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 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.

AI/ML Overview

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.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 9, 2023

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

Re: K230709

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: March 14, 2023 Received: March 14, 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 (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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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,

Ariel G. Ashshakoor -S

Digitally signed by Ariel G. Ash-shakoor -S Date: 2023.06.09 16:02:44 -04'00'

For

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

Enclosure

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Indications for Use

510(k) Number (if known) K230709

Device Name Auryon™ Atherectomy System

Indications for Use (Describe)

The Auryon™ Atherectomy System and Auryon Atherectomy Catheters with aspiration are indicated for use as atherectorny 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)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Eximo Medical Ltd. Auryon Atherectomy System, Special 510(k)

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

Date Prepared: April 13, 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

K220116

Auryon Atherectomy Catheters 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 slight modification of the Auryon Atherectomy Catheters previously cleared under predicate 510(k) K220116; specifically, to modify the design of the existing 0.9 mm catheter to add a platinum/iridium marker band near the tip of the catheter for enhanced radiographic image contrast.

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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.

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.

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 Catheters (K220116)
Indication for Use	The Auryon™ Atherectomy Systemand Auryon Atherectomy Catheterswith aspiration are indicated for useas atherectomy devices for arterial	The Auryon™ Atherectomy Systemand Auryon Atherectomy Catheterswith aspiration are indicated for useas atherectomy devices for arterial

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	stenoses, 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.	stenoses, 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(only size 0.9 impacted by change)	0.9mm, 1.5 mm, 2.0mm, 2.35mm
Platinum/Iridium markerband	Included in 0.9 mm catheter only	None
Catheter SterilizationMethod	Ethylene Oxide	Ethylene Oxide

Comparison of Performance Data

The modified 0.9 mm Auryon Atheter was 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 guard tube length Catheter trackability in simulated anatomical shape Freedom from leakage during liquid infusion Pull testing of all joints Freedom from exposed optical fibers Optical Functionality test Catheter torque test

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Summary of Performance Testing

Evaluation of the hydrophilic coating of the catheters

Substantial Equivalence

Assessment of the similarities and differences of the proposed Auryon Atherectomy System and the predicate Auryon Atherectomy Catheters 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 added Pt/Ir component, 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).