(29 days)
The Cordis OptEase™ Permanent Vena Cava Filter is indicated for the prevention of recurrent pulmonary embolism via percutaneous placement in the inferior vena cava in the following situations:
• Pulmonary thromboembolism when anticoagulants are contraindicated,
• Failure of anticoagulant therapy in thromboembolic diseases,
• Emergency treatment following massive pulmonary embolism, where anticipated benefits of conventional therapy are reduced; and
• Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.
This is the same intended use as for the filter featured with the predicate devices: TrapEas, Günther Tulip Vena Cava MReye Filter set, and Vena Tech LGM Vena Cava Filter.
The VisEase Angiographic Vessel Dilator is designed to provide angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque contrast media to the Vena Cava.
This is the same intended use as for the VisEase Angiographic Vessel Dilator featured with the predicate device.
The subject device is a system that consists of a flexible, self-expanding vena cava filter to be deployed in the infra-renal inferior vena cava via a 6F sheathed introduction kit. The filter is designed to trap large, life threatening emboli and therefore prevent recurrent pulmonary embolism, while maintaining caval patency. The OptEase Permanent Vena Cava Filter is packaged with a filter introduction kit that includes the VisEase Angiographic Vessel Dilator, a directional filter storage tube, catheter sheath introducer and obturator for safe and accurate deployment of the filter.
The modification to the design of the OptEase Vena Cava Filter with respect to the number and configuration of the fixation hooks and the introduction of a filter extension at the caudal end of the filter basket, do not affect the intended use or basic fundamental technology of the device. The subject device is substantially equivalent to the predicate devices, i.e., TrapEase permanent Vena Cava Filter, Günther Tulip Vena Cava MReye Filter and the Vena Tech LGM Vena Cava Filter.
The provided text describes the Cordis OptEase™ Permanent Vena Cava Filter, focusing on its safety and effectiveness studies. However, it does not include acceptance criteria in the form of specific performance metrics (e.g., sensitivity, specificity, accuracy, or a numerical success rate) with corresponding thresholds. Instead, it details various in-vitro and in-vivo tests performed to demonstrate substantial equivalence to predicate devices.
Therefore, many of the requested items related to acceptance criteria, device performance against these criteria, and AI-specific study details cannot be extracted directly from this document.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| Not explicitly defined as numerical acceptance criteria with thresholds in the provided text. The overall "acceptance criterion" appears to be demonstrating substantial equivalence to predicate devices. | The device underwent a series of in-vitro and in-vivo tests to support its safety and effectiveness and its substantial equivalence to predicate devices such as the Cordis TrapEase Permanent Vena Cava Filter and Introduction Kit, Günther Tulip Vena Cava MReye™ Filter set, and Vena Tech LGM Vena Cava Filter. |
| In-vitro Tests: | Pass (implied by substantial equivalence determination) |
| - Visual Inspection: Storage Tube | Performed |
| - Visual Inspection: Filter position in Storage Tube | Performed |
| - Visual Inspection: Filter | Performed |
| - Dimensional Inspection: Marker position obturator | Performed |
| - Dimensional Inspection: Storage Tube | Performed |
| - Dimensional Inspection: Measurement of expanded filter diameter | Performed |
| - Suitability: Pull strength / Friction test Storage Tube | Performed |
| - Simulated Deployment & Introducer / sheath Suitability incl. Kink resistance | Performed |
| - Resistance to Migration in-vitro-test Subject and Predicate Devices | Performed |
| In-vivo Tests: | Pass (implied by substantial equivalence determination) |
| - Animal Study - Part I: Filter implantation with simulated thrombo-embolic load | Performed |
| - Animal Study - Part II: Filter implantation without simulated thrombo-embolic load | Performed |
Note: The document implies that the device "passed" these tests by concluding substantial equivalence, but it does not provide specific numerical results or thresholds for these tests as "acceptance criteria." The focus is on demonstrating equivalence rather than meeting pre-defined specific performance metrics.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a number. The "test set" consists of the in-vitro tests and two animal studies. The number of samples/animals for these studies is not quantified in the provided text.
- Data Provenance: Not explicitly stated (e.g., country of origin for the animal studies). The studies are labeled as in-vitro and in-vivo (animal studies).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. The "ground truth" for this medical device (a physical filter) is established through direct physical and biological testing (in-vitro and in-vivo animal studies), not by expert interpretation of images or other data that require "ground truthing" in the context of AI.
- Qualifications of Experts: Not applicable for establishing ground truth in this type of device submission.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The tests are physical and biological measurements/observations, not interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done? No. This information is not present in the document. An MRMC study is typically performed for AI or diagnostic devices where human readers interpret data, and the AI's impact on their performance is evaluated. This document describes a physical medical device (vena cava filter).
- Effect size of human readers improvement with AI vs. without AI assistance: Not applicable, as no MRMC study or AI component is mentioned.
6. Standalone (Algorithm Only) Performance Study
- Was it done? No. This document describes a physical medical device. There is no mention of an algorithm or an AI component that would have standalone performance.
7. Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for the device's performance is established through direct physical/functional measurements (e.g., dimensional inspection, pull strength, simulated deployment) and biological observations in animal models (filter implantation, simulated thrombo-embolic load). This is direct measurement and observation rather than expert consensus, pathology, or outcomes data in the usual sense for AI/diagnostic devices.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This document does not describe an AI/ML device that requires a training set. The device is a physical medical implant.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no training set mentioned for an AI/ML algorithm.
§ 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.”