(46 days)
The Instylla Microcatheter is intended for use in small vessel or super selective anatomy for peripheral diagnostic and interventional procedures. The Instylla Microcatheter can be used for the infusion of diagnostic, embolic, or therapeutic materials into vessels.
The Instylla Microcatheter device is a single lumen, multipurpose catheter intended for use in the peripheral vasculature. The basic operating principle is to advance the microcatheter through an outer guiding catheter and track coaxially over a steerable guidewire in order to access the treatment site. The microcatheter lumen is able to accommodate steerable guidewires that are ≤ 0.014 in (0.36 mm) in diameter. Once the target region has been accessed, the microcatheter can be used to deliver diagnostic, embolic, or therapeutic materials into vessels.
The Instylla Microcatheter has a 1.7Fr (0.56mm) OD with a constant flexibility along its length. The ID of the microcatheter is 0.016 in (0.41mm) along its length. The proximal end of the microcatheter incorporates a standard luer hub to enable the attachment of accessories, and a strain relief with a feature that allow for flexibility and securement inside a Tuohy-Borst adapter, for maintaining position inside a guiding catheter as needed. The Instylla Microcatheter has a radiopaque marker at the distal tip to aid in fluoroscopic visualization. A 4Fr Tuohy-Borst with side-port adapter, a short catheter extension and a long catheter extension adapter are also included. The Instylla Microcatheter is available in 122, 142 and 162 cm usable lengths.
The provided text describes Instylla, Inc.'s K191731 510(k) submission for their Instylla Microcatheter. The document outlines the device's characteristics, its comparison to predicate devices, and the performance and safety studies conducted to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text, while noting limitations in the information for certain requested points:
Acceptance Criteria and Device Performance for Instylla Microcatheter (K191731)
The acceptance criteria for the Instylla Microcatheter revolved around demonstrating substantial equivalence to a predicate device (CrossCath Support Catheter, K093052) through various performance benchmarks and safety assessments. Since this is a 510(k) submission, the "acceptance criteria" are implied by the comprehensive pre-clinical testing conducted to show that the device performs as safely and effectively as the predicate, and does not raise new questions of safety or effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
The text does not explicitly list numerical "acceptance criteria" values for each test, but it clearly states that the Instylla Microcatheter "met the predetermined acceptance criteria" for all tests and that "No new safety or performance issues were raised during testing."
Given the context of a 510(k), the implied acceptance criterion for each test is that the Instylla Microcatheter performs comparably to the predicate device or within recognized safety and effectiveness standards for such devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Visual Inspection of Components: Pass visual inspection. | Met specifications. |
| Dimensional Verification of Components: Meet specified dimensions. | Met specifications. |
| Trackability: Demonstrate effective navigation. | Met specifications. |
| Kink Resistance: Maintain lumen integrity under kinking stress. | Met specifications. |
| Pushability and Torqueability: Allow for controlled manipulation. | Met specifications. |
| Tip Radiopacity: Be visible under fluoroscopy. | Met specifications. |
| Fluid, Infusate, and Chemical Compatibility: Maintain integrity with various substances. | Met specifications. |
| Injection of Fluids (Flowrate) and Tip Stability: Deliver fluids effectively and stably. | Met specifications. |
| Freedom from Leakage: No leaks under specified pressure. | Met specifications. |
| Static Burst Pressure: Resist bursting at specified pressures. | Met specifications. |
| Catheter Shaft Tensile Strength: Withstand pulling forces. | Met specifications. |
| Microcatheter Compatibility with High Flow Microcatheters, Guidewires and Syringes: Ensure proper interface with accessories. | Met specifications. |
| Tuohy-Borst with Side-Port and Extension Accessory Compatibility and Functionality: Ensure proper interface with accessories. | Met specifications. |
| Biocompatibility: Pass ISO 10993-1 tests (Cytotoxicity, Sensitization, Irritation/Intracutaneous Toxicity, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, Hemolysis, Complement Activation Assay, Partial Thromboplastin Time, In Vivo Thromboresistance Jugular Vein). | Successfully completed all listed tests. |
| Sterility: Achieve SAL of 10^-6 via EO sterilization. | Achieved SAL of 10^-6. Endotoxin level |
§ 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).