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 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.

AI/ML Overview

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.

Summary

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September 26, 2022

Eximo Medical Ltd. c/o James Welsh Director, Regulatory Affairs AngioDynamics 603 Queensbury Ave Queensburgy, New York 12804

Re: K220116

Trade/Device Name: Auryon Atherectomy Catheters Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: August 30, 2022 Received: August 30, 2022

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,

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

Enclosure

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Indications for Use

510(k) Number (if known) K220116

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™ Atherectory 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: September 22, 2022

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

510(k) Reference 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

K202835

K220116

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

Purpose

The purpose of this 510(k) is to introduce into commercial distribution four new catheter item codes for use with the existing Auryon Atherectomy System which will have a hydrophilic coating on the external distal portion of the catheter shaft. The size range, intended purpose, and Indications for Use will be the same as the existing Auryon Atherectomy Catheters.

Device Description

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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 "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.

Indications for 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 system.

DeviceComparison	Subject Device:Auryon™Atherectomy System(with Hydrophiliccoating)	PredicateDevice: AuryonAtherectomySystem(K202835)	Reference Device:Auryon™Atherectomy System(K221077)	ReferenceDevice:SpectraneticsTurbo-Elite LaserAtherectomyCatheters(K170059)
Indication for Use	The Auryon™Atherectomy Systemand AuryonAtherectomyCatheters with	The AuryonAtherectomySystem isintended for usein the	The Auryon™Atherectomy Systemand AuryonAtherectomyCatheters with	The Turbo-Elitedevices areindicated for usein the treatment,including
	aspiration areindicated for use asatherectomy devicesfor arterial stenoses,including in-stentrestenosis (ISR), andto aspirate thrombusadjacent to stenosesin native and stentedintra-inguinalarteries.The Auryon™Atherectomy Systemand AuryonAtherectomyCatheters withoutaspiration areindicated for use inthe treatment,includingatherectomy, ofintra-inguinalstenoses andocclusions.	treatment,includingatherectomy, ofintra-inguinalstenoses andocclusions,including in-stent restenosis(ISR).	aspiration areindicated for use asatherectomy devicesfor arterial stenoses,including in-stentrestenosis (ISR), andto aspirate thrombusadjacent to stenosesin native and stentedintra-inguinalarteries.The Auryon™Atherectomy Systemand AuryonAtherectomyCatheters withoutaspiration areindicated for use inthe treatment,includingatherectomy, ofintra-inguinalstenoses andocclusions.	atherectomy, ofinfrainguinalstenoses andocclusions.The 0.014" and0.018" Over-the-wire (OTW)Turbo-Elite lasercatheters are alsoindicated for useas an accessoryto the use of theTurbo-TandemSystem in thetreatment offemoropoplitealartery in-stentrestenosis (ISR) inbare nitinolstents, whenused inconjunction withPercutaneousTransluminalAngioplasty(PTA).
RegulationNumber	21 CFR §870.4875	21 CFR§870.4875	21 CFR §870.4875	21 CFR§870.4875
Regulatory Class	Class II	Class II	Class II	Class II
Product Code	MCW	MCW	MCW	MCW
Catheter sizes	0.9mm, 1.5mm,2.0mm, 2.35mm	0.9mm, 1.5mm,2.0mm, 2.35mm	0.9mm, 1.5mm,2.0mm, 2.35mm	0.9mm, 1.4mm1.7mm, 2.0mm,2.3mm, and2.5mm
Hydrophiliccoating	Yes, all sizes	No	No	Yes, all sizes
CatheterSterilizationMethod	Ethylene Oxide	Ethylene Oxide	Ethylene Oxide	Ethylene Oxide

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Comparison of Performance Data

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. The specific tests are listed below

Summary of Performance Testing

Catheter shaft ID, OD, working length, and length of hydrophilic coating Catheter trackability in simulated anatomical shape Freedom from leakage during liquid infusion, and air leakage during aspiration (2.0 and 2.35mm sizes) Pull testing of catheter tip and catheter to handle joints Freedom from exposed optical fibers Catheter torque test Optical Functionality test Coating Characterization Coating integrity and particulate generation after simulated use

Substantial Equivalence

Assessment of the similarities and differences of the proposed hydrophilic coated Auryon Atherectomy Catheters and the predicate Auryon Atherectomy System and the reference device Spectranetics Turbo-Elite Laser 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 devices have the same Intended Use;
The proposed and reference device K221077 have the same 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,
The proposed and predicate catheters employ an identical overall design, essentially identical materials of manufacture, performance testing, sizes, and configurations.
The proposed device and the reference device K170059 employ hydrophilic coatings that are similar in formulation, performance, and intended purpose (reduction of friction).

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).