(29 days)
The Direxion and Direxion HI-FLO Torqueable Microcatheters are intended for peripheral vascular use. The pre-loaded Fathom and Transend Guidewires can be used to selectively introduce and position the microcatheter in the peripheral vasculature. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vessel.
The Direxion Microcatheter is available in small and large lumens. The Direxion Torqueable Microcatheter (Direxion) is a small lumen microcatheter with a distal outside diameter of 2.5F (0.85 mm), and a maximum outside diameter of 2.7F (0.95 mm). It has an inside diameter of 0.021 in (0.5 mm) minimally in the proximal and distal regions. The microcatheter lumen is able to accommodate steerable guidewires with diameters ≤ 0.018 in (0.47 mm).
The Direxion HI-FLO Torqueable Microcatheter (Direxion HI-FLO) is a large lumen microcatheter with a distal outside diameter of 2.9F (1.00 mm), and a maximum outside diameter of 3F (1.05 mm). It has an inside diameter of 0.027 in (0.6 mm) minimally in the proximal and distal regions. The microcatheter lumen is able to accommodate steerable guidewires with diameters ≤ 0.021 in (0.53 mm).
The Direxion and Direxion HI-FLO Microcatheters are available in a variety of tip shapes (Straight, Bern, Swan Neck, and J Shape) to aid with accessing challenging anatomy. The distal outer surface of the microcatheter is coated with a hydrophilic coating. A radiopaque marker is located at the distal tip to facilitate fluoroscopic visualization. Some Direxion Microcatheters have a second marker 3 cm proximal to the first marker. The distal tip of the microcatheter is steam shapeable. The proximal end incorporates a standard luer with rotating hemostatic valve (RHV) or Y-adapter.
The Direxion and Direxion HI-FLO Microcatheters are available with the following preloaded guidewires:
Fathom-16 Steerable Guidewire (K111485)
- 0.016 in (0.41 mm) diameter; 140 or 180 cm lengths
Transend 14/18 Steerable Guidewires (K971254 / K964611)
- 0.014 in (0.37 mm) or 0.018 in (0.47 mm) diameters; 135, 165 or 190 cm lengths
The guidewires have a hydrophilic coating to provide lubricity, which aids in the navigation of distal, tortuous vasculature. The guidewires are radiopaque to allow for visualization under fluoroscopy and the tips are shapeable.
Accessories may include a RHV or Y-adapter, steam shaping mandrel, microcatheter introducer, quidewire introducer and torque device.
The provided text describes a 510(k) premarket notification for microcatheters. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical or AI-centric studies. Therefore, many of the requested categories (e.g., effect size of human readers with AI assistance, algorithm-only performance, training set size, ground truth for training set) are not applicable to this document.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Microcatheter Luer Compatibility | Met predetermined acceptance criteria. |
| Microcatheter ID / OD Verification | Met predetermined acceptance criteria. |
| Catheter Usable Length | Met predetermined acceptance criteria. |
| Microcatheter Coating Integrity | Met predetermined acceptance criteria. |
| Particulate Evaluation | Met predetermined acceptance criteria. |
| Tensile Strength | Met predetermined acceptance criteria. |
| Corrosion Resistance | Met predetermined acceptance criteria. |
| Kink Resistance | Met predetermined acceptance criteria. |
| Distal Tip Flexibility | Met predetermined acceptance criteria. |
| Proximal Shaft Pushability | Met predetermined acceptance criteria. |
| Torsional Strength | Met predetermined acceptance criteria. |
| Maximum Infusion Pressure | Met predetermined acceptance criteria. |
| Freedom from Liquid Leakage | Met predetermined acceptance criteria. |
| Embolic Coil Compatibility | Met predetermined acceptance criteria. |
| PVA Particle and Embolic Sphere Compatibility | Met predetermined acceptance criteria. |
| Chemical Compatibility | Met predetermined acceptance criteria. |
| Guide Catheter Compatibility | Met predetermined acceptance criteria. |
| Guidewire Compatibility | Met predetermined acceptance criteria. |
| Torque Device Compatibility | Met predetermined acceptance criteria. |
| Y-Adapter / RHV Compatibility | Met predetermined acceptance criteria. |
| Shelf Life | Met predetermined acceptance criteria. |
| Packaging Testing | Met predetermined acceptance criteria. |
| Sterilization | Met predetermined acceptance criteria. |
| Biocompatibility | Met predetermined acceptance criteria. |
2. Sample size used for the test set and the data provenance
The document mentions "bench testing was conducted for design elements and performance characteristics." However, it does not specify sample sizes for these tests, nor does it refer to a "test set" in the context of patient data or algorithm evaluation. Data provenance (e.g., country of origin, retrospective/prospective) is not applicable as this concerns bench testing of the physical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. "Ground truth" in this context would refer to a benchmark for a diagnostic or AI device. This submission is for a physical medical device (microcatheter) where performance is evaluated through engineering and biocompatibility testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept belongs to studies where human experts or algorithms are evaluating data, typically for diagnostic accuracy.
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 microcatheter, not an AI-assisted diagnostic or treatment system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a microcatheter, not an AI algorithm.
7. The type of ground truth used
For the performance data listed, the "ground truth" is established through industry standards, engineering specifications, and validated test methods for material properties, functional performance (e.g., ID/OD dimensions, tensile strength, kink resistance, infusion pressure), compatibility, and biological safety.
8. The sample size for the training set
Not applicable. This device is a microcatheter, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This device is a microcatheter, not an AI algorithm.
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).