The Kittycat Catheter 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. The Kittycat Catheter is contraindicated for use in the illac, coronary, cerebral or carotid vasculature.

The Kittycat 2 Catheter 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. The Kittycat Catheter is contraindicated for use in the iliac, coronary, cerebral or carotid vasculature.

Device Description

The Kittycat Catheters consist of a Catheter Shaft with a Handle assembly at the proximal end and a rotating Distal Tip. The Kittycat Catheters have a working length of 140 cm and 150 cm for the Kittycat and Kittycat 2, respectively. A locking Luer at the proximal provides entry to a lumen that supports and facilitates movement of a guidewire. The Kittycat Catheters have been irradiated for sterility and are intended for single-use only. The Kittycat Catheters are fundamentally the same device and only differ in handle design and Distal Tip deflection mechanism: the Kittycat Catheter utilizes a slider-based Distal Tip deflection mechanism while the Kittycat 2 Catheter utilizes a pre-shaped Distal Tip.

AI/ML Overview

The provided text describes the 510(k) summary for the Kittycat and Kittycat 2 Catheters. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study outlining specific acceptance criteria and device performance in a clinical or standalone setting.

Therefore, the information requested regarding acceptance criteria, studies, sample sizes, expert involvement, and ground truth establishment is largely not present in the provided text, as these are typically part of a clinical trial or a performance study to prove efficacy, which is often not required for a 510(k) submission based on substantial equivalence.

Here's a breakdown of what can and cannot be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a specific clinical outcome. The acceptance criteria implied here are that the non-clinical testing results "fell well within pre-determined product specifications and external standard requirements." However, the specific "product specifications" and "external standard requirements" are not detailed.
Reported Device Performance: The document states that the non-clinical testing "confirmed that the Kittycat Catheters performs according to the stated intended use" and "demonstrated that the Kittycat Catheters are substantially equivalent to the predicate device." No specific, quantitative performance values are provided (e.g., success rates, accuracy metrics).

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

Sample Size: Not applicable/not provided. The submission focuses on non-clinical testing, not a clinical "test set" with patients.
Data Provenance: The "Non-Clinical Performance Data" section lists various tests conducted. These are laboratory/benchtop tests, not human data. No country of origin or retrospective/prospective designation applies here.

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

Not applicable/not provided. This information is relevant for clinical studies involving human interpretation or diagnosis. For non-clinical device testing, ground truth is typically established by engineering specifications, physical measurements, and industry standards.

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

Not applicable/not provided. Adjudication methods are used in clinical trials, especially when human readers are involved in assessing outcomes.

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:

No. This device is a percutaneous catheter, not an AI or imaging diagnostic device. Therefore, an MRMC study is not relevant.

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

No. This device is a physical catheter, not an algorithm.

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

The "ground truth" for this submission is based on engineering specifications, physical and mechanical test standards, and conformity to equivalent predicate device performance. The non-clinical tests (e.g., tensile testing, torque testing, biocompatibility, tip deflection testing) are designed to verify that the device meets predefined technical requirements and performs safely and effectively in simulated environments, aligning with the predicate device.

8. The sample size for the training set:

Not applicable/not provided. There is no "training set" as this is not an algorithm being developed. The phrase "non-clinical testing was previously conducted" implies a set of tests were run, but not in the context of a training dataset for an AI model.

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

Not applicable/not provided. As there's no training set, there's no ground truth established for one.

In summary, the provided 510(k) summary is for a medical device (a catheter) seeking market clearance based on substantial equivalence to a legally marketed predicate device. It relies heavily on non-clinical (benchtop) testing to demonstrate that the new device has comparable performance and safety characteristics to the existing one. It does not contain the kind of clinical study data, AI performance metrics, or extensive human expert involvement details that would be found in a submission for a diagnostic AI device.

Summary

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510(k) Summary

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
B. Contact Person Albert Boniske Regulatory Affairs Consultant (408) 400-0856
C. Date Prepared

January 27, 2012

D. Device Name

Trade Name:	Kittycat and Kittycat 2 Catheters
Common Name:	Percutaneous Catheter
Classification Name:	Percutaneous Catheter

Device Classification E.

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

E. Predicate Device

The Kittycat and Kittycat 2 Catheters are substantially equivalent to the Avinger Wildcat 6F Catheter (K111338).

G. Device Description

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deflection mechanism: the Kittycat Catheter utilizes a slider-based Distal Tip deflection mechanism while the Kittycat 2 Catheter utilizes a pre-shaped Distal Tip.

H. Intended Use

l, Substantial Equivalence

The Kittycat Catheters are substantially equivalent to the Avinger Wildcat 6F Catheter (K111338) and original Kittycat Catheters (K101647 and K112579). 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 only difference is the use of spiral flutes in the Distal Tip on the Kittycat Catheters as opposed to bilateral wedges as on the Wildcat 6F Catheter. The changes to the Wildcat 6F Catheter cleared under K111338 results in no significant changes to technological characteristics and do not raise any new issues of safety or effectiveness.

Non-Clinical Performance Data J.

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

• Visual and Dimensional Verification	• Spiral Blade Functional Testing
• Tensile Testing	• Coating Friction Testing
• Torque Testing	• Biocompatibility
• Guidewire advancement	• In Vitro Simulated Use Testing
• Device Advancement	• Packaging Testing

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· Tip Deflection Testing	· Shipping Testing
· Device leak testing	· Shelf Life Testing
· Luer Leak Testing	· Sterility Testing
· Flexibility/Trackability	· Tip Penetration Testing

The above testing confirmed that the Kittycat Catheters performs according to the stated intended use. All data fell well within pre-determined product specifications and external standard requirements. Results of non-clinical testing demonstrated that the Kittycat Catheters are substantially equivalent to the predicate device for the stated intended use.

K. Conclusions

The Kittycat Catheters have 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 Kittycat Catheters function as intended and meet design specifications. The comparison and non-clinical 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 consists of a stylized image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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

Avinger, Inc. c/o Mr. Albert Boniske Regulatory Consultant Experien Group, LLC 755 N. Mathilda Avenue, Suite 100 Sunnyvale, CA 94085

SEP 1 8 2013

Re: K120273

Trade/Device Name: Kittycat Catheter and Kittycat 2 Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PDU Dated: January 27, 2012 Received: January 30, 2012

Dear Mr. Boniske:

This letter corrects our substantially equivalent letter of March 30, 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

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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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Zm.2

Image /page/4/Picture/7 description: The image shows the handwritten word "for" in a cursive style. The letters are connected, with the "f" having a distinctive loop extending above the other letters. The writing appears to be in black ink on a white background, creating a high contrast.

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

KI20273 K 510(k) Number (if known):

Kittvcat 2 Catheter Device Name:

Indications for Use:

X Prescription Use

. 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)

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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).