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.

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 has a working length of 110 cm and is a sterile, single-use device that is compatible with 7 and 8F sheaths 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 Pantheris System described in K173862 is an updated version of a previously cleared device (K172236). Therefore, the acceptance criteria and performance data provided focus on demonstrating that the modifications to the device do not raise new questions of safety and effectiveness, and that the updated device remains substantially equivalent to its predicate.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission for modifications to an already cleared device, the "acceptance criteria" are implicitly that the modified device performs comparably to the predicate device and does not introduce new safety or effectiveness concerns. The "reported device performance" is largely demonstrating mechanical equivalence and biocompatibility, as well as satisfactory performance in an animal model.

Acceptance Criteria Category	Specific Criteria (Implicit for equivalence)	Reported Device Performance and Supporting Studies
Biocompatibility	No new or increased biocompatibility risks due to material changes in the torque shaft and balloon. Device materials must be safe for patient contact.	Passed all tests: Cytotoxicity, Sensitization, Irritation, Systemic Toxicity (acute), Pyrogenicity, Complement Activation, Hemolysis (extract and direct), In Vivo Thrombogenicity. (Details of specific pass/fail values not provided, but stated as "passed all tests.")
Electrical Safety	Maintain compliance with electrical safety standards.	Complies with IEC 60601-1 standard for safety.
EMC	Maintain compliance with electromagnetic compatibility standards.	Complies with IEC 60601-1-2 standard for EMC.
Software Functionality	No change in software functionality, ensuring continued safety and effectiveness of the software.	No change to the software with the subject device. (Implies existing verification and validation remain valid.)
Mechanical Performance	Modified components (stiffer shaft, modified cutter, longer nosecone, single balloon, depth markings) must maintain or improve mechanical performance, durability, and functionality relative to the predicate without compromising safety. Aspects like device advancement, cutting efficiency, imaging, etc., must be satisfactory.	Extensive Mechanical Testing performed: 3-month accelerated aging and package performance, Simulated use, Working length, Catheter flush and leak, OCT image generation and Sled interface, Catheter field of view, Distal tip rotation, Guidewire compatibility and insertion force, Catheter-Sheath insertion cycles, various insertion/retraction forces, Cutter exposure, Full 360° image, Balloon inflation cycles, Balloon burst, Cut/Pack cycles, Catheter Sled insertion cycles, Packed/Active position life cycle, Torque shaft torque-proof, Driveshaft torque-proof, Proximal section torque shaft torque, Luer tensile strength tests, Catheter functionality, compatibility, insertion, retraction, and post-procedure checks, Visualization with a single balloon, Cutter corrosion/heat/rotational speed/dimensional verification, Plaque removal efficiency. (All tests implicitly met their respective criteria to support substantial equivalence.)
Safety & Performance in vivo	Modified device performs safely and effectively in a living system, demonstrating adequate trackability, OCT imaging clarity, and directed atherectomy without significant adverse events, especially in target vessel diameters.	GLP Animal Study: Two female Yorkshire swine (one acute, one chronic) were used. The v1.4 Pantheris catheter (test device) and v1.3 Pantheris catheter (control device) were assessed for: trackability, advancement through vascular sheath, clarity of OCT imaging, orientation towards landmark, and minimum effective flow rate (MEFR) for acceptable OCT images across 3.0-7.0 mm vessel lumen diameters. Results: All treatment evaluation parameters and MEFR evaluations ranked "good" to "excellent." Only adverse event: minor perforation during MEFR assessment in one animal, deemed clinically insignificant and self-resolving. Conclusion: No new questions of safety and effectiveness were produced.
Clinical Effectiveness	No new clinical concerns introduced by the modifications.	No clinical testing of the modifications was deemed necessary, indicating that existing clinical data for the predicate device is considered applicable.

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

The provided text primarily details non-clinical testing.

Biocompatibility: The sample sizes for each specific biocompatibility test are not explicitly stated, but standard protocols are typically followed (e.g., multiple replicates per material, positive/negative controls).
Mechanical Testing: Specific sample sizes for each mechanical test are not provided. These are generally performed on a sufficient number of units to establish statistical confidence or engineering acceptance, often following ISO or ASTM standards.
Animal Study: Two female Yorkshire swine were enrolled (one for acute assessment, one for chronic assessment).
- Provenance: This was an animal study, not human data. The location of the GLP animal study is not specified, but it's likely a controlled laboratory setting.

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

Experts are primarily mentioned in the context of the animal study:

Animal Study: "the physician conducting the study" (singular).
- Qualifications: Likely a veterinarian or interventionalist with expertise in animal models and vascular procedures, though specific qualifications (e.g., years of experience, board certification) are not detailed. This physician made the clinical judgment on the significance of the minor perforation.

For other tests (biocompatibility, mechanical), "ground truth" is established by adherence to recognized standards and validated test methods, rather than human expert consensus.

4. Adjudication Method for the Test Set

Animal Study: The text mentions "the physician conducting the study" made a determination regarding the clinical significance of an adverse event. This implies a single expert's judgment rather than a formal multi-expert adjudication method (e.g., 2+1, 3+1).
Other Testing: Not applicable; acceptance is based on objective measurements against engineering specifications or standard pass/fail criteria.

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 MRMC study or AI assistance is mentioned. The Pantheris System is an atherectomy device with OCT imaging, not an AI-powered diagnostic or assistive tool for human readers. Therefore, this question is not applicable to the provided information.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The device is a surgical atherectomy system with integrated imaging, not a standalone algorithm. The imaging component (OCT) is meant to be used real-time by a human operator (physician) for guidance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Biocompatibility: Established by adherence to ISO standards and validated test methods (e.g., specific cell responses for cytotoxicity, immune responses for sensitization).
Mechanical Testing: Based on engineering specifications, design requirements, and validated test methods (e.g., force measurements, cycle counts, dimensional tolerances).
Animal Study:
- Direct Observation: For trackability, advancement, OCT image clarity, orientation, and MEFR, which were ranked as "good" to "excellent."
- Pathological/Clinical Assessment: For adverse events (minor perforation) and its clinical significance by the study physician. While not explicitly stated, post-mortem pathological examination is standard for chronic animal studies to confirm tissue response and healing.

8. The Sample Size for the Training Set

Not applicable. This device is a medical instrument, not a machine learning or AI model. Therefore, there is no "training set" in the context of algorithm development.

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

Not applicable, as there is no training set for this type of device.

Summary

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May 22, 2018

Avinger, Inc. Thomas Lawson, PhD VP, Clinical & Regulatory Affairs 400 Chesapeake Drive Redwood City, California 94063

Re: K173862

Trade/Device Name: Pantheris System Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: May 4, 2018 Received: May 10, 2018

Dear Dr. 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 (QS) regulation (21 CFR Part 820);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, 2018.05.22 Eleni Whatley 12:03:55 For -04'00' Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K173862

Device Name Pantheris System

Indications for Use (Describe)

The Pantheris System is intended to remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature with a reference diameter of 3.0mm, 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.

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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K173862 - 510(k) Summary

General Information

Submitter	Avinger, Inc.
Address	400 Chesapeake DriveRedwood City, CA 94063
FDA Registration Number	3007498664
Correspondence Person	Thomas Lawson, PhDVice President, Clinical & Regulatory AffairsAvinger Inc.
Contact Information	Email: tlawson@avinger.comPhone: 510-206-1794
Date Prepared	21 May 2018

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 7Fr
Premarket Notification	K172236
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 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

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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 has a working length of 110 cm and is a sterile, single-use device that is compatible with 7 and 8F sheaths and 0.014" guidewires. The Pantheris Catheter incorporates an optical fiber that allows for real-time OCT-guided directional atherectomy during the procedure. Note: This submission covers modifications only for the 7 Fr model: a later, separate submission will cover any necessary modifications for the 8Fr model.

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. Neither the Lightbox nor the Sled are subjects of this submission.

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 K172236 for the Pantheris system disclosed various modifications in manufacturing, the Sled, accessories, labeling, and software for both the 7Fr and 8Fr models of the device.

This 510(k) builds on the design changes cleared in K172236 and details additional minor modifications to the design of the Pantheris catheter to add in functionality of the device.

Indications for Use

The indications for use for the Pantheris System cleared under K172236 is not altered due to the modifications disclosed in this submission, and it remains:

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Both the subject device and the predicate device have the same intended use, which is 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 technological differences between predicate and subject devices are a stiffer shaft to add in advancement, markings on the shaft, removal of the occlusion balloon, modification of the cutter, and offering an extended nosecone with one of the models.

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

TechnologicalCharacteristic	Pantheris CatheterPredicate DeviceK172236	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 by	Same
	providing images of vessellumen, wall structures andvessel morphologies.The Pantheris System is NOTintended for use in the iliac,coronary, cerebral, renal orcarotid vasculature."	Same
Anatomical Site of Use	Peripheral Vasculature	Same
Components of the	Lightbox consoleSledPantheris Catheter	Same
Balloons on the cannula	Apposition BalloonOcclusion Balloon	Apposition Balloon only
Cutter design	Scalloped edge	Petal edge
Depth markings on thecannula of the catheter	No	Yes
Length of Nosecone	5.5 cm	5.5 cm & 8.5 cm
Diameter of catheter	7 Fr & 8 Fr	7 Fr
Imaging Modality	Optical CoherenceTomography	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 laserwhen the Sled driver isnot rotating	Yes	Yes
Imaging Capabilities	OCT-assisted orientationand imaging of vessellumen and wall structuresin the peripheralvasculature to facilitateatherectomy.Identify clinically relevantmorphologies and assesscomplex lesions in theperipheral vasculature.Differentiate and classifyplaque.	Same
Electrical Safety	Class I, Type CF,defibrillation proofIEC 60601-1	Same
Electromagneticcompatibility	IEC 60601-1-2	Same
Laser Safety	21 CFR Part 1040IEC 60825	Same
Software Level ofConcern	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

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While the technique of plaque excision between the subject and predicate devices are the same, the design changes are summarized below:

Manufacturing Changes

Modify the torque shaft of the catheter by the addition of a section of Pebax at the . mid-section and a section of Nylon 12 to the proximal end of the torque shaft
Add markings to the cannula
. Change in balloon material
Remove the occlusion balloon from the cannula .
Modify the edge of the cutter ●
Add the text "Inflation" and "Flush" to the lumens on the handle ●
Introduce a longer nosecone that is 8.5 cm in length .

Labeling Changes

. New IFU to inform user of only one balloon (the apposition balloon) being present and needing to be tested prior to use
. New unit/product labels identifying device as having a nosecone of standard length or extended length

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Testing was performed to demonstrate that these changes do not raise new questions of 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 K172236.

Biocompatibility testing

Modifications were made to the materials in the torque shaft and the balloon, so the following testing was performed, and the devices passed all tests:

o Cytotoxicity:
Sensitization; O
Irritation: O
Systemic toxicity (acute); O
Pyrogenicity; O
Complement Activation; O
O Hemolysis (extract);
Hemolysis (direct); and O
o In Vivo Thrombogenicity.

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

There is no change to the software with the subject device.

Mechanical Testing

The mechanical testing of the subject device included:

3-month accelerated aging and package performance testing; ●
Simulated use testing; ●
Working length test; ●
Catheter flush and leak test; ●
OCT image generation and Sled interface test;
Catheter field of view test; ●
Distal tip rotation test; ●
Guidewire compatibility and insertion force test; ●

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Catheter-Sheath insertion cycles test:
Insertion force through the hub test; ●
Retraction force through the hub test; ●
Insertion force over the arch test;
Insertion force out of the sheath test; ●
Cutter exposure test;
Full 360° image test;
Balloon inflation cycles test;
Balloon burst test;
Cut/Pack cycles test; ●
Catheter Sled insertion cycles test; ●
Packed position life cycle test;
Active position life cycle test;
Life-cycle tests; ●
Torque shaft torque-proof loading test; ●
Driveshaft torque-proof loading test;
Proximal section torque shaft torque test;
Balloon inflation luer tensile strength test;
Flush lumen luer tensile strength test;
Distal catheter joints tensile strength test;
Proximal catheter joints tensile strength test; ●
Catheter functionality test; ●
Catheter compatibility and insertion test;
Catheter post-insertion check test; ●
Multiple catheter insertion and excision test; ●
Catheter retraction test;
Catheter post-retraction test;
Catheter post-procedure check test; ●
Visualization with a single balloon test; ●
Cutter corrosion testing *:
Cutter heat generation testing;
Cutter rotational speed testing*:
Cutter dimensional verification*; and ●
Plaque removal efficiency. ●

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

Animal Testing

A GLP animal study was conducted to demonstrate the safety and performance of the Pantheris v1.4 design in arteries with a lumen diameter of 3.0 to 7.0 mm and to validate

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that the design fulfills the defined user needs and requirements. Two female Yorkshire swine were enrolled in this study-one for acute assessment and one for chronic (14 days post-procedure) assessment. A v1.4 Pantheris catheter (test device) and v1.3 Pantheris catheter (control device) were inserted and positioned at the appropriate size target location (e.g., internal or external femoral artery) and assessed for the catheters' capability to track through the anatomy, be advanced through the vascular sheath, clarity of the OCT imaging, oriented and directed toward a landmark, and assessment of the minimum effective flow rate (MEFR) required for acceptable OCT images across a range of vessel lumen diameters.

Data collected demonstrated that all treatment evaluation parameters and the MEFR evaluations were ranked from "good" to "excellent." The only adverse event reported was a minor perforation noted during the MEFR assessment in one animal; however, it was deemed to be clinically insignificant by the physician conducting the study and resolved without intervention or treatment.

No new questions of safety and effectiveness were produced when the device was used in arteries with a luminal diameter of 3.0 to 7.0 mm.

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 and components 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).