(87 days)
Not Found
No
The description focuses on the mechanical and optical components of the device and does not mention any AI or ML capabilities. The performance studies are based on physical and functional testing, not algorithmic performance.
Yes
The device is an atherectomy system used to treat arterial stenoses and occlusions, which are medical conditions, making it a therapeutic device.
No
The device is described as an "atherectomy device" used for treating arterial stenoses and occlusions by removing material, not for diagnosing conditions. While it has features like a marker band for radiographic contrast, this is for visualization during a therapeutic procedure, not for making a diagnosis.
No
The device description clearly outlines hardware components including a single-use catheter with optic fibers and a laser console. The submission also details physical modifications to the catheter and performance studies related to the hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used within the body (in vivo) for a therapeutic procedure (atherectomy and aspiration) on arteries. IVDs are used outside the body (in vitro) to examine specimens (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a catheter and a laser console designed to be inserted into arteries to treat blockages. This is consistent with an in-vivo therapeutic device, not an in-vitro diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, or any of the typical components or processes associated with in-vitro diagnostics.
The mention of "Radiographic image contrast" is related to the visibility of the device during the in-vivo procedure, not for analyzing an in-vitro sample.
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
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 300cm 0.014" guide wire that crosses the lesion intra-luminally. The catheters are available in four sizes (0.9mm, 1.5mm, 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 platinum/iridium marker band within the wall of the 0.9 mm coated and uncoated catheters adjacent to the existing stainless steel inner blade. This marker band will enhance the radiographic contrast of the device.
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
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 modified 0.9 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
Optical Functionality test
Catheter torque test
Evaluation of the hydrophilic coating of the catheters
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which 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 9, 2023
Eximo Medical Ltd. % James Welsh Director, Regulatory Affairs AngioDynamics 603 Oueensbury Ave Queensbury, New York 12804
Re: K230709
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: March 14, 2023 Received: March 14, 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 (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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ariel G. Ashshakoor -S
Digitally signed by Ariel G. Ash-shakoor -S Date: 2023.06.09 16:02:44 -04'00'
For
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230709
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™ 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) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Eximo Medical Ltd. Auryon Atherectomy System, Special 510(k)
510(k) Summary for the Eximo Medical Ltd. Auryon Atherectomy System
Date Prepared: April 13, 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
K220116
Auryon Atherectomy Catheters 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 Auryon Atherectomy Catheters previously cleared under predicate 510(k) K220116; specifically, to modify the design of the existing 0.9 mm catheter to add a platinum/iridium marker band near the tip of the catheter for enhanced radiographic image contrast.
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 300cm 0.014" guide wire that crosses the lesion intra-luminally. The catheters are available in four sizes (0.9mm, 1.5mm, 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 platinum/iridium marker band within the wall of the 0.9 mm coated and uncoated catheters adjacent to the existing stainless steel inner blade. This marker band will enhance the radiographic contrast of the device.
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.
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 Catheters (K220116) |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | The Auryon™ Atherectomy System
and Auryon Atherectomy Catheters
with aspiration are indicated for use
as atherectomy devices for arterial | The Auryon™ Atherectomy System
and Auryon Atherectomy Catheters
with aspiration are indicated for use
as atherectomy devices for arterial |
5
| | 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. | 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
(only size 0.9 impacted by change) | 0.9mm, 1.5 mm, 2.0mm, 2.35mm |
| Platinum/Iridium marker
band | Included in 0.9 mm catheter only | None |
| Catheter Sterilization
Method | Ethylene Oxide | Ethylene Oxide |
Comparison of Performance Data
The modified 0.9 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 Optical Functionality test Catheter torque test
6
Summary of Performance Testing
Evaluation of the hydrophilic coating of the catheters
Substantial Equivalence
Assessment of the similarities and differences of the proposed Auryon Atherectomy System and the predicate Auryon 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 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 added Pt/Ir component, 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.