The Auryon Atherectomy System is intended for use in the treatment, including atherectomy, of infra-inguinal stenoses and occlusions, including in-stent restenosis (ISR).

Device Description

The Auryon™ Atherectomy System consists of two sub-units: 1) a single use catheter ("Auryon catheter"); and 2) a laser system. The Auryon catheter is a single use catheter that is 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 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. 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. These devices should not be used in ISR cases.

The larger B-Laser™ 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 "offcenter" feature 2.35mm only). The aspiration feature is intended for debris and thrombus collection and removal from the vessel during the atherectomy procedure.

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

Here's an analysis of the provided text regarding the Auryon Atherectomy System, focusing on acceptance criteria and the study proving it meets them:

Device: Auryon Atherectomy System

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance document (K202835) is for a modification to an already cleared device (B-Laser Atherectomy System, K181642). Therefore, the "acceptance criteria" for this submission are primarily focused on demonstrating that the modified device performs equivalently to the predicate device and that the changes do not raise new questions of safety or effectiveness. The document states: "The modified 1.5 mm Auryon Atheter was tested using the same methods and acceptance criteria as was done in the predicate device 510(k)."

Therefore, the acceptance criteria are not explicitly detailed as specific numerical thresholds in this document, but rather as successful completion of the listed tests to demonstrate equivalent performance to the predicate device.

Acceptance Criteria Category	Reported Device Performance (as stated in the document)
Physical Dimensions & Integrity
Catheter shaft ID, OD, and working length	Compliant (Implied, as no issues were raised and deemed substantially equivalent).
Catheter guard tube length	Compliant (Implied, as no issues were raised and deemed substantially equivalent).
Freedom from exposed optical fibers	Compliant (Implied, as no issues were raised and deemed substantially equivalent).
Mechanical Strength & Durability
Freedom from leakage during liquid infusion	Compliant (Implied, as no issues were raised and deemed substantially equivalent).
Pull testing of all joints	Compliant (Implied, as no issues were raised and deemed substantially equivalent).
Catheter torque test	Compliant (Implied, as no issues were raised and deemed substantially equivalent).
Fatigue testing (ability to deliver maximum duration without	Compliant (Implied, as no issues were raised and deemed substantially equivalent).
Functional Performance
Catheter trackability in simulated anatomical shape	Compliant (Implied, as no issues were raised and deemed substantially equivalent).
Optical Functionality test	Compliant (Implied, as no issues were raised and deemed substantially equivalent).
Laser output power stabilization performance	Compliant (Implied, as no issues were raised and deemed substantially equivalent). The device also includes "Dynamic stabilization of laser output power."
Electrical Safety & Compatibility
Electrical safety and EMC testing	Compliant (Implied, as no issues were raised and deemed substantially equivalent).

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

The document does not provide specific sample sizes (e.g., number of catheters tested) for each of the performance tests listed. Since this is a 510(k) for a modification (changing fiber diameter and subtle length differences in the 1.5mm catheter), the testing would likely involve a statistically appropriate number of units of the modified device to demonstrate equivalence, but this detail is not present in the provided text.

The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective). However, given that it's for regulatory submission, the testing would be conducted under controlled laboratory conditions, likely at the manufacturer's facility.

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

This information is not provided. The listed tests are primarily engineering and bench-top performance tests, not clinical studies requiring expert ground truth for diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable, as the tests are primarily objective physical and functional performance assessments, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This device is not an AI diagnostic tool and does not involve human readers interpreting AI output. It is an atherectomy system (a physical medical device for removing plaque from arteries).

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

Not applicable. This is a physical medical device.

7. The Type of Ground Truth Used

For the engineering and bench-top performance tests, the "ground truth" is typically defined by engineering specifications, international standards (e.g., ISO, ASTM), and the performance characteristics of the predicate device. For example, "trackability" would be assessed against a defined force or successful navigation through a simulated tortuous path. "Fatigue testing" would have a defined duration or cycles to be met without failure.

8. The Sample Size for the Training Set

Not applicable. This device does not have a "training set" in the context of machine learning or AI models. It is a physical medical device.

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

Not applicable. Refer to point 8.

Summary

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

December 2, 2020

Eximo Medical Ltd. % James Welsh Director, RA AngioDynamics 603 Queensbury Avenue Queensbury, New York 12804

Re: K202835

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: October 29, 2020 Received: November 2, 2020

Dear Mr. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (QS) 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 medical devices and radiation-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) K202835

Device Name Auryon Atherectomy System

Indications for Use (Describe)

The Auryon Atherectomy System is intended for use in the treatment, including atherectomy, of infra-inguinal stenoses and occlusions, including in-stent restenosis (ISR).

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

Date Prepared: December 1, 2020

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

K181642

B-Laser 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 slight modification of the B-Laser Atherectomy System previously cleared under predicate 510(k) K181642; specifically, to modify the design of the existing 1.5 mm catheter to replace the current 100 µm diameter optical fibers with the same 70 µm diameter optical fibers that are in use for the other sizes (0.9 mm, 2.0mm, and 2.35mm) cleared via the predicate 510(k) K181642. In addition to the change in the diameter of the optical fibers, the length of the stainless steel tubing at the 1.5 mm catheter (the inner and outer blades) are slightly longer than for the predicate devce, without altering the overall length of the 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.

Indications for Use/Intended Use

The Auryon™ Atherectomy System is intended for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions, including in-stent restenosis (ISR).

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 B-Laser Atherectomy system.

Device Comparison	Subject Device: AuryonAtherectomy System	Predicate Device: B-LaserAtherectomy System (K181642)
Indication for Use /Intended Use	The Auryon Atherectomy System isintended for use in the treatment,including atherectomy, of infra-inguinal stenoses and occlusions,including in-stent restenosis (ISR).	The B-Laser Atherectomy System isintended for use in the treatment,including atherectomy, of infra-inguinal stenoses and occlusions,including in-stent restenosis (ISR).
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

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Pulse Duration	10-25 ns	10-25 ns
Maximum output	33.5 mJ	33.5 mJ
RFID for catheteridentification	Included	Not Present
Dynamic stabilization oflaser output power	Included	Not Present
Catheter sizes	0.9mm, 1.5 mm, 2.0mm, 2.35mm	0.9mm, 1.5 mm, 2.0mm, 2.35mm
Optical Fiber diameter	70 µm all sizes	100 µm for 1.5 mm catheter70 µm all other sizes
Catheter SterilizationMethod	Ethylene Oxide	Ethylene Oxide

Comparison of Performance Data

The modified 1.5 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 Catheter torque test Optical Functionality test Fatigue testing (the ability to deliver maximum duration without significant reduction in transmitted laser energy) Electrical safety and EMC testing Laser output power stabilization performance

Substantial Equivalence

Assessment of the similarities and differences of the proposed Auryon Atherectomy System and the predicate B-Laser Atherectomy Systems 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 and/or Intended Uses;
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 employ nearly identical overall design, materials of manufacture, performance testing, sizes, and configurations.

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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 and 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).