(63 days)
Not Found
No
The summary describes a device that uses OCT for real-time visualization and a PC-based processing system to interpret the signal, but there is no mention of AI or ML being used for image analysis, decision support, or any other function. The processing appears to be standard signal interpretation and visualization.
Yes
The device is intended to remove plaque (atherectomy) from partially occluded vessels, which is a direct treatment for a medical condition.
No
The intended use of the Pantheris System is to remove plaque (atherectomy). While it uses OCT for orientation, its primary function is therapeutic (plaque removal), not diagnostic interpretation for disease identification or characterization.
No
The device description clearly outlines multiple hardware components including a catheter, sled, umbilical, and imaging console, in addition to the software for image processing.
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. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a catheter-based system designed for atherectomy (plaque removal) and uses OCT for guidance during the procedure. It interacts directly with the patient's anatomy.
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
The Pantheris System performs a therapeutic intervention within the body, guided by imaging. It does not analyze specimens taken from the body.
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 as an adjunct to fluoroscopy.
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 consists of the Pantheris Catheter (packaged with the Flush Fixture), Lightbox Sled (referred to as Sled), the Lightbox HS Imaging Console, the Lightbox Umbilical (referred to as Umbilical), Sterile Drape (accessory) and the Occlusion Sheath (optional accessory). The Pantheris System combines the use of Avinger's Optical Coherence Tomography (OCT) technology with peripheral vascular atherectomy capabilities.
The Pantheris Catheter has a working length of 130 cm and is a sterile, singleuse device that is compatible with 8F sheaths and 0.014" guidewires. The Pantheris Catheter consists of an imaging assembly, a rotating cutter, an apposition mechanism (balloon) and a flexible, tiltable nosecone. It also incorporates an Optical Fiber that allows for real-time OCT guided directional atherectomy during the procedure. The Pantheris Catheter and optional Occlusion Sheath accessory are provided sterile and are intended for single-use only.
The Pantheris Catheter is connected to the Lightbox HS Imaging Console via the Sled and the Umbilical. The Sled provides optical and rotational power to the Pantheris Catheter. The Umbilical is a 3-meter long optical and electrical extension cable that connects the Sled to the Lightbox HS Imaging Console.
The Lightbox HS Imaging Console 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 PC-based processing system. The Lightbox provides a visualization platform that allows for real-time OCT-assisted directional atherectomy. The Lightbox HS Imaging Console consists of a cart with two monitors; a PC based processing system, an isolation transformer and an OCT system.
Mentions image processing
The Lightbox HS Imaging Console 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 PC-based processing system. The Lightbox provides a visualization platform that allows for real-time OCT-assisted directional atherectomy.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical Coherence Tomography (OCT), fluoroscopy
Anatomical Site
Peripheral vasculature (excluding iliac, coronary, cerebral, renal or carotid vasculature).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
Study Type: Clinical trial (VISION Study), prospective, multi-center, non-randomized study.
Sample Size: 162 subjects enrolled (134 subjects in the Intention-To-Treat (ITT) Cohort and 28 subjects in the Roll-In Cohort). Primary focus on 130 Per Protocol Cohort subjects.
Standalone Performance: The Pantheris System successfully excised plaque below the prespecified target stenosis of ≤ 50% in 96% (158/164) of lesions treated.
Key Results:
Primary effectiveness endpoint: technical success, defined as the percent of target lesions that have a residual diameter stenosis
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure, represented by three overlapping profiles, positioned to the right of the department's name. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 14, 2015
Avinger, Inc. c/o Ms. Patty Hevev Vice President, Clinical and Regulatory Affairs 400 Chesapeake Drive Redwood City, CA 94063
Re: K152275
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: August 11, 2015 Received: August 12, 2015
Dear Ms. Hevey:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance 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.
of Surveillance and Biometrics/Division of Postmarket Surveillance.
Sincerely yours,
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) K152275
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 as an adjunct to fluoroscopy.
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 1.0
510(k) Notification K152275
GENERAL INFORMATION
Applicant:
Avinger, Inc. 400 Chesapeake Drive Redwood City, CA 94063 U.S.A. Phone: 650-241-7900 Fax: 650-241-7901
Contact Person:
Patty Hevey Vice President, Clinical and Regulatory Affairs Avinger, Inc. Phone: 650-222- 3666 Fax: 650-241-7901
Date Prepared:
August 11th, 2015
DEVICE INFORMATION
Trade Name:
Pantheris System
Generic/Common Name:
Peripheral Atherectomy Catheter
Classification:
21 CFR§870.4875, Intraluminal Artery Stripper, Class II 21 CFR$892.1560, Ultrasonic Pulsed Echo Imaging System, Class II
Product Codes:
MCW, NQQ
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PREDICATE DEVICES
- Medtronic, Inc. (formerly Fox Hollow Technologies) SilverHawk Peripheral . Plaque Excision System (K061188)
- . Avinger Ocelot System (K140185)
DEVICE DESCRIPTION
The Pantheris System consists of the Pantheris Catheter (packaged with the Flush Fixture), Lightbox Sled (referred to as Sled), the Lightbox HS Imaging Console, the Lightbox Umbilical (referred to as Umbilical), Sterile Drape (accessory) and the Occlusion Sheath (optional accessory). The Pantheris System combines the use of Avinger's Optical Coherence Tomography (OCT) technology with peripheral vascular atherectomy capabilities.
The Pantheris Catheter has a working length of 130 cm and is a sterile, singleuse device that is compatible with 8F sheaths and 0.014" guidewires. The Pantheris Catheter consists of an imaging assembly, a rotating cutter, an apposition mechanism (balloon) and a flexible, tiltable nosecone. It also incorporates an Optical Fiber that allows for real-time OCT guided directional atherectomy during the procedure. The Pantheris Catheter and optional Occlusion Sheath accessory are provided sterile and are intended for single-use only.
The Pantheris Catheter is connected to the Lightbox HS Imaging Console via the Sled and the Umbilical. The Sled provides optical and rotational power to the Pantheris Catheter. The Umbilical is a 3-meter long optical and electrical extension cable that connects the Sled to the Lightbox HS Imaging Console.
The Lightbox HS Imaging Console 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 PC-based processing system. The Lightbox provides a visualization platform that allows for real-time OCT-assisted directional atherectomy. The Lightbox HS Imaging Console consists of a cart with two monitors; a PC based processing system, an isolation transformer and an OCT system.
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 to 7.0 mm, using OCT-assisted orientation as an adjunct to fluoroscopy. The Pantheris System is NOT intended for use in the iliac, coronary, cerebral, renal or carotid vasculature.
5
SUBSTANTIAL EQUIVALENCE
The Pantheris System intended use, technological characteristics and principles of operation are similar to the Avinger Ocelot System (K140185) and the Medtronic SilverHawk Peripheral Plaque Excision System (K061188) with the exception of the following:
- Catheter working length ●
- Distal catheter outer diameter ●
- Minimum vessel diameter access ●
- Method of vessel apposition ●
- Method of distal catheter deflection
- Cutting component speed ●
- Length of excised cut
- . Catheter OCT element
Any differences between the Pantheris System and the predicate devices do not alter the intended use of the Pantheris System. The significance of the differences between the Pantheris System and the predicate devices was evaluated in the VISION clinical trial.
NONCLINICAL TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION
All necessary performance testing was conducted on the Pantheris System to support a determination of substantial equivalence to the predicate devices. The nonclinical testing conducted on the Pantheris System provided in the IDE G130159 submission and remaining applicable to the current Pantheris System includes:
- Pantheris design verification and validation studies ●
- Packaging and shelf-life ●
- Biocompatibility ●
- Sterilization ●
- Software verification and validation ●
- Electrical safety, electromagnetic compatibility, and laser safety testing ●
- Pantheris GLP Animal Safety and Performance Report ●
The collective results of the non-clinical testing demonstrate that the Pantheris System meets the established specifications necessary for consistent performance for its intended use.
CLINICAL TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION
The VISION Study is a prospective, multi-center, non-randomized study to evaluate the safety and effectiveness of the Pantheris System. The primary effectiveness endpoint of this study was technical success, defined as the percent of target lesions
6
that have a residual diameter stenosis 70% by visual estimation) who met all eligibility criteria. The primary disease had to be located in reference vessel diameters of >3.0 mm and ≤7.0 and not exceed