The Ocelot System is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention using OCT-assisted orientation as an adjunct to fluoroscopy. The Ocelot System is contraindicated for use in the iliac, coronary, cerebral, renal or carotid vasculature.

Device Description

The Ocelot System consists of the Ocelot Catheter, the Lightbox Console and the Umbilical. The Ocelot Catheter is an over-the-wire device that is compatible with a 6F sheath and 0.014" guidewire. The Ocelot Catheter has a working length of 110cm and incorporates an optical fiber used to facilitate Optical Coherence Tomography (OCT)-assisted orientation as an adjunct to fluoroscopy.

AI/ML Overview

The Ocelot System, as described in the provided 510(k) Premarket Notification (K122380), is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions in the peripheral vasculature. The device's performance was evaluated through a multi-center, prospective, non-randomized study called CONNECT II.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Primary Safety Endpoint: Composite endpoint including site-reported major adverse events (MAEs) and angiographic data (clinically significant perforations, embolizations, and Grade C or greater dissections).	Met. Two clinically significant perforations (2%) occurred during the procedure, with no reported sequelae prior to discharge. No MAEs (0.0%) or unanticipated adverse events.
Primary Effectiveness Endpoint: Successful CTO crossing by the Ocelot System and subsequent guidewire positioning through the distal true lumen (confirmed by angiography).	Met. Achieved in 97% of subjects.

2. Sample Size and Data Provenance

Test Set Sample Size: 122 subjects.
Data Provenance: The study (CONNECT II) was a multi-center study conducted in the United States and European Union. The data was collected prospectively.

3. Number of Experts and Qualifications for Ground Truth

The document states that "Primary safety and effectiveness endpoints were based on independent angiographic reviewers." However, the specific number of experts and their qualifications (e.g., years of experience, subspecialty) are not explicitly mentioned in the provided text.

4. Adjudication Method for the Test Set

The document notes that endpoints were assessed by "independent angiographic reviewers." This implies that the reviewers independently assessed the angiographic data to establish the ground truth for the safety and effectiveness endpoints. However, the specific adjudication method (e.g., 2+1, 3+1, none, or if there was a consensus or tie-breaking process) is not detailed. It simply states "independent angiographic reviewers," which could suggest individual independent assessments rather than a strict consensus or multiple-reader adjudication process.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in the provided text. The study evaluated the performance of the Ocelot System as a tool, not the improvement of human readers with AI assistance. The Ocelot System uses OCT-assisted orientation as an adjunct to fluoroscopy, implying it assists the clinician, but the study design was not an MRMC to quantify the improvement of human readers.

6. Standalone (Algorithm Only) Performance Study

No, a standalone performance study (i.e., algorithm only without human-in-the-loop performance) was not conducted for the Ocelot System. The system is described as an "OCT-assisted orientation as an adjunct to fluoroscopy," indicating it's designed to be used by a human operator to facilitate guidewire placement. The effectiveness endpoint explicitly states "successful CTO crossing by the Ocelot System and subsequent guidewire positioning," implying human interaction.

7. Type of Ground Truth Used

The ground truth used was primarily expert judgment/consensus based on angiographic data, along with site-reported safety data.

Effectiveness: Confirmed by angiography, assessed by independent angiographic reviewers.
Safety: Site-reported safety data (MAEs) and angiographic data (clinically significant perforations, embolizations, and Grade C or greater dissections) assessed by independent angiographic reviewers.

8. Sample Size for the Training Set

The document does not specify a sample size for a training set. The CONNECT II study is described as evaluating the device's performance, not as a study to train an algorithm or AI component. While the Ocelot System incorporates "OCT-assisted orientation," the text does not suggest an AI model that requires a distinct training set in the context of this 510(k) submission.

9. How Ground Truth for the Training Set Was Established

As no specific training set is mentioned in the context of an AI-driven system requiring ground truth for training, this information is not applicable and not provided in the given text. The "OCT-assisted orientation" is technology integrated into the device, not an AI algorithm that would typically undergo a separate training phase with a dedicated ground truth dataset.

Summary

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AVINGER, INC.

OCELOT SYSTEM 510(k) Premarket Notification

510(k) Notification K122380

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:

Albert Boniske Sr. Manager, Regulatory and Quality Affairs Avinger, Inc. Phone: 650-241-7004 Fax: 650-241-7992

SIDK S

Date Prepared:

August 3, 2012

DEVICE INFORMATION

Trade Name:

Ocelot System

Generic/Common Name:

Percutaneous catheter

Classification:

21 CFR§870.1250, Percutaneous catheter, Class II

Product Code:

DQY,

PREDICATE DEVICE(S)

Avinger Wildcat Catheter (K111338) o
Safe-Cross® Radio Frequency Total Occlusion Crossing System ("Safe-Cross . System") (K050916)

NOV 7 2012

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INDICATIONS FOR USE

DEVICE DESCRIPTION

SUBSTANTIAL EQUIVALENCE

The indications for use for the predicate devices are substantially equivalent to the proposed indications for use for the Ocelot System. The Ocelot Cather operates using the p op boundly would be acteristics for the same intended use as its predicate in the Avinger family of catheters, the Wildcat Catheter. The Ocelot System provides information on intravascular orientation using a similar interferometry-based technology for the same intended use as the Safe-Cross System. The nonclinical and clinical testing results demonstrate that any differences in the technological characteristics between the subject and predicate devices do not raise any new issues of safety or effectiveness. Thus, the Ocelot System is substantially equivalent to the predicate devices.

NONCLINICAL TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION

All necessary performance testing was conducted on the Ocelot System to support a determination of substantial equivalence to the predicate devices. The non-clinical bench testing included:

Design verification and bench validation studies 0
Biocompatibility 0
o Sterilization
Packaging and shelf-life 0
Software verification and validation 0
Electrical safety, electromagnetic compatibility, and laser safety testing o

Two acute in-vivo animal studies were also conducted for the Ocelot System. One study evaluated the trackability of the catheter in the peripheral vasculature and one characterized the flow rate and the related pressures to capture OCT images. These studies were conducted in a healthy porcine model and supported the clinical use of the Ocelot System. The collective results of the non-clinical testing demonstrate that the Ocelot

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System meets the established specifications necessary for consistent performance for its intended use.

CLINICAL TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION

A multi-center, prospective, non-randomized study (CONNECT II Study) was conducted to evaluate the safety and effectiveness of the Ocelot System used to cross chronic total occlusions in the superficial femoral and popliteal arteries. Subjects were followed through 30-days post procedure.

The Ocelot System was used in 122 subjects enrolled in the study from 15 sites in the United States and European Union. The population consisted of those presenting with Peripheral Artery Disease who met all eligibility criteria, including documented Rutherford Classification ranging from 2-5 and angiographic evidence of 99-100% stenosed femoropopliteal arteries that were ≥ 1 cm and ≤ 30 cm in length. Primary safety and effectiveness endpoints were based on independent angiographic reviewers.

The primary safety endpoint was a composite endpoint identified by both site reported safety data (MAEs) and angiographic data (clinically significant perforations, embolizations and Grade C or greater dissections) assessed by independent angiographic reviewers. Two clinically significant perforation (2%) occurred at the time of the procedure, as identified by the independent angiographic reviewers. No further sequelae were reported by any of the subjects prior to discharge. There were no occurrences of MAEs (0.0%) or unanticipated adverse events. The primary safety endpoint was met.

The primary effectiveness endpoint, defined as successful CTO crossing by the Ocelot System and subsequent guidewire positioning through the distal true lumen (confirmed by angiography), was achieved in 97% of subjects. The primary effectiveness endpoint was met.

In conclusion, the results of the CONNECT II Study demonstrate that the Ocelot System was able to safely and effectively facilitate crossing of CTOs in the peripheral vasculature where a conventional guidewire was unsuccessful.

CONCLUSION

The results of the nonclinical and clinical testing demonstrate that the Ocelot System is a safe and effective device when used for the stated indication for use. The clinical testing demonstrates that the new technological characteristics employed by the Ocelot System do not raise any new issues of safety or effectiveness. Therefore, the Ocelot System is substantially equivalent to the predicate devices.

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

Avinger, Inc. Mr. Albert Boniske Sr. Manager, Regulatory and Ouality Affairs 400 Chesapeake Drive Redwood City, CA 94063

SEP 1 8 2013

Re: K122380

Trade/Device Name: Ocelot System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PDU Dated: October 10, 2012 Received: October 11, 2012

Dear Mr. Boniske:

This letter corrects our substantially equivalent letter of November 7, 2012.

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

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Page 2 - Mr. Albert Boniske

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 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" (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 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.

Sincerely yours.

Zucker, Z.

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 STATEMENT 3.0

510(k) Number (if known): ≤22380

Device Name: Ocelot System

Indications For Use:

Prescription Use _ X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

.25. Hilliber

(Division Sign-Off) (Division Sign-Off)
Division of Cardiovascular Devices X122380 510(k) Number _

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).