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The AXS Catalyst™ Distal Access Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The AXS Catalyst Distal Access Catheter is also indicated for use as a conduit for retrieval devices.

Device Description

The AXS Catalyst™ Distal Access Catheter is a sterile, single lumen, variable stiffness catheter designed for use in facilitating the insertion and guidance of appropriately sized interventional devices into the peripheral and neuro vascular system. The catheter shaft has a hydrophilic coating to reduce friction during use. The catheter includes a radiopaque marker on the distal end for angiographic visualization and a luer hub on the proximal end allowing attachments for flushing and aspiration. It is packaged with a Rotating Hemostastic Valve (RHV) and Tuohy Borst valve with sideport for flushing, insertion of catheters and aspiration. The peel away introducer sheaths are designed to protect the distal tip of the catheter during insertion into the RHV or Tuohy Borst.

AI/ML Overview

The medical device in question is the AXS Catalyst™ Distal Access Catheter.

Here's an analysis of its acceptance criteria and the studies that prove its compliance:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present acceptance criteria in a quantitative table format for all tests. Instead, it states conclusions for each test, indicating whether the device "meets acceptance criteria" or for biocompatibility, "PASS" and a conclusion.

Test Category	Specific Test	Acceptance Criteria (Implicit)	Reported Device Performance
Bench Performance	Dimensional Verification	Dimensions conform to specifications.	Dimensional verification meets acceptance criteria.
	Tip Configuration	Distal tip is smooth, rounded, tapered, or similarly finished to minimize trauma to vessels during use (per EN ISO 10555-1).	Tip configuration meets acceptance criteria.
	Surface Integrity	External surface is free from extraneous matter, process and surface defects, and drops of lubricant fluids.	Surface integrity meets acceptance criteria.
	Tip Buckling	Maximum force required to cause buckling is within specified limits.	Tip buckling meets acceptance criteria.
	Catheter lubricity and durability	Frictional force of the device sample when pulled between two clamped pads is within specified limits after 5 cycles. (Implied: acceptable lubricity and durability as per performance expectations).	Coating lubricity and durability meets acceptance criteria.
	Trackability	Peak tracking force through a neurovascular model over a microcatheter is within specified limits.	Track advance force meets acceptance criteria.
	Tensile Strength	Tensile force required to induce failure of fused joints, shaft junctions, and marker band is above specified minimums (based on EN ISO 10555-1).	Tensile strength meets acceptance criteria.
	Liquid Leak Resistance	Meets freedom from leakage-liquid leak requirement 4.7.1 of EN ISO 10555-1 and catheter hub meets liquid leakage requirement 4.2.1 of EN 1707 (no visible leaks at 300kPa for 30s).	Liquid leak resistance of catheter meets acceptance criteria.
	Air Leak Resistance	Meets freedom from leakage-air aspiration requirement 4.7.2 of EN ISO 10555-1 and catheter hub meets air leakage requirement 4.2.2 of EN 1707 (no air bubbles upon withdrawal of syringe plunger to 10cc mark for 15s).	Air leak resistance of catheter meets acceptance criteria.
	Catheter Torsional Bond Strength	Torque strength (number of rotations before failure) is above specified minimums.	Catheter torsional bond strength meets acceptance criteria.
	Flexural Fatigue	Catheter shaft shows no functional impact or degradation after specified number of cycles through a tortuous model.	Flexural fatigue meets acceptance criteria.
	Catheter Kink Radius	Kink radius at distal and specific mid-shaft joint sections is within acceptable limits.	Catheter kink radius meets acceptance criteria.
	Catheter Tip and Lumen Patency (Adjunctive Aspiration)	No tip or lumen collapse and tip integrity maintained during aspiration with a 60cc syringe in a simulated use model.	Catheter tip and lumen patency during adjunctive aspiration meets acceptance criteria.
	Catheter Tip and Lumen Patency (with retrieval device)	Ablility to deliver and withdraw retrieval device 3 times in a tortuous path without functional impact and integrity to the tip.	Catheter tip and lumen patency meets acceptance criteria.
	Chemical Compatibility	Visual and dimensional integrity of catheter maintained after exposure to saline, non-ionic, and ionic contrast liquids; inner lumen integrity maintained.	Chemical compatibility meets acceptance criteria.
	Hub Gauging	Catheter hub meets gauging requirement 4.1 of EN 1707.	Hub gauging meets acceptance criteria.
	Simulated Use	Performance design attributes are deemed acceptable through user evaluation in an in vitro flow model that replicates neurovasculature tortuosity, diameter, and location in simulated arterial circulation.	Simulated use meets acceptance criteria.
Biocompatibility	MEM Elution Cytotoxicity (ISO 10993-5)	No biological activity (e.g., Grade 0 cytotoxicity) in specified mammalian cells at 48 hours post exposure; suitability of test system confirmed by controls.	PASS: No cytotoxicity or cell lysis.
	Guinea Pig Maximization Sensitization (ISO 10993-10)	No reaction at challenge (0% sensitization) following induction phase with specified extracts.	PASS: No evidence of sensitization.
	Intracutaneous Reactivity (ISO 10993-10)	Test article sites do not show a significantly greater biological reaction than control sites (e.g., difference of overall mean score = 0.0).	PASS: Non-irritant.
	Acute Systemic Injection (ISO 10993-11)	Specified extracts do not induce a significantly greater biological reaction than control extracts in test animals (e.g., no mortality or systemic toxicity).	PASS: No mortality or evidence of systemic toxicity.
	Rabbit Pyrogen (ISO 10993-11)	No rabbit injected with test article extract shows an individual rise in temperature of 0.5°C or more.	PASS: Non-pyrogenic.
	Hemolysis Extract/Direct Contact Method (ISO 10993-4)	Hemolysis percentage is within acceptable limits (e.g., low percentage above negative control).	PASS: Non-hemolytic (0.17% above negative control via direct, 0.12% via indirect).
	In Vitro Hemocompatibility (ISO 10993-4)	Results for WBC, RBC, platelets, hematocrit, and hemoglobin are comparable to the Negative Control (e.g., within specific percentage ranges 89%-105%).	PASS. (Group 1: 89%-98%, Group 2: 97%-103%, Group 3: 100%-105%, Group 4: 98%-105%).
	Complement Activation (SC5b-9) (ISO 10993-4)	Concentration of SC5b-9 in test articles is not statistically higher than negative control; not considered potential activator of complement system.	PASS.
	Complement Activation (C3a) (ISO 10993-4)	Concentration of C3a in test articles is not statistically higher than negative control; not considered potential activator of complement system.	PASS.
	Partial Thromboplastin (PTT) (ISO 10993-4)	Clotting time of test sample is comparable to predicate sample and meets requirements of the test (e.g., considered minimal activators with clotting time >= 90.0% of Negative Control).	PASS. Results comparable to Negative Control. Test articles considered minimal activators with clotting time being 90.0% (catheter) and 92.1% (tubing) of the Negative Control and, therefore, met the requirements of the test.
Shelf Life/Sterility	Shelf Life Testing (Product and Packaging)	Meets established criteria for product and packaging integrity and functionality after 6 months.	Results met established criteria.
	Sterilization (Ethylene Oxide Residuals)	Ethylene Oxide residuals

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