(97 days)
No
The summary describes a device that uses OCT imaging and a PC-based processing system for visualization, but there is no mention of AI or ML being used for image analysis, decision support, or any other function. The focus is on real-time OCT guidance and atherectomy.
Yes
The device is intended to remove plaque (atherectomy) from partially occluded vessels, which is a therapeutic intervention.
No
Explanation: The device is primarily an atherectomy system intended to remove plaque. Although it uses OCT for guidance and imaging, its core function is therapeutic (plaque removal), not solely diagnostic. The imaging is an "adjunct to fluoroscopy" and provides "real-time OCT guided directional atherectomy," indicating its role in facilitating the therapeutic procedure rather than providing a stand-alone diagnosis.
No
The device description explicitly details multiple hardware components including a catheter, sled, and console, in addition to software.
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 using atherectomy, guided by OCT imaging. This is a therapeutic and imaging procedure performed directly on the patient's body.
- Device Description: The device is a system that includes a catheter inserted into the body, an optical system for imaging within the body, and a console for processing and displaying those images. This is consistent with an in vivo (within the living body) device.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not analyze specimens taken from the body.
The Pantheris System is an interventional medical device used for treatment and imaging directly within the patient's peripheral vasculature.
N/A
Intended Use / Indications for Use
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, 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 System is NOT intended for use in the iliac, coronary, cerebral, renal or carotid vasculature.
Product codes
MCW, NQQ
Device Description
The Pantheris System (cleared initially under K152275) combines the use of Avinger's optical coherence tomography (OCT) technology with peripheral vascular atherectomy 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 comes in both a 7Fr and an 8Fr size. Both sizes have a working length of 110 cm and are sterile, single-use devices that are compatible with 7 and 8F sheaths (respectively) and 0.014" guidewires. The Pantheris Catheter incorporates an Optical Fiber that allows for real-time OCT guided directional atherectomy during the procedure.
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.
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 of K162326 for the Pantheris system was focused solely on a change in the system software that permits the use of OCT images to identify vessel lumen, wall structures, and vessel morphologies.
This Special 510(k) details modifications to improve manufacturing compatibility, modify accessories that have no direct patient contact, and describes a patch of the system software that allows the attenuation of the laser whenever the drive in the Sled is not rotating.
Mentions image processing
Yes
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
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 K163264.
Biocompatibility testing:
There are no changes in patient-contacting materials in the subject device when compared to the predicate device. The only material change is to an accessory provided with the device, a pair of tweezers, which were nylon in the predicate device and in the subject device are stainless steel. The stainless steel tweezers do not have direct patient contact, but were subjected nonetheless to the following testing and passed all tests:
- Cytotoxicity
- Sensitization
- Irritation
- Systemic toxicity.
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:
Software verification and validation testing, as well as regression testing, were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. The software for this device is considered as a "moderate" level of concern.
Mechanical Testing:
The mechanical testing of the subject device included:
- Sheath insertion cycle test
- Destructive balloon burst test
- Torque capacity
- Leak evaluation
- Bond joint tensile strength
- Life-cycle tests:
- 8-month accelerated shelf life study
- Simulated use testing
- Corrosion testing
- Heat generation testing
- Rotational speed testing
- Dimensional verification
- Balloon inflation/deflation cycle test
- Plaque removal efficiency
- Flushing tool capacity.
(device historical data/information was provided to support the test conclusions)
Animal Testing: No preclinical testing of the modifications of the subject device was necessary.
Clinical Studies: No clinical testing of the modifications of the subject device was necessary.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
October 30, 2017
Avinger, Inc. Thomas Lawson Director, Regulatory and Clinical Affairs 400 Chesapeake Drive Redwood City, California 94063
Re: K172236
Trade/Device Name: Pantheris System Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW, NQQ Dated: September 29, 2017 Received: October 2, 2017
Dear Mr. 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Kenneth J. Cavanaugh - S
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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Indications for Use
510(k) Number (if known) K172236
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 3.0 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 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 Drive |
| Redwood City, CA 94063 | |
| FDA Registration Number | 3007498664 |
| Correspondence Person | Thomas Lawson, PhD |
| Director, Clinical & Regulatory Affairs | |
| Avinger Inc. | |
| Contact Information | Email: tlawson@avinger.com |
| Phone: 510-206-1794 | |
| Date Prepared | 29 September 2017 |
Proposed Device
| Trade Name | Pantheris System |
|---|---|
| Common Name | Avinger Pantheris 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 | Pantheris System |
|---|---|
| Common Name | Avinger Pantheris Catheter |
| Premarket Notification | K162326 |
| 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 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
4
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 comes in both a 7Fr and an 8Fr size. Both sizes have a working length of 110 cm and are sterile, single-use devices that are compatible with 7 and 8F sheaths (respectively) and 0.014" guidewires. The Pantheris Catheter incorporates an Optical Fiber that allows for real-time OCT guided directional atherectomy during the procedure.
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.
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 of K162326 for the Pantheris system was focused solely on a change in the system software that permits the use of OCT images to identify vessel lumen, wall structures, and vessel morphologies.
This Special 510(k) details modifications to improve manufacturing compatibility, modify accessories that have no direct patient contact, and describes a patch of the system software that allows the attenuation of the laser whenever the drive in the Sled is not rotating.
Indications for Use
The indications for use for the Pantheris System cleared under K163264 is not altered due to the software and other modifications disclosed in this submission:
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.
5
Both the subject device and the predicate device have the same intended use for 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 only technological difference is that the patch release of the software in the subject device allows the attenuation of the laser whenever the drive in the Sled is not rotating. In the predicate device, the laser is not stopped when the drive is not rotating.
Summary of Technological Characteristics of the Subject Device Compared to Those of the Predicate Device
| Technological
Characteristic | Pantheris Catheter
Predicate Device
K162326 | Pantheris Catheter
Subject Device of this
Submission |
|---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| 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 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 | Same |
| | lumen, wall structures and vessel morphologies.
The Pantheris System is NOT intended for use in the iliac, coronary, cerebral, renal or carotid vasculature." | Same |
| Anatomical Site of Use | Peripheral Vasculature | Same |
| Components of the System | Lightbox console
Sled
Pantheris Catheter | Same |
| Imaging Modality | Optical Coherence Tomography | Same |
| Imaging Energy Type | Near-infrared light | Same |
| Optical Output Power |