(87 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-inguinal arteries.
The Auryon™ Atherectomy System and Auryon Atherectomy Catheters without aspiration are indicated for use in the treatment, including atherectomy, of infra-inguinal 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 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. The catheters are available in four sizes (0.9mm, 1.5mm, 2.0mm and 2.35mm), with and without hydrophilic coating.
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.
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 modification associated with this submission is to add a platinum/iridium marker band within the wall of the 0.9 mm coated and uncoated catheters adjacent to the existing stainless steel inner blade. This marker band will enhance the radiographic contrast of the device.
There are no changes to the Auryon Laser Console unit associated with this submission.
The provided text describes a 510(k) premarket notification for a medical device called the Auryon Atherectomy System. This submission is a "Special 510(k)" to introduce a slight modification to an already cleared device: adding a platinum/iridium marker band to the 0.9 mm catheter for enhanced radiographic image contrast.
The document states that the modified device was tested using the same methods and acceptance criteria as the predicate device (K220116). However, it does not explicitly state the acceptance criteria values nor the reported device performance for each criterion in numerical terms, only that the tests were conducted and support substantial equivalence. It also does not discuss any multi-reader multi-case (MRMC) comparative effectiveness studies, standalone algorithm performance, or details about training sets, as the modification is to a physical device for improved imaging, not an AI/ML algorithm.
Therefore, the following information is extracted based on what is available in the document, and where information is not present, it is explicitly stated.
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the modified 0.9 mm Auryon Atherectomy Catheter was tested using the "same methods and acceptance criteria as was done in the predicate device 510(k)." While the specific numerical acceptance criteria and reported device performance are not explicitly detailed in this document, the types of performance tests conducted are listed.
| Acceptance Criteria (Type of Test) | Reported Device Performance |
|---|---|
| Catheter shaft ID, OD, and working length | Not explicitly detailed, but implied to meet criteria |
| Catheter guard tube length | Not explicitly detailed, but implied to meet criteria |
| Catheter trackability in simulated anatomical shape | Not explicitly detailed, but implied to meet criteria |
| Freedom from leakage during liquid infusion | Not explicitly detailed, but implied to meet criteria |
| Pull testing of all joints | Not explicitly detailed, but implied to meet criteria |
| Freedom from exposed optical fibers | Not explicitly detailed, but implied to meet criteria |
| Optical Functionality test | Not explicitly detailed, but implied to meet criteria |
| Catheter torque test | Not explicitly detailed, but implied to meet criteria |
| Evaluation of the hydrophilic coating of the catheters | Not explicitly detailed, but implied to meet criteria |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only refers to "performance testing" of the modified catheter.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable/not provided as the device modification is physical (addition of a marker band) and the testing described relates to mechanical and functional performance, not diagnostic accuracy requiring expert ground truth establishment.
4. Adjudication Method for the Test Set
This information is not applicable/not provided as the testing primarily involves objective physical and functional measurements, not subjective interpretation requiring adjudication among experts.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done or described. The submission is for a physical modification of an atherectomy catheter, not an AI/ML diagnostic system. The improvement mentioned is enhanced radiographic contrast, which facilitates device visualization rather than directly improving human reader diagnostic accuracy in a comparative study involving AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm only) performance study was not done or described. This submission pertains to a physical medical device.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically used in AI/ML validation (e.g., expert consensus, pathology, outcomes data) is not applicable to the type of device modification and testing described in this document. The "tests" are for physical properties and functionality against predefined engineering specifications.
8. The Sample Size for the Training Set
This information is not applicable/not provided as the submission is for a physical medical device and does not involve AI/ML algorithms that require a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided as the submission is for a physical medical device and does not involve AI/ML algorithms that require a training set and corresponding ground truth.
§ 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).