(154 days)
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.
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 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.
This document is a 510(k) summary for the Pantheris LV Atherectomy Catheter. It outlines the device's indications for use, compares it to predicate and reference devices, and describes the performance data used to demonstrate substantial equivalence.
Based on the provided text, the Pantheris LV Atherectomy Catheter is not an AI/ML enabled device. This conclusion is drawn from the following observations:
- Absence of AI/ML terminology: The document does not mention any terms typically associated with AI or machine learning, such as "algorithm," "model," "deep learning," "neural network," "AI assistance," "inference," "training data," "validation data," "ground truth establishment" for algorithms, or "performance metrics" relevant to AI (e.g., sensitivity, specificity, AUC for an AI-driven diagnostic).
- Focus on mechanical and optical characteristics: The device description and performance data sections primarily detail mechanical properties, optical coherence tomography (OCT) imaging capabilities (which are optical imaging not AI-driven image interpretation), electrical safety, electromagnetic compatibility, and biocompatibility.
- Comparison to existing devices based on physical design: The substantial equivalence argument relies heavily on comparing the Pantheris LV's physical design attributes (e.g., catheter size, tip length, working length, mechanism of atherectomy) and shared operational characteristics with existing cleared devices, rather than any advanced computational functionalities.
- Nature of the device: The device is described as an "atherectomy catheter" used to "remove plaque." Its functionality involves physical plaque removal assisted by OCT imaging for guidance, not AI-driven diagnosis, interpretation, or decision-making. The OCT is explicitly stated as "OCT-assisted orientation and imaging" and "an adjunct to fluoroscopy by providing images of vessel lumen, wall structures, and vessel morphologies," referring to human interpretation of these images, not AI analysis of them.
- Lack of AI-specific study types: The "Performance Data" section details mechanical, electrical, and biocompatibility testing. There is no mention of studies that would be typical for an AI/ML device, such as those evaluating diagnostic accuracy (e.g., standalone performance, MRMC studies, reader studies). The sections on "Animal Testing" and "Clinical Studies" explicitly state they "were not necessary" for this particular submission, further indicating the absence of complex data-driven (AI) performance validation.
Therefore, the request to describe acceptance criteria and study data for an AI/ML device is not applicable to the Pantheris LV Atherectomy Catheter based on this document. The provided text does not contain information related to AI/ML acceptance criteria or studies.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
General Information
| Submitter | Avinger, Inc. |
|---|---|
| Address | 400 Chesapeake DriveRedwood City, CA 94063 |
| FDA Registration Number | 3007498664 |
| Correspondence Person | Thomas Lawson, PhDVP, Clinical & Regulatory AffairsAvinger Inc. |
| Contact Information | Email: tlawson@avinger.comPhone: 510-206-1794 |
| Date Prepared | 5 June 2023 |
Proposed Device
| Trade Name | Pantheris LV Atherectomy Catheter |
|---|---|
| Common Name | Pantheris LV |
| Regulation Number andClassification Name | 21 CFR§870.4875, Intraluminal Artery Stripper21 CFR§892.1560, Imaging System Optical CoherenceTomography (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 andClassification Name | 21 CFR§870.4875, Intraluminal Artery Stripper21 CFR§892.1560, Imaging System Optical CoherenceTomography (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 andClassification Name | 21 CFR§870.4875, Intraluminal Artery Stripper21 CFR§892.1560, Imaging System Optical CoherenceTomography (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 DevicePantheris SV System(Avinger, Inc.) | Reference DevicePantheris System(Avinger, Inc.) | Subject DevicePantheris LV System(Avinger, Inc.) | |
|---|---|---|---|
| K182341 | K173862 &K212047 | (This Submission) | |
| Indication forUse | The Pantheris SV catheteris intended to removeplaque (atherectomy)from partially occludedvessels in the peripheralvasculature with areference diameter of 2.0mm to 4.0 mm, usingOCT-assisted orientationand imaging. The systemis an adjunct tofluoroscopy by providingimages of vessel lumen,wall structures and vesselmorphologies. ThePantheris SV System isNOT intended for use inthe iliac, coronary,cerebral, renal or carotidvasculature. | The Pantheris Systemis intended to removeplaque (atherectomy)from partiallyoccluded native orrestenotic vessels,including in-stentrestenosis (ISR), inthe peripheralvasculature with areference diameter of3.0 mm to 7.0 mm,using OCT-assistedorientation andimaging. The systemis an adjunct tofluoroscopy byproviding images ofvessel lumen, wallstructures and vesselmorphologies. ThePantheris System isNOT intended for usein the iliac, coronary,cerebral, renal orcarotid vasculature. | Identical to thePantheris v1.4catheter |
| Intended use | Remove plaque(atherectomy) frompartially occludedperipheral arteries | Identical | Identical |
| Contraindications | The Pantheris SV Systemis contraindicated for usein the iliac, coronary, | Identical | Identical |
| cerebral, renal or carotidvasculature. | |||
| Product Code | MCW & NQQ | Identical | Identical |
| TreatmentMethod | Debulking of plaquewithin the lumen ofperipheral arteries | Identical | Identical |
| TechnicalCharacteristics | |||
| Components ofthe System | CatheterLightbox ImagingConsoleSled | Identical | Identical |
| ImagingModality | Optical coherencetomography | Identical | Identical |
| Imaging EnergyType | Near-infrared Light | Identical | Identical |
| Optical OutputPower | < 30 mW(Class 1 laser) | Identical | Identical |
| OpticalSensitivity(signal : noiseratio) | 90 db minimum | Identical | Identical |
| ImagingCapabilities | OCT-assisted orientationand imaging of vessellumen and wall structuresin the peripheralvasculature to facilitatecrossing of vesselocclusions. | Identical | Identical |
| Measurement of vessellumen by OCT | Identical | Identical | |
| Electrical Safety | Class I, Type CF,defibrillation proofIEC 60601-1 | Identical | Identical |
| ElectromagneticCompatibility | IEC 60601-1-2 | Identical | Identical |
| Laser Safety | 21 CFR Part 1040IEC 60825 | Identical | Identical |
| Software Levelof Concern | Moderate | Identical | Identical |
| SterilizationMethod | e-beam irradiation | Identical | Identical |
| SterilityAssurance Level | 10-6 | Identical | Identical |
| Biocompatibilityof Materials | Meets ISO 10993requirements | Identical | Identical |
| OperationalCharacteristics | |||
| Outer diameter ofthe cannula | 2 mm (6 Fr) | 2.3 mm (7 Fr) | 2.3 mm (7 Fr) |
| Tip length | 4 cm | 6 cm | 6 cm |
| Working lengthof the catheter | 140 cm | 110 cm | 110 cm |
| Sheathcompatibility forthe catheter | 6 Fr | 7 Fr | 7 Fr |
| OCT imagingsweep/window | 360 degrees | Identical | Identical |
| Mechanismperformingatherectomy | Cutting assemblycomprised of a rotatinginner blade containedwithin a tubular housing | Identical | Identical |
| Guidewirecompatibility | 0.014 inch | Identical | Identical |
| Procedure Site | Hospital Cardiac CatheterLabOffice-based Lab | Identical | Identical |
| Anatomical Siteof Use | Peripheral Vasculature | Identical | Identical |
| Reference vesseldiameter | 2 to 4 mm | 3 to 7 mm | 3 to 7 mm |
| TreatmentMethod | The cutting blade"shaves" plaque from thevessel wall and capturesit in the nosecone of thedevice.Cutting sequence isrepeated as necessary toachieve the desireddegree of plaque excision | Identical | Identical |
| Provided Sterile | Yes | Yes | Yes |
| Single-usecatheter | 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.
§ 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).