intravascular filter, and its FDA 510(k) submission (K101431). However, it does not contain information related to acceptance criteria or a study proving device performance using clinical data, AI, or human-in-the-loop performance.
The submission focuses on demonstrating substantial equivalence to a predicate device (K093659) based on modifications primarily related to labeling and minor physical changes (addition of a kangaroo pouch). The performance testing described is limited to in vitro testing for packaging, sterilization, and latex, which are not directly about the clinical efficacy or diagnostic performance of the filter itself.
Therefore, most of the requested information cannot be extracted from this document.
Here's what can be gathered:
1. A table of acceptance criteria and the reported device performance
- NotFound: The document does not provide specific acceptance criteria or clinical performance metrics related to the filter's efficacy (e.g., emboli capture rate, complication rates). It only mentions that in vitro tests (packaging, sterilization, latex) demonstrated comparability to the predicate device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- NotFound: No clinical test set or data provenance is mentioned. The testing was in vitro.
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)
- NotFound: As no clinical test set is described, there's no mention of experts establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- NotFound: Not applicable as there's no clinical test set.
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
- No: No MRMC study was done, and the device is a physical filter, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No: This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable: For the in vitro tests mentioned (packaging, sterilization, latex), "ground truth" would relate to meeting pre-defined physical or chemical specifications, not clinical outcomes or expert consensus on a diagnosis.
8. The sample size for the training set
- NotFound: No training set is mentioned as this is a physical device, not an AI model.
9. How the ground truth for the training set was established
- Not Applicable: No training set is mentioned.
§ 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.”