Pantheris LV Atherectomy Catheter

K230005 · Avinger, Inc. · MCW · Jun 6, 2023 · Cardiovascular

Device Facts

• Record ID: K230005
• Device Name: Pantheris LV Atherectomy Catheter
• Applicant: Avinger, Inc.
• Product Code: MCW · Cardiovascular
• Decision Date: Jun 6, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4875
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pantheris LV System is intended to remove plaque (atherectomy) from partially occluded native or restenotic vessels, including in-stent restenosis (ISR), 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 an adjunct to fluoroscopy by providing images of vessel lumen, wall structures, and vessel morphologies. The Pantheris LV System is NOT intended for use in the iliac, coronary, cerebral, renal or carotid vasculature.

Device Story

Pantheris LV is a 7 Fr, 110 cm peripheral atherectomy catheter used in hospital/office-based cardiac catheter labs. It consists of an outer support catheter and inner rotating drive shaft/cutter assembly. The device connects to a Lightbox Imaging Console and Sled. During procedures, the physician advances the catheter through an indwelling vascular sheath to the target lesion. An integrated optical fiber provides real-time intravascular OCT imaging (360-degree sweep) to visualize vessel lumen, wall structures, and morphology, serving as an adjunct to fluoroscopy. The physician uses OCT guidance to orient the rotating cutter, which 'shaves' plaque from the vessel wall and captures it in a nosecone. This process is repeated to debulk the lesion, improving blood flow. The device is single-use and sterile.

Clinical Evidence

No clinical data was required or provided. Substantial equivalence was demonstrated through mechanical bench testing, including simulated use, OCT image generation, catheter-sheath insertion cycles, and tensile/torque strength testing. Biocompatibility was assessed via cytotoxicity testing.

Technological Characteristics

7 Fr, 110 cm atherectomy catheter; OCT imaging modality using near-infrared light (<30 mW, Class 1 laser); 360-degree imaging sweep; rotating mechanical cutter; e-beam sterilization; biocompatible materials per ISO 10993; electrical safety per IEC 60601-1; EMC per IEC 60601-1-2; software level of concern: Moderate.

Indications for Use

Indicated for plaque removal (atherectomy) in partially occluded native or restenotic peripheral vessels (including ISR) with 3.0-7.0 mm reference diameter. Contraindicated for iliac, coronary, cerebral, renal, or carotid vasculature.

Regulatory Classification

Identification

An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)

Predicate Devices

• Pantheris SV Atherectomy Catheter (K201330)

Reference Devices

• Pantheris Atherectomy Catheter (K173862)
• Pantheris Atherectomy Catheter (K212047)

Submission Summary (Full Text)

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June 6, 2023

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

Re: K230005

Trade/Device Name: Pantheris LV Atherectomy Catheter Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal artery stripper Regulatory Class: Class II Product Code: MCW, NQQ Dated: May 2, 2023 Received: May 4, 2023

Dear Thomas Lawson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Image /page/1/Picture/5 description: The image shows a digital signature. The signature is for Eleni Whatley -S. The date of the signature is 2023.06.06. The time of the signature is 12:56:40 -04'00'.

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K230005

#### Device Name

Pantheris LV Atheterctomy Catheter

#### Indications for Use (Describe)

The Pantheris LV System is indicated to remove plaque (atherectomy) from partially occluded native or restenotic vessels, including in-stent restenosis (ISR), 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 LV System is NOT intended for use in the iliac, coronary, cerebral, renal or carotid vasculature.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------|---------------------------------------------------------------------------|
| <div> <span>☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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# 510(k) SUMMARY

# General Information

| Submitter | Avinger, Inc. |
|-------------------------|-------------------------------------------------------------------------|
| Address | 400 Chesapeake Drive<br>Redwood City, CA 94063 |
| FDA Registration Number | 3007498664 |
| Correspondence Person | Thomas Lawson, PhD<br>VP, Clinical & Regulatory Affairs<br>Avinger Inc. |
| Contact Information | Email: [e-mail]<br>Phone: [phone] |
| Date Prepared | 5 June 2023 |

## Proposed Device

| Trade Name | Pantheris LV Atherectomy Catheter |
|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Common Name | Pantheris LV |
| Regulation Number and<br>Classification Name | 21 CFR§870.4875, Intraluminal Artery Stripper<br>21 CFR§892.1560, Imaging System Optical Coherence<br>Tomography (OCT) |
| Product Code | MCW, NQQ |
| Regulatory Class | II |
| NOTE: This is the first 510(k) submission for this device. | |

# Primary Predicate Device

| Trade Name | Pantheris SV Atherectomy Catheter |
|------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Common Name | Pantheris |
| Premarket Notification | K201330 |
| Regulation Number and<br>Classification Name | 21 CFR§870.4875, Intraluminal Artery Stripper<br>21 CFR§892.1560, Imaging System Optical Coherence<br>Tomography (OCT) |
| Product Code | MCW, NQQ |
| Regulatory Class | II |
| Note: This predicate device has not been subject to a design-related recall. | |

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| Trade Name | Pantheris Atherectomy Catheter |
|------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Common Name | Pantheris |
| Premarket Notification | K173862 & K212047 |
| Regulation Number and<br>Classification Name | 21 CFR§870.4875, Intraluminal Artery Stripper<br>21 CFR§892.1560, Imaging System Optical Coherence<br>Tomography (OCT) |
| Product Code | MCW, NQQ |
| Regulatory Class | II |
| Note: This reference device has not been subject to a design-related recall. | |

#### Reference Device

#### Device Description and Proposed Modifications

The Pantheris LV catheter combines the use of Avinger's optical coherence tomography (OCT) technology with peripheral vascular atherectomy capabilities. The Pantheris LV System consists of the Pantheris LV catheter, a Lightbox Sled with integrated umbilical (referred to as "Sled"), and the Lightbox Imaging Console (referred to as "Lightbox").

The subject device of this submission is a product line extension of the Pantheris SV System reviewed and cleared earlier under K182341.

The Pantheris LV catheter is a 7 French device with a working length of 110 cm. It is comprised of two components-an outer support catheter and an inner assembly or drive shaft. It is provided sterile and is a single-use device compatible with 5 Fr vascular sheaths. The Pantheris LV catheter incorporates an optical fiber that allows real-time diagnosis of vessel condition and morphology as well as OCT-guided atherectomy during the procedure with its connection to the Lightbox.

The Pantheris LV catheter is to be used in a healthcare facility, such as a cardiac catheter lab or a hospital. It is to be used and in contact with patient tissue for less than 24 hours and is made of materials that are biocompatible.

This Traditional 510(k) builds on the Pantheris SV (K182341) and Pantheris v1.4 (K173862) atherectomy catheter designs and details additional minor modifications to the design of the Pantheris catheter family to add in functionality of the device.

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#### Indications for Use

The indication for use for the Pantheris LV catheter is:

The Pantheris LV System is intended to remove plaque (atherectomy) from partially occluded native or restenotic vessels, including in-stent restenosis (ISR), 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 an adjunct to fluoroscopy by providing images of vessel lumen, wall structures, and vessel morphologies. The Pantheris LV System is NOT intended for use in the iliac, coronary, cerebral, renal or carotid vasculature.

Both the subject device and the reference device have the same intended use of debulking plaque in the lumen of peripheral arteries sized 3 to 7 mm in diameter. The subject device and predicate device are made from the same materials and use the same packaging.

# Comparison of Technological Characteristics with the Predicate and Reference Devices

Avinger Inc. has identified the Pantheris SV catheter (K182341) as the predicate device and the Pantheris v1.4 (K173862) catheter as the reference device for the Pantheris LV catheter.

The Pantheris LV catheter is substantially equivalent to the predicate device with its design of a jog in the distal segment of the cannula that results in the cutter contacting target tissue as is the design of the Pantheris SV catheter. The Pantheris LV catheter is substantially equivalent to the Pantheris v1.4 catheter in its outer diameter (7 Fr) and indications of use in peripheral vessels 3 to 7 mm in diameter.

The Pantheris LV catheter is substantially equivalent to the predicate and reference devices in its clinical utility based upon the following factors:

- The three devices are intended to be used to debulk lesions disrupting and restricting blood flow in peripheral vessels.
- · The three devices are used in cardiac catheter labs in either a hospital or an office-based lab.
- · The three devices are advanced to the target lesion through an indwelling vascular sheath.
- · Advancement of the three devices is monitored by external fluoroscopy and the catheters' on-board intravascular OCT imaging component.
- · The three devices consist of a rotating cutter that actively engages the plaque

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tissue causing removal of the occlusive tissue and a power source to cause the device rotation of the cutter and display the OCT image during the procedure.

Comparison of the Pantheris LV catheter to the Pantheris SV catheter (predicate device), and the Pantheris v1.4 catheter (reference device).

| | Predicate Device<br>Pantheris SV System<br>(Avinger, Inc.) | Reference Device<br>Pantheris System<br>(Avinger, Inc.) | Subject Device<br>Pantheris LV System<br>(Avinger, Inc.) |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| | K182341 | K173862 &<br>K212047 | (This Submission) |
| Indication for<br>Use | The Pantheris SV catheter<br>is intended to remove<br>plaque (atherectomy)<br>from partially occluded<br>vessels in the peripheral<br>vasculature with a<br>reference diameter of 2.0<br>mm to 4.0 mm, using<br>OCT-assisted orientation<br>and imaging. The system<br>is an adjunct to<br>fluoroscopy by providing<br>images of vessel lumen,<br>wall structures and vessel<br>morphologies. The<br>Pantheris SV System is<br>NOT intended for use in<br>the iliac, coronary,<br>cerebral, renal or carotid<br>vasculature. | The Pantheris System<br>is intended to remove<br>plaque (atherectomy)<br>from partially<br>occluded native or<br>restenotic vessels,<br>including in-stent<br>restenosis (ISR), in<br>the peripheral<br>vasculature with a<br>reference diameter of<br>3.0 mm to 7.0 mm,<br>using OCT-assisted<br>orientation and<br>imaging. The system<br>is an adjunct to<br>fluoroscopy by<br>providing images of<br>vessel lumen, wall<br>structures and vessel<br>morphologies. The<br>Pantheris System is<br>NOT intended for use<br>in the iliac, coronary,<br>cerebral, renal or<br>carotid vasculature. | Identical to the<br>Pantheris v1.4<br>catheter |
| Intended use | Remove plaque<br>(atherectomy) from<br>partially occluded<br>peripheral arteries | Identical | Identical |
| Contraindications | The Pantheris SV System<br>is contraindicated for use<br>in the iliac, coronary, | Identical | Identical |
| | cerebral, renal or carotid<br>vasculature. | | |
| Product Code | MCW & NQQ | Identical | Identical |
| Treatment<br>Method | Debulking of plaque<br>within the lumen of<br>peripheral arteries | Identical | Identical |
| <b>Technical<br/>Characteristics</b> | | | |
| Components of<br>the System | Catheter<br>Lightbox Imaging<br>Console<br>Sled | Identical | Identical |
| Imaging<br>Modality | Optical coherence<br>tomography | Identical | Identical |
| Imaging Energy<br>Type | Near-infrared Light | Identical | Identical |
| Optical Output<br>Power | < 30 mW<br>(Class 1 laser) | Identical | Identical |
| Optical<br>Sensitivity<br>(signal : noise<br>ratio) | 90 db minimum | Identical | Identical |
| Imaging<br>Capabilities | OCT-assisted orientation<br>and imaging of vessel<br>lumen and wall structures<br>in the peripheral<br>vasculature to facilitate<br>crossing of vessel<br>occlusions. | Identical | Identical |
| | Measurement of vessel<br>lumen by OCT | Identical | Identical |
| Electrical Safety | Class I, Type CF,<br>defibrillation proof<br>IEC 60601-1 | Identical | Identical |
| Electromagnetic<br>Compatibility | IEC 60601-1-2 | Identical | Identical |
| Laser Safety | 21 CFR Part 1040<br>IEC 60825 | Identical | Identical |
| Software Level<br>of Concern | Moderate | Identical | Identical |
| Sterilization<br>Method | e-beam irradiation | Identical | Identical |
| Sterility<br>Assurance Level | 10-6 | Identical | Identical |
| Biocompatibility<br>of Materials | Meets ISO 10993<br>requirements | Identical | Identical |
| Operational<br>Characteristics | | | |
| Outer diameter of<br>the cannula | 2 mm (6 Fr) | 2.3 mm (7 Fr) | 2.3 mm (7 Fr) |
| Tip length | 4 cm | 6 cm | 6 cm |
| Working length<br>of the catheter | 140 cm | 110 cm | 110 cm |
| Sheath<br>compatibility for<br>the catheter | 6 Fr | 7 Fr | 7 Fr |
| OCT imaging<br>sweep/window | 360 degrees | Identical | Identical |
| Mechanism<br>performing<br>atherectomy | Cutting assembly<br>comprised of a rotating<br>inner blade contained<br>within a tubular housing | Identical | Identical |
| Guidewire<br>compatibility | 0.014 inch | Identical | Identical |
| Procedure Site | Hospital Cardiac Catheter<br>Lab<br>Office-based Lab | Identical | Identical |
| Anatomical Site<br>of Use | Peripheral Vasculature | Identical | Identical |
| Reference vessel<br>diameter | 2 to 4 mm | 3 to 7 mm | 3 to 7 mm |
| Treatment<br>Method | The cutting blade<br>"shaves" plaque from the<br>vessel wall and captures<br>it in the nosecone of the<br>device.<br><br>Cutting sequence is<br>repeated as necessary to<br>achieve the desired<br>degree of plaque excision | Identical | Identical |
| Provided Sterile | Yes | Yes | Yes |
| Single-use<br>catheter | Yes | Yes | Yes |

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## Performance Data

The performance testing conducted establishes that the Pantheris LV catheter did not raise new questions of the safety and effectiveness from those reviewed and cleared in the previous atherectomy catheter submissions K182341 and K173862.

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## Biocompatibility testing

The Pantheris LV catheter is manufactured from materials with a long history in medical devices and that are used in the Pantheris SV catheter (K182341), which were tested under 10993-1. As a result, the full biocompatibility suite of tests is not necessary; however, the Pantheris LV catheter was assessed with the cytotoxicity test and found to be noncytotoxic.

## Electrical safety and electromagnetic compatibility (EMC)

The subject and predicate devices comply with IEC 60601-1 standard for safety and the IEC 60601-1-2 standard for EMC, as reviewed in K182341 (for the L250 console) and K212468 (for the L300 console).

# Mechanical Testing

The mechanical testing of the subject device 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 ●
- Packed position life cycle test .
- Active position life cycle test ●
- Torque shaft torque-proof loading test
- Driveshaft torque-proof loading test ●
- . Guidewire lumen peel strength-proof loading test

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- Proximal section torque shaft torque test .
- Flush lumen luer tensile strength test (following ISO 10555-1:2013) ●
- Distal catheter joints tensile strength test (following ISO 10555-1:2013)
- Proximal catheter joints tensile strength test (following ISO 10555-1:2013). .

## Animal Testing

Preclinical (animal) testing of the subject device was not necessary. The testing that was completed was sufficient to demonstrate substantial equivalence of this model of Avinger's atherectomy catheters.

## Clinical Studies

Clinical testing of the subject device was not necessary. The testing that was completed was sufficient to demonstrate substantial equivalence of this model of Avinger's atherectomy catheters.

## Conclusion

The information submitted in this premarket notification confirms that the extension of the Pantheris Family of Atherectomy Catheters to now include the Pantheris LV catheter raises no new questions of safety and effectiveness and that the Pantheris LV catheter is

substantially equivalent to the predicate device.