(296 days)
The OPTEASE Vena Cava Filter is indicated for the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the inferior vena cava in the following situations: Pulmonary thromboembolism when anticoagulants are contraindicated, Failure of anticoagulant therapy in 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 radiopaque contrast media to the vena cava. The Cordis OPTEASE Retrieval Catheter is has been designed for retrieval of an implanted OPTEASE Filter in patients who no longer require a filter. Retrieval of the filter can be performed only by femoral approach.
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 Angiographic Vessel Dilator, a directional filter storage tube, catheter sheath introducer and obturator for safe and accurate deployment of the filter.
This is a 510(k) premarket notification for a medical device called the OPTEASE® Vena Cava Filter and OPTEASE® Retrieval Catheter. It is a request for substantial equivalence to previously cleared devices. Therefore, the device does not provide specific acceptance criteria or an explicit study proving performance against those criteria in the same way a new, de novo device or a PMA submission might.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices based on intended use, application, and user application. The regulatory review process for a 510(k) primarily assesses whether the new device is as safe and effective as a legally marketed predicate device.
Based on the provided text, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission seeking substantial equivalence to predicate devices, there are no explicit "acceptance criteria" in the form of specific performance metrics with target values that a study was designed to meet for the subject device. The "reported device performance" is essentially the claim of substantial equivalence to the predicate devices.
| Acceptance Criteria Category | Specific Criteria (Implicit via Substantial Equivalence Claim) | Reported Device Performance (Claim) |
|---|---|---|
| Intended Use | Must be same as predicate device(s). | "The subject OPTEASE Vena Cava Filter is substantially equivalent to the predicate devices... in terms of intended use." |
| Application | Must be same as predicate device(s). | "The subject OPTEASE Vena Cava Filter is substantially equivalent to the predicate devices... in terms of... application." |
| User Application | Must be same as predicate device(s). | "The subject OPTEASE Vena Cava Filter is substantially equivalent to the predicate devices... in terms of... user application." |
| Safety and Effectiveness | Must be at least as safe and effective as predicate device(s). | Implied through the assertion of substantial equivalence based on the above categories and adherence to general controls and special controls (e.g., ISO-10993, sterility guidance, specific filter guidance). The FDA's clearance letter confirms: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent for use in the prevention of recurrent pulmonary embolism to legally marketed predicate devices..." |
Regarding the "Study that proves the device meets the acceptance criteria":
The document does not describe a new clinical or performance study for the subject device to prove specific performance metrics. Instead, the "proof" is based on demonstrating that the modified device (the current OPTEASE Vena Cava Filter and Retrieval Catheter) is fundamentally unchanged from its predicate, except for labeling:
"The change to the predicate devices, OPTEASE Vena Cava Filter and OPTEASE Retrieval Catheter, only affects the labeling."
This statement is critical. It implies that no new significant performance data was required because the physical device and its mechanism of action were not altered. The "study" here is essentially a comparison to predicate devices and a declaration of labeling changes only, rather than a full-scale performance study.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The submission states only labeling was changed, implying no new clinical or performance test data was generated for a "test set" to establish equivalence. The equivalence is based on the previously cleared predicate device's performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No new test set requiring expert ground truth establishment is described in the provided text, as the change was only to labeling.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No new test set requiring adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a vena cava filter and retrieval catheter, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical medical implant and retrieval system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. As noted earlier, the submission states that only the labeling was changed, implying no new performance data was generated for the subject device beyond what existed for the predicate devices. The "ground truth" for the predicate devices' performance would have been established through clinical trials, bench testing, and potentially post-market surveillance associated with their initial clearances.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning 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.”