(139 days)
The Recovery™ Filter System is 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 anticoagulation 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.
The Recovery Filter System consists of a nitinol vena cava filter and a delivery system. The filter has two levels of filtration and is prepackaged in a storage tube. The delivery system consists of a 7 Fr ID introducer sheath and dilator and a pusher system. Both components of the system are packaged in Tyvek/film pouches. The filter consists of twelve, shape memory nitinol wires emanating from a central nitinol sleeve. The wires form two levels of filtration: six arms and six legs. The delivery system is used to place the filter into the inferior vena cava.
The acceptance criteria and study proving the device meets them are described below:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (Simon Nitinol Filter/Straightline™ System and Titanium Greenfield® Vena Cava Filter) | Bench testing showed that the Recovery Filter is substantially equivalent to the Bard predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states that "Bench testing was performed per the FDA guidance document, 'Guidance for Cardiovascular Intravascular Filter 510(k) Submission'". However, it does not provide specific details on the sample size used for the test set during this bench testing. Similarly, the data provenance (e.g., country of origin, retrospective or prospective) for this bench testing is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The study described is bench testing, which typically involves engineering and material science evaluations rather than expert consensus on medical images or patient outcomes.
4. Adjudication Method for the Test Set
This information is not provided in the document. As stated above, the study is bench testing, not clinical evaluation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The submission relies on bench testing for substantial equivalence.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a physical medical device (vena cava filter) and not an algorithm or AI system. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply. The performance evaluated was the physical characteristics and function of the filter.
7. The Type of Ground Truth Used
For the bench testing, the "ground truth" would be engineering specifications, material properties, and performance benchmarks established by the FDA guidance document for cardiovascular intravascular filters. The device's performance was compared against these established standards and the characteristics of the predicate devices.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical product, not an AI or machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
§ 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.”