Tigereye CTO-Crossing Catheter
Device Facts
| Record ID | K212468 |
|---|---|
| Device Name | Tigereye CTO-Crossing Catheter |
| Applicant | Avinger, Inc. |
| Product Code | PDU · Cardiovascular |
| Decision Date | Jan 6, 2022 |
| 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
The Tigereye System is a peripheral vascular CTO-crossing device used in hospital cardiac catheter labs or office-based labs by physicians. It consists of a 5 French coaxial catheter, an optical Sled, and the Lightbox 3 imaging console. The catheter features a rotating tip and an integrated optical fiber. During procedures, the device is advanced through a vascular sheath to the target occlusion. The Lightbox 3 console transmits near-infrared light through the catheter to perform Optical Coherence Tomography (OCT) of the vessel lumen and wall. The system provides real-time OCT images on a touchscreen monitor, serving as an adjunct to fluoroscopy. The physician uses these images to orient the catheter and guide the crossing of occlusions. By creating a channel through the tissue, the device facilitates the placement of guidewires for subsequent percutaneous interventions. The system benefits patients by providing visual guidance for navigating complex peripheral vascular lesions.
Clinical Evidence
No clinical data was necessary for this submission. Substantial equivalence was established through bench testing, including mechanical performance, electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), laser safety (IEC 60825-1), and software verification and validation.
Technological Characteristics
System includes a 5 Fr coaxial catheter, optical Sled, and Lightbox 3 console. Imaging uses swept-source laser (Class 1, 1245–1375 nm). Console features PC-based processing, touchscreen interface, and 3240x2160 resolution display. Catheter uses spiral flutes for tissue dissection. Electrical safety: Class I, Type CF, defibrillation proof. Connectivity: Standalone console. Sterilization: Catheter provided sterile (SAL 10^-6). Software: Moderate level of concern.
Indications for Use
Indicated for patients requiring intraluminal guidewire placement beyond stenotic lesions, including chronic total occlusions, in the peripheral vasculature. 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)
Reference Devices
Submission Summary (Full Text)
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January 6, 2022
Avinger, Inc. Thomas Lawson VP, Regulatory Affairs 400 Chesapeake Drive Redwood City, California 94063
Re: K212468
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: December 2, 2021 Received: December 3, 2021
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 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
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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
### Indications for Use
510(k) Number (if known) K212468
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 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.
| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| <div> <span> <span style="padding-right: 20px;"> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> </div> | |
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# 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<br>Director, Clinical & Regulatory Affairs<br>Avinger Inc. |
| Contact Information | Email: tlawson@avinger.com<br>Phone: 510-206-1794 |
| Date Prepared | 4 January 2022 |
# Proposed Device
| Trade Name | Tigereye CTO-Crossing Catheter |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Tigereye |
| 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. | |
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#### 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 3 Imaging Console (referred to as "Lightbox 3" or "L300").
The subject device of this submission is a line extension of the Tigereve System reviewed and cleared earlier under K201330.
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 3 imaging console.
The Lightbox 3 console is comprised of a PC and an OCT engine, all contained within a casing. The operator monitor has a touchscreen that allows the user to interact with the console software for controlling the console, monitoring the procedure, and facilitating data input before, during, and after the procedure. The Lightbox 3 console is an optical transceiver, transmitting light to the intraluminal environment through an optical fiber in the catheter and receiving and interpreting the signal from the tissue using a PC-based processing system. The resulting OCT image is displayed on the monitor and provides a qualitative view of the vessel's structure inside traversed vessels as an adjunct to standard imaging techniques (e.g., fluoroscopy) during percutaneous peripheral vascular procedures.
The software of the Lightbox 3 console has been updated to version 1.0.300, which builds on version 4.6.0 that was reviewed and cleared under K201330.
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) is focused solely on the updates to the software and design of the Lightbox 3 imaging console component of the Tigereye System. The Tigereye CTOcrossing catheter and the Sled in this submission are exactly the same as the catheter and Sled that were cleared in K201330.
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#### Indications for Use
The indication for use for the Tigereye System 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 Tigereve system is contraindicated for use in the iliac, coronary, cerebral, renal or carotid vasculature.
Both the subject device and the Tigereye predicate device components of the system have the same intended use of the crossing of chronic total occlusions in order to facilitate placement of guidewires in the peripheral vasculature.
#### Comparison of Technological Characteristics with the Predicate Device
The Tigereye CTO-crossing catheter is substantially equivalent to the predicate device based upon the following similarities:
Similarities of the Tigereye System (this submission) and the Tigereye System (K201330):
- · 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.
- · Both devices use the OCT imaging software contained in the Lightbox 3 console to measure the lumen of vessels in which they are indwelling;
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- · 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 catheters are packaged in a lidded tray made from identical materials that then is placed within a pouch and then sealed.
Comparison of the Tigereye System (this submission) to the predicate device, the Tigereye System (K201330).
| | Subject Device | Predicate Device |
|---------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Tigereye System<br>(Avinger, Inc.) | Tigereye System<br>(Avinger, Inc.) |
| | (This Submission) | K201330 |
| Indication for Use | The Tigereye System is<br>intended to facilitate the<br>intraluminal placement<br>of conventional<br>guidewires beyond<br>stenotic lesions<br>(including sub and<br>chronic total occlusions)<br>in the peripheral<br>vasculature prior to<br>further percutaneous<br>intervention using OCT-<br>assisted orientation and<br>imaging. The system is<br>an adjunct to fluoroscopy<br>by providing images of<br>vessel lumen and wall<br>structures.<br><br>The Tigereye system is<br>contraindicated for use in<br>the iliac, coronary,<br>cerebral, renal or carotid<br>vasculature | Same |
| Intended use | Crossing chronic total<br>occlusions in peripheral<br>arteries using real-time<br>optical coherence<br>tomography assisted | Same |
| | orientation during<br>catheter intervention | |
| Product Code | PDU NQQ | Same |
| Treatment Method | CTO crossing | Same |
| <b>Technical<br/>Characteristics</b> | | |
| Components of<br>the System | Catheter<br>Lightbox 3 Console<br>Sled | Catheter<br>Lightbox 250 Console<br>Sled |
| Lightbox Imaging<br>Console | Lightbox 3<br>Software version 1.0.300 | Lightbox 250<br>Software version 4.6.0 |
| Lightbox Imaging<br>Console Use | OCT imaging in<br>peripheral vascular<br>procedures in<br>conjunction with a<br>compatible Avinger<br>product | Same |
| Compatible<br>Avinger Products | Pantheris atherectomy<br>catheter (K172236)<br><br>Pantheris SV<br>atherectomy catheter<br>(K182341)<br><br>Tigereye CTO-crossing<br>catheter (K201330) | Same |
| Imaging Console<br>dimensions | Height: 27 cm<br>Width: 44 cm<br>Depth: 13 cm | Height: 175 cm<br>Width: 69 cm<br>Depth: 71 cm |
| Lightbox Imaging<br>Console Weight | < 25 pounds | < 260 pounds |
| Imaging Modality | Optical coherence<br>tomography | Same |
| Imaging Energy<br>Type | Near-infrared Light | Same |
| Laser | Swept Source Laser<br>Class 1 | Same |
| Optical<br>Sensitivity (signal<br>: noise ratio) | 90 dB minimum | Same |
| Imaging<br>Capabilities | OCT-assisted orientation<br>and imaging of vessel<br>lumen and wall<br>structures in the<br>peripheral vasculature to | Same |
| | facilitate crossing of<br>vessel occlusions.<br>Measurement of lumen<br>by OCT | |
| 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 |
| Power input<br>voltage | 100 – 240 V 50/60 Hz | Same |
| Optical output<br>power | 14 mW (imaging laser)<br>35 µW (aiming laser) | Same |
| Optical source<br>wavelength | 1245 – 1375 nm | 1260 – 1370 nm |
| A lines per frame | 3000 (min) | 1000 (min) |
| A-scan range in<br>saline | ~ 5.3 mm | ~ 3 mm |
| A-scans/second | 100,000 Hz | 20,000 Hz |
| Dynamic range | > 100 dB | > 50 dB |
| Pulse duration | $≤$ 10 µs | 30 µs |
| Axial resolution | $≤$ 20 µm | Same |
| Lateral resolution | $<$ 300 µm (in water) | Same |
| Imaging range | 4 mm | 3.3 mm |
| Imaging speed<br>(frame rate) | 8 Hz (min)<br>33 Hz (max) | Same |
| Method of<br>inputting<br>information about<br>the case and<br>device selection | Touch screen user<br>interface on the operator<br>monitor for both case<br>information input and<br>procedure options | Typing information on<br>a keyboard to input<br>case information and<br>procedure options with<br>a trackball pointing<br>device located on the<br>top surface of the<br>console cart |
| Console display<br>resolution (w x h) | 3240 x 2160 | 2560 x 1440 |
| Software Level of<br>Concern | Moderate | Moderate |
| Operational<br>Characteristics<br>of the Catheter | | |
| Outer diameter of<br>the cannula | 1.67 mm (5Fr) | Same |
| Tip geometry | Spiral flutes | Same |
| Tip deflection<br>range | Can be modified during<br>the procedure from 0 to<br>0.28 inch | Same |
| Working length of<br>the catheter | 140 cm | Same |
| Depth of<br>insertion<br>markings on the<br>shaft | Yes | Yes |
| Sheath<br>compatibility for<br>the catheter | 5 Fr | 5 Fr |
| Rotation speed<br>(max) | 1000 RPM | Same |
| OCT imaging<br>sweep/window | 360 degrees | Same |
| Procedure Site | Hospital Cardiac<br>Catheter Lab<br>Office-based Lab | Same |
| Anatomical Site<br>of Use | Peripheral Vasculature | Same |
| Treatment<br>Method | CTO crossing | Same |
| Catheter Provided<br>Sterile | Yes | Yes |
| Sterility<br>Assurance Level<br>of the Catheter | 10-6 | Same |
| Single-use<br>catheter | Yes | Yes |
| Packaging | Catheter is placed in a<br>lidded tray contained in a<br>Tyvek pouch<br><br>Imaging console is<br>shipped in a 5 mm thick<br>wall corrugated plastic<br>container with pre-cut<br>foam to support the<br>console | Exactly the same for<br>the catheter<br><br>Imaging console is<br>shipped in a wooden<br>container with straps<br>holding it to the floor<br>of the container |
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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 from that of the Tigereye System cleared under K201330.
#### Biocompatibility testing
The Tigereye catheter is manufactured from materials with a long history in medical devices and passed all tests:
- Cytotoxicity. O
- Sensitization, O
- Irritation. O
- Systemic toxicity, O
- Materials-mediated pyrogenicity, O
- Hemocompatibility (dog thrombogenicity), O
- Hemocompatibility (platelet and leukocyte PLC with predicate device), O
- Hemocompatibility (hemolysis direct and indirect), о
- Hemocompatibility (complement activation), and O
- о Hemocompatibility (partial thromboplastin time, human plasma).
These tests were reviewed in K201330.
The Lightbox 3 console does not contact the patient, so biocompatibility testing was not necessary.
#### Electrical safety and electromagnetic compatibility (EMC)
The subject and predicate devices comply with IEC 60601-1:2005 AMD1:2012 standard for electrical safety, IEC 60601-1-2:2014 standard for EMC, and IEC 60825-1:2014 standard for laser safety.
#### Software Verification and Validation Testing
The software of the Lightbox component of the system has been upgraded to version 1.0.300. 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
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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 reviewed in K201330 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;
- Proximal section torque shaft torque; ●
- Flush lumen luer tensile strength; ●
- Distal catheter joints tensile strength; and ●
- Proximal catheter joints tensile strength. ●
The mechanical testing of the Lightbox 3 imaging console included:
- Hipot testing, ●
- OCT engine laser power,
- OCT image accuracy,
- Console verification testing.
- Console validation testing, ●
- Electromagnetic compatibility, ●
- Laser safety, ●
- Electrical safety, .
- Software verification testing, and ●
- Software validation testing. .
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#### 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 Tigereye System of CTO-crossing catheters to include the Lightbox 3 imaging console raises no new questions of safety and effectiveness and that the Tigereye catheter with the Lightbox 3 imaging console is substantially equivalent to the predicate device.
