(253 days)
The ALN Optional Vena Cava Filter and the ALN Optional Vena Cava Filter with Hook are indicated for the prevention of recurrent pulmonary embolism via placement 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.
The ALN Optional Vena Cava Filter and the ALN Optional Vena Cava Filter with Hook may be retrieved with the ALN Extraction and/or Repositioning Kit 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 Instructions For Use of this medical device.
The ALN Extraction and/or Repositioning Kit is indicated for the removal of an implanted ALN Optional Vena Cava Filter and ALN Optional Vena Cava Filter with Hook in patients who no longer require a filter. The retrieval of the filter can be performed only by jugular approach.
The ALN Optional Vena Cava Filter and ALN Extraction and/or Repositioning Kit consists of a 9 leg 316L stainless steel vena cava filter with or without a retrieval hook supplied with a delivery kit, and a retrieval kit with an 8 arm 316L stainless steel clamp. The ALN Optional Vena Cava Filter is designed to stop free thrombus in the vena cava of high risk patients. The filter design consists of legs with barbs that are intended to help stabilize the device inside the vein and prevent migration.
The filter is prepackaged in a filter holder designed to facilitate the insertion of the filter in the introducer sheath. The insertion of the filter can be made by jugular, brachial or femoral approach with a 7F sheath. The retrieval can be made only by the jugular approach.
The provided document is a 510(k) summary for a medical device (ALN Optional Vena Cava Filter and ALN Extraction and/or Repositioning Kit). This document focuses on modifications to the device's packaging and does not contain information about the device's clinical performance or the studies one would typically associate with proving a device meets acceptance criteria for its intended clinical use.
Therefore, I cannot provide the detailed information requested in your prompt regarding acceptance criteria, study details, expert qualifications, ground truth, or MRMC studies. The document only mentions performance testing related to the packaging modification, not the fundamental function or safety of the Vena Cava Filter itself.
Here's what I can extract from the provided text regarding "Performance Testing," which in this context refers only to the change in device packaging:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (for Packaging) | Reported Device Performance (for Packaging) |
|---|---|
| Package testing requirements met | The results of these tests meet the established expectations. |
| Sterilization validation and residuals testing successful | The results of these tests meet the established expectations and demonstrate conformity of the device with the requirements for its use. |
| USP 661 testing for plastics used to package medical devices met | The results of these tests meet the established expectations. |
Missing Information (Not Available in the Provided Text):
- Sample sized used for the test set and the data provenance: Not specified for packaging tests, and certainly not for clinical performance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for packaging tests, and not provided for clinical performance.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for packaging tests, and not provided for clinical performance.
- 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, as this is not an AI/imaging device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/imaging device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for packaging tests, and not provided for clinical performance.
- The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable, as this is not an AI/machine learning device.
Summary of the Document's Focus:
The core message of this 510(k) submission (K163699) is that a modification to the device packaging for the ALN Optional Vena Cava Filter and ALN Extraction and/or Repositioning Kit does not raise new questions of safety and effectiveness, and therefore the device remains substantially equivalent to its predicate device (K113124). The "performance testing" mentioned is specifically limited to this packaging change (e.g., integrity of the sterile barrier, extractables from plastics). It is not a re-evaluation of the filter's clinical performance, efficacy in preventing pulmonary embolism, or retrieval success rates.
§ 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.”