(140 days)
The Sentry IVC Filter is indicated for the prevention of recurrent pulmonary embolism via percutaneous placement in the inferior vena cava in patients with a transient high risk of PE, 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.
The Sentry IVC Filter is a bioconvertible IVC filter intended for percutaneous implantation in the IVC and designed to provide protection against PE in patients at transient risk of PE.
The Sentry IVC Filter is designed for use in inferior vena cavae with diameters between 16mm and 28mm and has a maximum deployed length of 57.7mm. It is preloaded in a Loading Tool that can be orientated for either left/right femoral vein or a right jugular vein approach and is delivered through a 7 French ID Introducer Sheath (max OD 9.75Fr).
The Sentry IVC Filter consists of a cylindrical Nitinol frame and a Filter Cone formed by 6 Filter Arms held together in the center of the IVC by means of a bioabsorbable filament. The Filter Cone is designed to trap emboli and thereby reduce the risk of PE while maintaining caval patency after it has converted. The Sentry IVC Filter converts into a non-filtering configuration, the Filter Cone opens and the arms retract towards the IVC wall.
Here's an analysis of the provided text regarding the Sentry Inferior Vena Cava Filter's acceptance criteria and the study proving its compliance, framed within your requested structure.
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device's comprehensive clinical trial results. Therefore, details regarding extensive clinical studies with specific performance metrics against pre-defined acceptance criteria (especially for a new AI/software device, which this is not) are limited. The information primarily pertains to bench testing and biocompatibility.
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
The document lists various evaluations performed but does not explicitly state quantitative acceptance criteria or specific performance values for the modified Sentry IVC Filter. It generally states that "All tests met the pre-determined acceptance criteria." and that "Test results demonstrate that the modified device meets the established specifications and is comparable to the predicate device."
| Evaluation/Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Mechanical/Physical | Meets pre-determined specifications for design and function. | All tests met pre-determined acceptance criteria. |
| Delivery System visual & dimensional | Specifications for visual characteristics and dimensions. | Met pre-determined acceptance criteria. |
| Delivery System integrity | Integrity standards for the delivery system. | Met pre-determined acceptance criteria. |
| Filter visual and dimensional | Specifications for visual characteristics and dimensions of the filter. | Met pre-determined acceptance criteria. |
| Fatigue resistance | Resistance to fatigue under specified conditions. | Met pre-determined acceptance criteria. |
| Filter Corrosion | Resistance to corrosion under specified conditions. | Met pre-determined acceptance criteria. |
| Migration resistance | Resistance to migration in a simulated environment. | Met pre-determined acceptance criteria. |
| Radial Force | Force exerted radially by the filter. | Met pre-determined acceptance criteria. |
| Ease of device use | Usability and ease of deployment. | Met pre-determined acceptance criteria. |
| Simulated Deployment | Successful deployment under simulated conditions. | Met pre-determined acceptance criteria. |
| Accuracy of Deployment | Accuracy of device placement upon deployment. | Met pre-determined acceptance criteria. |
| Packaging Visual Inspection | Visual quality and integrity of packaging. | Met pre-determined acceptance criteria. |
| Labeling Visual Inspection | Visual quality and accuracy of labeling. | Met pre-determined acceptance criteria. |
| Tyvek Pouch Peel | Peel strength/integrity of Tyvek pouch. | Met pre-determined acceptance criteria. |
| Foil Pouch Peel | Peel strength/integrity of foil pouch. | Met pre-determined acceptance criteria. |
| Bubble Leak Testing | Absence of leaks in packaging/device. | Met pre-determined acceptance criteria. |
| Transportation testing | Device and packaging integrity after transportation simulation. | Met pre-determined acceptance criteria. |
| Biocompatibility | Meets ISO 10993 standards and FDA guidance. | Biocompatibility studies performed; biological risks assessed and managed. |
| Chemical characterization | Meets specified chemical profiles. | Performed, results consistent with safety. |
| Toxicological evaluation | Meets allowable limits for leachable substances. | Performed in accordance with ISO 10993-17. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify the exact sample sizes for each bench test conducted. It generally refers to "bench studies" and "design verification results."
- Data Provenance: The data is generated from bench studies and biocompatibility evaluations within the context of the manufacturer's design verification and validation program. This is not human patient data. There is no mention of country of origin for this testing, but the submitting company is based in Galway, Ireland, implying the testing was likely overseen by them or conducted by their chosen labs. The data is retrospective in the sense that the testing was performed to validate a modified device against pre-existing standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- This question is not applicable in the context of this 510(k) summary. The document describes bench testing and biocompatibility studies for a physical medical device (Inferior Vena Cava Filter), not an AI/software device that requires expert-established ground truth from images or clinical data. The "ground truth" for these tests would be the physical properties and performance measured against engineering specifications, often established by engineers and scientists, not clinical experts for diagnostic accuracy.
4. Adjudication Method for the Test Set
- This question is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in clinical trials or studies where multiple human readers interpret data, and discrepancies need to be resolved to establish a gold standard. The tests mentioned here are primarily objective, quantitative engineering and laboratory tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Improvement with AI vs. Without AI Assistance
- This question is not applicable. The device is a physical medical implant (an IVC filter), not an AI system. Therefore, no MRMC study or AI-assisted human reader improvement analysis would have been conducted or applicable for this type of device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable. This is a physical medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used
- For bench testing, the "ground truth" refers to pre-established engineering specifications, material properties, and performance standards (e.g., specific dimensions, fatigue limits, corrosion resistance measured in a lab, and successful deployment as per design).
- For biocompatibility, the ground truth is based on international standards (ISO 10993 series) and regulatory guidance from the FDA, evaluating the biological response of materials.
8. The Sample Size for the Training Set
- This question is not applicable. This refers to a physical medical device, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable, as there is no training set for a physical medical 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.”