(255 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 Catheters are single use catheters 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 of the predicate device Auryon Atherectomy 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 Catheter must work over a commercially available 300cm 0.014" guide wire that crosses the lesion intra luminally. The new catheters which are the subject of this 510(k) include a hydrophilic coating on the external distal portion of the catheter shaft.
The predicate device Auryon Atherectomy Catheters are available in four sizes (0.9mm, 1.5mm, 2.0mm and 2.35mm, without hydrophilic coating. The subject device Auryon Atherectomy Catheters are available in the same four sizes (0.9mm, 1.5mm, 2.0mm and 2.35mm, but with a 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 provided text describes the substantial equivalence of the Auryon™ Atherectomy System (with hydrophilic coating) to its predicate device (Auryon Atherectomy System without hydrophilic coating) and a reference device (Spectranetics Turbo-Elite Laser Atherectomy Catheters). The focus of the submission is the addition of a hydrophilic coating to the catheter shaft.
Here's an analysis of the acceptance criteria and supporting studies, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implicit from "same methods and acceptance criteria as predicate") | Reported Device Performance (Implicit: Met acceptance criteria) |
|---|---|---|
| Catheter shaft ID, OD, working length, and length of hydrophilic coating | Same as or within specifications of predicate, with added hydrophilic coating length. | Tested and found acceptable (implicitly, by stating "were tested using the same methods and acceptance criteria as was done in the predicate device 510(k)"). |
| Catheter trackability in simulated anatomical shape | Equivalent to or better than predicate device. | Tested and found acceptable. |
| Freedom from leakage during liquid infusion, and air leakage during aspiration (2.0 and 2.35mm sizes) | No leakage. | Tested and found acceptable. |
| Pull testing of catheter tip and catheter to handle joints | Withstand specified tensile forces without failure. | Tested and found acceptable. |
| Freedom from exposed optical fibers | No exposed optical fibers. | Tested and found acceptable. |
| Catheter torque test | Withstand specified torque without damage or functional degradation. | Tested and found acceptable. |
| Optical Functionality test | Proper optical transmission and energy delivery. | Tested and found acceptable. |
| Coating Characterization | Hydrophilic properties as intended, equivalent to or better than reference device. | Demonstrated similarity in formulation, performance, and intended purpose (reduction of friction) to reference device K170059. |
| Coating integrity and particulate generation after simulated use | Maintain integrity and not generate excessive particulates. | Tested and found acceptable. |
Note: The document explicitly states, "The hydrophilic coated Auryon Atherectory Catheters were tested using the same methods and acceptance criteria as was done in the predicate device 510(k). In addition, coating performance was tested, with comparison to the performance of the reference device K170059." This implies that all listed tests met the established (but not explicitly detailed in this document) acceptance criteria that were used for the predicate device, and the coating performance was comparable to the reference.
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on the specific sample sizes used for each test. It mentions "performance testing" and "additional testing" without quantifying the number of devices or units tested. There is no information regarding data provenance (e.g., country of origin, retrospective or prospective data), as this is a premarket notification for a device, not a clinical study involving patient data. The tests described are bench and functional tests of the device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The studies described are engineering and performance tests of the device, not clinical studies requiring expert interpretation of patient data to establish ground truth.
4. Adjudication Method for the Test Set
This information is not applicable. The studies described are engineering and performance tests, not clinical evaluations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This submission focuses on the substantial equivalence of a medical device (atherectomy catheter) based on its physical and functional characteristics, particularly the addition of a hydrophilic coating, not on the comparative clinical effectiveness of an AI system with human readers.
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. The device in question is an atherectomy catheter, a physical medical instrument, not an algorithm or AI system.
7. The Type of Ground Truth Used
The ground truth for the performance testing was based on engineering specifications and established test methodologies from the predicate device and relevant industry standards. For coating performance, the ground truth involved comparison to the performance of a legally marketed reference device (Spectranetics Turbo-Elite Laser Atherectomy Catheters).
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set.
§ 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).