(74 days)
The Fibrex™ Catheter Patency Device is intended to disrupt fibrin sheath formation on both the external and internal surface of vascular access catheters, thus restoring functional patency.
The Fibrex™ Catheter Patcncy Device is a tri-axial delivery catheter assembly comprised of an outer catheter storing an inner guide structure and an inner stripping coil. The inner guide structure is for directing and guiding the stripping coil through the catheter to the free end of the catheter and back up around the exterior surface of the vascular catheter. The stripping coil is formed of a shape memory or super-elastic material, wherein the stripping coil is preformed to assume a helical shape wrapping about the outer surface of the vascular catheter in a manner providing for the stripping of build-up from the outer surface of the vascular catheter when the stripping coil is moved relative to the vascular catheter. The tri-axial delivery catheter assembly is attached to an injection molded plastic hand assembly that controls the movement of the guide catheter and subsequent insertion of the stripping coil. The delivery catheter assembly is adapted for selectively coupling to a luer connector secured to the venous lumen of a traditional vascular catheter. The outer catheter of the Fibrex™ device is made from a biocompatible Polyimid/PTFF. composite. The inner dual lumen tube is made from nylon. A Nitinol wire is housed in one lumen of the guide curve catheter to provide directional memory for the actuation and operation of the Nitinol stripping coil . Both the outer catheter and the guide catheter contain distal marking bands made from gold.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Fibrex™ Catheter Patency Device:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state quantitative acceptance criteria in terms of specific performance metrics or thresholds. Instead, it frames the testing as a comparison to a predicate device.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Fibrin stripping capabilities (Qualitative) | "The Fibrex™ Catheter Patency Device was subjected to an animal study to evaluate the fibrin stripping capabilities of the device." |
| "The results of the testing indicated that they are comparable to the predicate device." | |
| Ring retention (Qualitative) | "It was also subjected to ring retention, and tensile tests." |
| "The results of the testing indicated that they are comparable to the predicate device." | |
| Tensile strength (Qualitative) | "It was also subjected to ring retention, and tensile tests." |
| "The results of the testing indicated that they are comparable to the predicate device." | |
| Technical Equivalence to Predicate Device | Examinined attributes: |
- Intended use
- French Sizes
- Length
- Lumens
- Distal end configuration
- Intended anatomical location of distal end
- Proximal end configuration
- Materials
- Labeling
Result: "found to be comparable to the predicate device." |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: The document mentions an "animal study" but does not specify the number of animals or the specific experimental setup (e.g., number of catheters tested, number of observations).
- Data Provenance: The study was an "animal study," implying it was conducted in a controlled laboratory environment. The country of origin is not specified but is likely the US given the submission to the FDA. The study is implicitly prospective for the duration of the animal experiment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts used or their qualifications for evaluating the results of the animal study or the other functional and safety tests. The determination of "comparable to the predicate device" would have involved expert assessment, but details are not provided.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for establishing ground truth for the test set. Given the nature of the tests (animal study, ring retention, tensile tests), it's likely standard laboratory protocols were followed, but no specific adjudication process like 2+1 or 3+1 is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in the provided text. The device is a physical medical device (catheter) and not an AI-based diagnostic or assistive technology that would typically involve human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This question is not applicable as the Fibrex™ Catheter Patency Device is a physical medical device, not an algorithm or software. Its performance is inherent to its mechanical and material properties, not an algorithm's output. The "standalone performance" is essentially the results of the functional and safety tests described.
7. Type of Ground Truth Used
The ground truth for the animal study (fibrin stripping capabilities) would have been established through direct observation and measurement within the animal model, potentially involving histological analysis or other methods to quantify fibrin sheath disruption. For ring retention and tensile tests, the ground truth is established by physical measurement against engineering specifications or observed performance characteristics. The overarching "ground truth" for the 510(k) submission is the demonstration of substantial equivalence to a legally marketed predicate device.
8. Sample Size for the Training Set
This question is not applicable. The Fibrex™ Catheter Patency Device is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This question is not applicable as there is no training set for a physical medical device.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).