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 System consists of the Pantheris Catheter, Lightbox Sled (referred to as Sled), the Lightbox HS Imaging Console and the Sterile Drape (accessory).

AI/ML Overview

The Pantheris System and its modified version (K153460) are intended to remove plaque from partially occluded peripheral vasculature. The device uses OCT-assisted orientation as an adjunct to fluoroscopy.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and the Reported Device Performance

The document does not explicitly present a "table of acceptance criteria" with corresponding "reported device performance" in a quantitative manner that would typically be seen for diagnostic device accuracy (e.g., sensitivity, specificity, AUC). Instead, the studies performed are primarily focused on demonstrating the safety and effective function of the device's modifications and ensuring substantial equivalence to a previously cleared predicate device.

The acceptance criteria for this device seem to be implicitly defined by the successful completion of various non-clinical engineering and biological tests, and the modified device's performance matching or exceeding that of its predicate. The "reported device performance" is qualitative and indicates "meets established specifications necessary for consistent performance for its intended use."

The identified non-clinical tests and their implicit acceptance criteria are:

Acceptance Criteria (Implied by Test Name)	Reported Device Performance (Qualitative)
Design Verification
Working Length	Meets specifications
Catheter Flush	Meets specifications
OCT Image Generation and Sled Interface	Meets specifications
Catheter Field of View	Meets specifications
Distal Tip Rotation	Meets specifications
Guidewire compatibility	Meets specifications
Distal Tip Max OD	Meets specifications
Insertion Force	Meets specifications
Force to Overcome User Slide Lock	Meets specifications
Force to Remove Sled Bag	Meets specifications
Force to Remove Sled Bag ring	Meets specifications
Full 360° Image	Meets specifications
Inflation Cycles	Meets specifications
Cut/Pack Cycles	Meets specifications
Packed Position Life Cycle	Meets specifications
Active position Life Cycle	Meets specifications
Balloon Burst	Meets specifications
Torque Shaft Torque Proof loading	Meets specifications
Drive Shaft Torque Proof loading	Meets specifications
Inflation Luer Tensile Strength	Meets specifications
Flush Lumen Tensile Strength	Meets specifications
Distal Catheter Joints Tensile Strength	Meets specifications
Proximal Catheter Joints Tensile Strength	Meets specifications
Simulated Use (Design Validation)
Setup (Ease of Use & Sterility)	Meets specifications
Functionality (Visualization, Flushing, Device Tracking, Target Sites, Treatment, Markings, Safety)	Meets specifications
Insertion/Retraction force	Meets specifications
Number of Insertions	Meets specifications
Post-Retraction (Visualization, Device Tracking, Treatment, Markings, Safety)	Meets specifications
Sterilization Validation	Meets specifications
Packaging Validation	Meets specifications
Product Shelf Life	Meets specifications
Biocompatibility	Meets specifications
Cytotoxicity	Meets specifications
Sensitization	Meets specifications
Intracutaneous Reactivity	Meets specifications
Systemic Toxicity	Meets specifications
Hemolysis extract	Meets specifications
Hemolysis direct	Meets specifications
Complement Activation	Meets specifications
Material Mediated (Rabbit) Pyrogenicity	Meets specifications
Preclinical Animal Testing
Porcine Study (acute and chronic histopathological assessments, in vivo performance comparison)	Acceptable histopathological assessments; in vivo performance deemed comparable to predicate
Functionality (Radiopacity, OCT marker visibility, Insertion/Retraction, Advance to target location, Ability to orient device to a landmark)	Demonstrated
Minimum Effective Flow Rate (MEFR) for clear OCT imaging	Meets specifications
Thrombogenicity	Meets specifications
Safety Assessment	Acceptable safety profile

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

The document mentions a "Porcine Study" as a preclinical animal test. The sample size for this study is not explicitly stated, only that it involved "acute and chronic histopathological assessments." The data provenance is from an animal model (porcine), and it is a prospective study design to evaluate the modified device. No human test set data is provided or referenced in this 510(k) summary for this specific modification. The study is a "comparison to a predicate device."

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

For the preclinical porcine study, the documentation refers to "histopathological assessments." This implies that experts (likely veterinary pathologists) were involved in establishing the ground truth regarding tissue response and safety. However, the exact number of experts and their specific qualifications (e.g., "veterinary pathologist with X years of experience") are not provided in this document.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set, as it does not present a clinical study with human outcomes that would typically require independent expert adjudication. For the animal study, the pathological assessments would likely follow standard practices for veterinary pathology reporting, but no specific adjudication process (e.g., 2+1, 3+1 consensus) is detailed.

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

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor is there any discussion of AI assistance or human reader improvement. The Pantheris System (and its modification) is a medical device for atherectomy, and while it uses "OCT-assisted orientation," this is not presented as an AI-driven diagnostic aid for human readers.

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

This document describes a medical device rather than an algorithm. Its performance is assessed through engineering tests, biocompatibility, and preclinical animal studies. Therefore, the concept of "standalone algorithm performance" is not applicable here. The device's OCT imaging component is an "adjunct to fluoroscopy" and is part of a human-operated system for guided intervention.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the preclinical animal study, the ground truth was primarily established through pathology (histopathological assessments). The functional aspects of the device in vivo were also evaluated. For the extensive non-clinical and design validation testing, the ground truth was based on pre-defined engineering specifications and performance standards.

8. The Sample Size for the Training Set

This document does not describe the development of an artificial intelligence or machine learning algorithm. Therefore, the concept of a "training set" in that context is not applicable. The device's design and modifications are based on engineering principles and iterative design, not on machine learning training data.

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

As there is no mention of an AI/ML algorithm or a training set in this document, this question is not applicable.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 1, 2016

Avinger, Inc. Ms. Patty Hevey Vice President, Clinical and Regulatory Affairs 400 Chesapeake Drive Redwood City, CA 94063

Re: K153460

Trade/Device Name: Pantheris System Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: January 27, 2016 Received: January 28, 2016

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 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) K153460

Device Name Pantheris System

Indications for Use (Describe)

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

510(k) Notification K_________________________________________________________________________________________________________________________________________________________

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 VP, Clinical and Regulatory Affairs Avinger, Inc. Phone: 650-222-3666 Email: phevey@avinger.com

Date Prepared:

November 30th, 2015

DEVICE INFORMATION

Trade Name:

Pantheris System

Generic/Common Name:

Peripheral Atherectomy Catheter

Classification:

21 CFR§870.4875, Intraluminal Artery Stripper, Class II

Product Codes: MCW

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PREDICATE DEVICES

The modified Pantheris Catheter is substantially equivalent to the original Pantheris Catheter cleared under K152275.

DEVICE DESCRIPTION

The Pantheris System recently received clearance under K152275 to remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature using OCTassisted orientation. The Pantheris Catheter reviewed as part of K152275 has since been modified to help improve manufacturability and usability of the catheter. The Pantheris System consists of the Pantheris Catheter, Lightbox Sled (referred to as Sled), the Lightbox HS Imaging Console and the Sterile Drape (accessory).

INDICATIONS FOR USE

SUBSTANTIAL EQUIVALENCE

The modified Pantheris Catheter is essentially the same device as the original Pantheris Catheter cleared under K152275; both share the same basic design, principles of operations, mechanism of action and indications for use. Any differences between the modified Pantheris Catheter and the original Pantheris Catheter do not alter the intended use of the Pantheris System. The modifications made to the original Pantheris Catheter (K152275) to create the proposed device are provided in Table 1 below. The information included in this submission will establish the substantial equivalency of the modified Pantheris Catheter to the original Pantheris Catheter cleared under K152275.

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Catheter Section	Design Modifications
Distal Assembly	Offering a 7Fr catheter option Modifying the shape of the Apposition Balloon Including additional viewing windows and increasing the length of the Nosecone Housing Replacing the flush channel with vent holes
Torque Shaft Assembly	Reducing the working length from 130cm to 110cm Relocating the Occlusion Balloon to the Torque Shaft (thereby obsoleting the optional accessory, Occlusion Sheath) Increasing the Torque Shaft stiffness
Handle Assembly	Improving the ergonomics of the handle design Extending the blue color coding across the entire Flush Lumen length
Packaged Accessories	Replacing 1mL Syringe with 6mL and 10mL Syringes

Table 1: Modified Pantheris Catheter Changes

NON-CLINICAL TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION

To demonstrate the substantial equivalences of the Pantheris Catheter to the selected predicate device, the performance and technological characteristics were evaluated by completion of the following testing:

o Design Verification
- Working Length O
- Catheter Flush O
- OCT Image Generation and Sled Interface O
- O Catheter Field of View
- Distal Tip Rotation O
- Guidewire compatibility O
- Distal Tip Max OD O
- Insertion Force O
- Force to Overcome User Slide Lock O
- Force to Remove Sled Bag o
- Force to Remove Sled Bag ring O
- Full 360° Image O
- O Inflation Cycles
- Cut/Pack Cycles O
- Packed Position Life Cycle O
- Active position Life Cycle O
- Balloon Burst O

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o Torque Shaft Torque Proof loading
Drive Shaft Torque Proof loading o
Inflation Luer Tensile Strength O
Flush lumen Tensile Strength O
Distal Catheter Joints Tensile Strength O
Proximal Catheter Joints Tensile Strength O
Simulated Use (Design Validation) 0
- Setup (Ease of Use & Sterility) O
- Functionality (Visualization, Flushing, Device Tracking, Target Sites, o Treatment, Markings, Safety)
- Insertion/Retraction force o
- Number of Insertions O
- Post-Retraction (Visualization, Device Tracking, Treatment, Markings, o Safety)
Sterilization Validation ●
Packaging Validation ●
Product Shelf Life ●
Biocompatibility ●
- O Cytotoxicity
- Sensitization O
- Intracutaneous Reactivity O
- o Systemic Toxicity
- Hemolysis extract O
- Hemolysis direct O
- Complement Activation o
- Material Mediated (Rabbit) Pyrogenicity о
Preclinical Animal Testing ●
- O Porcine Study with acute and chronic histopathological assessments and in vivo performance comparison to a predicate device, with 8F Pantheris catheter
- Functionality o
  - Radiopacity
  - OCT marker visibility ■
  - 트 Insertion/Retraction
  - Advance to target location ■
  - Ability to orient device to a landmark ■
- Minimum Effective Flow Rate (MEFR) for clear OCT imaging o
- Thrombogenicity O
- Safety Assessment O

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The collective results of the non-clinical testing demonstrate that the modified Pantheris Catheter meets the established specifications necessary for consistent performance for its intended use.

CONCLUSION

The modified Pantheris Catheter has been carefully compared to the original Pantheris Catheter device with respect to intended use and fundamental technological characteristics. Performance testing was conducted to verify and validate the performance of the devices and ensure the modified Pantheris Catheter functions as intended and meet design specifications. The comparison and performance testing results demonstrate that the modified Pantheris Catheter is substantially equivalent to the original Catheter cleared under K152275 for the stated intended use.

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).