Tigereye CTO-Crossing Catheter
Device Facts
| Record ID | K201330 |
|---|---|
| Device Name | Tigereye CTO-Crossing Catheter |
| Applicant | Avinger, Inc. |
| Product Code | PDU · Cardiovascular |
| Decision Date | Sep 10, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1250 |
| Device Class | Class 2 |
Indications for Use
The Tigereye 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. The Tigereye system is contraindicated for use in the iliac, coronary, cerebral, renal or carotid vasculature.
Device Story
Tigereye CTO-Crossing Catheter facilitates guidewire placement through peripheral vascular stenotic lesions/CTOs. System inputs: real-time OCT imaging via integrated optical fiber; fluoroscopy. Operation: 5 French coaxial catheter with rotating tip (up to 1000 RPM) and inner assembly; tip deflection (0-0.28 inch) adjustable during procedure. Device connects to Lightbox HS Imaging Console via Sled. Output: real-time OCT images of vessel lumen/wall structures displayed on console. Used in cardiac catheter labs/hospitals by physicians. OCT imaging provides orientation to guide catheter tip, allowing physician to navigate occlusions, compress tissue, and create channel for guidewires. Benefits: enables crossing of difficult lesions under visual guidance, facilitating subsequent percutaneous interventions.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing, including mechanical performance (torque, tensile strength, insertion force, life cycle), biocompatibility (ISO 10993), electrical safety (IEC 60601-1), and software verification/validation.
Technological Characteristics
5 French coaxial catheter (140 cm length). Materials: biocompatible, ISO 10993 compliant. Imaging: OCT (near-infrared light, <30 mW, Class 1 laser). Connectivity: Lightbox HS console via Sled. Sterilization: e-beam irradiation. Software: Moderate level of concern. Tip: spiral flutes, 1000 RPM max, adjustable deflection 0-0.28 inch.
Indications for Use
Indicated for patients with stenotic lesions, including sub and chronic total occlusions, 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
- Ocelot PIXL CTO-Crossing Catheter (K123532)
Reference Devices
- Pantheris SV Catheter (K182341)
Submission Summary (Full Text)
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September 10, 2020
Avinger, Inc. Thomas Lawson VP, Clinical & Regulatory Affairs 400 Chesapeake Drive Redwood City, California 94063
Re: K201330
Trade/Device Name: Tigereye CTO-Crossing Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PDU, NQQ Dated: August 19, 2020 Received: August 21, 2020
### 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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
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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
#### Indications for Use
510(k) Number (if known) K201330
Device Name Tigereye CTO-Crossing Catheter
#### Indications for Use (Describe)
The Tigereye 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. The Tigereye system is contraindicated for use in the iliac, coronary, cerebral, renal or carotid vasculature.
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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# 510(k) SUMMARY- K201330
# General Information
| Submitter | Avinger, Inc. |
|-------------------------|-------------------------------------------------------------------------------|
| Address | 400 Chesapeake Drive<br>Redwood City, CA 94063 |
| FDA Registration Number | 3007498664 |
| Correspondence Person | Thomas Lawson, PhD<br>Director, Clinical & Regulatory Affairs<br>Avinger Inc. |
| Contact Information | Email: tlawson@avinger.com<br>Phone: 510-206-1794 |
| Date Prepared | 9 September 2020 |
## Proposed Device
| Trade Name | Tigereye CTO-Crossing Catheter |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Common Name | Tigereye |
| Regulation Number and<br>Classification Name | 21 CFR§870.1250, Percutaneous Catheter<br>21 CFR§892.1560, Ultrasonic Pulsed Echo Imaging<br>System |
| Product Code | PDU, NQQ |
| Regulatory Class | II |
# Predicate Device
| Trade Name | Ocelot PIXL CTO-Crossing Catheter |
|------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Common Name | Ocelot PIXL |
| Premarket Notification | K123532 |
| Regulation Number and<br>Classification Name | 21 CFR§870.1250, Percutaneous Catheter<br>21 CFR§892.1560, Ultrasonic Pulsed Echo Imaging<br>System |
| Product Code | PDU, NQQ |
| Regulatory Class | II |
| Note: This predicate device has not been subject to a design-related recall. | |
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| Trade Name | Pantheris SV Catheter |
|------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Common Name | Pantheris SV 6 French Catheter |
| Premarket Notification | K182341 |
| Regulation Number and<br>Classification Name | 21 CFR§870.4875, Intraluminal Artery Stripper<br>21 CFR§892.1560, Ultrasonic Pulsed Echo Imaging<br>System |
| Product Code | MCW, NQQ |
| Regulatory Class | II |
| Note: This reference device has not been subject to a design-related recall. | |
#### Reference Device
# Device Description and Proposed Modifications
The Tigereye System combines the use of Avinger's optical coherence tomography (OCT) technology with peripheral vascular chronic total occlusion (CTO) crossing capabilities. The Tigereye System consists of the Tigereye CTO-crossing catheter, a Lightbox Sled with integrated umbilical (referred to as "Sled"), and the Lightbox HS Imaging Console (referred to as "Lightbox").
The subject device of this submission is a line extension of the Ocelot System reviewed and cleared earlier under K122380 and K123532.
The Tigereye 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 CTO-crossing head incorporates an optical fiber that allows real-time diagnosis of vessel condition and morphology as well as OCT-guided CTO crossing during the procedure with its connection to an optical Sled and Lightbox. The software of the Lightbox has been updated to version 4.6.0, which builds on version 4.4.0 that was reviewed and cleared under K182341.
The Tigereye 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 Ocelot PIXL CTO-crossing catheter (K123532) and details additional minor modifications to the design of the Ocelot catheter family to add in functionality of the device.
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### Indications for Use
The indication for use for the Tigereye CTO-crossing catheter is:
The Tigereye 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.
The Tigereye system is contraindicated for use in the iliac, coronary, cerebral, renal or carotid vasculature.
Both the subject device and the Ocelot PIXL predicate device have the 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 Pantheris SV reference device are made from the same materials and use the same packaging.
# Comparison of Technological Characteristics with the Predicate and Reference Devices
Avinger Inc. has identified the predicate device for the Tigereye CTO-crossing catheter as the Ocelot PIXL CTO-crossing catheter (K123532) due to shared properties such as its intended use, dimensions, and use of optical coherence tomography (OCT) imaging; and identified the Pantheris SV catheter (K182341) as a reference device due to its shared materials, sterilization method, packaging, and method of connection to the Lightbox console.
The Tigereye CTO-crossing catheter is substantially equivalent to the predicate device based upon the following similarities:
Similarities of Tigereye and Ocelot PIXL 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;
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- · 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.
Similarities of Tigereye and the reference device, the Pantheris SV catheter:
- . 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 devices is monitored by external fluoroscopy and ● intravascular OCT imaging;
- . Both devices use the OCT imaging software contained in the Lightbox console to measure the lumen of vessels in which they are indwelling;
- . Both devices are connected to the Lightbox via an accessory, termed the Sled, that is covered by a sterile drape in order to separate sterile and non-sterile surfaces: and
- Both devices are packaged in a lidded tray made from identical materials that then is placed within a pouch and then sealed.
Comparison of the Tigereye catheter to the Ocelot PIXL catheter and the Pantheris SV catheter.
| | Subject Device | Predicate Device | Reference Device |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Tigereye System<br>5 French<br>(Avinger, Inc.)<br>(This Submission) | Ocelot PIXL<br>System<br>5 French<br>(Avinger, Inc.)<br>K123532 | Pantheris SV System<br>6 French<br>(Avinger, Inc)<br>K182341 |
| Indication for<br>Use | The Tigereye System is<br>intended to facilitate<br>the intraluminal<br>placement of<br>conventional<br>guidewires beyond<br>stenotic lesions<br>(including sub and<br>chronic total<br>occlusions) in the<br>peripheral vasculature<br>prior to further<br>percutaneous | The Ocelot PIXL<br>System is intended<br>to facilitate the<br>intraluminal<br>placement of<br>conventional<br>guidewires beyond<br>stenotic lesions<br>(including sub and<br>chronic total<br>occlusions) in the<br>peripheral<br>vasculature prior to | The Pantheris System is<br>intended to remove<br>plaque (atherectomy)<br>from partially occluded<br>vessels in the peripheral<br>vasculature with a<br>reference diameter of<br>2.0 mm to 4.0 mm,<br>using OCT-assisted<br>orientation and<br>imaging. The system is<br>as an adjunct to<br>fluoroscopy by |
| intervention using<br>OCT-assisted<br>orientation and<br>imaging. The system is<br>an adjunct to<br>fluoroscopy by<br>providing images of<br>vessel lumen and wall<br>structures.<br>The Tigereye system is<br>contraindicated for use<br>in the iliac, coronary,<br>cerebral, renal or<br>carotid vasculature | further percutaneous<br>intervention using<br>OCT-assisted<br>orientation and<br>imaging. The<br>system is an adjunct<br>to fluoroscopy by<br>providing images of<br>vessel lumen and<br>wall structures.<br>The Ocelot PIXL<br>system is<br>contraindicated for<br>use in the iliac,<br>coronary, cerebral,<br>renal or carotid<br>vasculature. | providing images of<br>vessel lumen, wall<br>structures and vessel<br>morphologies.<br>The Pantheris System is<br>NOT intended for use<br>in the iliac, coronary,<br>cerebral, renal or<br>carotid vasculature. | |
| Intended use | Crossing chronic<br>total occlusions in<br>peripheral arteries<br>using real-time<br>optical coherence<br>tomography assisted<br>orientation during<br>catheter intervention | Crossing chronic<br>total occlusions in<br>peripheral arteries<br>using real-time<br>optical coherence<br>tomography<br>assisted<br>orientation during<br>catheter<br>intervention | Remove plaque<br>(atherectomy) from<br>partially occluded<br>vessels in the<br>peripheral<br>vasculature |
| Product Code | PDU NQQ | PDU NQQ | MCW NQQ |
| Treatment<br>Method | CTO crossing | CTO crossing | Directional<br>Atherectomy |
| Technical<br>Characteristics | | | |
| Components of<br>the System | Catheter<br>Lightbox Console<br>Sled | Catheter<br>Lightbox Console<br>Umbilical Cord | Catheter<br>Lightbox Console<br>Sled |
| Configuration of<br>the catheter | 2 components—an<br>outer cannula that<br>acts as a support<br>catheter and an inner<br>assembly that<br>contains the rotating<br>tip and the OCT<br>imaging fiber | 1 cannula that<br>contains the<br>rotating tip and<br>the OCT imaging<br>fiber | 1 cannula that<br>contains the rotating<br>cutter head and the<br>OCT imaging fiber |
| Imaging<br>Modality | Optical coherence<br>tomography | Same | Same |
| | | | |
| Imaging Energy<br>Type | Near-infrared Light | Same | Same |
| Optical Output<br>Power | < 30 mW<br>(Class 1 laser) | Same | Same |
| Optical<br>Sensitivity<br>(signal : noise<br>ratio) | 90 db minimum | Same | Same |
| Imaging<br>Capabilities | OCT-assisted<br>orientation and<br>imaging of vessel<br>lumen and wall<br>structures in the<br>peripheral<br>vasculature to<br>facilitate crossing of<br>vessel occlusions.<br><br>Measurement of<br>lumen by OCT | OCT-assisted<br>orientation and<br>imaging of vessel<br>lumen and wall<br>structures in the<br>peripheral<br>vasculature to<br>facilitate crossing<br>of vessel<br>occlusions.<br><br>Measurement of<br>lumen by OCT | OCT-assisted<br>orientation and<br>imaging of vessel<br>lumen and wall<br>structures in the<br>peripheral<br>vasculature to<br>facilitate<br>atherectomy.<br><br>Measurement of<br>lumen by OCT |
| Electrical Safety | Class I, Type CF,<br>defibrillation proof<br>IEC 60601-1 | Same | Same |
| Electromagnetic<br>Compatibility | IEC 60601-1-2 | Same | Same |
| Laser Safety | 21 CFR Part 1040<br>IEC 60825 | Same | Same |
| Software Level<br>of Concern | Moderate | Same | Same |
| Sterilization<br>Method | e-beam irradiation | Ethylene Oxide | e-beam irradiation |
| Sterility<br>Assurance Level | 10-6 | Same | Same |
| Biocompatibility<br>of Materials | Meets ISO 10993<br>requirements | Same | Same |
| Operational<br>Characteristics | | | |
| Outer diameter<br>of the cannula | 1.67 mm (5Fr) | 1.67 mm (5 Fr) | 2 mm (6 Fr) |
| Tip geometry | Spiral flutes | Same | N/A |
| Tip deflection<br>range | Can be modified<br>during the procedure<br>from 0 to 0.28 inch | Manually set prior<br>to insertion from 0<br>to 0.12 inch | Can be modified<br>during the procedure<br>from 0 to 0.2 inch |
| | | | |
| Working length<br>of the catheter | 140 cm | 135 & 150 cm | 140 cm |
| Depth of<br>insertion<br>markings on the<br>shaft | Yes | No | Yes |
| Sheath<br>compatibility for<br>the catheter | 5 Fr | 5 Fr | 6 Fr |
| Rotation speed<br>(max) | 1000 RPM | 60 RPM | 2000 RPM |
| OCT imaging<br>sweep/window | 360 degrees | Same | Same |
| Procedure Site | Hospital Cardiac<br>Catheter Lab<br>Office-based Lab | Same | Same |
| Anatomical Site<br>of Use | Peripheral<br>Vasculature | Same | Same |
| Treatment<br>Method | CTO crossing | CTO crossing | Directional<br>Atherectomy |
| Provided Sterile | Yes | Yes | Yes |
| Single-use<br>catheter | Yes | Yes | Yes |
| Packaging | Placed in a lidded<br>tray contained in a<br>Tyvek pouch | Placed on a<br>backing card<br>contained in a<br>Tyvek pouch | Placed in a lidded<br>tray contained in a<br>Tyvek pouch |
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### Performance Data
The performance tests conducted, including design validation and user testing, establishes that the Tigereye CTO-crossing catheter does not raise new questions of the safety and effectiveness for the Ocelot PIXL System cleared under K123532.
# Biocompatibility testing
The Tigereye catheter is manufactured from materials with a long history in medical devices and passed all tests:
- O Cytotoxicity,
- Sensitization, O
- Irritation, O
- Systemic toxicity, O
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- Materials-mediated pyrogenicity, O
- Hemocompatibility (dog thrombogenicity), o
- Hemocompatibility (platelet and leukocyte PLC with predicate device), O
- Hemocompatibility (hemolysis direct and indirect), O
- Hemocompatibility (complement activation), and O
- Hemocompatibility (partial thromboplastin time, human plasma). O
#### 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 been upgraded to version 4.6.0. Software verification and validation testing, as well as regression testing, were conducted and documentation is provided as recommended by FDA's Guidance for Industry and FDA Staff, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. The software for this device is considered as a "moderate" 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; ●
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- Force to cross a simulated occlusion cap;
- Torque shaft torque proof loading; ●
- Drive shaft torque; ●
- Proximal section torque shaft torque; .
- Flush lumen luer tensile strength;
- Distal catheter joints tensile strength; and
- Proximal catheter joints tensile strength. ●
#### Animal Testing
No preclinical testing of the subject device was necessary.
### Clinical Studies
No clinical testing of the subject device was necessary.
#### Conclusion
The information submitted in this premarket notification confirms that the extension of the Ocelot System of CTO-crossing catheters to now include the Tigereye catheter raises no new questions of safety and effectiveness and that the Tigereye catheter is substantially equivalent to the predicate device.
