(56 days)
The Option (TM) ELITE Vena Cava Filter System is intended for the prevention of recurrent pulmonary embolion (PE) via placement in the vena cava in the following conditions:
- · Pulmonary thromboembolism when anticoagulant therapy is contraindicated;
- · Failure of anticoagulant therapy in thromboembolic diseases;
- · Emergency treatment following massive pulmonary embolism when anticipated beaeffits of conventional therapy are realised;
- · Chronic, recurrent pulmonary embolism when anticoagulation therapy has failed or is contraindicated
The filter may be retrieved according to the instructions supplied in section entitled "Optional " in patients who no longer require a filter. Retrieval of the fitter can be performed only by jugular approach.
The Option™ ELITE Vena Cava Filter is designed for the prevention of recurrent pulmonary embolism via percutaneous delivery in the inferior vena cava (IVC).
The self-centering Option™ ELITE Filter is laser cut from nickel - itanium alloy (Nitinol) tubing. The Option™ ELITE Filter consists of shape memory Nitinol struts emanating from a central location and is designed for optimal clot capture. Retention anchors (retention hooks) are located at the proximal or caudal portion of the filter. These anchors are intended for filter fixation to the vessel wall. The Option™ ELITE Filter is intended to be used in caval diameters up to 30mm. A retrieval hook is centrally located at the cranial extremity.
The constrained Option™ ELITE Filter is flexible and expands to the internal diameter of the IVC upon deployment. The Option™ ELITE Filter imparts an outward radial force on the luminal surface of the vena cava to ensure proper positioning and stability. The Option™ ELITE Filter is designed to prevent pulmonary embolism while maintaining caval patency through central filtration.
The introduction kit is comprised of a filter housed in a filter cartridge, Catheter Sheath Introducer (5F ID), Angiographic Vessel Dilator with an open end, and a Pusher with deployment marker. The Angiographic Vessel Dilator has side holes and 2 radiopaque markers, separated by 32mm (between the marker bands), that provide linear measurement of the inferior vena cava and assists in angiographic visualization when radiopaque contrast is delivered. The pusher advances the filter through the Catheter Sheath Introducer up to the deployment marker, and is then used to fi x the filter in place during uncovering. The location of the distal end of the Catheter Sheath Introducer can be controlled by rotating the entire device to position the Catheter Sheath Introducer in the vena cava. The Filter Cartridge houses the Option™ ELITE Filter. The body of the Cartridge has text and colored arrows printed on it that identify assembly orientation, femoral is printed in green and jugular is printed in blue. The arrow of the desired access site will point into the Catheter Sheath Introducer hub. The Angiographic Vessel Dilator is designed to provide angiographic visualization and linear measurement of the vasculature when used in conjunction with the delivery of radiopaque contrast media to the vena cava.
The provided text describes a 510(k) submission for the REX MEDICAL Option™ ELITE Vena Cava Filter System. This document focuses on the substantial equivalence of the modified device to a predicate device, rather than the development and validation of an AI/ML-driven medical device.
Therefore, the information required to describe the acceptance criteria and study proving an AI/ML device meets those criteria (e.g., sample sizes for training/test sets, expert qualifications, ground truth establishment, MRMC studies, standalone performance) is not available in the provided text.
The document discusses:
- Device Description: The physical characteristics and mechanism of the vena cava filter.
- Intended Use: The clinical conditions for which the filter is designed.
- Technological Characteristics: How the device is similar to its predicate.
- Modifications: Specific changes made to the Option™ ELITE compared to its predecessor (e.g., number and type of retention hooks, sheath material/design, alternate implantation procedure).
- Non-Clinical Performance Testing: A brief mention that testing was derived from risk assessment and aimed to evaluate safety and effectiveness of design modifications, with acceptance criteria derived from Rex Medical and related ISO standards. However, it does not specify what those acceptance criteria were in detail, nor does it present the results in a table format that would demonstrate meeting those criteria. It also doesn't detail the study that proves this, beyond saying "performance testing."
- Conclusion: A statement of substantial equivalence based on performance testing and similarities.
In summary, this document is a regulatory submission for a physical medical device, not an AI/ML diagnostic or therapeutic device. As such, the requested information regarding AI/ML device acceptance criteria and validation studies (like those featuring human readers, ground truth consensus panels, training datasets, etc.) is not applicable and is not present in the provided text.
§ 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.”