(155 days)
The VenaTech® Convertible™ Vena Cava Filter System is indicated for the prevention of recurrent pulmonary embolism via placement in the vena cava 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.
When clinically indicated after implantation, the VenaTech Convertible filter can be converted to an open configuration to discontinue filtration according to the 'Conversion Procedure' in the Instructions for Use.
The VenaTech Convertible Vena Cava Filter is a flexible, symmetrical, cobalt-chromium metal alloy, self-expanding vena cava filter intended for permanent implantation into the infrarenal inferior vena cava to provide protection against pulmonary embolism. When clinically indicated, the clot-trapping features of the VenaTech Convertible filter can be deactivated by percutaneously converting the filter to an open configuration. The VenaTech Convertible filter is pre-loaded in a cartridge (syringe) and provided as a system with introducer accessories and instructions to accommodate delivery and implantation either using the femoral or jugular approach.
Here's an analysis of the provided text regarding the VenaTech Convertible Vena Cava Filter System, based on your requested criteria:
The document (K152765) is a 510(k) summary for the VenaTech Convertible Vena Cava Filter System. It describes the device, its intended use, and the studies conducted to demonstrate substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a typical quantitative pass/fail format for each tested characteristic. Instead, it lists evaluations performed and generally concludes that the device performed according to its intended use or was sufficiently robust. For the clinical study, a primary objective was defined.
| Evaluation/Criterion | Reported Device Performance |
|---|---|
| Non-Clinical Evaluations (Bench) - General Statement | The VenaTech Convertible filter is sufficiently robust for its intended use as a permanent vena cava filter and demonstrates the mechanical integrity and performance of the filter's convertible feature. |
| ISO 25539-3 Compliant DV&V Test Areas: | (Implicitly met "sufficiently robust" criterion for each) |
| Cavography ability | Performed |
| Clot trapping test | Performed |
| Conversion force | Performed |
| Dilator spinlock resistance | Performed |
| Dimension of introduction system | Performed |
| Fatigue resistance (fracture, cracks, and corrosion) | Performed |
| Filter dimension | Performed |
| Filter head resistance | Performed |
| Filter radio-opacity | Performed |
| Filter welding resistance | Performed |
| Head assembly resistance | Performed |
| Hook crimping strength | Performed |
| Introduction sheath radioopacity | Performed |
| Introduction system traction resistance | Performed |
| Introduction sheath water tightness | Performed |
| Migration resistance | Performed |
| (Packaging) Transportation | Performed |
| (Packaging) Fall (drop) | Performed |
| Passage in sheath | Performed |
| Radial force | Performed |
| Radial pressure (contact pressure) | Performed |
| Magnetic resonance (MR) testing | Performed |
| Chemical Characterization (ISO 10993) | Performed |
| Animal Studies (Simulated Use in Sheep Model) | Demonstrated that the VenaTech Convertible filter performed according to its intended use and thus supports substantial equivalence. |
| Clinical Study - Primary Objective (Technical Success) | Achieved in 92.7% of subjects. |
| Details of Technical Success | 96 attempted conversions, 93 actual conversions, and 89 successful conversions with no technical complications. |
2. Sample Size Used for the Test Set and Data Provenance
- Clinical Study Test Set Sample Size: 149 subjects were enrolled and successfully implanted. 96 attempted conversions.
- Data Provenance: Multi-center, prospective, single-arm clinical study. The country of origin of the data is not specified, but the submission is to the U.S. FDA. It's a prospective study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
The document does not provide information on the number or qualifications of experts used to establish ground truth for the clinical study. It states that investigator discretion was used for subjects unable to undergo conversion.
4. Adjudication Method for the Test Set
The document does not describe a specific adjudication method (e.g., 2+1, 3+1). It refers to "investigator discretion" for clinical decisions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size
No, an MRMC comparative effectiveness study was not conducted. The clinical study was a single-arm study, not comparing human readers with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This device is a physical medical implant (vena cava filter), not a software algorithm. Therefore, the concept of "standalone algorithm performance" or "human-in-the-loop performance" as typically applied to AI/software devices is not relevant here and was not performed.
7. The Type of Ground Truth Used
For the clinical study, the "ground truth" for the primary objective of "technical success" appears to be based on the direct observation and assessment of the procedure by the investigators (physicians/clinicians). For the adverse event reporting, it would be based on clinical outcomes.
8. The Sample Size for the Training Set
This product is a physical medical device. There is no "training set" in the context of machine learning or AI models. The design and validation relied on engineering principles, bench testing, and animal studies.
9. How the Ground Truth for the Training Set Was Established
As explained in point 8, there is no training set in the AI sense. The "ground truth" for the non-clinical and animal studies would be established through:
- Bench Testing: Engineering specifications, standardized test methods (e.g., ISO standards), and physical measurements.
- Animal Studies: Direct observation of device performance in a live biological model by trained veterinary and research staff.
§ 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.”