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 and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen and wall structures. 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 Imaging Console, and the Umbilical. Unless otherwise specified, the terms "Ocelot: System" and "Ocelot Catheter" are inclusive of all Ocelot Catheters in the Ocelot Catheter family. The Ocelot Catheter is an over-the-wire, sterile, single-use device that is compatible with a 0.014" guidewire. The Ocelot Catheter incorporates an optical fiber used to facilitate Optical Coherence Tomography (OCT)-assisted orientation and imaging as an adjunct to fluoroscopy. The Lightbox Imaging Console is an optical transceiver, transmitting light to the intraluminal environment through the optical fiber on the Ocelot Catheter and receiving and interpreting the signal from the tissue using a PC-based processing system. The Lightbox Imaging Console consists of a cart with two monitors, a PC, an isolation transformer, and the OCT system. The Umbilical is a 3-meter long optical and electrical extension cable that connects the Ocelot Catheter and the Lightbox Imaging Console. The Umbilical is reusable, nonsterile, and is intended for use outside of the sterile field.

AI/ML Overview

The provided text describes the Avinger Ocelot System (K140185) and its equivalence to predicate devices, but it does not explicitly detail specific acceptance criteria or the study that "proves" the device meets them in a quantitative sense. The document focuses on demonstrating substantial equivalence through non-clinical and prior clinical testing.

Here's an analysis of the available information against your requested points:

1. A table of acceptance criteria and the reported device performance

This information is not explicitly provided in the text. The document states:

"The collective results of the non-clinical testing demonstrate that the Ocelot System meets the established specifications necessary for consistent performance for its intended use."
"Validation testing included the use of the predicate device, the C7 XR Imaging System™ with the C7 Dragonfly™ Imaging Catheter (K093857). The completed testing results demonstrate that the Ocelot System is substantially equivalent to the predicate device... with respect to imaging of vessel lumen and wall structures."
"The system specifications and technological characteristics for the subject device and predicate device also demonstrate substantial equivalence with respect to OCT imaging system technology and imaging specifications."

These statements indicate that acceptance criteria (referred to as "established specifications") were met, and performance showed substantial equivalence, but the specific metrics, thresholds, and reported performance data are not quantified or tabulated.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size: Not specified for the non-clinical or clinical testing. The document refers to "Design verification and bench validation studies" and an "In-vivo animal validation study" as well as "Clinical testing results... included in the prior K122380 submission." No numerical sample sizes are given for any of these.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The "In-vivo animal validation study" indicates animal data. The "Clinical testing" referenced from K122380 would be human data, but details are absent.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not specified. Given the nature of medical device studies at this level, expert review would likely be involved, especially for the "imaging of vessel lumen and wall structures" aspect, but the document does not mention the number or qualifications of experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not specified.

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/Not specified. The Ocelot System is described as an Optical Coherence Tomography (OCT) imaging catheter and console that provides "OCT-assisted orientation and imaging as an adjunct to fluoroscopy." It is a direct imaging device, not an AI or algorithmic interpretation system that would assist human readers in the way an MRMC study typically assesses. Therefore, "human readers improve with AI vs without AI assistance" does not directly apply to this device's function as described.

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

Not applicable. The device provides images to facilitate guidewire placement, and its utility is in providing visual information for a human operator (physician) to guide an intervention. It is not an "algorithm only" device meant to perform a task without human interpretation or intervention.

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

Partially implied but not explicitly stated.

For the "imaging of vessel lumen and wall structures," the ground truth would likely involve direct visual assessment/measurements by experts and/or comparison to established imaging modalities or potentially pathology if tissue samples were taken during the animal study.
The "In-vivo animal validation study" implies physiological measurements or assessments in live subjects.
The clinical testing from K122380 would have focused on safety and effectiveness outcomes.

8. The sample size for the training set

Not applicable/Not specified. This device is an imaging system, not an AI model that requires a distinct "training set" in the context of machine learning. The term "training set" is usually associated with AI/ML development. This submission describes testing and validation of hardware and software for image generation and display.

9. How the ground truth for the training set was established

Not applicable. As above, no "training set" in the machine learning sense is described for this device.

Summary of what is available regarding verification and validation:

The document states that:

"Verification and validation testing has been completed for the Ocelot System."
"Validation testing included the use of the predicate device, the C7 XR Imaging System™ with the C7 Dragonfly™ Imaging Catheter (K093857)."
Non-clinical, bench testing included:
- Design verification and bench validation studies
- Packaging and shelf-life
- Software verification and validation
- Electrical safety, electromagnetic compatibility, and laser safety testing
Prior K122380 and K123532 submissions included:
- Biocompatibility
- In-vivo animal validation study
- Sterilization
- Clinical testing results to demonstrate safety and effectiveness.

The core of the K140185 approval hinges on demonstrating substantial equivalence to an existing predicate device (Ocelot System K122380/K123532 and C7 XR Imaging System K093857) through these various tests, rather than a single study proving specific performance metrics against defined acceptance criteria. The change in this submission was primarily a revision to the Indications For Use to explicitly include "imaging of vessel lumen and wall structures," for which the testing showed substantial equivalence to the C7 XR Imaging System.

Summary

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AVINGER, INC.

MAY 0 1 2014

OCELOT SYSTEM 510(k) PREMARKET NOTIFICATION

4.0 510(K) Summary

510(k) Notification K__K140185

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:

Sherry Kim Sr. Regulatory Affairs Specialist Avinger, Inc. Phone: 650-241-7004 Fax: 650-241-7901

Date Prepared:

January 23, 2014

DEVICE INFORMATION

Trade Name:

Ocelot System, Ocelot PIXL Catheter

Generic/Common Name:

Percutaneous Catheter

Classification:

21 CFR§870.1250, Percutaneous Catheter, Class II 21 CFR§892.1560, Ultrasonic Pulsed Echo Imaging System, Class II

Product Codes:

PDU, NQQ

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ﺎﺋﻴﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ

PREDICATE DEVICES

Avinger Ocelot System (K122380) / Ocelot PIXL Catheter (K123532) .
C7 XR Imaging System™ with the C7 Dragonfly™ Imaging Catheter . (K093857)

DEVICE DESCRIPTION

PROPOSED INDICATIONS FOR USE

SUBSTANTIAL EQUIVALENCE

Predicate device: Ocelot System (K122380) / Ocelot PIXL Catheter (K123532) There are no differences in the device design and technological characteristics between the Ocelot System presented in this submission and the predicate Ocelot System and Ocelot PIXL Catheter cleared under K122380 and K123532, respectively. The Ocelot System's Indications For Use cleared under K122380 and K123532 are being revised to include imaging of vessel lumen and wall structures.

Predicate device: C7 XR Imaging System™ with the C7 Dragonfly™ Imaging Catheter (K093857)

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AVINGER, INC.

K140185

Verification and validation testing has been completed for the Ocelot System. Validation testing included the use of the predicate device, the C7 XR Imaging System™ with the C7 Dragonfly™ Imaging Catheter (K093857). The completed testing results demonstrate that the Ocelot System is substantially equivalent to the predicate device, C7 XR Imaging System™ with the C7 Dragonfly™ Imaging Catheter (K093857) with respect to imaging of vessel lumen and wall structures. The system specifications and technological characteristics for the subject device and predicate device also demonstrate substantial equivalence with respect to OCT imaging system technology and imaging specifications.

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 provided in this submission includes:

Design verification and bench validation studies .
Packaging and shelf-life .
. Software verification and validation
Electrical safety, electromagnetic compatibility, and laser safety testing .

The non-clinical, bench testing conducted on the Ocelot System provided in the prior K122380 and K123532 submissions and still applicable to the current Ocelot System included:

. Biocompatibility
In-vivo animal validation study .
Sterilization .

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

CLINICAL TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION

Clinical testing results to demonstrate safety and effectiveness of the Ocelot System were included in the prior K122380 submission. No new clinical testing is included in this 510(k) submission.

CONCLUSION

As demonstrated in the testing summaries, no new issues of safety or effectiveness are raised in this submission and the Ocelot System is substantially equivalent to the predicate devices listed above.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

May 1, 2014

Avinger Inc Sherry Kim Sr. Regulatory Affairs Specialist 400 Chesapeake Drive Redwood City, CA 94063

Re: K140185

Trade/Device Name: Ocelot System: Ocelot Catheter, Ocelot PIXL Catheter, & Light Box Console

Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PDU/NQQ Dated: March 27, 2014 Received: March 28, 2014

Dear Ms. Sherry Kim:

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

Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or a bird in flight.

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Page 2 - Ms. Sherry Kim

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 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" (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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

forBram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Avinger, Inc.

Ocelot System 510(k) PREMARKET NOTIFICATION

3.0 INDICATIONS FOR USE STATEMENT

K140185 510(k) Number (if known): _

Device Name: Ocelot System

Indications For Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)

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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).