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-inquinal arteries.

The Auryon ™ Atherectomy System and Auryon Atherectomy Catheters without aspiration are indicated for use in the treatment, including atherectomy, of infra-inquinal 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 mJ/mm2 to the occluded or narrowed artery. The laser delivers very short high intensity pulses which travel from the laser, through the fibers, and emerge from the polished ends of the individual fibers. As the UV light emerges from the fiber end, it will be absorbed by the fluid, and create a cavitation bubble within the fluid. The collapse of this bubble results in a photoacoustic shockwave that disintegrates rigid materials such as calcified lesions without relying on thermal degradation to break down the stenotic material.

The Auryon™ Atherectomy System must work over a commercially available guide wire that crosses the lesion intra-luminally. The catheters are available in seven configurations (0.9mm, 0.9mm, 1.5mm, 1.5mm XL, 1.7mm, 2.0mm and 2.35mm), with and without hydrophilic coating.

For the small size catheters (i.e., 0.9mm.1.5mm, and 1.7mm), there is a designated lumen tube for a guidewire at the center of the inner blunt blade. The 0.9mm, 1.5mm, and 1.7mm 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 is a 510(k) summary for the Auryon Atherectomy Catheter 1.7mm. It describes modifications to an existing device (K233668 Auryon™ Atherectomy System) by adding a new catheter size (1.7mm). The key aspect of this submission is demonstrating that the new 1.7mm catheter maintains substantial equivalence to the predicate device.

The document does not describe a study to prove medical device effectiveness or performance in a clinical setting against acceptance criteria for a diagnostic aid or an AI/ML-driven device. Instead, it details engineering and compatibility testing to ensure the new catheter size functions safely and effectively within the established parameters of the predicate device.

Given the nature of the document, the following points address the questions based on the provided information, indicating where the information is not available for a typical AI/ML-driven medical device evaluation:

Table of acceptance criteria and the reported device performance:

The document lists the types of tests performed for the new 1.7mm catheter to demonstrate it meets the same standards as the predicate device. However, it does not provide
a table with specific numerical acceptance criteria and reported performance values for each test. Instead, it states that the new catheter was tested "using the same methods and acceptance criteria as the predicate device."

Test Type	Acceptance Criteria (Not explicitly stated, assumed to be same as predicate)	Reported Device Performance (No specific data provided in this summary)
Catheter Shaft OD, ID, Working Length	Conformance to specifications	"The new 1.7mm Auryon Atherectomy System Catheter was tested using the same methods and acceptance criteria as the predicate device." (Implies successful conformance)
Guard Tube Length	Conformance to specifications	(Implies successful conformance)
Catheter Trackability (Simulated Use)	Safe and effective navigation in simulated vessels	(Implies successful conformance)
Shaft Pull Test	Strength and integrity	(Implies successful conformance)
Inner Blade Pull Test	Strength and integrity	(Implies successful conformance)
Proximal Section Pull Test	Strength and integrity	(Implies successful conformance)
Luer Pull vs Handle Pull Test	Secure connection	(Implies successful conformance)
Distal Tip Evaluation	Conformance to design and functionality	(Implies successful conformance)
Optical Functionality Test	Proper laser energy transmission	(Implies successful conformance)
Catheter Torque Strength	Resistance to twisting	(Implies successful conformance)
Fatigue Test	Durability over repeated use	(Implies successful conformance)
Catheter Optical Durability	Laser fiber integrity and performance	(Implies successful conformance)
Evaluation of Hydrophilic Coating	Adhesion, lubricity, and integrity	(Implies successful conformance)
Bioburden Determination	Sterility levels within acceptance	(Implies successful conformance per sterilization validation)
LAL Testing	Endotoxin levels within acceptance	(Implies successful conformance per sterilization validation)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This document focuses on engineering and performance testing of a physical device component (catheter), not a study involving patient data relevant to AI/ML. Therefore, typical "sample size for a test set" and "data provenance" as applied to clinical data or imagery are not applicable or detailed in this context. The testing would involve a sufficient number of manufactured units of the 1.7mm catheter to ensure statistical validity for each engineering test. The document does not specify these sample sizes.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. The ground truth for engineering tests like shaft pull or optical functionality is established by engineering specifications and physical measurements, not clinical expert consensus.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This concept pertains to clinical studies often involving multiple readers interpreting data or images.
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 is not an AI/ML-driven device or study.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML-driven device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the tests mentioned (e.g., Catheter Shaft OD, ID, Working Length, Shaft Pull Test, Optical Functionality Test, etc.) would be established by the device's engineering specifications, design requirements, and industry standards for atherectomy catheters. For sterilization, the ground truth is established by regulatory standards and validated protocols for bioburden and LAL testing.
The sample size for the training set:
Not applicable, as this is not an AI/ML device.
How the ground truth for the training set was established:
Not applicable, as this is not an AI/ML device.

In summary, this 510(k) pertains to an engineering modification of an existing medical device, not a new AI/ML-powered diagnostic or treatment device. The "study" described is a series of engineering and performance tests to ensure the new catheter size is substantially equivalent and performs as safely and effectively as the predicate device.

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). On the left is the Department of Health & Human Services logo. To the right of that 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 27, 2024

Eximo Medical, Ltd. Kasey Newcomb Manager, Regulatory Affairs AngioDynamics, Inc 603 Oueensbury Ave Queensbury, New York 12804

Re: K241553

Trade/Device Name: Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: May 31, 2024 Received: May 31, 2024

Dear Kasey Newcomb:

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.

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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).

Your device is also subject to, among other requirements, the Quality System (QS) 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,

Ariel G. Ash- Digitally signed by
Ariel G. Ash-shakoor -S
shakoor -S Date: 2024.06.27
15:37:25 -04'00'

For

Gregory O'Connell Assistant Director

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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

Submission Number (if known)

K241553

Device Name

Auryon Atherectomy Catheter 1.7mm;

Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating

Indications for Use (Describe)

The Auryon ™ Atherectomy System and Auryon Atherectomy Catheters without aspiration are indicated for use in the treatment, including atherectomy, of infra-inquinal 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 AURYON ATHERECTOMY SYSTEM

SPONSOR

Eximo Medical Ltd Pekeris St 3 Rehovot, Israel 7670203

CONTACT

Yoel Zabar	Kasey E Newcomb
Sr. Director, R&D & Site Manager	Manager, Global Regulatory Affairs
Eximo Medical Ltd.	AngioDynamics, Inc
Telephone: 972-8-6307639	Tel: 508.658.7813
Email: yoelz@eximomedical.com	Email: knewcomb@angiodynamics.com
DEVICE NAME

Auryon Atherectomy Catheter 1 7mm

Trade Name

Trade Name:	Auryon Atherectomy Catheter 1.7mm;Auryon Atherectomy Catheter 1.7mm with Hydrophilic Coating
Common/Usual Name:	Peripheral Atherectomy Catheter
Classification Name:	Intraluminal Artery Stripper(21 CFR § 870.4875, Class II, Pro-Code MCW)
Classification Panel:	Cardiovascular
PREDICATE DEVICE
510(k):	K233668
Trade Name:	Auryon™ Atherectomy System
Common/Usual Name:	Peripheral Atherectomy Catheter
Classification Name:	Intraluminal Artery Stripper(21 CFR § 870.4875, Class II, Pro-Code MCW)
Classification Panel:	Cardiovascular

DEVICE DESCRIPTION

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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.

INDICATION 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 TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEVICE

The proposed Auryon Atherectomy System is substantially equivalent to the predicate Auryon Atherectomy K233668. Both laser atherectomy devices have identical laser wavelength (355 nm), laser fluence levels (50 and 60 ml/mm²), pulse rate (40Hz), pulse duration (10-25ns), maximum output (33.5ml) and materials. The difference between the proposed device and predicate device is the addition of a 1.7mm catheter (1.75mm/0.069inch diameter) with a 150cm long working length. The 1.7mm catheter is offered both with and without a hydrophilic coating. The technological characteristic of the proposed device is substantially equivalent with the respect of the system design and function to that of the specified predicate device.

DEVICE MODIFICATIONS AND RISK ASSOCIATED WITH THE DESIGN MODIFICATION(S)

Modifications made to the Auryon Atherectomy System were limited to introducing a 1.7mm Catheter. There is no change to the principles of operations, indications for use, intended purpose, technology characteristics, between the proposed system and the predicate.

The impact of the change as described within this submission were evaluated a part of the Risk analysis activity in terms of new/existing risks and new/existing failure modes. The results of this Risk Analysis activity were compared to the current risk Analysis; the conclusion drawn from this assessment, determined that the additional catheter size did not impact or modify an existing risk nor necessitate a new or modified risk.

COMPARISON OF PERFORMANCE DATA

The new 1.7mm Aurvon Atherectomy System Catheter was tested using the same methods and acceptance criteria as the predicate device. Specific tests are listed below:

. Catheter Shaft OD, ID, Working Length
Guard Tube Length
Catheter Trackability (Simulated Use)
Shaft Pull Test
. Inner Blade Pull Test
Proximal Section Pull Test .
. Luer Pull vs Handle Pull Test
. Distal Tip Evaluation
Optical Functionality Test
Catheter Torque Strength
Fatigue Test
Catheter Optical Durability
Evaluation of Hydrophilic Coating ●

STERILIZATION VALIDATION

Both the proposed 1.7mm Auryon Atherectomy System Catheter and the predicate Auryon Atherectomy System Catheters will be sterilized via the same process. Sterilization Validation on the proposed 1.7mm Auryon Atherectomy System Catheter was conducted per the below:

Bioburden Determination ●
LAL Testing

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CONCLUSION

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 Pro-Code, 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 catheter size, 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).