(68 days)
The Auryon Atherectomy System is intended for use in the treatment, including atherectomy, of infra-inguinal stenoses and occlusions, including in-stent restenosis (ISR).
The Auryon™ Atherectomy System consists of two sub-units: 1) a single use catheter ("Auryon catheter"); and 2) a laser system. The Auryon catheter is a single use catheter that is made of an array of optic fibers and 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 ml/mm² to the occluded or narrowed artery. The Auryon™ Atherectomy System must work over a commercially available 300cm 0.014" guide wire that crosses the lesion intra-luminally. For the small size catheters (i.e., 0.9mm and 1.5mm), there is a designated lumen tube for a guidewire at the center of the inner blunt blade. The 0.9mm and 1.5mm catheters do not have an aspiration feature and have not been tested in ISR lesions. These devices should not be used in ISR cases.
The larger B-Laser™ 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 "offcenter" feature 2.35mm only). The aspiration feature is intended for debris and thrombus collection and removal from the vessel during the atherectomy procedure.
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.
Here's an analysis of the provided text regarding the Auryon Atherectomy System, focusing on acceptance criteria and the study proving it meets them:
Device: Auryon Atherectomy System
1. Table of Acceptance Criteria and Reported Device Performance
The FDA clearance document (K202835) is for a modification to an already cleared device (B-Laser Atherectomy System, K181642). Therefore, the "acceptance criteria" for this submission are primarily focused on demonstrating that the modified device performs equivalently to the predicate device and that the changes do not raise new questions of safety or effectiveness. The document states: "The modified 1.5 mm Auryon Atheter was tested using the same methods and acceptance criteria as was done in the predicate device 510(k)."
Therefore, the acceptance criteria are not explicitly detailed as specific numerical thresholds in this document, but rather as successful completion of the listed tests to demonstrate equivalent performance to the predicate device.
| Acceptance Criteria Category | Reported Device Performance (as stated in the document) |
|---|---|
| Physical Dimensions & Integrity | |
| Catheter shaft ID, OD, and working length | Compliant (Implied, as no issues were raised and deemed substantially equivalent). |
| Catheter guard tube length | Compliant (Implied, as no issues were raised and deemed substantially equivalent). |
| Freedom from exposed optical fibers | Compliant (Implied, as no issues were raised and deemed substantially equivalent). |
| Mechanical Strength & Durability | |
| Freedom from leakage during liquid infusion | Compliant (Implied, as no issues were raised and deemed substantially equivalent). |
| Pull testing of all joints | Compliant (Implied, as no issues were raised and deemed substantially equivalent). |
| Catheter torque test | Compliant (Implied, as no issues were raised and deemed substantially equivalent). |
| Fatigue testing (ability to deliver maximum duration without | Compliant (Implied, as no issues were raised and deemed substantially equivalent). |
| Functional Performance | |
| Catheter trackability in simulated anatomical shape | Compliant (Implied, as no issues were raised and deemed substantially equivalent). |
| Optical Functionality test | Compliant (Implied, as no issues were raised and deemed substantially equivalent). |
| Laser output power stabilization performance | Compliant (Implied, as no issues were raised and deemed substantially equivalent). The device also includes "Dynamic stabilization of laser output power." |
| Electrical Safety & Compatibility | |
| Electrical safety and EMC testing | Compliant (Implied, as no issues were raised and deemed substantially equivalent). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific sample sizes (e.g., number of catheters tested) for each of the performance tests listed. Since this is a 510(k) for a modification (changing fiber diameter and subtle length differences in the 1.5mm catheter), the testing would likely involve a statistically appropriate number of units of the modified device to demonstrate equivalence, but this detail is not present in the provided text.
The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective). However, given that it's for regulatory submission, the testing would be conducted under controlled laboratory conditions, likely at the manufacturer's facility.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. The listed tests are primarily engineering and bench-top performance tests, not clinical studies requiring expert ground truth for diagnostic accuracy.
4. Adjudication Method for the Test Set
Not applicable, as the tests are primarily objective physical and functional performance assessments, not subjective interpretations requiring adjudication.
5. 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 device is not an AI diagnostic tool and does not involve human readers interpreting AI output. It is an atherectomy system (a physical medical device for removing plaque from arteries).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device.
7. The Type of Ground Truth Used
For the engineering and bench-top performance tests, the "ground truth" is typically defined by engineering specifications, international standards (e.g., ISO, ASTM), and the performance characteristics of the predicate device. For example, "trackability" would be assessed against a defined force or successful navigation through a simulated tortuous path. "Fatigue testing" would have a defined duration or cycles to be met without failure.
8. The Sample Size for the Training Set
Not applicable. This device does not have a "training set" in the context of machine learning or AI models. It is a physical medical device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. Refer to point 8.
§ 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).