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 provided 510(k) summary for the Ocelot Catheter (K123462) describes the device, its intended use, and substantial equivalence to a predicate device (original Ocelot Catheter K122380). However, it does not include any specific acceptance criteria or details of a study demonstrating the device meets such criteria in terms of clinical performance metrics like sensitivity, specificity, accuracy, etc.

Instead, the submission focuses on non-clinical performance data which primarily demonstrate the physical and functional aspects of the catheter in comparison to its predicate. The "study" mentioned refers to this non-clinical testing.

Here's an analysis based on the provided text, highlighting the absence of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Acceptance Criteria (as reported)	Reported Device Performance (as reported)
Mechanical Performance	Catheter does not advance when tip is engaged in tissue (Tip penetration testing)	Confirmed that the Ocelot Catheter performs according to the stated intended use. All data fell well within pre-determined product specifications.
Physical Characteristics	Visual and Dimensional Verification	Confirmed that the Ocelot Catheter performs according to the stated intended use. All data fell well within pre-determined product specifications.
Functional Testing	Spiral Blade Functional Testing	Confirmed that the Ocelot Catheter performs according to the stated intended use. All data fell well within pre-determined product specifications.
Material/Durability	Tensile Testing	Confirmed that the Ocelot Catheter performs according to the stated intended use. All data fell well within pre-determined product specifications.
Surface Properties	Coating Friction Testing	Confirmed that the Ocelot Catheter performs according to the stated intended use. All data fell well within pre-determined product specifications.
Ease of Use/Handling	Torque Testing, Guidewire advancement, Device Advancement, Flexibility/Trackability	Confirmed that the Ocelot Catheter performs according to the stated intended use. All data fell well within pre-determined product specifications.
Safety/Integrity	Device leak testing, Luer Leak Testing, Tip-Stall Testing	Confirmed that the Ocelot Catheter performs according to the stated intended use. All data fell well within pre-determined product specifications.
Simulated Use	In Vitro Simulated Use Testing	Confirmed that the Ocelot Catheter performs according to the stated intended use. All data fell well within pre-determined product specifications.
Shelf Life	Shelf Life Testing	Confirmed that the Ocelot Catheter performs according to the stated intended use. All data fell well within pre-determined product specifications.
Clinical Performance (e.g., accuracy, sensitivity, specificity for Ocelot system's intended function of guiding wires)	NOT SPECIFIED IN K123462 SUBMISSION	NOT REPORTED IN K123462 SUBMISSION

Crucially, the document does not list any acceptance criteria related to its clinical effectiveness in facilitating guidewire placement or the accuracy of its OCT-assisted orientation. It only states that the non-clinical testing "confirmed that the Ocelot Catheter performs according to the stated intended use."

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not specified. The document mentions "non-clinical testing" and lists various tests (e.g., visual, dimensional, tensile, torque, in vitro simulated use). For these engineering tests, the "sample size" would refer to the number of catheters tested for each specific test, which is not provided.
Data Provenance: The data is based on non-clinical (bench/lab) testing conducted by Avinger, Inc. There is no information on country of origin of the data beyond "Avinger, Inc. 400 Chesapeake Drive Redwood City, CA 94063." The data is presented as retrospective as it was conducted to support a determination of substantial equivalence (i.e., after the design changes were made).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. The "ground truth" for the non-clinical tests would be defined by engineering specifications and objective measurements, not by expert consensus in the way a clinical study would use clinicians for ground truth.

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

Not Applicable. As this is non-clinical engineering testing, there is no mention or need for an adjudication method in the context described. Results would be compared directly to pre-determined product specifications.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No. The provided 510(k) summary does not mention any MRMC comparative effectiveness study. It focuses solely on non-clinical testing for substantial equivalence.

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

Not Applicable. The Ocelot Catheter is a medical device (a physical catheter with OCT imaging capability for human-assisted guidance), not a standalone algorithm. Its intended use inherently involves human interaction (manual advancement of the catheter, interpretation of OCT images as an adjunct to fluoroscopy).

7. The type of ground truth used:

For the non-clinical tests, the "ground truth" was based on pre-determined product specifications and external standard requirements. For example, a tensile test would have a specified breaking strength; the measurement from the test would be compared to that specification.

8. The sample size for the training set:

Not Applicable. This submission describes a physical medical device. There is no "training set" in the context of an algorithm or AI model that would be trained on data. The device's design and manufacturing rely on engineering principles and quality control, not machine learning training.

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

Not Applicable. As there is no training set for an algorithm, there is no corresponding ground truth for it.

Summary

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510(k) Summary

DEC 7 2012

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Name and Address of Applicant A. Avinger, Inc. 400 Chesapeake Drive Redwood City, CA 94063 Contact Person B. Albert Boniske Sr. Manager, Regulatory and Quality Affairs (650) 241-7004

C. Date Prepared

November 8, 2012

D. Device Name

Trade Name:	Ocelot Catheter
Common Name:	Percutaneous Catheter
Classification Name:	Percutaneous Catheter

Device Classification E.

Classification:	21 CFR §870.1250
Product Code:	DQY
Device Class:	Class II

F. Predicate Device

The Ocelot Catheter is substantially equivalent to the original Ocelot Catheter (K122380).

G. Device Description

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Image /page/1/Picture/1 description: The image shows a close-up of handwritten text. The text appears to be a combination of letters and numbers, with "K12346" on the top line and "2/3" on the bottom line. The handwriting is bold and clear, making the characters easily distinguishable.

Intended Use H.

Substantial Equivalence I.

The Ocelot Catheter is substantially equivalent to the originally cleared Ocelot Catheter (K122380). The subject and predicate devices have the same mechanism of action (manual advancement) and perform the same function (placement of guidewires beyond stenotic lesions in the peripheral vasculature). The design changes implemented to create Ocelot NEXT include a slightly larger torque coil and modified torque shaft, a longer hypotube in the handle assembly, a strain relief just distal to the rotator knob, the addition of a coil around the shaped distal segment and a modified spiral flute design in the distal tip. The modified distal tip represents a hybrid between the original Ocelot Catheter spiral flute configuration and the Wildcat Catheter's bilateral wedges (K111338). The changes to the Ocelot Catheter cleared under K122338 results in no significant changes to technological characteristics and do not raise any new issues of safety or effectiveness.

Non-Clinical Performance Data ).

The following non-clinical testing was previously conducted with the Ocelot Catheter to support a determination of substantial equivalence to the predicate Tip penetration testing was performed to ensure the catheter did not device. advance when the tip is engaged in tissue.

• Visual and Dimensional Verification	• Spiral Blade Functional Testing
• Tensile Testing	• Coating Friction Testing
• Torque Testing	• Tip Penetration Testing
• Guidewire advancement	• In Vitro Simulated Use Testing
• Device Advancement	• Shelf Life Testing
• Tip Deflection Testing	• Tip-Stall Testing
• Device leak testing	• Tip Penetration Testing
• Luer Leak Testing	• Flexibility/Trackability

The above testing confirmed that the Ocelot Catheter performs according to the stated intended use. All data fell well within pre-determined product specifications

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Avinger, Inc.

and external standard requirements. Results of non-clinical testing demonstrated that the Ocelot Catheter is substantially equivalent to the predicate device for the stated intended use.

K. Conclusions

The Ocelot Catheter has been carefully compared to legally marketed devices with respect to intended use and technological characteristics. Non-clinical testing was conducted to validate the performance of the devices and ensure the Ocelot Catheter functions as intended and meet design specifications. The comparison and nonclinical results demonstrate that the devices are substantially equivalent to the predicate device for the stated intended use.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird in flight, represented by three curved lines. The bird is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.

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 Quality Affairs 400 Chesapeake Drive Redwood City, CA 94063

SFP 1 8 2013

Re: K123462

Trade/Device Name: Ocelot Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PDU Dated: November 8, 2012 Received: November 9, 2012

Dear Mr. Boniske:

This letter corrects our substantially equivalent letter of December 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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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 (OS) 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,

Zin.Z.

Bra
Dir
Div

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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Avinger, Inc.

Indications for Use Statement

510(k) Number (if known): K_ | 2346 Z

Device Name: Ocelot Catheter

Indications for Use:

The Ocelot System is intended to facilitate the intraluminal placement of conventional The Occlose System is meetidons (including sub and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention using OCT-assisted performeral valuature processory. The Ocelot System is contraindicated for use in the iliac, coronary, cerebral, renal or carotid vasculature.

Prescription Use	X	Or	Over-The-Counter Use	____
------------------	---	----	----------------------	------

(per 21 CFR 801.109)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number	K123462
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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).