(27 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
- 0.016 in (0.41 mm) diameter; 140 or 180 cm lengths
Transend 14/18 Steerable Guidewires
- 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, guidewire introducer and torque device.
The provided text is a 510(k) premarket notification for the Direxion and Direxion HI-FLO Torqueable Microcatheters. It describes the device and claims substantial equivalence to a predicate device. However, it does not contain the kind of detailed information requested about a study to prove the device meets acceptance criteria, especially in the context of an AI/ML powered medical device.
The information provided is for a traditional medical device (microcatheter) and focuses on bench testing to demonstrate physical properties and equivalence to a predicate device, rather than performance metrics related to diagnostic or therapeutic efficacy that would typically be evaluated in an AI/ML study.
Therefore, most of the requested fields are not applicable or cannot be extracted from this document. I will fill in what can be gleaned from the text and note where information is missing or not relevant for an AI/ML study.
Here's a breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Bench Testing) | Reported Device Performance (Met Criteria) |
|---|---|
| Hub / Shaft Tensile Strength | Met predetermined acceptance criteria |
| Proximal Shaft Pushability | Met predetermined acceptance criteria |
| System Removal from Carrier Tube | Met predetermined acceptance criteria |
| Kink Resistance | Met predetermined acceptance criteria |
Note: The specific qualitative or quantitative acceptance criteria for each test (e.g., "Tensile strength must be > X Newtons") are not detailed in this summary, nor are the exact measured performance values.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The testing described is bench testing of physical properties, not a clinical study involving patients or a test set of data points in the AI/ML sense.
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)
Not applicable. This is not an AI/ML powered device, and the testing described does not involve expert adjudication of ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 is not an AI/ML powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the bench tests, the "ground truth" would be the engineering specifications and validated test methods (e.g., a certain force required to cause failure, or a certain degree of flex without kinking). The document states the device "met the predetermined acceptance criteria."
8. The sample size for the training set
Not applicable. This is not an AI/ML powered device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML powered device.
§ 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).