Auryon Atherectomy System

K202835 · Eximo Medical, Ltd. · MCW · Dec 2, 2020 · Cardiovascular

Device Facts

• Record ID: K202835
• Device Name: Auryon Atherectomy System
• Applicant: Eximo Medical, Ltd.
• Product Code: MCW · Cardiovascular
• Decision Date: Dec 2, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4875
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Auryon Atherectomy System consists of a single-use catheter and a laser system. Catheter features an array of optic fibers surrounded by a circumferential blunt blade at the distal tip. System transmits laser energy at pre-set fluence levels (50 and 60 mJ/mm²) to occluded or narrowed arteries to perform atherectomy. Operates over a 0.014" guidewire. Larger catheters (2.0mm, 2.35mm) include aspiration for debris/thrombus removal; 2.35mm model includes an 'off-center' feature for debulking beyond catheter diameter. Used in clinical settings by physicians to treat peripheral arterial disease. Laser energy facilitates lesion debulking, potentially improving blood flow and patient outcomes. System includes RFID for catheter identification and dynamic stabilization of laser output power.

Clinical Evidence

Bench testing only. Performance testing included catheter dimensions, trackability, leakage, pull testing, joint integrity, optical fiber exposure, torque, optical functionality, fatigue testing, electrical safety, EMC, and laser output power stabilization. All tests met pre-defined acceptance criteria.

Technological Characteristics

Nd:YAG laser source (355 nm wavelength). Catheter sizes: 0.9mm, 1.5mm, 2.0mm, 2.35mm. Materials include stainless steel tubing and optical fibers (70 µm diameter). Energy: 50-60 mJ/mm² fluence, 10-25 ns pulse duration, 40 Hz pulse rate. Sterilization: Ethylene Oxide. Features RFID for catheter identification and dynamic laser output power stabilization. Connectivity: Standalone system.

Indications for Use

Indicated for patients with infra-inguinal stenoses and occlusions, including in-stent restenosis (ISR).

Regulatory Classification

Identification

An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)

Predicate Devices

• B-Laser Atherectomy System (K181642)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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: [phone] Email: [e-mail]

#### 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 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.

## 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: Auryon<br>Atherectomy System | Predicate Device: B-Laser<br>Atherectomy System (K181642) |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use /<br>Intended Use | The Auryon Atherectomy System is<br>intended for use in the treatment,<br>including atherectomy, of infra-<br>inguinal stenoses and occlusions,<br>including in-stent restenosis (ISR). | The B-Laser Atherectomy System is<br>intended for use in the treatment,<br>including atherectomy, of infra-<br>inguinal stenoses and occlusions,<br>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 catheter<br>identification | Included | Not Present |
| Dynamic stabilization of<br>laser 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 catheter<br>70 µm all other sizes |
| Catheter Sterilization<br>Method | 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.