Pantheris SV
Device Facts
| Record ID | K182341 |
|---|---|
| Device Name | Pantheris SV |
| Applicant | Avinger, Inc. |
| Product Code | MCW · Cardiovascular |
| Decision Date | Apr 9, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.4875 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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.
Device Story
Pantheris SV is a monorail directional atherectomy catheter; used in hospital cardiac catheter labs or office-based labs by physicians. Device inputs include OCT signals (near-infrared light) for vessel imaging; mechanical rotation for plaque excision. System comprises catheter, Lightbox console, and Sled driver. Physician uses OCT images as adjunct to fluoroscopy to orient the rotating cutter head toward target plaque; cutter shaves plaque and captures it in distal nosecone. Device provides real-time visualization of vessel lumen and wall structures; aids in identifying morphologies and assessing lesions. Benefits include precise, image-guided plaque removal in small peripheral vessels. Device is single-use; compatible with 6 Fr sheath and 0.014" guidewire.
Clinical Evidence
No clinical data. Evidence includes bench testing (mechanical, electrical, EMC, biocompatibility) and a GLP animal study (n=2 pigs, acute and 14-day chronic). Animal study validated tracking, OCT image clarity, and plaque excision capability in 2.0-4.0 mm vessels; results ranked 'good' to 'excellent' with no thrombus or adverse events.
Technological Characteristics
Monorail catheter (144 cm length, 6 Fr compatible). Materials: biocompatible, ISO 10993 compliant. Imaging: OCT (near-infrared, <30 mW, 90 dB sensitivity). Energy: Electron beam sterilization; electrical driver for cutter. Connectivity: Lightbox console interface. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), 21 CFR 1040/IEC 60825 (laser safety), BS EN 1707:1997 (flush/leak), ISO 10555-1:2013 (tensile).
Indications for Use
Indicated for plaque removal (atherectomy) in partially occluded peripheral vessels (2.0 mm to 4.0 mm diameter) using OCT-assisted imaging. Not 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
- HawkOne H1-S (K161361)
Reference Devices
- Pantheris System (K173862)
Submission Summary (Full Text)
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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
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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 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: tlawson@avinger.com<br>Phone: 510-206-1794 |
| Date Prepared | 3 April 2019 |
### Proposed Device
| Trade Name | Pantheris SV |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Common Name | Avinger Pantheris SV 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 | HawkOne H1-S |
|------------------------------------------------------------------------------|-----------------------------------------------|
| Common Name | HawkOne 6 French |
| Premarket Notification | K161361 |
| Regulation Number and<br>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<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 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;
- 3. 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
- 6. 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<br>(Avinger, Inc.)<br>(This Submission) | HawkOne H1-S<br>(Medtronic Vascular)<br>K161361 | Pantheris v1.4<br>(Avinger, Inc)<br>K173862 |
| Indication for Use | The Pantheris<br>System is intended<br>to remove plaque<br>(atherectomy)<br>from partially<br>occluded vessels in<br>the peripheral<br>vasculature with a<br>reference diameter<br>of 2.0 mm to 4.0 | The HawkOne<br>peripheral<br>directional<br>atherectomy<br>system is<br>intended for use<br>in atherectomy<br>of the<br>peripheral | The Pantheris<br>System is intended<br>to remove plaque<br>(atherectomy) from<br>partially occluded<br>vessels in the<br>peripheral<br>vasculature with a<br>reference diameter<br>of 3.0 mm to 7.0 |
| | | | |
| | mm, using OCT-<br>assisted orientation<br>and imaging. The<br>system is as an<br>adjunct to<br>fluoroscopy by<br>providing images<br>of vessel lumen,<br>wall structures and<br>vessel<br>morphologies.<br>The Pantheris SV<br>is NOT intended<br>for use in the iliac,<br>coronary, cerebral, | vasculature.<br>The HawkOne<br>catheter is NOT<br>intended for use<br>in the coronary,<br>carotid, iliac, or<br>renal<br>vasculature. | mm, using OCT-<br>assisted orientation<br>and imaging. The<br>system is as an<br>adjunct to<br>fluoroscopy by<br>providing images of<br>vessel lumen, wall<br>structures and<br>vessel<br>morphologies.<br>The Pantheris<br>System is NOT<br>intended for use in<br>the iliac, coronary, |
| | renal or carotid<br>vasculature." | | cerebral, renal or<br>carotid<br>vasculature." |
| Intended use | Remove plaque<br>(atherectomy)<br>from partially<br>occluded vessels in<br>the peripheral<br>vasculature | Directional<br>atherectomy of<br>the peripheral<br>vasculature | Remove plaque<br>(atherectomy) from<br>partially occluded<br>vessels in the<br>peripheral<br>vasculature |
| Technical<br>Characteristics | | | |
| Components of the<br>System | Catheter<br>Lightbox Console<br>Sled | Catheter<br>Cutter Driver | Catheter<br>Lightbox Console<br>Sled |
| Imaging Modality | Optical Coherence<br>Tomography | No Imaging<br>Modality | Optical Coherence<br>Tomography |
| Imaging Energy Type | Near-infrared light | N/A | Near-infrared light |
| Optical Output Power | < 30 mW<br>(Class 1M laser<br>output) | N/A | < 30 mW<br>(Class 1M laser<br>output) |
| Optical sensitivity<br>(signal:noise ratio) | 90 db minimum | N/A | 90 db minimum |
| Attenuation of the laser<br>when the Sled driver is<br>not rotating | No | N/A | No |
| Imaging Capabilities | OCT-assisted<br>orientation and<br>imaging of vessel | No Imaging<br>Capabilities | OCT-assisted<br>orientation and<br>imaging of vessel |
| | | | |
| | lumen and wall structures in the peripheral vasculature to facilitate atherectomy.<br>Identify clinically relevant morphologies and assess complex lesions in the peripheral vasculature.<br>Differentiate and classify plaque | | lumen and wall structures in the peripheral vasculature to facilitate atherectomy.<br>Identify clinically relevant morphologies and assess complex lesions in the peripheral vasculature.<br>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 |
| <b>Operational Characteristics</b> | | | |
| 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<br><br>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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# 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.
