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The SOFIA Distal Access Catheter is intended for general intravascular use, including the neuro and peripheral vasculature. It can be used to facilitate the introduction of diagnostic agents. It is not intended for use in coronary arteries.

Device Description

The SOFIA™ Distal Access Catheter is a single-lumen, flexible catheter designed with coil and braid reinforcement. The distal segment is steam-shapeable and it has a hydrophilic coating for navigation through the vasculature. The radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy. An introducer sheath and shaping mandrel are also provided.

AI/ML Overview

The provided document describes the SOFIA Distal Access Catheter and compares it to a predicate device (K131482). The submission aims to demonstrate substantial equivalence, not to prove clinical effectiveness or diagnostic accuracy in specific use cases as is common for AI/ML devices. Therefore, many of the requested criteria are not applicable, as this is a traditional medical device submission focused on bench testing and biocompatibility.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as pass/fail thresholds in a single table, but rather implied by the "Results" and "Conclusions" for each bench test and biocompatibility assessment. The reported device performance is outlined in the "Results" column.

Test Name	Acceptance Criteria (Implied)	Reported Device Performance (Results)
Bench Testing
Simulated Use	Device performs as intended under simulated use conditions.	Test articles achieved a rating ≥ 3 for preparation/ease of assembly, introducer sheath interaction, introducer peel away, tracking with guidewire/microcatheter, microcatheter/guidewire lockup, lubricity and durability of hydrophilic coating, microcatheter/guidewire removal. Removal/ aspiration of clot, mechanical clot retriever and stent delivery with no particles.
Equipment Interface	Device compatible with recommended accessories commonly used in intravascular procedures.	Test articles compatible with 0.035-inch and 0.038-inch guidewires, 6F or larger guide catheter/guiding sheath, common RHVs using insertion tool, stopcocks and ≤ 0.027-inch microcatheters.
Dimensional and Physical Attributes	Device meets established dimensional and physical specifications.	Test articles met the specified dimensional requirements for catheter OD, catheter ID, overall working length, length of distal section, length of distal tip to marker band and total length of hub/strain relief.
Kink Resistance	Device resistant to kinking around small radii turns.	No kinks at 1 cm, 4 cm, 12 cm and 25 cm from distal tip when wrapped around 0.025-inch and 0.030-inch pin gauges. No kinks noted during simulated use testing.
Tip Shapeability	Shapeability of distal tip after steam shaping equivalent to competitive devices.	Tip angle of test article equivalent to competitive devices after steam shaping using mandrel with an angle of approximately 90°.
Radio Detectability	Device radiopacity equivalent to or better than predicate and competitive devices.	Distal marker band visible under fluoroscopy.
Gauging (ISO 594-2)	Device hub meets the requirements of ISO 594-2.	Gauging pin and hub align in limit planes.
Separation Force (ISO 594-2)	Device hub meets the requirements of ISO 594-2 (separation force greater than 25 N).	Mating parts separation force greater than 25 N.
Unscrewing Torque (ISO 594-2)	Device hub meets the requirements of ISO 594-2 (luer remains attached after applying a torque not less than 0.02 Nm for a minimum of 10 seconds).	Test article luer remains attached after applying an unscrewing torque not less than 0.02 Nm for a minimum of 10 seconds.
Stress Cracking (ISO 594-2)	Device hub meets the requirements of ISO 594-2 (no stress cracks).	No stress cracks on test article hub.
Ease of Assembly (ISO 594-2)	Device hub meets the requirements of ISO 594-2 (components fit securely with no resistance).	Components fit together securely with no resistance observed between test article luer and reference fitting.
Resistance to Overriding (ISO 594-2)	Device hub meets the requirements of ISO 594-2 (luer does not override reference fitting threads).	Test article luer does not override reference fitting threads.
Durability/Lubricity of Hydrophilic Coating	Device tracks easily with no coating cracking or separation (achieved a rating ≥ 3).	Test article achieved a rating of ≥ 3 during simulated use testing for coating durability and lubricity.
Catheter Stiffness	Device tracks in tortuous anatomy while advancing to target site (stiffness equivalent to predicate and competitive devices).	Device stiffness equivalent to predicate and competitive devices.
Torque Strength	Device torque strength same as predicate device (no catheter breakage after 50 rotations).	No catheter breakage after 50 rotations.
Catheter Flexural Fatigue	Device integrity suitable for intended clinical use (no flexural fatigue).	No flexural fatigue following repeated bending during simulated use testing and repeated hoop stress following pressure and air aspiration testing.
Surface Contamination	Device integrity suitable for intended clinical use (free from surface contaminants, smooth distal tip, PTFE inner layer not delaminated).	Test article free from surface contaminants from uncured coating surface particulates > 0.02 mm², embedded particulates. Distal tip smooth and tapered. PTFE inner layer not delaminated.
Force at Break (Distal and Hub)	Tensile strength test results equivalent to predicate and competitive devices (catheter force at break ≥ 2.25 lbf for distal section and hub/catheter junction).	Catheter force at break ≥ 2.25 lbf for distal section and hub/catheter junction.
Flow Rate	Device meets specified requirements for delivery of diagnostic agents (flow rate at 100 psi and 300 psi with diagnostic agents equivalent to predicate device).	Flow rate at 100 psi and 300 psi with diagnostic agents (e.g., saline, contrast media) equivalent to predicate device.
Static Burst Pressure	Device integrity suitable for intended clinical use and met requirements of ISO 10555-1 (no damage at 46 psi).	No damage of pressurized catheter at 46 psi.
Fluid Leakage at > 46 psi	Device integrity suitable for intended clinical use and met requirements of ISO 10555-1 (no liquid leakage from hub and catheter shaft at 46 psi for 30 seconds).	No liquid leakage from hub and catheter shaft at 46 psi for 30 seconds.
Air Leakage	Device integrity suitable for intended clinical use and met requirements of ISO 10555-1 (no air leakage at hub into syringe for 15 seconds).	No air leakage at hub into syringe for 15 seconds.
Dynamic Burst	Device met labeled maximum infusion pressure of 300 psi (did not burst at or below 300 psi).	Test articles did not burst at or below 300 psi.
Particulate Test	Device met specifications for maximum allowable particles (less than 25 particles > 10 microns/ml, less than 3 particles > 25 microns/ml, no particles > 70 microns).	Less than 25 particles greater than 10 microns per ml volume and less than 3 particles greater than 25 microns per ml volume. No particles greater than 70 microns.
Biocompatibility
Cytotoxicity (ISO 10993-5) - MEM elution assay	Non-cytotoxic (cell culture treated with test article exhibits only slight reactivity, Grade 1).	Cell culture treated with test article exhibited slight reactivity (Grade 1).
Sensitization/Irritation (ISO 10993-10) - Guinea pig maximization sensitization	Weak allergic potential or sensitizing capacity (extracts elicited no reaction at challenge, 0% sensitization, Grade 1).	Extracts of the test article elicited no reaction at the challenge (0% sensitization) following the induction phase (Grade 1).
Sensitization/Irritation (ISO 10993-10) - Intracutaneous reactivity	Non-irritant (extracts did not show a significantly greater biological reaction than control sites).	Extracts of the test article did not show a significantly greater biological reaction than the sites injected with the control article.
Hemocompatibility – Rabbit Blood Direct and Indirect Contact (ISO 10993-4)	Non-hemolytic (hemolysis index

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