(68 days)
Not Found
No
The description focuses on the mechanical and laser-based operation of the device, with no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is described as "intended for use in the treatment, including atherectomy, of infra-inguinal stenoses and occlusions," which directly indicates a therapeutic purpose.
No
The device is an atherectomy system designed for the treatment (removal) of stenoses and occlusions using laser energy, not for diagnosing conditions.
No
The device description clearly outlines hardware components including a single-use catheter with optic fibers and a blunt blade, and a laser system. The performance studies also focus on hardware-related testing.
Based on the provided text, the Auryon Atherectomy System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the treatment of infra-inguinal stenoses and occlusions through atherectomy. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a system consisting of a catheter and a laser system designed to physically remove plaque and blockages from blood vessels. This is an interventional device.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing samples (blood, tissue, etc.) in vitro (outside the body) to provide diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Auryon Atherectomy System is a surgical/interventional device used for treatment.
N/A
Intended Use / Indications for 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).
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
infra-inguinal
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 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
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
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 and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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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3
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: +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
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.
4
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
Atherectomy System | Predicate Device: B-Laser
Atherectomy System (K181642) |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use /
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). | The B-Laser Atherectomy System is
intended for use in the treatment,
including atherectomy, of infra-
inguinal stenoses and occlusions,
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 |
5
| Pulse Duration | 10-25 ns | 10-25 ns |
|---|---|---|
| Maximum output | 33.5 mJ | 33.5 mJ |
| RFID for catheter | ||
| identification | Included | Not Present |
| Dynamic stabilization of | ||
| 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 |
| 70 µm all other sizes | ||
| Catheter Sterilization | ||
| 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.
6
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.