(95 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 may be retrieved according to the instructions supplied in the section labeled "Optional Retrieval Procedure."
The Günther Tulip™ Vena Cava Filter Retrieval Set has been designed for retrieval of implanted Günther Tulip™ and Cook Celect™ Vena Cava Filters in patients who no longer require a filter. Retrieval of the filter can be performed only by jugular approach.
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 Cook Celect Vena Cava Filter is constructed from a biocompatible alloy. The filter is 48 mm long along its main axis when compressed to a diameter of 30 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 Günther Tulip Vena Cava Filter Retrieval Set consists of a retrieval loop system with a braided platinum wire loop, a coaxial retrieval sheath system, an entry needle, a wire guide, and a dilator. The outer sheath is provided with a radiopaque band on the distal tip for assisting in positioning of the sheath.
Acceptance Criteria and Study for Cook Celect™ Vena Cava Filter and Günther Tulip™ Vena Cava Filter Retrieval Set
This submission (K073374) is for an expansion in the indications for use for the Cook Celect™ Vena Cava Filter and Günther Tulip™ Vena Cava Filter Retrieval Set, specifically to include the retrievability of the Celect filter.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Clinical Study: 95% success rate for retrieval of the Celect filter. | Clinical Study: Achieved a 95% success rate in retrieving the Celect filter. |
| Kaplan-Meier analysis: Predict an 89% probability of successful retrieval at 52 weeks. | Clinical Study: Kaplan-Meier analysis of the data predicts an 89% probability of successful retrieval at 52 weeks. |
| Bench Testing: Devices demonstrating that the Celect filter can be retrieved. | Bench Testing: Bench testing successfully demonstrated that the Celect filter can be retrieved. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 43 patients.
- Data Provenance: Not explicitly stated whether the study was retrospective or prospective, or the country of origin. However, the context of a 510(k) submission for an expanded indication typically relies on prospective clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the given text.
4. Adjudication Method for the Test Set
This information is not provided in the given text. The study focuses on retrieval success, which is a clear clinical outcome rather than an interpretation requiring adjudication in the same way as an imaging study might.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The study was a clinical study demonstrating the retrievability of the device, not an assessment of human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not Applicable. The device described is a physical medical device (vena cava filter and retrieval set), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
The ground truth was established by clinical outcomes: whether the Cook Celect™ Vena Cava Filter was successfully retrieved from patients using the Günther Tulip™ Vena Cava Filter Retrieval Set.
8. The Sample Size for the Training Set
Not Applicable. As this is a physical medical device, there is no "training set" in the context of an algorithm or AI system. The "training" for the device would be its design, manufacturing, and preclinical testing, which are supported by the "bench testing" mentioned.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. (See #8). The product's development and verification would involve standard engineering and medical device testing methodologies. The submission explicitly states "bench testing on the devices demonstrating that the Celect filter can be retrieved" as a basis for the expanded indication.
§ 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.”