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510(k) Data Aggregation
(297 days)
The Cook Celect Vena Cava Filter is intended for the prevention of recurrent pulmonary embolism (PE) 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 when . anticipated benefits of conventional therapy are reduced; and
- Chronic, recurrent pulmonary embolism when anticoagulant therapy has . failed or is contraindicated.
The filter is intended for percutaneous placement via either the jugular vein or femoral vein for filtration of inferior vena cava (IVC) blood to prevent pulmonary thromboembolism. The filter is compatible with placement in vena cava diameters between 15 and 30 mm.
The Cook Celect Vena Cava Filter is an inferior vena cava filter, intended for use in prevention of pulmonary embolism. The filter is intended for percutaneous placement via either the jugular vein or femoral vein for filtration of inferior vena cava (IVC) blood. The filter is compatible with placement in vena cavae with diameters between 15 and 30 mm. The Cook Celect Vena Cava Filter is constructed from a biocompatible alloy. The filter is 46 mm long along its main axis, and, when unrestrained, the legs will expand radially to a base diameter of over 32 mm. 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 are the filter wires, distributed to catch thrombi in the caval bloodstream and they are shaped to assist in promote centering of the filter within the vena cava.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" with numerical targets for performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Günther Tulip Vena Cava Filter, #K000855) through a comparison of mechanical properties and performance. The implied acceptance criterion is that the new device performs at least as safely and effectively as the predicate.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Mechanical Characteristics | Substantially equivalent to predicate device | Met: "Both devices were tested for mechanical properties" and "All the testing conducted demonstrates that the Cook Celect Vena Cava Filter exhibits the same safety and performance qualities of the predicate device." |
| Performance Characteristics | Substantially equivalent to predicate device | Met: "Both devices were tested for ... performance of these devices, in vitro and in vivo." and "All the testing conducted demonstrates that the Cook Celect Vena Cava Filter exhibits the same safety and performance qualities of the predicate device." |
| Safety in vitro | Substantially equivalent to predicate device | Met: "Both devices were tested for ... safety ... in vitro." and "All the testing conducted demonstrates that the Cook Celect Vena Cava Filter exhibits the same safety and performance qualities of the predicate device." |
| Safety in vivo | Substantially equivalent to predicate device | Met: "Both devices were tested for ... safety ... in vivo." and "All the testing conducted demonstrates that the Cook Celect Vena Cava Filter exhibits the same safety and performance qualities of the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size for the "bench and animal testing."
The data provenance is from "Bench and animal testing" conducted by Cook Incorporated. The document does not specify the country of origin of this data, nor if it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The study is a comparison of mechanical and performance properties of a physical device with a predicate device, not an assessment of a device's output against human expert interpretation.
4. Adjudication Method for the Test Set:
Not applicable, as this was not a study requiring expert adjudication of results. The comparison was based on direct measurements and observations from bench and animal testing.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
No, a multi-reader multi-case comparative effectiveness study was not done. The study focuses on direct physical and biological performance comparison.
6. Standalone Performance Study:
Yes, a standalone study (termed "Non-clinical Testing") was conducted. The document states: "Bench and animal testing has been performed using the Cook Celect Vena Cava Filter, and the results have been compared with the predicate device." This indicates that the new device's performance was evaluated independently and then compared.
7. Type of Ground Truth Used:
The ground truth or reference for comparison was the performance of the legally marketed predicate device, the Günther Tulip Vena Cava Filter. The study aimed to demonstrate that the new device's mechanical and performance characteristics were "substantially equivalent" to the predicate.
8. Sample Size for the Training Set:
Not applicable. This is not an AI/machine learning device that requires a training set. The device is a physical medical implant.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. There is no training set mentioned or implied as this is a physical device submission.
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