(156 days)
The PROWLER SELECT PLUS Microcatheter is intended for the introduction of interventional devices, delivery of therapeutic devices, and infusion of diagnostic agents into the peripheral and neuro vasculature.
The PROWLER EX Microcatheter is intended for the introduction of interventional devices, delivery of therapeutic devices, and infusion of diagnostic agents into the peripheral and neuro vasculature.
The PROWLER SELECT PLUS Microcatheter and PROWLER EX Microcatheter are variable stiffness, single lumen catheters designed to access small, tortuous vasculature. They are available in a variety of outer and inner diameters. Each configuration has a hydrophilic coating to provide lubricity for navigation of vessels. The inner lumen is lined with lubricious PTFE to facilitate movement of guidewires and other devices. The distal sections of the catheter bodies are radiopaque to aid visualization under fluoroscopy, and the distal tips are clearly distinguished by a radiopaque marker.
The provided FDA 510(k) summary (K210838) is for a medical device, specifically a microcatheter. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. The document does not describe studies proving an AI/ML powered device meets acceptance criteria.
Therefore, I cannot extract the requested information regarding AI/ML acceptance criteria, performance tables, sample sizes, expert involvement, or MRMC studies from the provided text, as those concepts are not applicable to the device described (a physical microcatheter).
The document details performance testing for this physical device as follows:
Acceptance Criteria and Device Performance (Not applicable to AI/ML):
The document describes non-clinical performance testing for the PROWLER SELECT PLUS Microcatheter and PROWLER EX Microcatheter. The acceptance criteria are implicit in the "Test Method Summary" and the "Results" sections.
| Test | Test Method Summary | Results (Device Performance) |
|---|---|---|
| Simulated Use Testing in a tortuous anatomical model | To provide evidence that the subject devices can safely and effectively deliver interventional devices to the peripheral and neurovasculature. The test method and anatomical model were the same established for reference devices K162563 and K191237. | Test sample microcatheters successfully delivered interventional devices, including vascular stents, stent retrievers, and aneurysm coils. Results demonstrated substantial equivalence for delivery of interventional devices. |
| Particulate Testing | To evaluate and compare the quantity of particles generated by the subject device during simulated device delivery in a tortuous anatomical model versus particles generated by an applicable reference device (K131437). The test method and anatomical model were the same established for reference devices K162563 and K191237. | Particle generation from baseline and aged subject devices were comparable with the reference device (K131437). |
| Static Burst Pressure Testing | This test verified that the subject devices meet the established static burst pressure specification, after simulating the delivery of an interventional device. Static burst pressure specifications were the same as those established for predicate K021591. The test method was the same established for reference devices K162563 and K191237. | All tested baseline and aged samples met the minimum static burst pressure acceptance criteria with a demonstrated 95% confidence and 99% reliability and substantial equivalence for delivery of interventional devices. |
Regarding the specific questions asked for an AI/ML device:
- A table of acceptance criteria and the reported device performance: Provided above for the physical device.
- Sample sized used for the test set and the data provenance: Not explicitly stated (e.g., number of microcatheters tested in "test sample microcatheters" or "all tested baseline and aged samples"). The data is from non-clinical bench testing, not patient data (so no country of origin, retrospective/prospective information).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical microcatheter's performance is based on direct measurement and observation of physical properties and simulated use, not expert interpretation of AI output.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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, as this is a physical medical device, not an AI-powered diagnostic/analytic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for this device is based on established engineering specifications, physical testing standards, and direct observation of mechanical performance (e.g., successful delivery, particle generation counts, burst pressure measurements).
- The sample size for the training set: Not applicable (no AI model).
- How the ground truth for the training set was established: Not applicable (no AI model).
§ 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).