Tigereye ST CTO-Crossing Catheter
Device Facts
| Record ID | K230594 |
|---|---|
| Device Name | Tigereye ST CTO-Crossing Catheter |
| Applicant | Avinger, Inc. |
| Product Code | PDU · Cardiovascular |
| Decision Date | Apr 25, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1250 |
| Device Class | Class 2 |
Indications for Use
The Tigereye ST System is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen and wall structures.
Device Story
Tigereye ST is a 5 French, 140 cm coaxial catheter for crossing peripheral chronic total occlusions (CTOs). System includes catheter, Lightbox Imaging Console, and Sled. Catheter features rotating tip and optical fiber for real-time OCT imaging. Operated in cardiac catheter labs or hospital settings by physicians. Input: near-infrared light for OCT imaging. Transformation: rotating tip dissects occlusive tissue; cannula compresses tissue to create channel. Output: real-time OCT images of vessel lumen/wall structures displayed on console. Adjunct to fluoroscopy; provides visual guidance for guidewire placement. Benefits: facilitates intraluminal crossing of CTOs, improving procedural success in peripheral interventions.
Clinical Evidence
No clinical data. Substantial equivalence demonstrated through bench testing, including biocompatibility (ISO 10993-1), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and comprehensive mechanical performance testing (e.g., life cycle, tensile strength, torque, OCT image generation).
Technological Characteristics
5 Fr coaxial catheter; 140 cm length. Near-infrared OCT imaging (Class 1 laser, <30 mW). Rotating tip with spiral flutes (inner) and 3 longitudinal flutes (outer support). Biocompatible materials per ISO 10993. Sterilized via e-beam. Electrical safety: Class I, Type CF, defibrillation proof (IEC 60601-1). Connectivity: Lightbox console interface.
Indications for Use
Indicated for patients with stenotic lesions, including sub-total and chronic total occlusions (CTOs), in the peripheral vasculature requiring guidewire placement. Contraindicated for use in iliac, coronary, cerebral, renal, or carotid vasculature.
Regulatory Classification
Identification
A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.
Predicate Devices
- Tigereye CTO-Crossing Catheter (K201330)
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there 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.
April 25, 2023
Avinger, Inc. Thomas Lawson VP. Clinical & Regulatory Affairs 400 Chesapeake Drive Redwood City, California 94063
Re: K230594
Trade/Device Name: Tigereye ST CTO-Crossing Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PDU, NQQ Dated: March 2, 2023 Received: March 3, 2023
Dear Thomas Lawson:
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. Ash- Digitally signed by Ariel G. Ash-shakoor -S shakoor -S Date: 2023.04.25 15:02:22 -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 Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
### Indications for Use
510(k) Number (if known) K230594
#### Device Name
Tigereye ST CTO-crossing Catheter
#### Indications for Use (Describe)
The Tigereye ST System is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions) in the perior to further percutaneous intervention using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen and wall structures.
| Type of Use (Select one or both, as applicable) | <span> <span style="text-decoration: underline;">Prescription Use</span> (Part 21 CFR 801 Subpart D) </span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.***
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
*PRAStaff@fda.hhs.gov*
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
{3}------------------------------------------------
# 510(k) SUMMARY
## General Information
| Submitter | Avinger, Inc. | |
|-------------------------|---------------------------------------------------|--|
| Address | 400 Chesapeake Drive<br>Redwood City, CA 94063 | |
| FDA Registration Number | 3007498664 | |
| Correspondence Person | Thomas Lawson, PhD | |
| | VP, Clinical & Regulatory Affairs<br>Avinger Inc. | |
| Contact Information | Email: tlawson@avinger.com | |
| | Phone: 510-206-1794 | |
| Date Prepared | 25 April 2023 | |
### Proposed Device
| Trade Name | Tigereye ST CTO-Crossing Catheter |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Tigereye ST |
| Regulation Number and<br>Classification Name | 21 CFR§870.1250, Catheter for Crossing Total<br>Occlusions<br>21 CFR§892.1560, Imaging System Optical Coherence<br>Tomography (OCT) |
| Product Code | PDU, NQQ |
| Regulatory Class | II |
## Predicate Device
| Trade Name | Tigereye CTO-Crossing Catheter |
|------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Tigereye |
| Premarket Notification | K201330 |
| Regulation Number and<br>Classification Name | 21 CFR§870.1250, Catheter for Crossing Total<br>Occlusions<br>21 CFR§892.1560, Imaging System Optical Coherence<br>Tomography (OCT) |
| Product Code | PDU, NQQ |
| Regulatory Class | II |
| Note: This predicate device has not been subject to a design-related recall. | |
{4}------------------------------------------------
#### Device Description and Proposed Modifications
The Tigereye ST System combines the use of Avinger's optical coherence tomography (OCT) technology with peripheral vascular chronic total occlusion (CTO) crossing capabilities. The Tigereye ST System consists of the Tigereye ST CTO-crossing catheter, a Lightbox Sled with integrated umbilical (referred to as "Sled"), and the Lightbox Imaging Console (referred to as "Lightbox").
The subject device of this submission is a product improvement of the Tigereye CTOcrossing System reviewed and cleared earlier under K201330.
The Tigereye ST CTO-crossing catheter is a coaxial 5 French device with a working length of 140 cm. It is comprised of two components-an outer support catheter and an inner assembly or drive shaft. It is provided sterile and is a single-use device compatible with 5 Fr vascular sheaths. The Tigereye ST CTO-crossing head incorporates an optical fiber that allows real-time diagnosis of vessel condition and morphology as well as OCTguided CTO crossing during the procedure with its connection to an optical Sled and Lightbox. The software of the Lightbox has been not been updated since the version that was reviewed and cleared under K212468.
The Tigereye ST catheter is to be used in a healthcare facility, such as a cardiac catheter lab or a hospital. It is to be used and in contact with patient tissue for less than 24 hours and is made of materials that are biocompatible.
This Traditional 510(k) builds on the Tigereye CTO-crossing catheter (K201330) and details additional minor modifications to the design of the Ocelot catheter family to add in functionality of the device.
#### Indications for Use
The indication for use for the Tigereye ST CTO-crossing catheter is:
The Tigereye ST System is intended to facilitate the intraluminal placement of conventional guidewires bevond stenotic lesions (including sub and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen and wall structures.
Both the subject device and the predicate device have the exact same intended use of the crossing of chronic total occlusions in order to facilitate placement of guidewires in the peripheral vasculature. The subject device and predicate device have a slight difference in
{5}------------------------------------------------
materials and use the same packaging.
#### Comparison of Technological Characteristics with the Predicate Devices
Avinger Inc. has identified the Tigereye CTO-crossing catheter (K201330) as the predicate device for the Tigereye ST CTO-crossing catheter.
The Tigereye ST CTO-crossing catheter is substantially equivalent to the predicate device based upon the following similarities:
Similarities of Tigereye ST and Tigereye catheters:
- · Both devices are intended to be used to cross chronic total occlusions (CTOs) in peripheral vessels;
- · Both devices are used in cardiac catheter labs in either a hospital or an officebased lab;
- · Both devices are advanced to the target occlusion through an indwelling vascular sheath:
- Advancement of the both devices is monitored by external fluoroscopy and intravascular OCT imaging;
- · Both devices consist of a rotating tip that actively engages the occlusive tissue causing dissection of the tissue on multiple planes, a cannula that creates and sustains a channel through the tissue by compressing the tissue, and a power source to cause the device tip to move the occluding tissue aside;
- · Both devices create a channel through the occlusion to facilitate advancement of guidewires and other tools as needed for treatment of the patient; and
- · Both devices have equivalent sizes in terms of outer diameter and working length of the cannula.
Comparison of the Tigereye ST CTO-crossing catheter to the predicate device, the Tigereve CTO-crossing catheter.
| | Predicate Device | Subject Device |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Tigereye System<br>5 French<br>(Avinger, Inc.)<br><br>K201330 | Tigereye ST System<br>5 French<br>(Avinger, Inc.)<br>(This Submission) |
| Indication for<br>Use | The Tigereye System is<br>intended to facilitate the<br>intraluminal placement of | Same |
| | | |
| | conventional guidewires<br>beyond stenotic lesions<br>(including sub and chronic<br>total occlusions) in the<br>peripheral vasculature prior to<br>further percutaneous<br>intervention using OCT-<br>assisted orientation and<br>imaging. The system is an<br>adjunct to fluoroscopy by<br>providing images of vessel<br>lumen and wall structures. | |
| Intended use | Crossing chronic total<br>occlusions in peripheral<br>arteries using real-time<br>optical coherence<br>tomography assisted<br>orientation during catheter<br>intervention | Same |
| Contraindications | The Tigereye system is<br>contraindicated for use in the<br>iliac, coronary, cerebral, renal<br>or carotid vasculature. | Same |
| Product Code | PDU NQQ | Same |
| Treatment<br>Method | CTO crossing | Same |
| Technical<br>Characteristics | | |
| Components of<br>the System | Catheter<br>Lightbox Imaging Console<br>Sled | Same |
| Configuration of<br>the catheter | 2 components—(1) an<br>outer cannula that acts as a<br>support catheter and (2) an<br>inner assembly that<br>contains a rotating tip and<br>the OCT imaging fiber | 2 components—(1) an<br>outer cannula that acts as a<br>support catheter and has a<br>rotating tip, and (2) an<br>inner assembly that<br>contains a rotating tip and<br>the OCT imaging fiber |
| Imaging<br>Modality | Optical coherence<br>tomography | Same |
| Imaging Energy<br>Type | Near-infrared Light | Same |
| Optical Output<br>Power | < 30 mW<br>(Class 1 laser) | Same |
| Optical<br>Sensitivity | 90 db minimum | Same |
| (signal : noise<br>ratio) | | |
| Imaging<br>Capabilities | OCT-assisted orientation<br>and imaging of vessel<br>lumen and wall structures<br>in the peripheral<br>vasculature to facilitate<br>crossing of vessel<br>occlusions.<br>Measurement of vessel<br>lumen by OCT | Same |
| Electrical Safety | Class I, Type CF,<br>defibrillation proof IEC<br>60601-1 | Same |
| Electromagnetic<br>Compatibility | IEC 60601-1-2 | Same |
| Laser Safety | 21 CFR Part 1040<br>IEC 60825 | Same |
| Software Level<br>of Concern | Moderate | Same |
| Sterilization<br>Method | e-beam irradiation | Same |
| Sterility<br>Assurance Level | 10-6 | Same |
| Biocompatibility<br>of Materials | Meets ISO 10993<br>requirements | Same |
| Operational<br>Characteristics | | |
| Outer diameter of<br>the cannula | 1.67 mm (5 Fr) | Same |
| Geometry of the<br>tip of the drive<br>shaft | Spiral flutes | Same |
| Geometry of the<br>tip of the support<br>catheter | N/A this tip is not in the<br>design of Tigereye | 3 longitudinal flute<br>elements |
| Tip deflection<br>range | Can be modified during the<br>procedure from 0 to 0.28<br>inch | Can be modified during the<br>procedure from 0 to 0.24<br>inch |
| Working length<br>of the catheter | 140 cm | Same |
| Sheath<br>compatibility for<br>the catheter | 5 Fr | Same |
| Rotation speeds<br>possible | 600, 800, & 1000 RPM | Same |
| OCT imaging<br>sweep/window | 360 degrees | Same |
| Procedure Site | Hospital Cardiac Catheter<br>Lab<br>Office-based Lab | Same |
| Anatomical Site<br>of Use | Peripheral Vasculature | Same |
| Treatment<br>Method | CTO crossing | Same |
| Provided Sterile | Yes | Yes |
| Single-use<br>catheter | Yes | Yes |
{6}------------------------------------------------
{7}------------------------------------------------
{8}------------------------------------------------
#### Performance Data
The performance testing conducted establishes that the Tigereye ST CTO-crossing catheter did not raise new questions of the safety and effectiveness from those reviewed and cleared in the Tigereye catheter submission K201330.
#### Biocompatibility testing
The Tigereye ST catheter was tested and passed the appropriate 10993-1 tests for biocompatibility of materials following eBeam sterilization. The biocompatibility testing performed were:
- Cytotoxicity
- Sensitization - Magnusson-Klingman Method
- Irritation Intracutaneous Toxicity ●
- Systemic Toxicity ●
- Material-mediated Pyrogenicity ●
- Hemocompatibility Dog Thrombogenicity .
- Hemocompatibility Hemolysis Direct and Indirect .
- Hemocompatibility Complement Activation. .
{9}------------------------------------------------
#### Electrical safety and electromagnetic compatibility (EMC)
The subject and predicate devices comply with IEC 60601-1 standard for safety and the IEC 60601-1-2 standard for EMC.
#### Software Verification and Validation Testing
The software of the Lightbox component of the system has not been changed since the version that was reviewed and cleared in K212468. The software for this device is considered "moderate" in the level of concern.
#### Mechanical Testing
The mechanical testing of the subject device included:
- Effective length of the device; ●
- Catheter flush flow rate; ●
- OCT image generation; ●
- Catheter field of view: ●
- Distal tip rotation capability; ●
- Insertion force of the inner assembly through the hub of the support catheter component;
- Insertion force over a simulated arterial arch; ●
- OCT image generation and Sled interface capabilities; ●
- Guidewire compatibility and insertion force through the support catheter ● component;
- Passive mode life cycle; ●
- Active mode life cycle;
- . Active mode with the tip deflected life cycle;
- Tip deflection cycle;
- OCT image generation and Sled interface;
- Force to cross a simulated occlusion cap; ●
- Torque shaft torque proof loading;
- Drive shaft torque;
- . Drive shaft disengagement;
- Guidewire delivery; ●
- Tip compression: ●
- . Proximal section torque shaft torque;
- Flush lumen luer tensile strength;
- Distal catheter joints tensile strength; and
- Proximal catheter joints tensile strength. .
{10}------------------------------------------------
### Animal Testing
The performance bench testing was sufficient to demonstrate substantial equivalence to the predicate device.
### Clinical Studies
The performance bench testing was sufficient to demonstrate substantial equivalence to the predicate device.
#### Conclusion
The information submitted in this premarket notification confirms that the extension of the Ocelot Family of CTO-crossing catheters to now include the Tigereye ST catheter raises no new questions of safety and effectiveness and that the Tigereye ST catheter is substantially equivalent to the predicate device.
