The Pantheris System is intended to remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature with a reference diameter of 3.0 mm, using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen, wall structures, and vessel morphologies. The Pantheris System is NOT intended for use in the iliac, coronary, cerebral, renal or carotid vasculature.

Device Description

The Pantheris System combines the use of Avinger's optical coherence tomography (OCT) technology with peripheral vascular atherectomy capabilities. The Pantheris System consists of the Pantheris catheter, Lightbox Sled with integrated Umbilical (referred to as "Sled") and the Lightbox HS Imaging Console (referred to as "Lightbox"). The Pantheris Catheter comes in both a 7Fr and an 8Fr size. Both sizes have a working length of 110 cm and are sterile, single-use devices that are compatible with 7 and 8F sheaths (respectively) and 0.014" guidewires. The Pantheris Catheter incorporates an Optical Fiber that allows for real-time OCT guided directional atherectomy during the procedure. The Pantheris catheter is connected to the Lightbox via the Sled. The Lightbox is an optical transceiver, transmitting light to the intraluminal environment through the optical fiber on the Pantheris Catheter and receiving and interpreting the signal from the tissue using a PCbased processing system. The Lightbox provides a visualization platform for the real-time OCT-assisted directional atherectomy. The Lightbox consists of a cart with two monitors, a PC-based processing system, software, an isolation transformer, and an OCT system.

AI/ML Overview

The provided document is a 510(k) Summary for the Pantheris System, which describes modifications to an already cleared device. This submission focuses on demonstrating that these modifications do not impact the safety and effectiveness of the device compared to its predicate. Therefore, the "acceptance criteria" and "device performance" primarily revolve around showing equivalence to the predicate and passing various safety and performance tests.

Here's the information extracted and organized as requested:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Biocompatibility	No changes in patient-contacting materials; accessories (tweezers) without direct patient contact must pass: Cytotoxicity, Sensitization, Irritation, Systemic Toxicity.	Patient-contacting materials unchanged. Stainless steel tweezers (accessory) passed Cytotoxicity, Sensitization, Irritation, and Systemic Toxicity tests.
Electrical Safety	Compliance with IEC 60601-1 standard for safety.	Complies with IEC 60601-1.
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2 standard for EMC.	Complies with IEC 60601-1-2.
Software	Verification and validation testing, including regression testing, conducted per FDA Guidance for Medical Device Software (Moderate Level of Concern).	Software V&V and regression testing conducted, documentation provided per FDA guidance. Device software determined to be "moderate" level of concern.
Mechanical Testing	Device modifications must not negatively impact mechanical performance. Tests include: Sheath insertion cycle, Destructive balloon burst, Torque capacity, Leak evaluation, Bond joint tensile strength, Life-cycle tests (8-month accelerated shelf life, simulated use), Corrosion, Heat generation, Rotational speed, Dimensional verification, Balloon inflation/deflation cycle, Plaque removal efficiency, Flushing tool capacity.	All listed mechanical tests were performed. (Specific pass/fail results for each test are not detailed in the summary, but the conclusion states "these modifications do not impact the safety and effectiveness").
Plaque Removal Efficiency	Maintain equivalent plaque removal efficiency to the predicate device.	Testing for "Plaque removal efficiency" was performed.
Clinical Equivalence	The modifications should not raise new questions of safety and effectiveness, maintaining substantial equivalence to the predicate (K163264).	"The information submitted... confirms that the minor modifications... raise no new questions of safety and effectiveness and that the device is substantially equivalent to the predicate device."

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

The document does not specify exact sample sizes for each mechanical or biocompatibility test. It mentions that "Testing was performed to demonstrate that these changes do not impact the safety and effectiveness of the final device."

Test Set Sample Sizes: Not explicitly stated for each test.
Data Provenance: The studies are described as "Performance Data" from various tests (Biocompatibility, Electrical Safety, EMC, Software, Mechanical). These are laboratory-based, non-clinical tests conducted by the manufacturer to demonstrate compliance with standards and equivalence. There is no mention of country of origin for the data or if it's retrospective or prospective, as these are device performance tests, not clinical studies on patients.

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

This type of information is not applicable (N/A) to this 510(k) submission. The submission describes a device with mechanical, electrical, and software components, not an AI or diagnostic application requiring expert review for ground truth in a test set. The performance tests (e.g., destructive balloon burst, torque capacity) rely on engineering specifications and physical measurements, not expert consensus on medical images or clinical outcomes.

4. Adjudication Method for the Test Set

This information is not applicable (N/A) for the reasons stated above. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human readers interpreting medical data, not for engineering performance tests of a physical device.

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

No, an MRMC comparative effectiveness study was not done, and this type of study is not applicable (N/A) to this 510(k) submission. This submission is for modifications to an atherectomy system that includes OCT imaging as an adjunctive visualization tool, not an AI-powered diagnostic system requiring human reader performance evaluation.

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

This information is not applicable (N/A). While the device contains software and OCT imaging, it is an interventional atherectomy system. The OCT provides real-time, surgeon-guided visualization, it's not a standalone diagnostic algorithm that would typically undergo "algorithm-only" performance testing in the context of a 510(k) for an AI device. The software update specifically mentioned is an attenuation of the laser when the drive is not rotating, a safety feature, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed is based on engineering specifications, established physical properties, and compliance with recognized standards. For example:

Biocompatibility: Adherence to ISO standards for material compatibility.
Electrical/EMC Safety: Compliance with IEC standards (e.g., IEC 60601-1).
Mechanical Testing: Meeting specified tensile strengths, torque capacities, leak rates, burst pressures, cycle counts, dimensional accuracies, and plaque removal efficiency based on defined test methods.
Software Validation: Successful execution of test cases against documented requirements and expected outcomes.

There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for these device modification performance tests.

8. The Sample Size for the Training Set

This information is not applicable (N/A) as the device functionality described does not involve a "training set" in the context of machine learning or AI algorithms requiring such a dataset. The software update mentioned is a safety feature for laser attenuation, not a complex algorithm dependent on a training set.

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

This information is not applicable (N/A) for the same reason as point 8.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

October 30, 2017

Avinger, Inc. Thomas Lawson Director, Regulatory and Clinical Affairs 400 Chesapeake Drive Redwood City, California 94063

Re: K172236

Trade/Device Name: Pantheris System Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW, NQQ Dated: September 29, 2017 Received: October 2, 2017

Dear Mr. 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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{1}------------------------------------------------

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Kenneth J. Cavanaugh - S

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K172236

Device Name Pantheris System

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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	29 September 2017

Proposed Device

Trade Name	Pantheris System
Common Name	Avinger Pantheris Catheter
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

Predicate Device

Trade Name	Pantheris System
Common Name	Avinger Pantheris Catheter
Premarket Notification	K162326
Regulation Number andClassification Name	21 CFR§870.4875, Intraluminal Artery Stripper21 CFR§892.1560, Ultrasonic Pulsed Echo ImagingSystem
Product Code	MCW, NQQ
Regulatory Class	IINote: This predicate device has not been subject to a design-related recall.

Device Description and Proposed Modifications

The Pantheris System (cleared initially under K152275) combines the use of Avinger's optical coherence tomography (OCT) technology with peripheral vascular atherectomy

{4}------------------------------------------------

capabilities. The Pantheris System consists of the Pantheris catheter, Lightbox Sled with integrated Umbilical (referred to as "Sled") and the Lightbox HS Imaging Console (referred to as "Lightbox").

The Pantheris Catheter comes in both a 7Fr and an 8Fr size. Both sizes have a working length of 110 cm and are sterile, single-use devices that are compatible with 7 and 8F sheaths (respectively) and 0.014" guidewires. The Pantheris Catheter incorporates an Optical Fiber that allows for real-time OCT guided directional atherectomy during the procedure.

The Pantheris catheter is connected to the Lightbox via the Sled. The Lightbox is an optical transceiver, transmitting light to the intraluminal environment through the optical fiber on the Pantheris Catheter and receiving and interpreting the signal from the tissue using a PCbased processing system. The Lightbox provides a visualization platform for the real-time OCT-assisted directional atherectomy. The Lightbox consists of a cart with two monitors, a PC-based processing system, software, an isolation transformer, and an OCT system.

The Pantheris 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.

The submission of K162326 for the Pantheris system was focused solely on a change in the system software that permits the use of OCT images to identify vessel lumen, wall structures, and vessel morphologies.

This Special 510(k) details modifications to improve manufacturing compatibility, modify accessories that have no direct patient contact, and describes a patch of the system software that allows the attenuation of the laser whenever the drive in the Sled is not rotating.

Indications for Use

The indications for use for the Pantheris System cleared under K163264 is not altered due to the software and other modifications disclosed in this submission:

The Pantheris System is intended to remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature with a reference diameter of 3.0mm to 7.0mm, using OCT-assisted orientation and imaging. The system is as an adjunct to fluoroscopy by providing images of vessel lumen, wall structures and vessel morphologies. The Pantheris System is NOT intended for use in the iliac, coronary, cerebral, renal or carotid vasculature.

{5}------------------------------------------------

Both the subject device and the predicate device have the same intended use for the removal of plaque from partially occluded vessels in the peripheral vasculature.

Comparison of Technological Characteristics with the Predicate Device

Excision of plaque from peripheral vessels through atherectomy is the technological principle for both the subject and predicate devices.

At a high level, the subject and predicate devices are based upon the same technological elements:

. Device is advanced to the point of treatment through an indwelling sheath;
Measurement and display of vessel lumen, wall structures, and vessel morphology ● via the OCT-imaging component located directly behind the tissue cutter component;
Rotation of the OCT-imaging and cutter components by drives in the Sled ● component of the system;
Display of OCT-generated images on monitors attached to the Lightbox component ● of the system;
Excision of targeted tissue by a cutter component; and .
Packing of excised tissue into the nosecone component of the catheter. ●

The only technological difference is that the patch release of the software in the subject device allows the attenuation of the laser whenever the drive in the Sled is not rotating. In the predicate device, the laser is not stopped when the drive is not rotating.

Summary of Technological Characteristics of the Subject Device Compared to Those of the Predicate Device

TechnologicalCharacteristic	Pantheris CatheterPredicate DeviceK162326	Pantheris CatheterSubject Device of thisSubmission
Indication for Use	The Pantheris System isintended to remove plaque(atherectomy) from partiallyoccluded vessels in theperipheral vasculature with areference diameter of 3.0 mmto 7.0 mm, using OCT-assisted orientation andimaging. The system is as anadjunct to fluoroscopy byproviding images of vessel	Same
	lumen, wall structures and vessel morphologies.The Pantheris System is NOT intended for use in the iliac, coronary, cerebral, renal or carotid vasculature."	Same
Anatomical Site of Use	Peripheral Vasculature	Same
Components of the System	Lightbox consoleSledPantheris Catheter	Same
Imaging Modality	Optical Coherence Tomography	Same
Imaging Energy Type	Near-infrared light	Same
Optical Output Power	< 30 mW(Class 1M laser output)	Same
Optical sensitivity (signal:noise ratio)	90 db minimum	Same
Attenuation of the laser when the Sled driver is not rotating	No	Yes
Imaging Capabilities	OCT-assisted orientation and imaging of vessel lumen and wall structures in the peripheral vasculature to facilitate atherectomy.Identify clinically relevant morphologies and assess complex lesions in the peripheral vasculature.Differentiate and classify plaque	Same
Electrical Safety	Class I, Type CF, defibrillation proof IEC 60601-1	Same
Electromagnetic compatibility	IEC 60601-1-2	Same
Laser Safety	21 CFR Part 1040IEC 60825	Same
Software Level of Concern	Moderate	Same
Sheath compatibility forthe catheter	7 Fr & 8 Fr	Same
Working length of thecatheter	110 cm	Same
Guidewire compatibilityof the catheter	0.014 in	Same
Distal tip OD of thecatheter	0.100 (7 Fr)0.110 (8 Fr)	Same
Provided Sterile	Yes	Yes
Single-use catheter	Yes	Yes

{6}------------------------------------------------

{7}------------------------------------------------

While the technique of plaque excision between the subject and predicate devices are the same, there have been design changes to the subject device to improve manufacturability and usability of the catheter, changes to the tweezers and flush fixture accessories, modification of the Sled component of the system, updates to the instructions for use, and a patch release of the system's software. The design changes are summarized below.

Summary of design and other changes of the subject device covered in this 510(k) submission:

Manufacturing

. Modify balloon inflation test during assembly
Shorten the torque shaft hypotube length ●
Add strain relief in the handle to reduce tension pulling on fibers from the lens ●
Modify the edge of the cutter ●
Modify the bushing that aligns the cutter

Sled

Modify the integrated connector of the umbilical cable
Modify the FORJ, which increased the length of the Sled slightly

Accessories

. Change tweezers material from nylon to stainless steel and change the shape of its tip
Length the flush fixture increased .

Labeling

. Revise the IFU in terms of volume of CO2 used to inflate the balloons
Revise the IFU to instruct user to test balloon inflation prior to insertion of the ● catheter

{8}------------------------------------------------

Software

Update of software to allow attenuation of the laser whenever the drive in the Sled is not rotating
Testing was performed to demonstrate that these changes do not impact the safety and effectiveness of the final device.

Performance Data

The performance testing conducted establishes that these minor modifications do not raise new questions of the safety and effectiveness for the Pantheris System cleared under K163264.

Biocompatibility testing

There are no changes in patient-contacting materials in the subject device when compared to the predicate device. The only material change is to an accessory provided with the device, a pair of tweezers, which were nylon in the predicate device and in the subject device are stainless steel. The stainless steel tweezers do not have direct patient contact, but were subjected nonetheless to the following testing and passed all tests:

o Cytotoxicity:
Sensitization: O
Irritation: and O
o Systemic toxicity.

Electrical safety and electromagnetic compatibility (EMC)

The predicate and subject devices comply with IEC 60601-1 standard for safety and the IEC 60601-1-2 standard for EMC.

Software Verification and Validation Testing

Software verification and validation testing, as well as regression testing, were conducted and documentation was 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:

Sheath insertion cycle test; ●
Destructive balloon burst test; ●

{9}------------------------------------------------

Torque capacity; ●
Leak evaluation; ●
Bond joint tensile strength; ●
. Life-cycle tests:
8-month accelerated shelf life study;
Simulated use testing;
Corrosion testing*;
Heat generation testing;
Rotational speed testing*; ●
Dimensional verification*;
Balloon inflation/deflation cycle test; ●
Plaque removal efficiency; and ●
Flushing tool capacity. ●

*device historical data/information was provided to support the test conclusions

Animal Testing

No preclinical testing of the modifications of the subject device was necessary.

Clinical Studies

No clinical testing of the modifications of the subject device was necessary.

Conclusion

The information submitted in this premarket notification confirms that the minor modifications to the Pantheris catheter, components, and system software raise no new questions of safety and effectiveness and that the device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 870.4875 Intraluminal artery stripper.

(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).