(139 days)
The Option(TM) ELITE Vena Cava Filter 100cm System is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following conditions:
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Pulmonary thromboembolism when anticoagulant therapy is contraindicated;
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Failure of anticoagulant therapy in thromboembolic diseases;
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Emergency treatment following massive pulmonary embolism when anticipated benefits of conventional therapy are reduced:
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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 Procedure for Filter Retrieval" in patients who no longer require a filter 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 Option ELITE Vena Cava Filter 100cm System is designed for IVC filter insertion, delivery, deployment and placement via the popliteal and antecubital approach.
The self-centering Option™ ELITE Filter is laser cut from nickel -titanium 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 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 fix the filter in place during uncovering. The distal end of the Catheter Sheath Introducer can be controlled by rotating the entire device to position the Catheter Sheath Introducer in the center of 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 femoral orientation is used for the popliteal approach and the jugular orientation is used for the antecubital approach. The arrow of the desired access site will point into the Catheter Sheath Introducer hub. The Angiographic Vessel Dilator is designed to provide angiorraphic visualization and linear measurement of the vasculature when used in conjunction with the delivery of radiopaque contrast media to the vena cava.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Option™ ELITE Vena Cava Filter 100cm System:
The document is a 510(k) premarket notification for a medical device. This type of submission aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, rather than providing extensive clinical efficacy studies typically required for a PMA (Premarket Approval). Therefore, the "studies" described are primarily non-clinical and focus on demonstrating equivalence in performance and safety.
Since this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are implied to be that the device performs as safely and effectively as the predicate device, particularly for the modifications made (increased length for new access approaches). There isn't an explicit table of acceptance criteria for diagnostic performance metric.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Simulated Use Testing: | |
| Absence of failures during deployment from antecubital/popliteal approaches in challenging anatomy. | Relevant deployment forces and filter tilt angles were measured. The occurrence of failures, filter or delivery system damage, excessive resistance, filter off the vessel wall, and tilting when removing the guidewire were recorded. (No specific numerical performance outcomes are provided in this summary, but the implication is that these were within acceptable limits when compared to the predicate or established safety thresholds.) |
| No filter or delivery system damage. | |
| No excessive resistance during deployment. | |
| Filter not off the vessel wall post-deployment. | |
| No tilting when removing the guidewire. | |
| Biocompatibility: | The device utilized identical materials to the predicate device, which was presumably deemed biocompatible. |
| Meeting ISO Standards (e.g., ISO 10555-1, ISO 10993-1). | Testing adhered to these standards. |
| Comparison to Predicate: | The Option™ ELITE Vena Cava Filter 100cm System is considered substantially equivalent to the predicate device (Option™ ELITE Vena Cava Filter System K133243) based on performance testing and similarities in indications for use, materials, technological characteristics, principle of operation and design features. |
| Maintenance of current intended use. | Intended use is identical to the previously cleared predicate device. |
| No new safety or effectiveness concerns. | The risk assessment evaluated the safety and performance of the design modifications, implying no new concerns were identified that would negate substantial equivalence. |
| Identical materials, principle of operation, design features to predicate (where not modified). | The self-centering Option™ ELITE Filter is laser cut from nickel -titanium 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. The device utilized identical materials for the filter. |
Study Description:
The study was a non-clinical performance testing effort, focused on demonstrating the safety and performance of the device's modifications, specifically the increased length to allow for new access approaches (antecubital and popliteal).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify a numerical sample size for the simulated use testing. It states "A simulated use model... was used for testing." It's likely that a sufficient number of tests were performed to demonstrate consistency, but this detail is not provided.
- Data Provenance: The data is generated from non-clinical bench testing and simulated use testing conducted by the manufacturer, Rex Medical, L.P. The origin is the manufacturer's testing facilities (implied, likely USA given the submission to the FDA).
- Retrospective or Prospective: This is a prospective non-clinical study, as the tests were designed and conducted specifically to support this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable for this type of non-clinical, bench-testing study. Ground truth in this context relates to the physical and mechanical performance of the device, which is evaluated against engineering specifications and industry standards, not against expert medical diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This was not a human-reader study requiring adjudication of interpretations. The "adjudication" was implicitly done by engineers/scientists evaluating the physical performance and measurements against pre-defined acceptance criteria.
5. 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. This device is a physical medical implant (vena cava filter), not an AI/software-as-a-medical-device (SaMD) that assists human readers in interpreting medical images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or SaMD.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this non-clinical study was based on:
- Engineering specifications and design requirements: The device had to perform within specified ranges for deployment forces, tilt angles, and other mechanical parameters.
- Risk assessment: The potential failure modes identified in the risk assessment guided the testing.
- Relevant ISO standards: ISO 10555-1 (Sterile, single-use intravascular catheters) and ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process) provided the framework for testing methodology and performance expectations for certain aspects, particularly biocompatibility and catheter characteristics.
- Predicate device performance: The ultimate "ground truth" for substantial equivalence is that the modified device performs comparably to the predicate.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
Summary of Study:
The study was a series of non-clinical bench and simulated use tests conducted by Rex Medical. The primary objective was to demonstrate that modifications to the Option™ ELITE Vena Cava Filter System (specifically the increased length for new access approaches) did not negatively impact its safety and efficacy, maintaining substantial equivalence to its predicate device (K133243). The tests evaluated aspects like deployment forces, filter tilt, integrity of the system, and adherence to relevant ISO standards, ensuring the modified device continued to perform as intended and was safe for its stated indications for use. No clinical trials or human-reader studies were conducted or required for this 510(k) submission.
§ 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.”