The Pantheris SV is intended to remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature with a reference diameter of 2.0 mm to 4.0 mm, using OCTassisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen, wall structures and vessel morphologies. The Pantheris SV is NOT intended for use in the iliac, coronary, cerebral, renal or carotid vasculature.

Device Description

The Pantheris SV catheter is a monorail (rapid exchange) device with a working length of 144 cm, compatible with a 6 French sheath and an 0.014" guidewire. It consists of a lubricious coated torque shaft with a proximal handle assembly and an atraumatic distal assembly. The distal assembly of the catheter consists of an imaging assembly, a rotating cutter, and a flexible, tiltable nosecone. The catheter is sterilized by electron beam radiation and is intended for single use only. The Pantheris SV 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.

AI/ML Overview

This document is a 510(k) summary for the Pantheris SV atherectomy catheter. It describes the device, its intended use, and compares it to a predicate device and a reference device. It also details the non-clinical performance data supporting the device's substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria in a tabular format for each test. Instead, it states that the device "passed all tests" or that parameters were "ranked from 'good' to 'excellent'." No specific quantitative acceptance values are provided, as this is a 510(k) submission focused on substantial equivalence rather than a detailed performance study with pre-defined statistical endpoints for a new technology.

However, based on the Mechanical Testing and Animal Testing sections, we can infer some performance indicators:

Acceptance Criteria (Inferred from testing)	Reported Device Performance
Biocompatibility standards met	Passed all ISO 10993 tests (Cytotoxicity, Sensitization, Irritation, Material-mediated pyrogenicity, Systemic toxicity, Complement activation, Partial thromboplastin time, Platelet and leukocyte count, Hemolysis extract, Hemolysis direct)
Electrical safety standards met	Complies with IEC 60601-1
Electromagnetic compatibility (EMC) standards met	Complies with IEC 60601-1-2
Software Verification & Validation	Successfully upgraded to version 4.4.0 (for Lightbox console)
Mechanical integrity (e.g., Simulated use, working length, flush & leak, image generation, rotation, guidewire compatibility, insertion force, retraction force, cutter exposure, full 360° image, cut/pack cycles, coating integrity, life cycle, torque-proof loading, tensile strengths, functionality performance)	All mechanical tests performed at time 0 and 3 months. Implied successful completion as no issues are reported.
Animal study safety	No significant procedural adverse events, no evidence of acute vessel trauma, no evidence of thrombus, no tissue reaction (gross necropsy and histopathology).
Animal study performance (tracking, advancement, OCT clarity, orientation, MEFR)	All treatment evaluation parameters and MEFR evaluations ranked from "good" to "excellent." No thrombus visualized, no device failures.

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

Mechanical Testing: The document does not specify the exact sample size (number of catheters/units) used for each mechanical test. It lists the types of tests conducted.
Animal Testing: Two pigs were enrolled in this study.
- Data Provenance: The study was a GLP (Good Laboratory Practice) animal study. While the country isn't explicitly stated, GLP studies are typically highly regulated, and the context of an FDA submission suggests it was conducted under U.S. or comparable international standards. It is a prospective study for the purpose of demonstrating safety and performance.

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

For the animal study, the document mentions "gross necropsy and histopathology" which would typically involve qualified veterinary pathologists. However, the number of experts or their specific qualifications (e.g., board-certified veterinary pathologist with X years of experience) are not specified in this summary. The ranking of treatment evaluation parameters from "good" to "excellent" implies expert assessment, but the details are missing.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for the animal study or mechanical testing. Given the summary's content, it's likely that a single expert or a team within the company assessed the results of the animal study, but no formal adjudication process (like 2+1 or 3+1 consensus) is outlined.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "No clinical testing of the subject device was necessary." The testing involved mechanical and animal studies.

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

The Pantheris SV catheter incorporates Optical Coherence Tomography (OCT) for imaging, and the "Lightbox Console" has software (version 4.4.0). The device is characterized as "OCT-assisted orientation and imaging" with the system acting "as an adjunct to fluoroscopy." This implies human interaction/interpretation of the OCT images for directional atherectomy. Therefore, a purely standalone algorithm without human-in-the-loop performance cannot be definitively inferred from this document as the primary mode of operation. The "Imaging Capabilities" section describes the system as one to "facilitate atherectomy" and "identify clinically relevant morphologies," which suggests human interpretation of the images provided by the device.

7. The Type of Ground Truth Used

Mechanical Testing: Ground truth is established by engineering specifications, standardized test methods (e.g., BS EN 1707:1997, ISO 10555-1:2013), and direct physical measurement/observation against those specifications.
Animal Testing: Ground truth for safety was established by gross necropsy and histopathology performed by veterinary professionals (implied, though not explicitly stated as "experts"). Ground truth for performance was based on direct observation during the procedure and subsequent evaluation/ranking by the study team.

8. The Sample Size for the Training Set

This document describes a 510(k) submission for a medical device (atherectomy catheter with OCT imaging). It is not an AI/Machine Learning submission where a training set of data for an algorithm would be used in the conventional sense. The "Software Verification and Validation Testing" refers to the Lightbox component's software, but this typically involves testing the software against functional requirements and software design specifications, not training an AI model with a data set. Therefore, a "training set" as understood in AI systems is not applicable to this submission.

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

As explained in point 8, a "training set" for an AI model is not applicable to this submission. The "ground truth" for the device's functional software would be its adherence to documented software requirements and design specifications, established through V&V activities.

Summary

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the acronym "FDA" above the words "U.S. FOOD & DRUG ADMINISTRATION."

April 9th, 2019

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

Re: K182341

Trade/Device Name: Pantheris SV Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW, NQQ Dated: March 1, 2019 Received: March 6, 2019

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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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,

For

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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K182341 - 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	3 April 2019

Proposed Device

Trade Name	Pantheris SV
Common Name	Avinger Pantheris SV 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	HawkOne H1-S
Common Name	HawkOne 6 French
Premarket Notification	K161361
Regulation Number andClassification Name	21 CFR§870.4875, Intraluminal Artery Stripper
Product Code	MCW
Regulatory Class	II
Note: This predicate device has not been subject to a design-related recall.

Reference Device

Trade Name	Pantheris System
Common Name	Avinger Pantheris Catheter v1.4

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Premarket Notification	K173862
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.

Device Description

The distal assembly of the catheter consists of an imaging assembly, a rotating cutter, and a flexible, tiltable nosecone.

The catheter is sterilized by electron beam radiation and is intended for single use only.

The Pantheris SV 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 design changes cleared in K173862 and details additional minor modifications to the design of the Pantheris catheter family to add in functionality of the device.

Indications for Use

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

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Comparison of Technological Characteristics with the Predicate Device and Reference Device

Excision of plaque from small peripheral vessels through atherectomy is the technological principle for both the subject and predicate device. The OCT imaging capability of the subject device builds from the OCT imaging function of the reference device.

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

1. The intended use of the predicate device and the subject device is for atherectomy in small vessels of the peripheral vasculature;
The three devices are introduced into the body via an indwelling vascular access 2. sheath;
1. The three devices are used for directional atherectomy in peripheral vessels using a cutting head that is energized by a separately supplied driver;
The subject device is similar to the predicate device in terms of dimensions and 4. diameter of vessel in which it will be placed;
ડ. The subject device is similar to the reference device in terms of use of optical coherence tomography (OCT) for intravascular imaging: and
1. All three devices are made from biocompatible materials.

Comparison of the 6 Fr Pantheris catheter to the predicate device, the HawkOne H1-S catheter, and the reference device, the v1.4 Pantheris catheter.

	Subject Device	Predicate Device	Reference Device
	Pantheris SV(Avinger, Inc.)(This Submission)	HawkOne H1-S(Medtronic Vascular)K161361	Pantheris v1.4(Avinger, Inc)K173862
Indication for Use	The PantherisSystem is intendedto remove plaque(atherectomy)from partiallyoccluded vessels inthe peripheralvasculature with areference diameterof 2.0 mm to 4.0	The HawkOneperipheraldirectionalatherectomysystem isintended for usein atherectomyof theperipheral	The PantherisSystem is intendedto remove plaque(atherectomy) frompartially occludedvessels in theperipheralvasculature with areference diameterof 3.0 mm to 7.0

	mm, using OCT-assisted orientationand imaging. Thesystem is as anadjunct tofluoroscopy byproviding imagesof vessel lumen,wall structures andvesselmorphologies.The Pantheris SVis NOT intendedfor use in the iliac,coronary, cerebral,	vasculature.The HawkOnecatheter is NOTintended for usein the coronary,carotid, iliac, orrenalvasculature.	mm, using OCT-assisted orientationand imaging. Thesystem is as anadjunct tofluoroscopy byproviding images ofvessel lumen, wallstructures andvesselmorphologies.The PantherisSystem is NOTintended for use inthe iliac, coronary,
	renal or carotidvasculature."		cerebral, renal orcarotidvasculature."
Intended use	Remove plaque(atherectomy)from partiallyoccluded vessels inthe peripheralvasculature	Directionalatherectomy ofthe peripheralvasculature	Remove plaque(atherectomy) frompartially occludedvessels in theperipheralvasculature
TechnicalCharacteristics
Components of theSystem	CatheterLightbox ConsoleSled	CatheterCutter Driver	CatheterLightbox ConsoleSled
Imaging Modality	Optical CoherenceTomography	No ImagingModality	Optical CoherenceTomography
Imaging Energy Type	Near-infrared light	N/A	Near-infrared light
Optical Output Power	< 30 mW(Class 1M laseroutput)	N/A	< 30 mW(Class 1M laseroutput)
Optical sensitivity(signal:noise ratio)	90 db minimum	N/A	90 db minimum
Attenuation of the laserwhen the Sled driver isnot rotating	No	N/A	No
Imaging Capabilities	OCT-assistedorientation andimaging of vessel	No ImagingCapabilities	OCT-assistedorientation andimaging 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		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
Electrical Safety	Class I, Type CF, defibrillation proof IEC 60601-1	N/A	Class I, Type CF, defibrillation proof IEC 60601-1
Electromagnetic compatibility	IEC 60601-1-2	N/A	IEC 60601-1-2
Laser Safety	21 CFR Part 1040 IEC 60825	N/A	21 CFR Part 1040 IEC 60825
Software Version	V 4.4.0	N/A	V 4.2.1
Software Level of Concern	Moderate	N/A	Moderate
Sterilization method	Electron Beam Radiation	Ethylene oxide	Electron Beam Radiation
Sterility Assurance Level	$10^{-6}$	Same	Same
Biocompatibility of Materials	Meets ISO 10993 requirements	Same	Same
Operational Characteristics
Distal tip OD of the catheter	2 mm (6 Fr)	2 mm (6 Fr)	2.3 mm (7 Fr)
Tip length	4 cm	5.9 cm	6 cm
Working length of the catheter	144 cm	151 cm	116 cm
Effective length of the catheter	140 cm	145 cm	110 cm
Mechanism performing atherectomy	Cutting assembly comprised of a rotating inner	Same	Same
	blade contained within a tubular housing
Means by which the cutter head is oriented to the target tissue	Heat-set curve in the cannula of the device	Same	Inflation of a balloon adjacent to the cutter head
Guidewire compatibility	0.014 inch	Same	Same
Vascular Sheath compatibility	6 Fr	6 Fr	7 Fr
Procedure Site	Hospital Cardiac Catheter Lab Office-based Lab	Same	Same
Anatomical Site of Use	Peripheral Vasculature	Same	Same
Treatment Method	Directional Atherectomy	Same	Same
Reference Vessel Diameter	2 to 4 mm	2 to 4 mm	3 to 7 mm
The means by which plaque is removed	Cutting blade “shaves” plaque from the vessel wall and captures it in the nosecone of the deviceCutting sequence is repeated as necessary to achieve the desired degree of plaque excision	Same	Same
Provided Sterile	Yes	Yes	Yes
Single-use catheter	Yes	Yes	Yes

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Performance Data

The performance testing conducted establishes that the Pantheris SV catheter does not raise new questions of the safety and effectiveness for the Pantheris System cleared under K172236.

Biocompatibility testing

Pantheris SV catheter is manufactured from materials with a long history in medical devices and passed all tests:

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Cytotoxicity: o
Sensitization; O
Irritation; O
Material-mediated pyrogenicity; O
Systemic toxicity (acute): O
Complement (SC5b-9) activation; O
Partial thromboplastin time (PTT); o
Platelet and leukocyte count; O
Hemolysis (extract); and o
Hemolysis (direct). o

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

The software of the Lightbox component of the Pantheris System has been upgraded to version 4.4.0.

Mechanical Testing

The mechanical testing of the subject device was performed at time 0 and at 3 months and included:

. Simulated use testing;
. Working length test;
Catheter flush and leak test (following BS EN 1707:1997); ●
OCT image generation and Sled interface test; ●
. Catheter field of view test;
Distal tip rotation test; .
. Guidewire compatibility and insertion force test;
. 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;
. OCT image generation and Sled interface test;
. Full 360° image test;
Cut/Pack cycles test; ●
. Catheter Sled insertion cycles test;

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. Coating integrity (pinch) 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;
Flush lumen luer tensile strength test (following ISO 10555-1:2013); .
. Nosecone polymer tensile test;
Distal catheter joints tensile strength test (following ISO 10555-1:2013); ●
Proximal catheter joints tensile strength test (following ISO 10555-1:2013); ●
. Catheter functionality test:
. Catheter insertion performance testing;
. Catheter compatibility and insertion test;
. Catheter post-insertion check test;
. Multiple catheter insertion and excision test;
. Catheter retraction test;
. Catheter post-retraction test; and
. Catheter post-procedure check test.

Animal Testing

A GLP animal study was conducted to demonstrate the safety and performance of the Pantheris SV catheter design in arteries with a lumen diameter of 2.0 to 4.0 mm and to validate that the design fulfills the defined user needs and requirements. Two pigs were enrolled in this study-one for acute assessment and one for chronic (14 days postprocedure) assessment. A Pantheris SV catheter (test device) and HawkOne H1-S 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 in the case of the Pantheris SV, 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.

Safety of this design was demonstrated due to no significant procedural adverse events, no evidence of acute vessel trauma, no evidence of thrombus, and no tissue reaction based on gross necropsy and histopathology being present.

Data collected demonstrated that all treatment evaluation parameters and the MEFR evaluations were ranked from "good" to "excellent." No thrombus was visualized, and no device failures were reported.

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The study demonstrated that the performance and safety of the Pantheris SV design fulfills the defined user needs and requirements set forth in the study with no compromises in safety or performance when the device was used in arteries with a luminal diameter of 2.0 to 4.0 mm.

Clinical Studies

No clinical testing of the subject device was necessary.

Conclusion

The information submitted in this premarket notification confirms that the Pantheris SV catheter model raise no new questions of safety and effectiveness and that it 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).