(203 days)
The catheter is intended to be used for the controlled infusion of physician specified therapeutic agents and contrast media into the neurovascular and peripheral systems.
The EASY RIDER® Micro Catheter is a single lumen infusion catheter designed to be introduced over a steerable guide wire into distal vasculature. The EASY RIDER® Micro Catheter has a hydrophilic coating to provide lubricity for navigation of vessels. A standard luer lock adapter on the proximal hub is used for the attachment of accessories. The catheter tip is indicated by a radiopaque marker to facilitate fluoroscopic visualization.
The device under consideration is the EASY RIDER® Micro Catheter.
Based on the provided text, the acceptance criteria are generally qualitative and focus on safety and performance rather than specific numerical performance metrics typical for AI/ML devices. The "study" described is a series of tests to demonstrate compliance with these criteria for a medical device submitted for 510(k) clearance.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Device must be biocompatible according to the International Standard for the Biological Evaluation of Medical Devices, Part 1: Guidance on Selection of Tests (ISO 10993-1:1992(E)). | "Results of the tests showed that the device passed biocompatibility testing and is suitable for its application." |
| Physical Performance | Device must meet dimensional specifications. | "All testing of the product yielded acceptable results." (This is a general statement covering multiple aspects of physical performance.) |
| Device must demonstrate adequate tensile strength. | "All testing of the product yielded acceptable results." | |
| Device must withstand specified burst pressure. | "All testing of the product yielded acceptable results." | |
| Device must have acceptable flow rates. | "All testing of the product yielded acceptable results." | |
| Device must exhibit acceptable torque performance. | "All testing of the product yielded acceptable results." | |
| Device must perform acceptably under simulated conditions. | "All testing of the product yielded acceptable results." | |
| Intended Use | The catheter is intended for controlled infusion of therapeutic agents and contrast media into neurovascular and peripheral systems. | This is the objective statement of the device's function, and the successful completion of the biocompatibility and physical performance tests contributes to the device's suitability for this intended use, leading to a determination of substantial equivalence (inferring it meets this intent safely and effectively). The FDA's 510(k) clearance confirms that the device is cleared for this intended use. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "testing of the product" but does not quantify the number of devices or units tested for each physical test or biocompatibility. Given the nature of a 510(k) submission for a device like a catheter, it would typically involve a statistically appropriate sample size for each test type, but these specific numbers are not provided in the summary.
- Data Provenance: Not specified, but generally for medical device testing, especially for 510(k) submissions, the testing is performed in controlled laboratory environments or by contract research organizations (CROs) in the country of the manufacturer (USA, in this case, Micro Therapeutics, Inc. Sits in San Clemente, CA). The tests are prospective in nature, meaning they are designed and conducted specifically to evaluate the device against predefined criteria.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For this type of physical medical device (catheter), "experts" are not typically used to establish a "ground truth" in the same way they would be for an AI/ML diagnostic algorithm. The ground truth for biocompatibility is whether the device causes a biological reaction (determined by laboratory tests), and for physical tests, it's whether the device meets engineering specifications (determined by measurements and operational tests). The "experts" involved would be technicians, engineers, and scientists conducting the tests and interpreting the results against established standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- None (Not Applicable). Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for establishing ground truth in diagnostic imaging where human interpretation is involved. For the physical and biocompatibility testing of a medical device like a catheter, the results are objectively measured or observed based on standardized protocols, not subject to individual interpretation requiring adjudication.
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:
- No. This is not an AI/ML medical device. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is not an AI/ML medical device, so there is no algorithm to test in a standalone manner.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Objective Measurement/Standardized Testing: The "ground truth" for this device is based on objective measurements against engineering specifications (for dimensional, tensile strength, burst pressure, flow rate, torque), and compliance with established international standards for biological evaluation (ISO 10993-1:1992(E)) for biocompatibility.
8. The sample size for the training set:
- Not Applicable. This is not an AI/ML medical device, so there is no "training set."
9. How the ground truth for the training set was established:
- Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant to this 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).