(30 days)
The Headway 21 Microcatheter is intended for general intravascular use, including the peripheral, coronary and neuro vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils.
The Headway 21 Microcatheter is a single lumen catheter designed to be introduced over a steerable guidewire to access small, tortuous vasculature. The semi-rigid proximal section transitions to a flexible distal tip to facilitate advancement through vessels. Dual radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the Microcatheter is coated with a hydrophilic polymer to increase lubricity. A luer fitting on the Microcatheter hub is used for the attachment of accessories.
The provided text describes the 510(k) summary for the Headway 21 Microcatheter. This is a medical device, and the acceptance criteria and study information provided are related to its physical and functional performance, not to an AI or software-based medical device that would have clinical performance metrics like sensitivity, specificity, or reader improvement.
Therefore, many of the requested fields (2-9, and the effect size in 5) are not applicable to this type of device and submission.
Here's the relevant information based on the provided text:
Acceptance Criteria and Device Performance
The Headway 21 Microcatheter performed a series of bench tests to demonstrate its design and functional equivalence to a predicate device. The acceptance criteria for these tests were met if the device "Pass"ed each specified test.
| Bench Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Surface and physical attributes | Pass | Pass |
| Distal tensile strength | Pass | Pass |
| Hub tensile strength | Pass | Pass |
| Leakage (liquid and air) | Pass | Pass |
| Static and dynamic burst pressure | Pass | Pass |
| Simulated use | Pass | Pass |
| Compatibility with devices | Pass | Pass |
| Flow rate | Pass | Pass |
| Kink resistance | Pass | Pass |
| Catheter flexural fatigue | Pass | Pass |
Study Details Based on the Provided Document:
-
A table of acceptance criteria and the reported device performance: See table above.
-
Sample size used for the test set and the data provenance: Not explicitly stated for each bench test. These are engineering/device performance tests, not clinical studies with patient data.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these physical tests would be defined by engineering standards and test methodology, not clinical expert consensus.
-
Adjudication method for the test set: Not applicable for these engineering tests. Results are typically determined by predefined pass/fail limits based on engineering specifications.
-
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 a physical medical device, not an AI or imaging diagnostic tool.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
-
The type of ground truth used: For bench testing, the "ground truth" is typically established by engineering specifications, validated test methods, and industry standards for medical devices of this type (e.g., tensile strength required for a given material, burst pressure, flow rate thresholds).
-
The sample size for the training set: Not applicable. This is a physical medical device, not a machine learning model.
-
How the ground truth for the training set was established: Not applicable.
§ 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).