(27 days)
The Auryon™ Atherectomy System and Auryon Atherectomy Catheters with aspiration are indicated for use as atherectomy devices for arterial stenoses, including in-stent restenosis (ISR), and to aspirate thrombus adjacent to stenoses in native and stented infra-inquinal arteries.
The Auryon ™ Atherectomy System and Auryon Atherectomy Catheters without aspiration are indicated for use in the treatment, including atherectomy, of infra-inquinal stenoses and occlusions.
The Auryon™ Atherectomy System consists of two sub-units: 1) a single use catheter ("Auryon catheter"); and 2) a laser console. The Auryon catheter is a single use catheter that is made of an array of optic fibers surrounded by a circumferential blunt blade at its distal tip. The Auryon™ catheter is connected to the laser system via its connector and transmits energy at pre-set fluence levels of 50 and 60 mJ/mm2 to the occluded or narrowed artery. The laser delivers very short high intensity pulses which travel from the laser, through the fibers, and emerge from the polished ends of the individual fibers. As the UV light emerges from the fiber end, it will be absorbed by the fluid, and create a cavitation bubble within the fluid. The collapse of this bubble results in a photoacoustic shockwave that disintegrates rigid materials such as calcified lesions without relying on thermal degradation to break down the stenotic material.
The Auryon™ Atherectomy System must work over a commercially available guide wire that crosses the lesion intra-luminally. The catheters are available in seven configurations (0.9mm, 0.9mm, 1.5mm, 1.5mm XL, 1.7mm, 2.0mm and 2.35mm), with and without hydrophilic coating.
For the small size catheters (i.e., 0.9mm.1.5mm, and 1.7mm), there is a designated lumen tube for a guidewire at the center of the inner blunt blade. The 0.9mm, 1.5mm, and 1.7mm catheters do not have an aspiration feature and have not been tested in ISR lesions.
The larger Auryon catheters (i.e., 2.0mm and 2.35mm) have an eccentric guidewire lumen and include additional features consisting of an aspiration feature (both catheters) and an "off-center" feature 2.35mm only. The aspiration feature is intended for debris and thrombus collection and removal from the vessel during the atherectomy procedure. These devices are also indicated for treatment of In-Stent Restenosis (ISR) lesions.
The "off-center" feature is included in the 2.35 mm catheter only and is designed to facilitate debulking of lesions in blood vessels beyond the catheter's diameter.
The provided text is a 510(k) summary for the Auryon Atherectomy Catheter 1.7mm. It describes modifications to an existing device (K233668 Auryon™ Atherectomy System) by adding a new catheter size (1.7mm). The key aspect of this submission is demonstrating that the new 1.7mm catheter maintains substantial equivalence to the predicate device.
The document does not describe a study to prove medical device effectiveness or performance in a clinical setting against acceptance criteria for a diagnostic aid or an AI/ML-driven device. Instead, it details engineering and compatibility testing to ensure the new catheter size functions safely and effectively within the established parameters of the predicate device.
Given the nature of the document, the following points address the questions based on the provided information, indicating where the information is not available for a typical AI/ML-driven medical device evaluation:
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Table of acceptance criteria and the reported device performance:
The document lists the types of tests performed for the new 1.7mm catheter to demonstrate it meets the same standards as the predicate device. However, it does not provide
a table with specific numerical acceptance criteria and reported performance values for each test. Instead, it states that the new catheter was tested "using the same methods and acceptance criteria as the predicate device."Test Type Acceptance Criteria (Not explicitly stated, assumed to be same as predicate) Reported Device Performance (No specific data provided in this summary) Catheter Shaft OD, ID, Working Length Conformance to specifications "The new 1.7mm Auryon Atherectomy System Catheter was tested using the same methods and acceptance criteria as the predicate device." (Implies successful conformance) Guard Tube Length Conformance to specifications (Implies successful conformance) Catheter Trackability (Simulated Use) Safe and effective navigation in simulated vessels (Implies successful conformance) Shaft Pull Test Strength and integrity (Implies successful conformance) Inner Blade Pull Test Strength and integrity (Implies successful conformance) Proximal Section Pull Test Strength and integrity (Implies successful conformance) Luer Pull vs Handle Pull Test Secure connection (Implies successful conformance) Distal Tip Evaluation Conformance to design and functionality (Implies successful conformance) Optical Functionality Test Proper laser energy transmission (Implies successful conformance) Catheter Torque Strength Resistance to twisting (Implies successful conformance) Fatigue Test Durability over repeated use (Implies successful conformance) Catheter Optical Durability Laser fiber integrity and performance (Implies successful conformance) Evaluation of Hydrophilic Coating Adhesion, lubricity, and integrity (Implies successful conformance) Bioburden Determination Sterility levels within acceptance (Implies successful conformance per sterilization validation) LAL Testing Endotoxin levels within acceptance (Implies successful conformance per sterilization validation) -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This document focuses on engineering and performance testing of a physical device component (catheter), not a study involving patient data relevant to AI/ML. Therefore, typical "sample size for a test set" and "data provenance" as applied to clinical data or imagery are not applicable or detailed in this context. The testing would involve a sufficient number of manufactured units of the 1.7mm catheter to ensure statistical validity for each engineering test. The document does not specify these sample sizes. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. The ground truth for engineering tests like shaft pull or optical functionality is established by engineering specifications and physical measurements, not clinical expert consensus. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This concept pertains to clinical studies often involving multiple readers interpreting data or images. -
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is not an AI/ML-driven device or study. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML-driven device. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the tests mentioned (e.g., Catheter Shaft OD, ID, Working Length, Shaft Pull Test, Optical Functionality Test, etc.) would be established by the device's engineering specifications, design requirements, and industry standards for atherectomy catheters. For sterilization, the ground truth is established by regulatory standards and validated protocols for bioburden and LAL testing. -
The sample size for the training set:
Not applicable, as this is not an AI/ML device. -
How the ground truth for the training set was established:
Not applicable, as this is not an AI/ML device.
In summary, this 510(k) pertains to an engineering modification of an existing medical device, not a new AI/ML-powered diagnostic or treatment device. The "study" described is a series of engineering and performance tests to ensure the new catheter size is substantially equivalent and performs as safely and effectively as the predicate device.
§ 870.4875 Intraluminal artery stripper.
(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).