(27 days)
Not Found
No
The device description focuses on the mechanical and optical aspects of a laser atherectomy system. There is no mention of AI, ML, or any computational processing that would suggest the use of these technologies. The performance studies listed are also focused on physical and functional characteristics, not algorithmic performance.
Yes
The device is indicated for atherectomy of arterial stenoses, including in-stent restenosis (ISR), and to aspirate thrombus. These are direct treatments for medical conditions, which falls under the definition of a therapeutic device.
No
The device is an atherectomy system designed for the treatment (removal) of arterial stenoses and aspiration of thrombus, which are therapeutic functions, not diagnostic ones.
No
The device description clearly outlines hardware components including a single-use catheter with optic fibers and a blunt blade, and a laser console. The performance studies also focus on physical characteristics and functionality of the hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Auryon™ Atherectomy System is a medical device used within the body (in vivo) to physically remove blockages (stenoses and occlusions) in arteries using a laser and aspiration. It directly interacts with the patient's anatomy.
- Lack of Sample Analysis: The description does not mention the analysis of any biological samples taken from the patient. The device's function is entirely focused on treating the blockage within the artery.
Therefore, the Auryon™ Atherectomy System is an interventional medical device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MCW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Native and stented infra-inguinal arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 ●
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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.
1
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
2
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
3
Indications for Use
Submission Number (if known)
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 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.
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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4
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
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.
5
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 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 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
6
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.