FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The SOFIA Distal Access Catheter is intended for general intravascular use, including The GOT IA Dicture al vasculature. It can be used to facilitate the introduction of the nours and therapeutic 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 text describes a medical device, the SOFIA™ Distal Access Catheter, and its verification testing for 510(k) clearance. This submission does not include information about AI/ML models, therefore, many of the requested fields related to AI/ML studies cannot be answered. The information pertains to traditional medical device testing.

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1. Table of Acceptance Criteria and Reported Device Performance

Note: The document presents internal acceptance criteria implicitly through the "Results" and "Conclusions" sections of the verification tests. The "Conclusions" often state that the device "met established specifications" or "performs as intended," implying these were the acceptance criteria.

Test Category	Specific Test	Acceptance Criteria (Implied)	Reported Device Performance
Functional	Simulated Use	Achieves a rating ≥ 3 for various parameters (preparation, tracking, lubricity, etc.) with no particles after procedures like clot aspiration or stent delivery.	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	Compatible with 0.035-inch and 0.038-inch guidewires, 6F+ guide catheter/sheath, common RHVs, and ≤ 0.027-inch microcatheters.	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.
	Kink Resistance	No kinks at specified distances (1, 4, 12, 25 cm) when wrapped around pin gauges (0.025-inch, 0.030-inch) and during simulated use.	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	Tip angle equivalent to competitive devices after steam shaping with a ~90° mandrel.	Tip angle of test article equivalent to competitive devices after steam shaping using mandrel with an angle of approximately 90°.
	Radiodetectability	Distal marker band visible under fluoroscopy, equivalent to or better than predicate/competitive devices.	Distal marker band visible under fluoroscopy.
	Durability/Lubricity of Hydrophilic Coating	Achieves a rating of ≥ 3 during simulated use for coating durability and lubricity.	Test article achieved a rating of ≥ 3 during simulated use testing for coating durability and lubricity.
	Catheter Stiffness	Stiffness equivalent to predicate and competitive devices to track in tortuous anatomy.	Device stiffness equivalent to predicate and competitive devices.
	Torque Strength	No catheter breakage after 50 rotations.	No catheter breakage after 50 rotations.
	Catheter Flexural Fatigue	No flexural fatigue during repeated bending in simulated use and hoop stress testing.	No flexural fatigue following repeated bending during simulated use testing and repeated hoop stress following pressure and air aspiration testing.
	Flow Rate	Flow rate at 100 psi and 300 psi with diagnostic agents equivalent to or better than competitive devices.	Flow rate at 100 psi and 300 psi with diagnostic agents (e.g., saline, contrast media) equivalent to or better than competitive devices.
	Static Burst Pressure	No damage at 46 psi, meeting ISO 10555-1.	No damage of pressurized catheter at 46 psi.
	Fluid Leakage at > 46 psi	No liquid leakage from hub and catheter shaft at 46 psi for 30 seconds, meeting ISO 10555-1.	No liquid leakage from hub and catheter shaft at 46 psi for 30 seconds.
	Air Leakage	No air leakage at hub into syringe for 15 seconds, meeting ISO 10555-1.	No air leakage at hub into syringe for 15 seconds.
	Dynamic Burst	No burst at or below 300 psi, meeting labeled maximum infusion pressure.	Test articles did not burst at or below 300 psi.
Dimensional/Physical	Dimensional and Physical Attributes	Meets specified dimensional requirements for catheter OD, ID, lengths, etc.	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.
	Gauging (ISO 594-2)	Gauging pin and hub align in limit planes (meets ISO 594-2).	Gauging pin and hub align in limit planes.
	Separation Force (ISO 594-2)	Mating parts separation force greater than 25 N (meets ISO 594-2).	Mating parts separation force greater than 25 N.
	Unscrewing Torque (ISO 594-2)	Luer remains attached after applying ≥ 0.02 Nm for ≥ 10 seconds (meets ISO 594-2).	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)	No stress cracks on test article hub (meets ISO 594-2).	No stress cracks on test article hub.
	Ease of Assembly (ISO 594-2)	Components fit securely with no resistance (meets ISO 594-2).	Components fit together securely with no resistance observed between test article luer and reference fitting.
	Resistance to Overriding (ISO 594-2)	Luer does not override reference fitting threads (meets ISO 594-2).	Test article luer does not override reference fitting threads.
	Surface Contamination	Free from surface contaminants from uncured coating, particulates > 0.02 mm², embedded particulates. Distal tip smooth and tapered, PTFE 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)	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.
	Particulate Test	10 microns/mL, 70 microns.	Less than 25 particles greater than 10 microns per ml volume and less than 3 particles less than 25 microns per ml volume. No particles greater than 70 microns.
Biocompatibility	Cytotoxicity - MEM Elution Assay (ISO 10993-5)	Cell culture treated with test article exhibits slight reactivity (Grade 1) or less (non-cytotoxic).	Cell culture treated with test article exhibited slight reactivity (Grade 1).
	Sensitization/Irritation - Kligman Maximization Test (ISO 10993-10)	No reaction at challenge (0% sensitization) (weak allergic potential or sensitizing capacity).	Extracts of the test article elicited no reaction at the challenge (0% sensitization) following the induction phase (Grade 1).
	Sensitization/Irritation - Intracutaneous Injection Test (ISO 10993-10)	Extracts do not show significantly greater biological reaction than control sites (non-irritating).	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)	Hemolysis index low (e.g.,

Summary

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).