Auryon Atherectomy Catheters

K220116 · Eximo Medical, Ltd. · MCW · Sep 26, 2022 · Cardiovascular

Device Facts

• Record ID: K220116
• Device Name: Auryon Atherectomy Catheters
• Applicant: Eximo Medical, Ltd.
• Product Code: MCW · Cardiovascular
• Decision Date: Sep 26, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4875
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Auryon Atherectomy System uses laser energy to treat arterial stenoses and occlusions. System consists of single-use catheters with optic fiber arrays and circumferential blunt blades at distal tips. Catheters connect to laser console, transmitting energy at 50 and 60 mJ/mm² to debulk lesions. Larger catheters (2.0mm, 2.35mm) include aspiration for debris/thrombus removal and eccentric guidewire lumens; 2.35mm model features 'off-center' capability for larger vessel debulking. Subject device adds hydrophilic coating to catheter shaft to reduce friction. Used in clinical settings by physicians; device tracks over 0.014" guidewires. Output is physical debulking of arterial plaque and thrombus aspiration, improving vessel patency. Benefits include minimally invasive treatment of peripheral artery disease and ISR.

Clinical Evidence

Bench testing only. Performance testing included catheter shaft dimensions, trackability in simulated anatomy, leakage testing (liquid/air), pull testing, optical functionality, and coating characterization (integrity and particulate generation). No clinical data presented.

Technological Characteristics

Single-use laser atherectomy catheters; optic fiber array with circumferential blunt blade. Sizes: 0.9mm, 1.5mm, 2.0mm, 2.35mm. Energy source: laser console (50-60 mJ/mm²). Features: hydrophilic coating, aspiration (2.0/2.35mm), eccentric guidewire lumen (2.0/2.35mm), off-center debulking (2.35mm). Sterilization: Ethylene Oxide. Connectivity: connects to Auryon laser console.

Indications for Use

Indicated for patients with infra-inguinal arterial stenoses and occlusions, including in-stent restenosis (ISR). Devices with aspiration are indicated for thrombus aspiration adjacent to stenoses in native and stented infra-inguinal arteries.

Regulatory Classification

Identification

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

Predicate Devices

• Auryon Atherectomy System (K202835)

Reference Devices

• Auryon Atherectomy System (K221077)
• Spectranetics Turbo-Elite Laser Atherectomy Catheters (K170059)

Submission Summary (Full Text)

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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 ([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) 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) | |
|--------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| <div> <span> <b> Prescription Use (Part 21 CFR 801 Subpart D) </b> </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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: [phone] Email: [e-mail]

#### 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

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

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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 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.

# Indications for Use

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.

## 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<br>Comparison | Subject Device:<br>Auryon™<br>Atherectomy System<br>(with Hydrophilic<br>coating) | Predicate<br>Device: Auryon<br>Atherectomy<br>System<br>(K202835) | Reference Device:<br>Auryon™<br>Atherectomy System<br>(K221077) | Reference<br>Device:<br>Spectranetics<br>Turbo-Elite Laser<br>Atherectomy<br>Catheters<br>(K170059) |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | The Auryon™<br>Atherectomy System<br>and Auryon<br>Atherectomy<br>Catheters with | The Auryon<br>Atherectomy<br>System is<br>intended for use<br>in the | The Auryon™<br>Atherectomy System<br>and Auryon<br>Atherectomy<br>Catheters with | The Turbo-Elite<br>devices are<br>indicated for use<br>in the treatment,<br>including |
| | aspiration are<br>indicated for use as<br>atherectomy devices<br>for arterial stenoses,<br>including in-stent<br>restenosis (ISR), and<br>to aspirate thrombus<br>adjacent to stenoses<br>in native and stented<br>intra-inguinal<br>arteries.<br>The Auryon™<br>Atherectomy System<br>and Auryon<br>Atherectomy<br>Catheters without<br>aspiration are<br>indicated for use in<br>the treatment,<br>including<br>atherectomy, of<br>intra-inguinal<br>stenoses and<br>occlusions. | treatment,<br>including<br>atherectomy, of<br>intra-inguinal<br>stenoses and<br>occlusions,<br>including in-<br>stent restenosis<br>(ISR). | aspiration are<br>indicated for use as<br>atherectomy devices<br>for arterial stenoses,<br>including in-stent<br>restenosis (ISR), and<br>to aspirate thrombus<br>adjacent to stenoses<br>in native and stented<br>intra-inguinal<br>arteries.<br>The Auryon™<br>Atherectomy System<br>and Auryon<br>Atherectomy<br>Catheters without<br>aspiration are<br>indicated for use in<br>the treatment,<br>including<br>atherectomy, of<br>intra-inguinal<br>stenoses and<br>occlusions. | atherectomy, of<br>infrainguinal<br>stenoses and<br>occlusions.<br>The 0.014" and<br>0.018" Over-the-<br>wire (OTW)<br>Turbo-Elite laser<br>catheters are also<br>indicated for use<br>as an accessory<br>to the use of the<br>Turbo-Tandem<br>System in the<br>treatment of<br>femoropopliteal<br>artery in-stent<br>restenosis (ISR) in<br>bare nitinol<br>stents, when<br>used in<br>conjunction with<br>Percutaneous<br>Transluminal<br>Angioplasty<br>(PTA). |
| Regulation<br>Number | 21 CFR §870.4875 | 21 CFR<br>§870.4875 | 21 CFR §870.4875 | 21 CFR<br>§870.4875 |
| Regulatory Class | Class II | Class II | Class II | Class II |
| Product Code | MCW | MCW | MCW | MCW |
| Catheter sizes | 0.9mm, 1.5mm,<br>2.0mm, 2.35mm | 0.9mm, 1.5mm,<br>2.0mm, 2.35mm | 0.9mm, 1.5mm,<br>2.0mm, 2.35mm | 0.9mm, 1.4mm<br>1.7mm, 2.0mm,<br>2.3mm, and<br>2.5mm |
| Hydrophilic<br>coating | Yes, all sizes | No | No | Yes, all sizes |
| Catheter<br>Sterilization<br>Method | 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.