(257 days)
The Micro Catheter is intended for the delivery of interventional devices or contrast media into the vasculature of the peripheral and neuro anatomy.
The Micro Catheter is a sterile, single-use, single lumen, variable stiffness, composite catheter. The Micro Catheter is available in three inner diameters (0.017″, 0.021″ and 0.027″), and two working lengths (150cm and 155cm). All models are designed with a straight tip, and are steam shapeable by the user. Single or dual radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic coating to increase lubricity. The proximal end of Micro Catheter incorporates a standard luer adapter to facilitate the attachment of accessories. The catheter body has a semi-rigid proximal end which transitions into the flexible distal end to facilitate the advancement of the catheter in the tortuous vasculature. The Micro Catheter is compatible with ≤ 0.014″ guidewires and 5F or larger guide catheters.
The provided 510(k) clearance letter pertains to a Micro Catheter and describes its performance and testing to demonstrate substantial equivalence to a predicate device. This document does not discuss an AI/ML powered device, nor does it present data from a study involving human readers or the establishment of ground truth for AI model training or testing. Therefore, I cannot address most of your specific questions related to AI device evaluation.
However, I can extract the acceptance criteria and performance data for the Micro Catheter based on the provided text.
Acceptance Criteria and Device Performance for Micro Catheter
The document describes the testing performed on the Micro Catheter to demonstrate its substantial equivalence to a predicate device. The "acceptance criteria" are implied by the "Results" column in the tables, indicating whether the device met the required performance standards for each test.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The FDA 510(k) summary for a medical device like a micro catheter focuses on engineering and biocompatibility performance rather than AI-specific metrics. The "acceptance criteria" are implicitly met if the "Results" indicate compliance, comparability to a predicate, or "met the acceptance criteria."
| Test (Category) | Specific Test Method Summary | Acceptance Criteria (Implied by Results) | Reported Device Performance |
|---|---|---|---|
| Bench Performance Testing | |||
| Dimensional Verification | Measured inner/outer diameter, effective length. | Met specified dimensions. | Micro Catheter and accessories met the acceptance criteria. |
| Radiopacity | Visualized under fluoroscopy. | Equivalent to predicate device. | Micro Catheter and the predicate device were imaged showing equivalence in terms of radiopacity. |
| Surface Inspection | Visual inspection under microscopy. | Met visual quality standards. | Micro Catheter met the acceptance criteria. |
| Corrosion Resistance | ISO 10555-1, Annex A. | No signs of corrosion. | Micro Catheter showed no signs of corrosion. |
| Peak Tensile Force/Bond Strength | Evaluated full system tensile force/bond strength. | Met minimum tensile strength requirement. | Micro Catheter met the acceptance criteria. |
| Liquid Leakage | ISO 10555-1, Annex C. | No leakage. | Micro Catheter showed no leakage. |
| Air Leakage | ISO 10555-1, Annex I. | No leakage. | Micro Catheter showed no leakage. |
| Hub Testing | ISO 80369-20. | Met hub standards. | Micro Catheter hub met the acceptance criteria. |
| Flowrate at Maximum Rated Infusion Pressure | Measured flow rate with saline, saline:contrast, contrast. | Met flow rate criteria; comparable to predicate. | Micro Catheter met the acceptance criteria. The mean flow rate values for the subject device and predicate device are comparable for the injectate media tested. |
| Dynamic Burst Pressure | ISO 10555-1, Annex G. | Met burst pressure criteria. | Micro Catheter met the acceptance criteria. |
| Static Burst Pressure | ISO 10555-1, Annex F. | Met burst pressure criteria. | Micro Catheter met the acceptance criteria. |
| Simulated Use | Evaluated in anatomical model for preparation, assembly, compatibility, trackability, lubricity, durability, kink resistance. | Met performance in simulated use. | Micro Catheter met the acceptance criteria. |
| Flexibility and Kink Test | Evaluated resistance to kinking in bends. | Met kink resistance criteria. | Micro Catheter met the acceptance criteria. |
| Torque Strength | Rotated in anatomical model with distal tip fixed; recorded rotations to failure. | Similar rotations to failure as cleared comparator. | Micro Catheter and a cleared comparator showed a similar number of rotations to failure. |
| Coating Integrity | Inspected pre- and post-simulated use. | Met coating integrity standards. | Micro Catheter met the acceptance criteria. |
| Coating Lubricity | Evaluated frictional forces on universal testing machine. | Similar frictional forces to predicate. | Micro Catheter and the predicate showed similar frictional forces. |
| Particulate Evaluation | Evaluated particulate generation during simulated use. | Similar particle numbers to predicate. | Micro Catheter and the predicate showed similar particle numbers. |
| Tip Stiffness | Distal tip deflected on universal testing machine. | Similar tip stiffness to cleared comparator. | Micro Catheter and a cleared comparator showed a similar tip stiffness. |
| Distal Tip Inspection | Inspected for defects. | Met defect criteria. | Distal tip met the acceptance criteria. |
| Tip Shapeability | Shaped using shaping mandrel. | Met shapeability criteria. | Distal tip met the acceptance criteria. |
| Lumen Collapse | Measured force to collapse catheter. | Similar forces to collapse catheter as predicate. | Micro Catheter and the predicate showed similar forces to collapse the catheter. |
| Compatibility tests | Inspected for damage post-simulated use with compatible interventional devices. | Met compatibility criteria. | Micro Catheter met the acceptance criteria. |
| Biocompatibility Testing | |||
| ISO MEM Elution Test | ISO 10993-5 | Reactivity grade ≤2. | Non-cytotoxic (reactivity grade of ≤2). |
| ISO Guinea Pig Maximization Sensitization Test | ISO 10993-10 | No evidence of delayed dermal contact sensitization. | Non-sensitizer. |
| Intracutaneous Reactivity Test in Rabbits | ISO 10993-23 | Differences between test and control mean scores |
§ 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).