(27 days)
No
The document describes a mechanical atherectomy system with OCT guidance and accessories (tweezers and stopcocks). There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is intended to remove plaque from partially occluded vessels, which is a therapeutic intervention.
No.
The device is intended for plaque removal from vessels (atherectomy), which is a treatment procedure, not for diagnosing conditions.
No
The device description explicitly details hardware components (catheter, tweezers, stopcocks) and their physical functions in an atherectomy procedure. There is no mention of software as the primary or sole component.
Based on the provided information, the Pantheris System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to remove plaque from blood vessels (atherectomy) using a physical device (catheter) and imaging guidance (OCT and fluoroscopy). This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device description focuses on the mechanical components used for plaque removal and accessory tools for handling the catheter and delivering fluids. There is no mention of analyzing biological samples or providing diagnostic information based on in vitro testing.
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device intended for use in vitro for the examination of specimens, including blood, tissues, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Pantheris System does not fit this definition.
The Pantheris System is a therapeutic device used for a surgical procedure within the patient's 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 3.0mm 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.
Product codes
MCW
Device Description
The Pantheris Catheter received clearance under K153460 to remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature using OCTassisted orientation. This Special 510(k) submission is intended to add Tweezers and two 3-way Stopcocks to the Pantheris Catheter packaging. The Tweezers are provided to assist in the extraction of tissue that is collected during the atherectomy procedure from the distal end of the catheter once the catheter is removed from the patient. The catheter can then be re-inserted into the vessel to continue plaque removal using the same technique. The Tweezers are not intended to come into direct contact with the patient.
The Stopcocks are standard, off the shelf accessories, used to facilitate the delivery of CO2 and saline to the catheter. The Syringes are connected to the Flush and Balloon Inflation Lumens (components on the catheter's handle assembly) via the Stopcocks. The Stopcocks are not intended to come into direct contact with the patient.
Both the Tweezers and the Stopcocks are provided in order to make readily available these commonly used accessories and for user's convenience.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
OCT-assisted orientation as an adjunct to fluoroscopy.
Anatomical Site
partially occluded vessels in the peripheral vasculature. NOT intended for use in the iliac, coronary, cerebral, renal or carotid vasculature.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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, sample size, AUC, MRMC, standalone performance, key results)
The performance testing conducted establishes that the addition of Tweezers and Stopcocks does not raise new questions of the safety and efficacy for the Pantheris Catheter cleared under K153460.
Tweezers and Stopcocks used in conjunction with the Pantheris Catheter has been evaluated in accordance with design specifications and applicable performance standards through biocompatibility assessment, packaging, sterilization and shelf life validation.
The biocompatability of the Tweezers and Stopcocks were verified per ISO10993-1:2009 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process and related collateral standards for patient contacting materials (see Section 13.3, Biocompatibility).
The packaging and shelf-life validation were performed to test the packaging tray configuration in accordance to ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems and ISO 11607-2:2006, Packaging for terminally sterilized medical devices- Part 2: Validation requirements for forming, sealing and assembly process
The Pantheris Catheter along with accessories is provided sterile and utilizes the same sterilization process as the cleared device. The sterilization was repeated to verify the product maintain the Sterility Assurance Level of 106 using Electron Beam sterilization per Method VDMax25 in accordance with ISO 11137-1:2006, Sterilization of health care products- Radiation, Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices and ISO 11137-2:2006 Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose.
The collective results of the non-clinical testing demonstrate that the Pantheris Catheter meets the established specifications necessary for consistent performance for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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).
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 21, 2016
Avinger, Inc. Ms. Golnaz Moeini Senior Regulatory Affairs Specialist 400 Chesapeake Drive Redwood City, California 94063
Re: K160827
Trade/Device Name: Pantheris Catheter Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: March 24, 2016 Received: March 25, 2016
Dear Ms. Moeini:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
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 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 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 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) K160827
Device Name Pantheris Catheter
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 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CER 801 Subnart D) | Over-The-Counter Use (21 CFR 801 Subnart C) |
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3
510(k) Summary
General Information
| 510(k) Sponsor | Avinger, Inc. |
|---|---|
| Address | 400 Chesapeake Drive |
| Redwood City, CA 94063 | |
| FDA Registration Number | 3007498664 |
| Correspondence Person | Golnaz Moeini |
| Sr. Regulatory Affairs Specialist | |
| Avinger Inc. | |
| Contact Information | Email: gmoeini@avinger.com |
| Phone: 408-504-3187 | |
| Date Prepared | March 23rd, 2016 |
Proposed Device
| Proprietary Name | Avinger Pantheris Accessories |
|---|---|
| Common Name | Avinger Pantheris Catheter |
| Classification Name | Intraluminal Artery Stripper |
| Regulation Number | 21 CFR§870.4875 |
| Product Code | MCW |
| Regulatory Class | II |
Predicate Device
| Proprietary Name | Avinger Pantheris Catheter (K153460) |
|---|---|
| Premarket Notification | K153460 |
| Classification Name | Intraluminal Artery Stripper |
| Regulation Number | 21 CFR§870.4875 |
| Product Code | MCW |
| Regulatory Class | II |
Device Description
The Pantheris Catheter received clearance under K153460 to remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature using OCTassisted orientation. This Special 510(k) submission is intended to add Tweezers and two 3-way Stopcocks to the Pantheris Catheter packaging. The Tweezers are provided to assist in the extraction of tissue that is collected during the atherectomy procedure from the distal end of the catheter once the catheter is removed from the patient. The catheter can then be re-inserted into the vessel to continue plaque removal using the
4
same technique. The Tweezers are not intended to come into direct contact with the patient.
The Stopcocks are standard, off the shelf accessories, used to facilitate the delivery of CO2 and saline to the catheter. The Syringes are connected to the Flush and Balloon Inflation Lumens (components on the catheter's handle assembly) via the Stopcocks. The Stopcocks are not intended to come into direct contact with the patient.
Both the Tweezers and the Stopcocks are provided in order to make readily available these commonly used accessories and for user's convenience.
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 3.0mm 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.
Comparison of Technological Characteristics with the Predicate Device
The cleared Pantheris Catheter package includes the catheter, a flush fixture and 6mL and 10mL Syringes. Avinger is proposing to add Tweezers and two 3-way Stopcocks to the Pantheris Catheter packaging. There are no modifications to the indications for use, intended use, material, design, functionality or performance of the catheter, flush fixture and syringes cleared under K153460. The Tweezers and Stopcocks are provided for user convenience purposes. The performance testing conducted establishes that the addition of Tweezers and Stopcocks does not raise new questions of the safety and efficacy for the Pantheris Catheter cleared under K153460.
Non-Clinical Test Data
Tweezers and Stopcocks used in conjunction with the Pantheris Catheter has been evaluated in accordance with design specifications and applicable performance standards through biocompatibility assessment, packaging, sterilization and shelf life validation.
The Pantheris Catheter design, performance, material, indications for use and fundamental technology are identical to the cleared Pantheris Catheter (K153460), supporting a determination of substantial equivalence.
5
The biocompatability of the Tweezers and Stopcocks were verified per ISO10993-1:2009 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process and related collateral standards for patient contacting materials (see Section 13.3, Biocompatibility).
The packaging and shelf-life validation were performed to test the packaging tray configuration in accordance to ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems and ISO 11607-2:2006, Packaging for terminally sterilized medical devices- Part 2: Validation requirements for forming, sealing and assembly process
The Pantheris Catheter along with accessories is provided sterile and utilizes the same sterilization process as the cleared device. The sterilization was repeated to verify the product maintain the Sterility Assurance Level of 106 using Electron Beam sterilization per Method VDMax25 in accordance with ISO 11137-1:2006, Sterilization of health care products- Radiation, Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices and ISO 11137-2:2006 Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose.
The collective results of the non-clinical testing demonstrate that the Pantheris Catheter meets the established specifications necessary for consistent performance for its intended use.
Conclusion
Based on the information submitted in this premarket notification, and based on the indications for use, technological characteristics, performance testing and material comparison to the predicate device, the Pantheris accessories raise no new questions of safety and effectiveness and the device is substantially equivalent to the predicate device.