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 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Tigereye CTO-Crossing Catheter, based on the provided FDA 510(k) summary:

The provided document is a 510(k) summary for a medical device (Tigereye CTO-Crossing Catheter) seeking clearance for a software and console update, not a device proving its initial efficacy or diagnostic performance. Therefore, many of the typical acceptance criteria related to diagnostic accuracy, sensitivity, specificity, and expert adjudication are not present in this document.

The focus of this submission is to demonstrate that the updated device (Tigereye System with Lightbox 3 imaging console) remains substantially equivalent to its predicate device (Tigereye System cleared under K201330) and that the changes do not raise new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a software/console update and not an initial efficacy study, the "acceptance criteria" are primarily related to meeting performance standards for the modified components and showing equivalence to the predicate.

Acceptance Criteria / Performance Aspect	Reported Device Performance (Tigereye System with Lightbox 3)	Justification/Reference
Biocompatibility	Catheter passed all biocompatibility tests (Cytotoxicity, Sensitization, Irritation, Systemic toxicity, Pyrogenicity, Hemocompatibility). Lightbox 3 console does not contact the patient, so no testing was necessary.	Reviewed in K201330; no changes to catheter or materials.
Electrical Safety	Complies with IEC 60601-1:2005 AMD1:2012.	Met standard.
Electromagnetic Compatibility (EMC)	Complies with IEC 60601-1-2:2014.	Met standard.
Laser Safety	Complies with IEC 60825-1:2014 and 21 CFR Part 1040.	Met standard.
Software Verification & Validation	Performed for Lightbox 3 (v1.0.300), including regression testing. Documentation provided as recommended by FDA guidance. Software "Moderate" Level of Concern.	Testing conducted.
Mechanical Testing (Catheter)	No new mechanical testing for the catheter. The catheter itself is identical to the predicate device cleared in K201330.	K201330 mechanical testing deemed sufficient.
Mechanical Testing (Lightbox 3 Console)	Hipot testing, OCT engine laser power, OCT image accuracy, Console verification, Console validation, EMC, Laser safety, Electrical safety, Software verification, Software validation.	All performed successfully.
Effect on Safety & Effectiveness	No new questions of safety and effectiveness were raised by the changes. Substantially equivalent to predicate.	Conclusion of 510(k) review.
Indications for Use	Remains the same as the predicate (facilitate guidewire placement beyond stenotic lesions in peripheral vasculature using OCT-assisted orientation and imaging, as an adjunct to fluoroscopy).	Confirmed.
Contraindications	Remains the same as the predicate (iliac, coronary, cerebral, renal, or carotid vasculature).	Confirmed.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable in the context of an efficacy study. This submission is for a software/console upgrade of an already cleared device. The performance data for the mechanical and electrical components likely involved a small number of test units (e.g., a few consoles and catheters) for engineering verification and validation.
Data Provenance: Not explicitly stated as real-world patient data. The tests described are primarily bench testing, electrical safety, EMC, and software testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not applicable. This submission does not involve clinical studies or expert consensus for diagnostic ground truth. The "ground truth" for the engineering performance tests would be established by validated test methods, reference standards, and specifications.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There is no expert adjudication for a test set in this 510(k) submission.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No MRMC comparative effectiveness study was done or reported in this 510(k) summary. This device is an imaging-assisted crossing catheter, not an AI-driven diagnostic system that assists human readers in interpreting images.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: Not applicable. The device is an imaging system providing real-time OCT images to a clinician during a procedure. It is inherently a human-in-the-loop device, not a standalone algorithm.

7. The Type of Ground Truth Used

Type of Ground Truth: For the mechanical, electrical, and software performance tests, the "ground truth" is based on engineering specifications, validated test methods, and compliance with recognized industry standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60825-1). For example, "OCT image accuracy" would be compared against a known, accurate reference.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This document does not describe the development of a machine learning or AI model, thus there is no "training set." The software updates are likely traditional software enhancements and bug fixes, verified and validated through standard software engineering practices.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable, as there is no training set for a machine learning model described here.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, 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.

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)

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

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	4 January 2022

Proposed Device

Trade Name	Tigereye CTO-Crossing Catheter
Common Name	Tigereye
Regulation Number andClassification Name	21 CFR§870.1250, Catheter for Crossing TotalOcclusions21 CFR§892.1560, Imaging System Optical CoherenceTomography (OCT)
Product Code	PDU, NQQ
Regulatory Class	II

Predicate Device

Trade Name	Tigereye CTO-Crossing Catheter
Common Name	Tigereye
Premarket Notification	K201330
Regulation Number andClassification Name	21 CFR§870.1250, Catheter for Crossing TotalOcclusions21 CFR§892.1560, Imaging System Optical CoherenceTomography (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 subject device of this submission is a line extension of the Tigereve System reviewed and cleared earlier under K201330.

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.

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Indications for Use

The indication for use for the Tigereye System is:

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(Avinger, Inc.)	Tigereye System(Avinger, Inc.)
	(This Submission)	K201330
Indication for Use	The Tigereye System isintended to facilitate theintraluminal placementof conventionalguidewires beyondstenotic lesions(including sub andchronic total occlusions)in the peripheralvasculature prior tofurther percutaneousintervention using OCT-assisted orientation andimaging. The system isan adjunct to fluoroscopyby providing images ofvessel lumen and wallstructures.The Tigereye system iscontraindicated for use inthe iliac, coronary,cerebral, renal or carotidvasculature	Same
Intended use	Crossing chronic totalocclusions in peripheralarteries using real-timeoptical coherencetomography assisted	Same
	orientation duringcatheter intervention
Product Code	PDU NQQ	Same
Treatment Method	CTO crossing	Same
TechnicalCharacteristics
Components ofthe System	CatheterLightbox 3 ConsoleSled	CatheterLightbox 250 ConsoleSled
Lightbox ImagingConsole	Lightbox 3Software version 1.0.300	Lightbox 250Software version 4.6.0
Lightbox ImagingConsole Use	OCT imaging inperipheral vascularprocedures inconjunction with acompatible Avingerproduct	Same
CompatibleAvinger Products	Pantheris atherectomycatheter (K172236)Pantheris SVatherectomy catheter(K182341)Tigereye CTO-crossingcatheter (K201330)	Same
Imaging Consoledimensions	Height: 27 cmWidth: 44 cmDepth: 13 cm	Height: 175 cmWidth: 69 cmDepth: 71 cm
Lightbox ImagingConsole Weight	< 25 pounds	< 260 pounds
Imaging Modality	Optical coherencetomography	Same
Imaging EnergyType	Near-infrared Light	Same
Laser	Swept Source LaserClass 1	Same
OpticalSensitivity (signal: noise ratio)	90 dB minimum	Same
ImagingCapabilities	OCT-assisted orientationand imaging of vessellumen and wallstructures in theperipheral vasculature to	Same
	facilitate crossing ofvessel occlusions.Measurement of lumenby OCT
Electrical Safety	Class I, Type CF,defibrillation proof IEC60601-1	Same
ElectromagneticCompatibility	IEC 60601-1-2	Same
Laser Safety	21 CFR Part 1040IEC 60825	Same
Power inputvoltage	100 – 240 V 50/60 Hz	Same
Optical outputpower	14 mW (imaging laser)35 µW (aiming laser)	Same
Optical sourcewavelength	1245 – 1375 nm	1260 – 1370 nm
A lines per frame	3000 (min)	1000 (min)
A-scan range insaline	~ 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(frame rate)	8 Hz (min)33 Hz (max)	Same
Method ofinputtinginformation aboutthe case anddevice selection	Touch screen userinterface on the operatormonitor for both caseinformation input andprocedure options	Typing information ona keyboard to inputcase information andprocedure options witha trackball pointingdevice located on thetop surface of theconsole cart
Console displayresolution (w x h)	3240 x 2160	2560 x 1440
Software Level ofConcern	Moderate	Moderate
OperationalCharacteristicsof the Catheter
Outer diameter ofthe cannula	1.67 mm (5Fr)	Same
Tip geometry	Spiral flutes	Same
Tip deflectionrange	Can be modified duringthe procedure from 0 to0.28 inch	Same
Working length ofthe catheter	140 cm	Same
Depth ofinsertionmarkings on theshaft	Yes	Yes
Sheathcompatibility forthe catheter	5 Fr	5 Fr
Rotation speed(max)	1000 RPM	Same
OCT imagingsweep/window	360 degrees	Same
Procedure Site	Hospital CardiacCatheter LabOffice-based Lab	Same
Anatomical Siteof Use	Peripheral Vasculature	Same
TreatmentMethod	CTO crossing	Same
Catheter ProvidedSterile	Yes	Yes
SterilityAssurance Levelof the Catheter	10-6	Same
Single-usecatheter	Yes	Yes
Packaging	Catheter is placed in alidded tray contained in aTyvek pouchImaging console isshipped in a 5 mm thickwall corrugated plasticcontainer with pre-cutfoam to support theconsole	Exactly the same forthe catheterImaging console isshipped in a woodencontainer with strapsholding it to the floorof 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.

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).