(381 days)
The SafeFlo® Vena Cava Filter set is indicated for the prevention of recurrent pulmonary embolism via percutaneous placement in the inferior 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.
The SafeFlo Filter is a Nitinol filter designed for simple, stable and safe implantation in the inferior vena cava to allow blood flow towards the heart while preventing the passage of emboli into the pulmonary arteries. The SafeFlo Filter set comprises the vena cava filter unit and a delivery system kit, provided in separate packages.
The SafeFlo Filter is inserted through a 6F (ID) delivery system. The filter is divided into two functional parts, the Double Ring Platform and the Filter Element. The Double Ring Platform is a fixator, which anchors itself in the vessel wall by over-sizing of the rings with respect to the circular diameter of the vessel. The Double Ring Platform has been designed to exit the delivery sheath and rotate through 90° to be positioned perpendicular to the vessel wall. This method of fixation does not utilize individual hooks and therefore vessel trauma is minimized and repositioning is possible.
The Filter Element is the functional unit of the filter; it is shaped from the continuation of the wires of the Double Ring Platform and is thereby supported securely within the bloodstream. The Filter Element's unique double strand structure forms an Outer Support Ring and an inner 5-leafed filtration configuration whose design allows relatively unhindered blood flow and traps clinically significant migrating emboli. The Filter Element's size (diameter) is designed to be up to 3mm smaller than the diameter of the IVC.
Here's an analysis of the provided text regarding the SafeFlo® Vena Cava Filter, focusing on acceptance criteria and the supporting study information.
Note: The provided document is a 510(k) summary, which is a premarket notification to the FDA. It declares substantial equivalence to previously cleared devices rather than a de novo approval requiring extensive clinical efficacy studies to establish new performance criteria. Therefore, the information regarding acceptance criteria and detailed study methodology is limited compared to what might be found for a novel device.
Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a table format as might be expected for a device proving novel efficacy. Instead, it relies on demonstrating substantially equivalent performance to predicate devices through bench, animal, and clinical testing. The "acceptance criteria" can be inferred as the device functioning as intended and its results being "as expected" and comparable to predicate devices in areas of safety and effectiveness.
| Performance Characteristic (Inferred Acceptance Criterion) | Reported Device Performance |
|---|---|
| Function as Intended | Demonstrated in bench, animal, and clinical testing. |
| Safety (e.g., minimize vessel trauma, secure anchoring) | "vessel trauma is minimized" due to fixation method; "fixator, which anchors itself in the vessel wall by over-sizing of the rings... does not utilize individual hooks" |
| Effectiveness (e.g., prevent emboli, allow blood flow) | "prevents the passage of emboli into the pulmonary arteries;" "unique double strand structure forms an Outer Support Ring and an inner 5-leafed filtration configuration whose design allows relatively unhindered blood flow and traps clinically significant migrating emboli." |
| Substantial Equivalence to Predicate Devices | "The SafeFlo Filter is as safe and effective as the Predicate Devices." |
Study Details
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: The document does not specify a distinct "test set" sample size in the context of human data. It mentions "clinical testing" but does not provide details on the number of patients. The focus is on demonstrating equivalence, not necessarily a large-scale efficacy trial with a specific test cohort.
- Data Provenance: Not explicitly stated for specific clinical data. Given the "Submitter's Name, Address, Telephone Number, Contact Person" points to a Delaware address but a phone number with a +972 prefix (Israel), it's possible clinical data (if any was collected on humans for this submission) could be from Israel or other international sites, but this is not confirmed. The study includes "bench, animal, and clinical testing."
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)
- This information is not provided. The 510(k) summary does not detail the methodology for establishing ground truth or expert involvement in clinical (or even animal) study evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not provided. Adjudication methods are typically detailed in clinical study protocols, which are not included in this summary.
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
- No MRMC study was done. This device is a physical medical implant (vena cava filter), not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC comparative effectiveness study regarding "human readers improving with AI" is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an implantable filter, not a software algorithm. Its "performance" is its physical function in the body to trap emboli and remain securely in place, as demonstrated through bench and animal testing, and presumably limited human observations if a clinical study was performed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The document implies ground truth would be established through:
- Bench Testing: Engineering measurements, physical properties, flow dynamics.
- Animal Testing: In-vivo observation of anchoring, emboli trapping, and biological response.
- Clinical Testing: (implicitly) Patient outcomes related to pulmonary embolism recurrence, complications, and filter integrity. However, specific methods for outcome analysis are not detailed.
8. The sample size for the training set
- Not applicable / Not provided. This is a physical device, so there isn't a "training set" in the sense of machine learning algorithms. If there were design optimization iterations, they would be part of engineering development rather than a formally defined training set for an algorithm.
9. How the ground truth for the training set was established
- Not applicable. As above, there is no "training set" in the context of an AI algorithm. Ground truth for device design and testing would be established through engineering specifications, scientific principles, and preclinical validation methods (bench, animal).
§ 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.”