(29 days)
The ALN Optional Vena Cava Filter with Hook and without Hook are indicated for the prevention of recurrent pulmonary embolism via placement in the vena cava in the following situations:
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Pulmonary thromboembolism when anticoagulants are contraindicated,
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Failure of anticoagulant therapy in thromboembolic diseases,
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Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced; and
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Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.
ALN Optional Vena Cava Filters with Hook and without Hook, may be retrieved with the ALN Extraction and /or Repositioning Kits according to the Instructions For Use of these devices.
The ALN Optional Vena Cava Filter with Hook may be also retrieved with a standard GooseNeck Snare according to the the Instructions For Use of this medical device.
The ALN Optional Vena Cava Filter is a conical-shaped structure made of 316LVM stainless steel and consisting of 9 legs (i.e., 9 filtering elements). The 6 shortest legs (i.e., anchoring legs) are ended with distal hooks and each leg has a different length to avoid intertwining when the filter is introduced into the sheath or released in the vessel. The 3 longest legs (i.e., centering legs) have no hooks and serve to line up the vena cava axis. The loop at the end of the longest one helps to push the filter during its implantation through the femoral vascular approach. All 9 legs are equally involved in capturing and breaking an embolus. The ALN Optional Vena Cava Filter is about 55 mm high and is suitable for vena cava diameters up to 32 mm. The implantation approaches may be jugular, brachial or femoral. The ALN Optional Vena Cava Filter with a Hook is the same ALN Optional Vena Cava Filter with an additional 4mm retrieval hook on the apex of the device.
This appears to be a 510(k) summary for a medical device (ALN Optional Vena Cava Filter), which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. The document states that the device itself is unchanged compared to the predicate device, and the submission is primarily for a labeling change requested by the FDA to include results from the PRESERVE study.
Therefore, the study described is not evaluating the performance of a new or modified device model. Instead, the PRESERVE study is cited as a clinical trial that demonstrates the safety and efficacy of IVC filters in general, including the predicate device (and thus, by substantial equivalence, the current device). The 510(k) process here relies on the equivalence of the device to one whose safety and efficacy performance has already been established, with the PRESERVE study providing updated clinical context for the class of device.
Given this context, many of your requested fields related to a direct study of the current device's performance will not be directly answerable from this document, as no such study on the unchanged device is described. Instead, I will parse the information about the PRESERVE study as presented.
Here's the information based on the provided text, focusing on the PRESERVE study as the relevant clinical data mentioned:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for the ALN Optional Vena Cava Filter's performance as part of this 510(k) submission, because the device itself is unchanged. The PRESERVE study, mentioned as the clinical data, is an FDA-directed multicenter, prospective, open-label, non-randomized trial that studied the safety and efficacy of IVC filters from multiple manufacturers. The summary states:
| Acceptance Criteria (Inferred from PRESERVE Study mention) | Reported Device/Study Performance (from PRESERVE Study summary) |
|---|---|
| To demonstrate safety and efficacy of IVC filters | "The study demonstrates inferior vena cava (IVC) filters are safe and effective way to treat venous thromboembolism (VTE)." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document states PRESERVE is a "multicenter" study, implying a larger sample size than a single institution, but does not provide the specific number of participants or filters included in the study.
- Data Provenance: The document does not specify the country of origin of the data. It mentions it is an "FDA-directed multicenter, prospective, open-label, non-randomized trial," indicating it included data from multiple centers. It is prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number or qualifications of experts used to establish ground truth within the PRESERVE study. As a trial assessing safety and efficacy, it would likely involve clinical endpoints determined by treating physicians and potentially adjudicated by independent committees, but these details are not provided.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method for the PRESERVE study's endpoints.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study comparing human readers with and without AI assistance is described. The PRESERVE study is a clinical trial assessing device safety and efficacy, not an imaging or diagnostic AI performance study.
6. Standalone (Algorithm Only) Performance Study
No standalone algorithm performance study is described. This device is a physical medical implant, not an AI or software device in the context of this submission. The PRESERVE study is a clinical trial involving physical devices and patient outcomes.
7. Type of Ground Truth Used
Based on the description of the PRESERVE study as assessing "safety and efficacy" and aiming to "treat venous thromboembolism (VTE)," the ground truth likely involved clinical outcomes data related to the prevention of pulmonary embolism, complication rates, and possibly other metrics of VTE prevention (e.g., freedom from new PE, successful filter implantation/retrieval). The document does not provide specific details on how these outcomes were defined or measured.
8. Sample Size for the Training Set
Not applicable. This document describes a physical medical device (vena cava filter) and primarily a labeling change based on a clinical study of such devices. There is no mention of a "training set" in the context of an AI/algorithm.
9. How the Ground Truth for the Training Set was Established
Not applicable, as no training set for an AI/algorithm is mentioned.
§ 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.”