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 Description

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 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.

AI/ML Overview

The provided text does not describe a study involving an AI/Machine Learning device. Instead, it is a 510(k) summary for the Tigereye CTO-Crossing Catheter, a medical device used for crossing chronic total occlusions in peripheral vasculature. The device utilizes Optical Coherence Tomography (OCT) for imaging and orientation, but this is a physical imaging technology, not an AI/ML algorithm.

Therefore, many of the requested elements, such as acceptance criteria for AI performance (e.g., sensitivity, specificity), ground truth establishment for AI models, sample sizes for training/test sets for AI, MRMC studies, or standalone algorithm performance, are not applicable to this submission.

The document focuses on demonstrating substantial equivalence to a predicate device (Ocelot PIXL CTO-Crossing Catheter) and a reference device (Pantheris SV Catheter) through:

Comparison of Technological Characteristics: Highlighting similarities in intended use, imaging modality (OCT), safety standards, materials, and operational characteristics.
Performance Data: This section details engineering and biocompatibility tests, not clinical or AI performance. These include:
- Biocompatibility testing (cytotoxicity, sensitization, hemocompatibility, etc.)
- Electrical safety and electromagnetic compatibility (EMC)
- Software verification and validation (for the Lightbox component, which houses the control software, not an AI for image analysis)
- Mechanical testing (e.g., catheter length, flow rate, tip rotation, force to cross occlusion, torque, tensile strength).

The conclusion states that the data "raises no new questions of safety and effectiveness and that the Tigereye catheter is substantially equivalent to the predicate device."

In summary, based on the provided text, it's impossible to fill out the requested table or answer most of the questions, as they pertain to the evaluation of an AI/Machine Learning device, which the Tigereye CTO-Crossing Catheter is not.

Summary

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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 DriveRedwood City, CA 94063
FDA Registration Number	3007498664
Correspondence Person	Thomas Lawson, PhDDirector, Clinical & Regulatory AffairsAvinger Inc.
Contact Information	Email: tlawson@avinger.comPhone: 510-206-1794
Date Prepared	9 September 2020

Proposed Device

Trade Name	Tigereye CTO-Crossing Catheter
Common Name	Tigereye
Regulation Number andClassification Name	21 CFR§870.1250, Percutaneous Catheter21 CFR§892.1560, Ultrasonic Pulsed Echo ImagingSystem
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 andClassification Name	21 CFR§870.1250, Percutaneous Catheter21 CFR§892.1560, Ultrasonic Pulsed Echo ImagingSystem
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 andClassification Name	21 CFR§870.4875, Intraluminal Artery Stripper21 CFR§892.1560, Ultrasonic Pulsed Echo ImagingSystem
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 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 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 System5 French(Avinger, Inc.)(This Submission)	Ocelot PIXLSystem5 French(Avinger, Inc.)K123532	Pantheris SV System6 French(Avinger, Inc)K182341
Indication forUse	The Tigereye System isintended to facilitatethe intraluminalplacement ofconventionalguidewires beyondstenotic lesions(including sub andchronic totalocclusions) in theperipheral vasculatureprior to furtherpercutaneous	The Ocelot PIXLSystem is intendedto facilitate theintraluminalplacement ofconventionalguidewires beyondstenotic lesions(including sub andchronic totalocclusions) in theperipheralvasculature prior to	The Pantheris System isintended to removeplaque (atherectomy)from partially occludedvessels in the peripheralvasculature with areference diameter of2.0 mm to 4.0 mm,using OCT-assistedorientation andimaging. The system isas an adjunct tofluoroscopy by
intervention usingOCT-assistedorientation andimaging. The system isan adjunct tofluoroscopy byproviding images ofvessel lumen and wallstructures.The Tigereye system iscontraindicated for usein the iliac, coronary,cerebral, renal orcarotid vasculature	further percutaneousintervention usingOCT-assistedorientation andimaging. Thesystem is an adjunctto fluoroscopy byproviding images ofvessel lumen andwall structures.The Ocelot PIXLsystem iscontraindicated foruse in the iliac,coronary, cerebral,renal or carotidvasculature.	providing images ofvessel lumen, wallstructures and vesselmorphologies.The Pantheris System isNOT intended for usein the iliac, coronary,cerebral, renal orcarotid vasculature.
Intended use	Crossing chronictotal occlusions inperipheral arteriesusing real-timeoptical coherencetomography assistedorientation duringcatheter intervention	Crossing chronictotal occlusions inperipheral arteriesusing real-timeoptical coherencetomographyassistedorientation duringcatheterintervention	Remove plaque(atherectomy) frompartially occludedvessels in theperipheralvasculature
Product Code	PDU NQQ	PDU NQQ	MCW NQQ
TreatmentMethod	CTO crossing	CTO crossing	DirectionalAtherectomy
TechnicalCharacteristics
Components ofthe System	CatheterLightbox ConsoleSled	CatheterLightbox ConsoleUmbilical Cord	CatheterLightbox ConsoleSled
Configuration ofthe catheter	2 components—anouter cannula thatacts as a supportcatheter and an innerassembly thatcontains the rotatingtip and the OCTimaging fiber	1 cannula thatcontains therotating tip andthe OCT imagingfiber	1 cannula thatcontains the rotatingcutter head and theOCT imaging fiber
ImagingModality	Optical coherencetomography	Same	Same

Imaging EnergyType	Near-infrared Light	Same	Same
Optical OutputPower	< 30 mW(Class 1 laser)	Same	Same
OpticalSensitivity(signal : noiseratio)	90 db minimum	Same	Same
ImagingCapabilities	OCT-assistedorientation andimaging of vessellumen and wallstructures in theperipheralvasculature tofacilitate crossing ofvessel occlusions.Measurement oflumen by OCT	OCT-assistedorientation andimaging of vessellumen and wallstructures in theperipheralvasculature tofacilitate crossingof vesselocclusions.Measurement oflumen by OCT	OCT-assistedorientation andimaging of vessellumen and wallstructures in theperipheralvasculature tofacilitateatherectomy.Measurement oflumen by OCT
Electrical Safety	Class I, Type CF,defibrillation proofIEC 60601-1	Same	Same
ElectromagneticCompatibility	IEC 60601-1-2	Same	Same
Laser Safety	21 CFR Part 1040IEC 60825	Same	Same
Software Levelof Concern	Moderate	Same	Same
SterilizationMethod	e-beam irradiation	Ethylene Oxide	e-beam irradiation
SterilityAssurance Level	10-6	Same	Same
Biocompatibilityof Materials	Meets ISO 10993requirements	Same	Same
OperationalCharacteristics
Outer diameterof the cannula	1.67 mm (5Fr)	1.67 mm (5 Fr)	2 mm (6 Fr)
Tip geometry	Spiral flutes	Same	N/A
Tip deflectionrange	Can be modifiedduring the procedurefrom 0 to 0.28 inch	Manually set priorto insertion from 0to 0.12 inch	Can be modifiedduring the procedurefrom 0 to 0.2 inch

Working lengthof the catheter	140 cm	135 & 150 cm	140 cm
Depth ofinsertionmarkings on theshaft	Yes	No	Yes
Sheathcompatibility forthe catheter	5 Fr	5 Fr	6 Fr
Rotation speed(max)	1000 RPM	60 RPM	2000 RPM
OCT imagingsweep/window	360 degrees	Same	Same
Procedure Site	Hospital CardiacCatheter LabOffice-based Lab	Same	Same
Anatomical Siteof Use	PeripheralVasculature	Same	Same
TreatmentMethod	CTO crossing	CTO crossing	DirectionalAtherectomy
Provided Sterile	Yes	Yes	Yes
Single-usecatheter	Yes	Yes	Yes
Packaging	Placed in a liddedtray contained in aTyvek pouch	Placed on abacking cardcontained in aTyvek pouch	Placed in a liddedtray contained in aTyvek 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.

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
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.(b)
Classification. Class II (performance standards).