(30 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 six 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.
This 510(k) is submitted to support a change to the design and manufacturing process for the Introducer Sheath of the Delivery System.
The provided text is a 510(k) summary for the Sentry Inferior Vena Cava Filter, specifically concerning a modification to its Introducer Sheath. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing a detailed study proving the device meets clinical acceptance criteria for its intended use through human studies.
Therefore, the information required to answer your prompt, particularly regarding multi-reader multi-case (MRMC) studies, expert ground truth, and comprehensive performance data for an AI/algorithm-based device, is not available in this document. This document describes a medical device, an IVC filter, which is a physical implant used to prevent pulmonary embolism, not a diagnostic AI or imaging device that would typically undergo the types of studies you are asking about.
However, I can extract the acceptance criteria and performance data for the specific modification described in this 510(k) submission:
The acceptance criteria here pertain to the Introducer Sheath of the delivery system, not the filter itself or its clinical efficacy in preventing PE. The study proves the modified Introducer Sheath functions equivalently to the previous version.
Here's what can be extracted from the provided text regarding the Acceptance Criteria and the study for the modified Introducer Sheath:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Introducer Sheath integrity | All tests met the pre-determined acceptance criteria. Results from the design verification program demonstrate the mechanical integrity and performance of the modified device. |
| Introducer Sheath patency | All tests met the pre-determined acceptance criteria. Results from the design verification program demonstrate the mechanical integrity and performance of the modified device. |
Note: The document confirms that all tests "met the pre-determined acceptance criteria," but it does not specify the quantitative values for these criteria (e.g., specific pressure limits for integrity, flow rates for patency) or the exact numerical results obtained.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document refers to "Bench studies" and "design verification program," implying a laboratory setting with test articles.
- Data Provenance: The studies were undertaken as part of Novate Medical Ltd.'s design verification program. Location is likely Ireland, where the submitter is based. The data is prospective in the sense that it was generated specifically for this submission to assess the design modification.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This is a physical device modification, and the "ground truth" for its performance (integrity, patency) would be established through engineering specifications and objective measurements, not human expert consensus.
4. Adjudication Method for the Test Set
Not applicable. Performance was assessed via objective bench testing against pre-determined engineering specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This type of study is for evaluating human performance, often with AI assistance, in interpreting medical images or data. This document describes a physical medical device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an algorithm. Bench tests were performed on the device itself.
7. The Type of Ground Truth Used
The ground truth was based on engineering specifications and measurable physical properties (e.g., material strength, dimensions, fluid flow characteristics) of the Introducer Sheath.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of a physical device modification and bench testing for substantial equivalence.
9. How the Ground Truth for the Training Set was Established
Not applicable.
§ 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.”