Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical atherectomy device with OCT imaging for guidance. There is no mention of AI or ML in the device description, intended use, or performance studies. The focus is on the mechanical removal of plaque and the use of OCT for visualization.

Therapeutic

Yes
The device is intended to remove plaque from occluded vessels, which is a therapeutic intervention aimed at treating a medical condition.

Diagnostic

No

Explanation: The device is primarily intended for plaque removal (atherectomy). While it uses OCT-assisted imaging for orientation and supplemental to fluoroscopy, its core function is interventional, not diagnostic. The imaging is used to guide the therapeutic procedure, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description clearly details a physical catheter with mechanical components (rotating cutter, flexible nosecone) and is intended for physical intervention (plaque removal). It is not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to remove plaque from blood vessels in the peripheral vasculature. This is a therapeutic procedure performed directly on the patient's body.
Device Description: The device is a catheter designed for physical intervention within the body.
Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide diagnostic information.
Anatomical Site: The device is used within the peripheral vasculature, which is inside the patient.
Performance Studies: The performance studies involve animal testing and focus on the device's ability to remove plaque and its safety within the vessel, not on its ability to diagnose a condition from a sample.

IVD devices are used to examine specimens obtained from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device is a therapeutic device used for a physical intervention within the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

MCW, NQQ

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.

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.

Mentions image processing

OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen, wall structures and vessel morphologies.

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Optical Coherence Tomography

Anatomical Site

Peripheral Vasculature

Indicated Patient Age Range

Not Found

Intended User / Care Setting

healthcare facility, such as a cardiac catheter lab or a hospital.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K161361

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K173862

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

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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

2

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 Drive
Redwood City, CA 94063
FDA Registration Number	3007498664
Correspondence Person	Thomas Lawson, PhD
Vice President, Clinical & Regulatory Affairs
Avinger Inc.
Contact Information	Email: tlawson@avinger.com
Phone: 510-206-1794
Date Prepared	3 April 2019

Proposed Device

Trade Name	Pantheris SV
Common Name	Avinger Pantheris SV catheter
Regulation Number and
Classification Name	21 CFR§870.4875, Intraluminal Artery Stripper
21 CFR§892.1560, Ultrasonic Pulsed Echo Imaging
System
Product Code	MCW, NQQ
Regulatory Class	II

Predicate Device

Trade Name	HawkOne H1-S
Common Name	HawkOne 6 French
Premarket Notification	K161361
Regulation Number and
Classification 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 and
Classification Name	21 CFR§870.4875, Intraluminal Artery Stripper
21 CFR§892.1560, Ultrasonic Pulsed Echo Imaging
System
Product Code	MCW, NQQ
Regulatory Class	II
Note: This reference device has not been subject to a design-related recall.

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.

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

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.

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 Pantheris
System 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	The HawkOne
peripheral
directional
atherectomy
system is
intended for use
in atherectomy
of the
peripheral	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 to 7.0

	mm, 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 SV
is NOT intended
for use in the iliac,
coronary, cerebral,	vasculature.
The HawkOne
catheter is NOT
intended for use
in the coronary,
carotid, iliac, or
renal
vasculature.	mm, 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,
	renal or carotid
vasculature."		cerebral, renal or
carotid
vasculature."
Intended use	Remove plaque
(atherectomy)
from partially
occluded vessels in
the peripheral
vasculature	Directional
atherectomy of
the peripheral
vasculature	Remove plaque
(atherectomy) from
partially occluded
vessels in the
peripheral
vasculature
Technical
Characteristics
Components of the
System	Catheter
Lightbox Console
Sled	Catheter
Cutter Driver	Catheter
Lightbox Console
Sled
Imaging Modality	Optical Coherence
Tomography	No Imaging
Modality	Optical Coherence
Tomography
Imaging Energy Type	Near-infrared light	N/A	Near-infrared light
Optical Output Power	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 device

Cutting 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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7

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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:

9

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;

10

. 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.

11

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.