(30 days)
The OPTEASE Filter is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous 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.
The OPTEASE Filter may be retrieved according to the instructions supplied in the Section labeled: "Optional Procedure for Filter Retrieval".
The Angiographic Vessel Dilator is designed to provide angiographic visualization and linear measurement of the vasculature when combined with the delivery of the radiopaque contrast media to the vena cava.
The Cordis OPTEASE® Vena Cava Filter (Filter) is designed for the prevention of recurrent pulmonary embolism via placement in the inferior vena cava (IVC). The self-centering OPTEASE® Filter is laser cut from nickel titanium alloy (Nitinol) tubing. The proximal and distal baskets of the OPTEASE® Filter, consisting of struts in a six-diamond shape configuration, are designed for optimal clot capture. The constrained filter is supplied in a unidirectional storage tube that is loaded as a system into the hemostasis valve of the sheath introducer. The subject device is comprised of the filter packaged within a unidirectional storage tube, introduction kit that includes angiographic vessel dilator, catheter sheath introducer and obturator. The OPTEASE® Retrieval catheter is packaged separately.
The Cordis OPTEASE® Vena Cava Filter and OPTEASE® Retrieval Catheter are devices designed for the prevention of recurrent pulmonary embolism. The 510(k) submission K140286 describes design verification and validation testing performed to demonstrate substantial equivalence to a predicate device (K034050 and K091077).
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Human Factor Assessment | Safer use, mitigated incorrect insertion risk | The proposed product configuration was safer to use and better at mitigating the risk of incorrect insertion. |
| Transfer filter into CSI | Meets Acceptance Criteria | Meets Acceptance Criteria |
| Filter release from storage tube | Meets Acceptance Criteria | Meets Acceptance Criteria |
| Fixation on mounting card | Meets Acceptance Criteria | Meets Acceptance Criteria |
| Fixation in storage tube | Meets Acceptance Criteria | Meets Acceptance Criteria |
| Dimensional Analysis | Meets Acceptance Criteria | Meets Acceptance Criteria |
| Visual inspection and verification of packaging and labeling | Meets Acceptance Criteria | Meets Acceptance Criteria |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size used for each of the tests (Human Factor Assessment, Transfer filter into CSI, Filter release from storage tube, Fixation on mounting card, Fixation in storage tube, Dimensional Analysis, Visual inspection and verification of packaging and labeling).
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. These appear to be laboratory-based engineering and performance tests conducted internally by Cordis Corporation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the test set. For tests like "Human Factor Assessment," it implies an evaluation, but the specifics of who conducted it and their expertise are not detailed. For the other performance tests, "ground truth" would likely refer to engineering specifications and performance standards.
4. Adjudication Method for the Test Set:
The document does not describe an adjudication method for the test set. Given the nature of the tests (engineering and performance benchmarks), it's likely that a pass/fail determination was made based on meeting predetermined specifications, rather than a consensus among multiple reviewers.
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 or reported in this 510(k) summary. This type of study is typically associated with diagnostic imaging devices or AI-assisted interpretation, where human reader performance is a key metric. This 510(k) concerns a medical device (vena cava filter) and its associated retrieval catheter, focusing on design verification and validation against established standards and a predicate device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Not applicable. The device is a physical medical device (vena cava filter) and its retrieval catheter, not an algorithm or AI system. Therefore, a "standalone algorithm performance" study is not relevant to this submission.
7. The Type of Ground Truth Used:
For the performance tests, the "ground truth" implicitly refers to the engineering specifications, design requirements, and performance characteristics established for the device. These are derived from its intended function, safety considerations, and comparison to the predicate device. For the Human Factor Assessment, the ground truth would be ergonomic and safety principles related to user interaction.
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/ML algorithm that requires a "training set." The tests described are for a physical medical device.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.
§ 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.”