(50 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 1.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.
This document describes a 510(k) premarket notification for the ECLIPSE™ Filter System. As such, it is focused on demonstrating substantial equivalence to a predicate device rather than presenting a novel clinical study with acceptance criteria and performance metrics for a new device. Therefore, the information typically found in a study proving acceptance criteria for a new AI/software device is not present.
However, I can extract the information provided about the device's "acceptance criteria" and "study" in the context of a 510(k) submission, acknowledging that this is a different type of evaluation than a clinical trial for an AI diagnostic.
Here's a breakdown based on the provided text, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "The ECLIPSE™ 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 phrasing indicates that there were internal acceptance criteria for design verification and validation, but the specific metrics are not detailed in this public summary. The "reported device performance" is summarized as meeting these criteria, implying successful completion of these tests.
Therefore, a table with specific performance metrics cannot be constructed from the provided text. The evaluation was primarily a comparison of technological characteristics to a predicate device to establish substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of an AI or diagnostic study evaluating performance on data. The "study" mentioned is the design verification and validation process.
- Sample Size: Not applicable/not specified in terms of patient data. The "acceptance criteria" relate to engineering and design testing.
- Data Provenance: Not applicable in the context of patient data. The process focuses on the device itself.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The document does not describe a study involving expert review of patient data to establish ground truth.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of adjudication of a test set based on expert review.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document is for a medical device (intravascular filter), not an AI algorithm requiring such a study.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device is a physical medical implant, not an algorithm.
7. The Type of Ground Truth Used
Not applicable in the context of an AI/diagnostic study. The "ground truth" for this submission would be defined by engineering specifications, device functionality, and adherence to industry standards, rather than clinical outcomes or pathology from patient data.
8. The Sample Size for the Training Set
No training set is mentioned as this is a physical medical device, not an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set is mentioned.
Summary regarding the "Study that Proves the Device Meets the Acceptance Criteria" from the 510(k) document:
The "study" referenced in the document is the design verification and validation process for the ECLIPSE™ Filter System. This process ensures the device meets its predetermined specifications and performance requirements through various engineering tests and evaluations.
Key points from the document regarding this process:
- Acceptance Criteria: These were "predetermined… as specified by applicable standards, guidance, test protocols and/or customer inputs." While the exact criteria (e.g., filtration efficiency, deployment success rate, material integrity under stress) are not detailed in this summary, the submission asserts that the device met all of them.
- Proof: The success in meeting these criteria is the "proof."
- Nature of the Device: The device is a physical intravascular filter, not a diagnostic algorithm. Therefore, the "studies" and "acceptance criteria" are related to mechanical, material, and functional performance of the device in a controlled environment, not clinical trial outcomes or AI performance metrics.
- Substantial Equivalence: The primary objective of this 510(k) submission is to demonstrate substantial equivalence to existing predicate devices (G2® EXPRESS Filter System). The "study" (design verification/validation) supports this by showing the modified device performs comparably to the predicate and meets safety and effectiveness requirements.
In essence, the document claims that the device met its acceptance criteria through a design verification and validation process, which is standard for medical device development, but it does not provide the specific details of those tests or their quantitative results in this 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.”