Pantheris System

K173862 · Avinger, Inc. · MCW · May 22, 2018 · Cardiovascular

Device Facts

• Record ID: K173862
• Device Name: Pantheris System
• Applicant: Avinger, Inc.
• Product Code: MCW · Cardiovascular
• Decision Date: May 22, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4875
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Pantheris System performs OCT-guided directional atherectomy in peripheral vasculature. System comprises sterile single-use catheter, Lightbox Sled, and Lightbox HS Imaging Console. Catheter incorporates optical fiber for real-time OCT imaging of vessel lumen, wall structures, and morphology; cutter component excises plaque; nosecone packs excised tissue. Physician operates device in cardiac catheter lab or hospital. Lightbox console processes optical signals, displaying real-time images on monitors. Clinician uses OCT visualization to orient cutter toward plaque, facilitating precise excision while avoiding healthy tissue. System provides real-time guidance, potentially improving procedural accuracy and patient outcomes compared to fluoroscopy alone.

Clinical Evidence

No clinical testing performed. Evidence consists of bench testing (biocompatibility, mechanical, electrical safety, EMC) and a GLP animal study (two Yorkshire swine) assessing tracking, imaging clarity, and minimum effective flow rate. Animal study results ranked performance as good to excellent; one minor perforation occurred, deemed clinically insignificant.

Technological Characteristics

Materials: Pebax, Nylon 12, biocompatible polymers. Sensing: Optical Coherence Tomography (OCT) using near-infrared light. Energy: <30 mW optical output (Class 1M laser). Dimensions: 110 cm working length, 7 Fr diameter, 0.014" guidewire compatible. Connectivity: PC-based processing system. Sterilization: Sterile, single-use. Software: Moderate level of concern, rule-based/processing algorithms for OCT image reconstruction.

Indications for Use

Indicated for plaque removal (atherectomy) in partially occluded peripheral vessels (3.0mm-7.0mm diameter) as an adjunct to fluoroscopy. Contraindicated for use in 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 System (K172236)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 Drive<br>Redwood City, CA 94063 |
| FDA Registration Number | 3007498664 |
| Correspondence Person | Thomas Lawson, PhD<br>Vice President, Clinical & Regulatory Affairs<br>Avinger Inc. |
| Contact Information | Email: [e-mail]<br>Phone: [phone] |
| Date Prepared | 21 May 2018 |

# Proposed Device

| Trade Name | Pantheris System |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Common Name | Avinger Pantheris Catheter |
| Regulation Number and<br>Classification Name | 21 CFR§870.4875, Intraluminal Artery Stripper<br>21 CFR§892.1560, Ultrasonic Pulsed Echo Imaging<br>System |
| Product Code | MCW, NQQ |
| Regulatory Class | II |

# Predicate Device

| Trade Name | Pantheris System |
|------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Common Name | Avinger Pantheris Catheter 7Fr |
| Premarket Notification | K172236 |
| Regulation Number and<br>Classification Name | 21 CFR§870.4875, Intraluminal Artery Stripper<br>21 CFR§892.1560, Ultrasonic Pulsed Echo Imaging<br>System |
| 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:

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.

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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

| Technological<br>Characteristic | Pantheris Catheter<br>Predicate Device<br>K172236 | Pantheris Catheter<br>Subject Device of this<br>Submission |
|---------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| Indication for Use | The Pantheris System is<br>intended to remove plaque<br>(atherectomy) from partially<br>occluded vessels in the<br>peripheral vasculature with a<br>reference diameter of 3.0 mm<br>to 7.0 mm, using OCT-<br>assisted orientation and<br>imaging. The system is as an<br>adjunct to fluoroscopy by | Same |
| | providing images of vessel<br>lumen, wall structures and<br>vessel morphologies.<br>The Pantheris System is NOT<br>intended for use in the iliac,<br>coronary, cerebral, renal or<br>carotid vasculature." | Same |
| Anatomical Site of Use | Peripheral Vasculature | Same |
| Components of the | Lightbox console<br>Sled<br>Pantheris Catheter | Same |
| Balloons on the cannula | Apposition Balloon<br>Occlusion Balloon | Apposition Balloon only |
| Cutter design | Scalloped edge | Petal edge |
| Depth markings on the<br>cannula 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 Coherence<br>Tomography | Same |
| Imaging Energy Type | Near-infrared light | Same |
| Optical Output Power | < 30 mW<br>(Class 1M laser output) | Same |
| Optical sensitivity<br>(signal:noise ratio) | 90 db minimum | Same |
| Attenuation of the laser<br>when the Sled driver is<br>not rotating | Yes | Yes |
| Imaging Capabilities | OCT-assisted orientation<br>and imaging of vessel<br>lumen and wall structures<br>in the peripheral<br>vasculature to facilitate<br>atherectomy.<br>Identify clinically relevant<br>morphologies and assess<br>complex lesions in the<br>peripheral vasculature.<br>Differentiate and classify<br>plaque. | Same |
| Electrical Safety | Class I, Type CF,<br>defibrillation proof<br>IEC 60601-1 | Same |
| Electromagnetic<br>compatibility | IEC 60601-1-2 | Same |
| Laser Safety | 21 CFR Part 1040<br>IEC 60825 | Same |
| Software Level of<br>Concern | Moderate | Same |
| Sheath compatibility for<br>the catheter | 7 Fr & 8 Fr | Same |
| Working length of the<br>catheter | 110 cm | Same |
| Guidewire compatibility<br>of the catheter | 0.014 in | Same |
| Distal tip OD of the<br>catheter | 0.100 (7 Fr)<br>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.