(30 days)
Not Found
No
The summary describes a laser atherectomy system with different catheter configurations. There is no mention of AI or ML in the intended use, device description, or performance studies. The modifications are related to catheter length and diameter.
Yes
The device is indicated for use in the treatment of arterial stenoses, including in-stent restenosis (ISR), and to aspirate thrombus, which are all therapeutic interventions.
No
The device is indicated for atherectomy, which is a treatment procedure to remove plaque from arteries, and to aspirate thrombus. It is a therapeutic device, not a diagnostic one.
No
The device description clearly outlines hardware components including a single-use catheter with optic fibers and a laser console. The submission also details performance studies related to the physical characteristics and functionality of the catheter.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for atherectomy (removing plaque) and aspirating thrombus within arteries. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a physical catheter with a laser and aspiration capabilities designed to interact with and modify tissue within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This device is used for a therapeutic intervention within the body.
N/A
Intended Use / Indications for Use
The Auryon™ Atherectomy System and Auryon Atherectomy Catheters with aspiration are indicated for use as atherectory 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 ml/mm² to the occluded or narrowed artery.
The Auryon™ Atherectomy System must work over a commercially available 0.014" guide wire that crosses the lesion intra-luminally. The catheters are available in six configurations (0.9mm, 0.9mm XL, 1.5mm, 1.5mm XL, 2.0mm and 2.35mm), with and without 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.
The modification associated with this submission is to add a second catheter length (225cm) for the size 0.9 and 1.5 mm catheter sizes. The ID of the 0.9mm catheter is also increased slightly.
There are no changes to the Auryon Laser Console unit associated with this submission.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
arterial stenoses, native and stented infra-inguinal arteries, infra-inguinal stenoses and occlusions
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 0.9 mm XL and 1.5 mm XL Auryon Atherectomy System devices were tested using the same methods and acceptance criteria as was done in the predicate device 510(k). The specific tests are listed below:
- Catheter shaft ID, OD, and working length
- Catheter trackability in simulated anatomical shape
- Optical Functionality test
- Catheter torque test
- Catheter optical durability
- Validation that the longer catheters can be sterilized in the predicate device sterilization process
- O B&F testing
- O Bioburden recovery rate
- Bioburden determination O
- Comparison of natural product resistance to Biological Indicators O
- O EO Residuals
- LAL testing O
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 15, 2023
Eximo Medical, Ltd. % James Welsh Director, Regulatory Affairs AngioDynamics, Inc 603 Queensbury Ave Oueensbury. New York 12804
Re: K233668
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: November 15, 2023 Received: November 15, 2023
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 (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.
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).
1
Your device is also subject to, among other requirements, the Quality System (OS) 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,
Gregory W. O'connell -S Digitally signed by Gregory W. O'connell -S Date: 2023.12.15 09:41:19 -05'00
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
2
Indications for Use
510(k) Number (if known) K233668
Device Name Auryon™ Atherectomy System
Indications for Use (Describe)
The Auryon™ Atherectomy System and Auryon Atherectomy Catheters with aspiration are indicated for use as atherectory 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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3
510(k) Summary for the Eximo Medical Ltd. Auryon Atherectomy System
Date Prepared: December 14, 2023
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
- 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
K230709
Auryon™ 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 modification of the Auryon Atherectomy System previously cleared under predicate 510(k) K230709, specifically:
- addition of new longer size 1.5 mm catheters (225 cm vs the current 150 cm)
- addition of new longer size 0.9 mm catheters (225 cm vs the current 150 cm)
- a slight 0.001" increase in the ID of the 0.9 mm catheter
4
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 ml/mm² to the occluded or narrowed artery.
The Auryon™ Atherectomy System must work over a commercially available 0.014" guide wire that crosses the lesion intra-luminally. The catheters are available in six configurations (0.9mm, 0.9mm XL, 1.5mm, 1.5mm XL, 2.0mm and 2.35mm), with and without 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.
The modification associated with this submission is to add a second catheter length (225cm) for the size 0.9 and 1.5 mm catheter sizes. The ID of the 0.9mm catheter is also increased slightly.
There are no changes to the Auryon Laser Console unit associated with this submission.
Indications for Use/Intended 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.
5
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 Catheters.
| Device Comparison | Subject Device: Auryon
Atherectomy System | Predicate Device: Auryon
Atherectomy System (K230709) |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | 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. |
| 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 |
| Pulse Duration | 10-25 ns | 10-25 ns |
| Maximum output | 33.5 mJ | 33.5 mJ |
| Catheter sizes | 0.9mm, 1.5 mm, 2.0mm, 2.35mm,
0.9mm XL, 1.5mm XL | 0.9mm, 1.5 mm, 2.0mm, 2.35mm |
| Platinum/Iridium marker
band | Included in 0.9 mm and 0.9mm XL
catheters only | Included in 0.9 mm catheter only |
| Catheter Sterilization
Method | Ethylene Oxide | Ethylene Oxide |
6
Comparison of Performance Data
The new 0.9 mm XL and 1.5 mm XL Auryon Atherectomy System devices were 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 trackability in simulated anatomical shape ●
- Optical Functionality test
- Catheter torque test
- Catheter optical durability
- Validation that the longer catheters can be sterilized in the predicate device sterilization process .
- O B&F testing
- O Bioburden recovery rate
- Bioburden determination O
- Comparison of natural product resistance to Biological Indicators O
- O EO Residuals
- LAL testing O
- O B&F testing
Substantial Equivalence
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 ProCode, 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 longer catheter length options, 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.