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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

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.

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The NES Reprocessed 0.9mm Turbo-Elite Laser Atherectomy Catheter (0.014" guidewire compatible and over-the-wire configuration) is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions.

The 0.014" Over-the-wire (OTW) Turbo-Elite laser catheters are also indicated for use as an accessory to the use of the Turbo-Tandem System in the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nutinol stents, when used in conjunction with Percutaneous Transluminal Angioplasty (PTA).

The NES Reprocessed Spectranetics Turbo-Elite Laser Catheters are percutaneous intravascular devices constructed of multiple optical fibers arranged around a guidewire lumen. Catheter sizing identification is printed on the catheters.

For NES Reprocessed Spectranetics Turbo-Elite Laser Catheters, Over-The-Wire (OTW) catheters, a Luer adapter located at the proximal end of the usable length facilitates the use of the laser catheter over the appropriately sized guidewire.

This document describes the NES Reprocessed 0.9mm Turbo-Elite Laser Atherectomy Catheter and its substantial equivalence to a predicate device, focusing on functional and safety testing rather than an AI/ML device. Therefore, many standard questions about acceptance criteria and studies for AI/ML devices (e.g., sample sizes for test/training sets, expert consensus, MRMC studies) are not applicable in this context.

However, I can extract the acceptance criteria and the type of studies performed to demonstrate the device's safety and effectiveness.

1. Table of Acceptance Criteria (from the perspective of a reprocessed medical device) and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

This information is not provided in the given text. For a reprocessed medical device, the "test set" would typically refer to the number of devices subjected to each specific functional and safety test (e.g., how many catheters were used for cleaning validation, how many for tissue ablation testing, etc.) and the number of reprocessing cycles they underwent. The provenance would be the manufacturing facility of Northeast Scientific, Inc., and the studies would be prospective bench and laboratory tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

This is not applicable as the document describes a physical medical device, not an AI/ML algorithm requiring expert interpretation to establish ground truth. The "ground truth" for this device is established through physical and chemical measurements, functional performance, and biological safety testing against established standards.

4. Adjudication Method for the Test Set:

This is not applicable for a physical medical device. Decisions are based on objective measurements and compliance with predetermined specifications and regulatory standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI algorithms where human reader performance is being evaluated with and without AI assistance. This document describes a physical laser atherectomy catheter.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This is not applicable. The device is a physical catheter, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for this reprocessed device is established through:

• Engineering specifications and design requirements: For dimensional checks, mechanical characteristics, and system compatibility.
• Chemical and microbiological standards: For cleaning, sterilization, and biocompatibility validations.
• Performance metrics: For hydrophilic coating efficacy, solarization, and tissue ablation effectiveness, compared against the original predicate device's performance or established clinical benchmarks.
• Regulatory standards: All testing is performed to meet FDA and international standards for medical devices.

8. The Sample Size for the Training Set:

This is not applicable as the document is for a physical medical device, not an AI/ML algorithm. There is no "training set" in the context of reprocessed medical devices; rather, there are manufacturing and process validation runs.

9. How the Ground Truth for the Training Set Was Established:

This is not applicable. As mentioned above, there is no "training set" for this type of device. The ground truth for validating the reprocessing process and the final device's performance is based on established engineering principles, scientific standards, and regulatory requirements specific to medical device manufacturing and reprocessing.

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