(255 days)
No
The summary describes a laser atherectomy system and catheters with mechanical and optical features. There is no mention of AI or ML in the device description, intended use, or performance studies. The focus is on the physical characteristics and function of the device.
Yes
The device is indicated for use in the treatment of arterial stenoses and occlusions, which are therapeutic interventions.
No
The device is indicated for atherectomy and aspiration, which are therapeutic interventions to remove arterial stenoses and thrombus, not to diagnose them.
No
The device description clearly details physical components like catheters, optic fibers, a blunt blade, and a guidewire lumen. It also describes physical features like hydrophilic coating and aspiration features. The performance studies focus on physical characteristics and functionality of the catheter hardware. This is not a software-only device.
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) to treat arterial stenoses and aspirate thrombus. IVDs are used outside the body (in vitro) to examine specimens like blood, urine, or tissue to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details a catheter with optic fibers and a blunt blade designed to be inserted into arteries. This is consistent with an in-vivo device, not an in-vitro diagnostic.
- 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 device is an atherectomy system, which is a type of medical device used for removing plaque from arteries.
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 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
infra-inguinal arteries, infra-inguinal stenoses
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 hydrophilic coated Auryon Atherectomy 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:
- 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
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.
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 the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
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,
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) 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) | |
|---|---|
| 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: 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: +972-8-6307639 Email: yoelz@eximomedical.com
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
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
4
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
Comparison | Subject Device:
Auryon™
Atherectomy System
(with Hydrophilic
coating) | Predicate
Device: Auryon
Atherectomy
System
(K202835) | Reference Device:
Auryon™
Atherectomy System
(K221077) | Reference
Device:
Spectranetics
Turbo-Elite Laser
Atherectomy
Catheters
(K170059) |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | The Auryon™
Atherectomy System
and Auryon
Atherectomy
Catheters with | The Auryon
Atherectomy
System is
intended for use
in the | The Auryon™
Atherectomy System
and Auryon
Atherectomy
Catheters with | The Turbo-Elite
devices are
indicated for use
in the treatment,
including |
| | 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
intra-inguinal
arteries.
The Auryon™
Atherectomy System
and Auryon
Atherectomy
Catheters without
aspiration are
indicated for use in
the treatment,
including
atherectomy, of
intra-inguinal
stenoses and
occlusions. | treatment,
including
atherectomy, of
intra-inguinal
stenoses and
occlusions,
including in-
stent restenosis
(ISR). | 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
intra-inguinal
arteries.
The Auryon™
Atherectomy System
and Auryon
Atherectomy
Catheters without
aspiration are
indicated for use in
the treatment,
including
atherectomy, of
intra-inguinal
stenoses and
occlusions. | atherectomy, of
infrainguinal
stenoses and
occlusions.
The 0.014" and
0.018" Over-the-
wire (OTW)
Turbo-Elite laser
catheters are also
indicated for use
as an accessory
to the use of the
Turbo-Tandem
System in the
treatment of
femoropopliteal
artery in-stent
restenosis (ISR) in
bare nitinol
stents, when
used in
conjunction with
Percutaneous
Transluminal
Angioplasty
(PTA). |
| Regulation
Number | 21 CFR §870.4875 | 21 CFR
§870.4875 | 21 CFR §870.4875 | 21 CFR
§870.4875 |
| Regulatory Class | Class II | Class II | Class II | Class II |
| Product Code | MCW | MCW | MCW | MCW |
| Catheter sizes | 0.9mm, 1.5mm,
2.0mm, 2.35mm | 0.9mm, 1.5mm,
2.0mm, 2.35mm | 0.9mm, 1.5mm,
2.0mm, 2.35mm | 0.9mm, 1.4mm
1.7mm, 2.0mm,
2.3mm, and
2.5mm |
| Hydrophilic
coating | Yes, all sizes | No | No | Yes, all sizes |
| Catheter
Sterilization
Method | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
5
6
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.