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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the Pantheris Catheter, focusing on acceptance criteria and study details.

Based on the provided document, the submission (K160827) is a Special 510(k) for adding accessories (Tweezers and 3-way Stopcocks) to an already cleared device (Pantheris Catheter, K153460). Therefore, the "device" in question for this specific submission is primarily the addition of these accessories and their impact on the overall system's safety and effectiveness, rather than a fundamental re-evaluation of the core Pantheris Catheter's performance.

The document explicitly states: "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." This means the performance of the Pantheris Catheter itself was established in a prior submission (K153460), and this current submission focuses on ensuring the accessories do not negatively impact safety or effectiveness.

Given this context, the acceptance criteria and supporting studies are framed around the accessories, not the catheter's primary function of plaque removal.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Biocompatibility	Tweezers and Stopcocks verified per ISO 10993-1:2009 and related collateral standards for patient contacting materials.
Packaging and Shelf-life Validation	Performed to test the packaging tray configuration in accordance with ISO 11607-1:2006 and ISO 11607-2:2006.
Sterilization Assurance Level (SAL)	Maintained a SAL of 10^-6 using Electron Beam sterilization per Method VDMax25, in accordance with ISO 11137-1:2006 and ISO 11137-2:2006.
No new questions of safety and effectiveness	The non-clinical testing collectively demonstrated that the Pantheris Catheter (with new accessories) meets established specifications, and the accessories raise no new questions of safety and effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the traditional sense of patient data or clinical trials for evaluating the performance of the atherectomy aspect of the device. Instead, the testing described is focused on the non-clinical performance of the new accessories and their impact on the existing system.

Sample Size for Test Set: Not applicable or not specified in terms of patient data. The non-clinical tests (biocompatibility, packaging, sterilization) would involve specific numbers of samples/units for each test, but these are not detailed in the summary.
Data Provenance: Not applicable for clinical data. The tests are non-clinical (laboratory/bench testing) of the device components.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. The ground truth for biocompatibility, packaging, and sterilization standards is defined by international standards (ISO series) and accepted regulatory practices, not by expert consensus on clinical data in this context.

4. Adjudication Method for the Test Set

Not applicable. There's no indication of clinical data requiring expert adjudication in this submission. The non-clinical tests rely on meeting predefined specifications and standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance.

Not applicable. This device is an atherectomy catheter, not an AI-powered diagnostic device. The submission does not mention any AI component or MRMC study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done.

Not applicable. This device is not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for this submission's acceptance criteria primarily relies on:

International Standards and Regulations: ISO 10993-1, ISO 11607-1, ISO 11607-2, ISO 11137-1, ISO 11137-2.
Design Specifications: The device (with accessories) meeting its established performance specifications.
Predicate Device Equivalence: The primary "ground truth" for the overall system's safety and effectiveness is its substantial equivalence to the previously cleared Pantheris Catheter (K153460), as no changes were made to the core functionality.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set was Established

Not applicable.

Summary of the Document's Focus:

This FDA 510(k) submission (K160827) is a "Special 510(k)" for minor modifications (adding accessories) to an already cleared medical device. The key takeaway is that the safety and effectiveness of the original Pantheris Catheter for its intended use were established previously. This submission's purpose is to demonstrate that the addition of Tweezers and Stopcocks does not introduce new risks or modify the fundamental performance of the catheter. Therefore, the "acceptance criteria" and "studies" are focused on standard non-clinical evaluations related to these new components' biocompatibility, packaging, and sterilization, ensuring they do not compromise the system's previous clearance basis. The document explicitly states: "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."

Summary

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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.

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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)

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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510(k) Summary

General Information

510(k) Sponsor	Avinger, Inc.
Address	400 Chesapeake DriveRedwood City, CA 94063
FDA Registration Number	3007498664
Correspondence Person	Golnaz MoeiniSr. Regulatory Affairs SpecialistAvinger Inc.
Contact Information	Email: gmoeini@avinger.comPhone: 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

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same technique. The Tweezers 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

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.

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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.

Regulation Number and Section

§ 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).