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 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 Auryon™ Atherectomy catheters are available in four sizes (0.9mm, 1.5mm, 2.0mm and 2.35mm):

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 "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

The provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria, as one would find for a software or AI-powered medical device. Instead, it is a 510(k) premarket notification for the Auryon™ Atherectomy System, a physical medical device.

The document describes Indication for Use for a medical device (Auryon™ Atherectomy System) and asserts its Substantial Equivalence to a predicate device, rather than providing details of an AI-based system's performance metrics against acceptance criteria.

The key points from the document regarding the device and its testing are:

Device: Auryon™ Atherectomy System (physical device, not AI/software)
Purpose of 510(k): To revise the Indications for Use for the existing device. No physical or software changes were made to the device itself.
Revised Indication: Specifically includes the ability for Auryon™ Atherectomy Catheters with aspiration to "aspirate thrombus adjacent to stenoses in native and stented infra-inguinal arteries."
Performance Testing for revised indication:
- Methodology: Fresh thrombus was created in simulated blood vessels and then removed using the Auryon™ Atherectomy System with aspiration.
- Efficacy Measurement: Thrombus removal efficacy was based on the weight of thrombus removed.
- Safety Measurement: Confirmation that emboli were not generated during thrombus removal was based on the absence of emboli in an in-line embolic protection device.
- Conclusion: This testing "confirmed that there are no new questions of safety or effectiveness" with the inclusion of thrombus removal in the Indications for Use.

Therefore, since the request is for details related to acceptance criteria and a study for an AI/software device, and the provided document is for a physical medical device and its updated indications for use, I cannot fulfill the request as specified. The document does not discuss:

A table of acceptance criteria and reported device performance (for AI/software).
Sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth for test set, training set sample size, or how ground truth was established for the training set.

These are all metrics and details relevant to AI/software validation, which are not present in this physical device 510(k) submission.

Summary

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June 9, 2022

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

Re: K221077

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: April 11, 2022 Received: April 12, 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.

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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 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 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.

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) K221077

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)
-------------------------------------------------

☑ 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: June 4, 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:

Reference Device

510(k) Reference Trade Name: Common Name: Regulation Number: Regulation Name: Regulatory Class: Product Code: Classification Panel:
K221077 Auryon™ Atherectomy System Peripheral Atherectomy Catheter 21CFR870.4875 Intraluminal Artery Stripper Class 2 MCW Cardiovascular Devices

K202835

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

K100462

Jetstream G3™ System, Jetstream G3™ L System Peripheral Atherectomy Catheter 21CFR870.4875 Intraluminal Artery Stripper Class 2 MCW Cardiovascular Devices

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Purpose

The purpose of this 510(k) is to revise the Indications for Use of the existing Auryon™ Atherectomy System. There are no physical changes to the device or software changes associated with the proposed change to the Indications for Use.

Device Description

The Auryon™ Atherectomy catheters are available in four sizes (0.9mm, 1.5mm, 2.0mm and 2.35mm):

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 "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.

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).

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.

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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 system.

Device Comparison	Subject Device: Auryon™ Atherectomy System	Predicate Device:Auryon™ Atherectomy System (K202835)	Reference Device:Jetstream G3 and G3L System (K100462)
Indication for Use	The Auryon™ Atherectomy System andAuryon Atherectomy Catheters with aspirationare indicated for use asatherectomy devices forarterial stenoses,including in-stentrestenosis (ISR), and toaspirate thrombusadjacent to stenoses innative and stented infra-inguinal arteries.The Auryon™ Atherectomy System andAuryon Atherectomy Catheters withoutaspiration are indicatedfor use in the treatment,including atherectomy, ofinfra-inguinal stenosesand occlusions.	The Auryon™ Atherectomy System isintended for use in thetreatment, includingatherectomy, of infra-inguinal stenoses andocclusions, including in-stent restenosis (ISR).	The Jetstream Systemis intended for use inatherectomy of theperipheral vasculatureand to break apart andremove thrombus fromthe upper and lowerextremity peripheralarteries. It is notintended for use incoronary, carotid, iliac,or renal vasculature.
Regulation Number	21 CFR §870.4875	21 CFR §870.4875	21 CFR §870.4875
Regulatory Class	Class II	Class II	Class II
Product Code	MCW	MCW	MCW
Catheter sizes	0.9mm, 1.5mm, 2.0mm,2.35mm	0.9mm, 1.5mm, 2.0mm,2.35mm	1.6 mm, 1.85 mm,2.1/3.0 mm,2.4/3.4 mm

In addition to the change in indications described above, this 510(k) also included the following list of Letter to File changes that have been implemented since the clearance of the predicate device.

As part of the tip polishing, a radius was added to the stainless steel outer blade.
For the 2.0 and 2.35 mm catheters sizes, minor dimensional changes were made to the stainless ● steel guidewire tube and the inner blade to improve the process for welding these two parts together.

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The process for forming groves in the surface of the inner blades of the 2.0 and 2.35 mm ● catheters was changed from machining to laser etching.
. The dimensions of the guidewire connecting tube of the 2.0 and 2.35 mm catheters was adjusted to eliminate the potential for an internal step within the guidewire lumen.
The allowed frequency tolerance for the RFID tag was reduced to reflect an improvement in the tag supplier's process.
The mechanism which imparts the off-centering behavior to the 2.35 mm catheter was changed from stainless steel to nitinol.
Within the laser console, a number of changes were made to improve manufacturability, reduce assembly costs, and improve mechanical robustness. None of these changes were to alter system behavior.
. Within the device software, improvements were made within the portions only accessible to service personnel.
Software improvements were made to decrease the potential for nuisance errors.
. Within the device software the operation of the mechanical shutter is linked to the activation of the foot pedal.

Comparison of Performance Data

The modification to the Indications for Use statement associated with this 510(k) submission does not require any changes to the physical devices or device software. The testing conducted was performed on the subject devices for the purpose of generating data in support of the inclusion of a specific reference to thrombus removal within the Indication for Use statement.

Summary of Performance Testing

Fresh thrombus was created in simulated blood vessels, and then removed using the Auryon™ Atherectomy System and Auryon™ Atherectomy Catheters with Aspiration. Removal efficacy was based upon weight of thrombus removed. Confirmation that emboli are not generated during thrombus removal was based upon the absence of emboli in an in-line embolic protection device.

Substantial Equivalence

This 510(k) submission is limited to a change in the Indications for Use statement. There are no physical or software changes associated with the change in the Indications for use. The vessel occlusions that may be encountered during an Atherectomy procedure often include fresh thrombus as well as varying levels of calcification. The change in the wording of the Indications for Use associated with this 510(k) represents a clarification that the Auryon™ Catheters with Aspiration will remove a range of thrombus including fresh thrombus as well as more organized vessel occlusions.

The sum of the information provided in this submission has led 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).