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.

Device Description

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 0.014" guide wire that crosses the lesion intra-luminally. The catheters are available in six configurations (0.9mm, 0.9mm XL, 1.5mm, 1.5mm XL, 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 second catheter length (225cm) for the size 0.9 and 1.5 mm catheter sizes. The ID of the 0.9mm catheter is also increased slightly.

There are no changes to the Auryon Laser Console unit associated with this submission.

AI/ML Overview

The provided text is a 510(k) Summary for the Auryon Atherectomy System. It describes a medical device, its intended use, and a comparison to a predicate device to demonstrate substantial equivalence for regulatory clearance. However, it does not contain information about acceptance criteria for a device's performance that would require a study with a test set, expert involvement, or specific statistical measures (like sensitivity, specificity, or effect sizes for human readers). Instead, it focuses on engineering and manufacturing performance testing related to the physical and functional aspects of the catheter sizes and manufacturing processes.

Therefore, I cannot fulfill the request for information related to "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance metrics of an AI/algorithm-based device. The document details the technical performance testing for a medical device (atherectomy system) where the "acceptance criteria" are related to physical dimensions, functionality, durability, and sterilization.

Here's how I can address the parts of your request based on the actual content of the document:

The document describes a 510(k) submission for the Auryon™ Atherectomy System, a medical device for treating arterial stenoses. The "study" described is a set of performance tests to demonstrate substantial equivalence to a predicate device, particularly for newly added longer catheter sizes and a slight ID increase.

The acceptance criteria are not broken out into a table with reported performance values in the level of detail requested (e.g., sensitivity, specificity) because this device is a physical atherectomy system, not an AI/algorithm with diagnostic performance metrics. The criteria are related to the physical and functional characteristics of the catheters. The document states that the new devices were tested "using the same methods and acceptance criteria as was done in the predicate device 510(k)." The implication is that the devices met these criteria, as substantial equivalence was concluded.

Here's the information extracted and interpreted based on the provided text, addressing your points where possible, and noting when the information is
not applicable (N/A) given the nature of the device and the content of the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance tests conducted, implying that the new device configurations met the established acceptance criteria, which were the same as those for the predicate device. Specific numerical acceptance values and test results are not provided in this summary document. The acceptance criteria are implicitly met for the device to be considered substantially equivalent.

Acceptance Criterion Category	Performance Test/Characteristic Assessed	Reported Device Performance (Implicitly Met)
Physical Dimensions	Catheter shaft ID, OD, and working length	Met predicate device specifications/tolerances for new longer sizes and slightly increased 0.9mm ID.
Mechanical Functionality	Catheter trackability in simulated anatomical shape	Demonstrated comparable trackability to predicate devices.
Optical Functionality	Optical Functionality test	Maintained optical performance characteristics.
Mechanical Durability	Catheter torque test	Demonstrated acceptable torque resistance.
Optical Durability	Catheter optical durability	Maintained optical integrity over its operational lifespan.
Sterilization Efficacy	Validation that longer catheters can be sterilized in predicate device sterilization process (O B&F testing, Bioburden recovery rate, Bioburden determination, Comparison of natural product resistance to Biological Indicators, EO Residuals, LAL testing)	Demonstrated that the sterilization process is effective and safe for the new catheter lengths, comparable to the predicate.

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

The document does not specify the sample sizes (e.g., number of catheters) used for each of the performance tests. The data provenance is implied to be from laboratory testing conducted by the manufacturer, Eximo Medical Ltd. The document does not indicate whether the data was retrospective or prospective in the clinical sense, as these are engineering and bench tests rather than clinical study data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This section is N/A. The "ground truth" for this type of device (an atherectomy system) is established through engineering specifications, material science, and functional performance benchmarks (e.g., does it fit through the artery, does it ablate tissue effectively, is it sterile) rather than expert interpretation of medical images or pathologies. There is no mention of external experts being used for "ground truth" in the context of diagnostic performance.

4. Adjudication Method for the Test Set

This section is N/A. Adjudication methods (like 2+1, 3+1) are common in clinical studies where human interpretation or consensus is required to establish ground truth for diagnostic accuracy, particularly with image-based AI. For the engineering and performance tests described, the "adjudication" would be through standard laboratory testing protocols and adherence to pre-defined passing criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This section is N/A. The device is an atherectomy system, not a diagnostic imaging AI. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to its type of evaluation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

This section is N/A. The device is a physical atherectomy system; it does not have a "standalone algorithm" in the diagnostic AI sense. Its performance is intrinsically linked to its use by a human operator in a medical procedure.

7. Type of Ground Truth Used

The "ground truth" for this device's evaluation is primarily based on:

Engineering Specifications: Defined dimensions, material properties, and functional requirements.
Bench Testing Standards: Established protocols for testing trackability, torque, optical function, and durability.
Sterilization Standards: Regulatory and industry standards for demonstrating product sterility and safety (e.g., bioburden, EO residuals, LAL testing).

There is no mention of expert consensus, pathology, or outcomes data being used to establish "ground truth" for the device's technical performance in this summary.

8. Sample Size for the Training Set

This section is N/A. This document describes the testing and clearance of a medical device (atherectomy system), not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of data used to train an algorithm.

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

This section is N/A for the same reason as point 8.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

December 15, 2023

Eximo Medical, Ltd. % James Welsh Director, Regulatory Affairs AngioDynamics, Inc 603 Queensbury Ave Oueensbury. New York 12804

Re: K233668

Trade/Device Name: Auryon™ Atherectomy System Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: November 15, 2023 Received: November 15, 2023

Dear James Welsh:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Gregory W. O'connell -S Digitally signed by Gregory W. O'connell -S Date: 2023.12.15 09:41:19 -05'00

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K233668

Device Name Auryon™ Atherectomy System

Indications for Use (Describe)

The Auryon™ Atherectomy System and Auryon Atherectomy Catheters with aspiration are indicated for use as atherectory 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.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary for the Eximo Medical Ltd. Auryon Atherectomy System

Date Prepared: December 14, 2023

Sponsor

Eximo Medical Ltd Pekeris St 3 Rehovot, Israel 7670203

Contact

Yoel Zabar Sr. Director, R&D & Site Manager Eximo Medical Ltd. Telephone: +972-8-6307639 Email: yoelz@eximomedical.com

Subject Device

Trade Name: Common Name: Regulation Number: Regulation Name: Regulatory Class: Product Code: Classification Panel:

Predicate Device

510(k) Reference Trade Name: Common Name: Regulation Number: Regulation Name: Regulatory Class: Product Code: Classification Panel:
Auryon™ Atherectomy System Peripheral Atherectomy Catheter 21CFR870.4875 Intraluminal Artery Stripper Class 2 MCW Cardiovascular Devices

K230709

Auryon™ Atherectomy System Peripheral Atherectomy Catheter 21CFR870.4875 Intraluminal Artery Stripper Class 2 MCW Cardiovascular Devices

Purpose

The purpose of this Special 510(k) is to introduce into commercial distribution a modification of the Auryon Atherectomy System previously cleared under predicate 510(k) K230709, specifically:

addition of new longer size 1.5 mm catheters (225 cm vs the current 150 cm)
addition of new longer size 0.9 mm catheters (225 cm vs the current 150 cm)
a slight 0.001" increase in the ID of the 0.9 mm catheter

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Device Description

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 second catheter length (225cm) for the size 0.9 and 1.5 mm catheter sizes. The ID of the 0.9mm catheter is also increased slightly.

There are no changes to the Auryon Laser Console unit associated with this submission.

Indications for Use/Intended Use

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.

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Comparison of Similarities and Differences in Technological Characteristics and Performance

As detailed below, the proposed Auryon Atherectomy System is Substantially Equivalent to the predicate device Auryon Atherectomy Catheters.

Device Comparison	Subject Device: AuryonAtherectomy System	Predicate Device: AuryonAtherectomy System (K230709)
Indication for Use	The Auryon™ Atherectomy Systemand Auryon Atherectomy Catheterswith aspiration are indicated for useas atherectomy devices for arterialstenoses, including in-stentrestenosis (ISR), and to aspiratethrombus adjacent to stenoses innative and stented infra-inguinalarteries.The Auryon™ Atherectomy Systemand Auryon Atherectomy Catheterswithout aspiration are indicated foruse in the treatment, includingatherectomy, of infra-inguinalstenoses and occlusions.	The Auryon™ Atherectomy Systemand Auryon Atherectomy Catheterswith aspiration are indicated for useas atherectomy devices for arterialstenoses, including in-stentrestenosis (ISR), and to aspiratethrombus adjacent to stenoses innative and stented infra-inguinalarteries.The Auryon™ Atherectomy Systemand Auryon Atherectomy Catheterswithout aspiration are indicated foruse in the treatment, includingatherectomy, of infra-inguinalstenoses and occlusions.
Regulation Number	21 CFR §870.4875	21 CFR §870.4875
Regulatory Class	Class II	Class II
Product Code	MCW	MCW
Active Medium	Nd:YAG	Nd:YAG
Laser Wavelength	355 nm	355 nm
Laser Fluence levels	50 and 60 mJ/mm²	50 and 60 mJ/mm²
Pulse Rate	40 Hz	40 Hz
Pulse Duration	10-25 ns	10-25 ns
Maximum output	33.5 mJ	33.5 mJ
Catheter sizes	0.9mm, 1.5 mm, 2.0mm, 2.35mm,0.9mm XL, 1.5mm XL	0.9mm, 1.5 mm, 2.0mm, 2.35mm
Platinum/Iridium markerband	Included in 0.9 mm and 0.9mm XLcatheters only	Included in 0.9 mm catheter only
Catheter SterilizationMethod	Ethylene Oxide	Ethylene Oxide

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Comparison of Performance Data

The new 0.9 mm XL and 1.5 mm XL Auryon Atherectomy System devices were tested using the same methods and acceptance criteria as was done in the predicate device 510(k). The specific tests are listed below

Summary of Performance Testing

Catheter shaft ID, OD, and working length
Catheter trackability in simulated anatomical shape ●
Optical Functionality test
Catheter torque test
Catheter optical durability
Validation that the longer catheters can be sterilized in the predicate device sterilization process .
- O B&F testing
  - O Bioburden recovery rate
  - Bioburden determination O
  - Comparison of natural product resistance to Biological Indicators O
  - O EO Residuals
  - LAL testing O

Substantial Equivalence

Assessment of the similarities and differences of the proposed Auryon Atherectomy System and the predicate Auryon Atherectomy System concludes that the devices are substantially equivalent to one another; specifically:

. The proposed and predicate device have the identical ProCode, Regulation Number, Regulation Name, and Regulatory Class;
. The proposed and predicate device have identical Indications for Use;
The proposed and predicate devices incorporate the identical operating principle, mechanism of action, and are intended for the same patient populations; and,
With the exception of the newly added longer catheter length options, the proposed and predicate employ an identical overall design, materials of manufacture, performance testing, sizes, and configurations.

The sum of these evaluations and determinations lead Eximo Medical Ltd. to conclude that substantial equivalence has been demonstrated, and that the existing data and additional testing have confirmed that there are no new questions of safety or effectiveness.

Regulation Number and Section

§ 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).