(170 days)
The Navien™ Intracranial Support Catheter is indicated for the introduction of interventional devices into the peripheral and neurovasculature.
The Navien™ Intracranial Support Catheter is a single lumen, flexible, variable stiffness composite catheter which has a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. The Navien™ Intracranial Support Catheter has a marker on the distal tip that is visible under fluoroscopy. The dimensions are included in the Navien™ Intracranial Support Catheter inner lumen can accommodate guidewires up to 0.038 inches in diameter to aid in placement of the catheter system. The catheter has both straight and pre-shaped tips.
The proximal end of the Navier™ Intracranial Support Catheter has a Luer fitting to allow attachment of accessories and infusion of liquids through the system. The Catheter is offered in various sizes to accommodate physician preferences and anatomical variations. The catheter is provided sterile, nonpyrogenic, and is intended for single use only.
The provided text describes the 510(k) premarket notification for the Navien™ Intracranial Support Catheter, focusing on demonstrating substantial equivalence to a previously cleared predicate device due to a coating change. The study primarily relies on non-clinical bench and design validation testing, with no clinical or animal studies performed for the new device.
Here's an analysis of the acceptance criteria and the study based on the provided document:
Acceptance Criteria and Device Performance
The device's acceptance criteria and reported performance are primarily presented in the "Performance Testing – Bench" subsection.
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensional Inspection | Usable length, proximal and distal inner and outer diameters must meet all inspection criteria. | All devices met acceptance criteria. |
| Torque to Failure | The catheter must withstand multiple revolutions without failure. | Torque to failure testing met acceptance criteria. |
| Coating Lubricity/Durability | Average Friction Force must be comparable to the predicate device. | Coating lubricity and durability testing met acceptance criteria. |
| Liquid Leakage | Catheter shall not leak per ISO 10555-1. | Liquid leakage met acceptance criteria. |
| Dynamic Burst | Catheter shall not burst or leak during a dynamic pressure test. | Dynamic burst testing met acceptance criteria. |
| Tip Buckling | Compressive load shall not be statistically significantly different to comparable and/or the predicate device. | Tip buckling force met acceptance criteria. |
| Particulate Testing | Particulate must be within limits per USP . | Number of particulates generated met acceptance criteria. |
| Physician Usability Testing | Assess navigation of Navien™ with new coating to the ICA and comparing Navien™ with new to Navien™ with old coating with regards to tip atraumaticity. | All test results met the acceptance criteria. |
| Biocompatibility (various tests) | As outlined in the "Biocompatibility" table (e.g., non-cytotoxic, non-sensitizer, non-irritant, non-pyrogenic, non-hemolytic, acceptable thromboresistance, no adverse effect on platelet/leukocyte/prothrombin, non-mutagenic). | All biocompatibility tests passed and met their respective criteria. |
Study Details
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Sample Size used for the test set and the data provenance:
- The document does not explicitly state specific sample sizes for each bench test beyond "All device met acceptance criteria" or "All test results met the acceptance criteria."
- The data provenance is from bench testing and in-vitro biocompatibility studies, performed at Micro Therapeutics, Inc. d/b/a ev3 Neurovascular and related contracted laboratories (e.g., Sterigenics for sterilization validation). As this is a medical device subject to FDA regulation in the USA, the testing would be expected to adhere to US regulatory standards. The data is retrospective in the sense that it evaluates the manufactured device against pre-defined criteria, rather than collecting new patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the "Physician Usability Testing," the document states "The device was navigated through a tortuous benchtop model to assess accessibility and the tip atraumatic profile." It also mentions assessing navigation and tip atraumaticity.
- The document does not specify the number of physicians or their qualifications used for this usability testing. It just refers to "Physician Usability Testing."
- For other bench tests, the ground truth is established by objective engineering and analytical measurements against established standards (e.g., ISO, USP).
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Adjudication method for the test set:
- The document does not describe an adjudication method in the context of expert review for the test set. Given the nature of the tests (bench and usability), outcomes are likely determined by direct measurement against criteria or consensus during usability observations, rather than a formal expert adjudication process typically used in clinical studies involving multiple readers.
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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, an MRMC comparative effectiveness study was not done. This document pertains to a medical device (intracranial support catheter), not an AI diagnostic or assistance system. Therefore, the concept of human readers improving with or without AI assistance is not applicable here.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, this is not applicable. The device is a physical catheter, not an algorithm or AI system.
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The type of ground truth used:
- For the bench testing, the ground truth is based on objective engineering measurements against established international standards (e.g., ISO 10555-1, USP ) and comparative performance relative to the predicate device.
- For biocompatibility testing, the ground truth is derived from standardized biological assays and chemical analysis against recognized guidelines (AAMI/ANSI/ISO 10993-1:2009, FDA Blue Book Memorandum G95-1, USP).
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The sample size for the training set:
- Not applicable. This submission is for a physical medical device (catheter), not an AI or machine learning model that requires a "training set." The testing performed is to demonstrate the physical and biological characteristics of the manufactured device.
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How the ground truth for the training set was established:
- Not applicable. As stated above, there is no "training set" in the context of this device submission.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).