The Wildcat 6F Guidewire Support Catheter is intended to support steerable guidewires in accessing discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices. It may also be used to deliver saline/contrast.

Device Description

The Wildcat 6F Guidewire Support Catheter is a 6F sheath and 0.035" guidewire compatible over-thewire device. It consists of a catheter shaft with handle assembly at the proximal end an atraumatic distal tip. The catheter is available in two sizes with a working length of either 110 cm or 135 cm. A locking luer connector at the proximal end provides entry to a lumen that supports and facilitates movement of a guidewire. The catheter has been irradiated for sterility and is intended for single use only.

AI/ML Overview

Here's an analysis of the provided text regarding the Avinger Wildcat 6F Guidewire Support Catheter, focusing on acceptance criteria and supporting studies.

Important Note: The provided text is a 510(k) Summary and FDA clearance letter. This type of document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics in the way a clinical trial report would for drug or novel device approval.

Acceptance Criteria and Device Performance

The core of this submission is substantial equivalence to an existing predicate device (Wildcat 7F Guidewire Support Catheter). Therefore, the "acceptance criteria" are largely focused on demonstrating that the new device (Wildcat 6F) performs at least as well as the predicate device in relevant non-clinical tests and that the modifications do not raise new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Requirement	Reported Device Performance
Mechanical Performance (Non-Clinical)	Tensile Strength	"All data fell well within pre-determined product specifications and external standard requirements." (Implies meeting or exceeding the performance of the predicate and/or industry standards.)
	Torque Strength	"All data fell well within pre-determined product specifications and external standard requirements."
	Coating Integrity	"All data fell well within pre-determined product specifications and external standard requirements."
	Device Compatibility (with guidewires and other devices)	"All data fell well within pre-determined product specifications and external standard requirements." (Likely means it functions as intended with 0.035" guidewires and allows passage of other interventional devices.)
Biocompatibility	EN ISO 10993-1 "Biological Evaluation of Medical Devices"	"Biocompatibility testing was conducted according to EN ISO 10993-1 'Biological Evaluation of Medical Devices'. All data fell well within pre-determined product specifications and external standard requirements." (Implies the materials are safe for human contact for the intended duration.)
Sterility	Irradiation for sterility	"The catheter has been irradiated for sterility..." (Implies that the sterilization method used is validated and achieves the required sterility assurance level. The specific sterility assurance level (e.g., SAL of 10^-6) is not explicitly stated but is a standard requirement for sterile medical devices.)
Intended Use Equivalence	Supports steerable guidewires in peripheral vasculature	"The Wildcat 6F Guidewire Support Catheter is intended to support steerable guidewires in accessing discrete regions of the peripheral vasculature." (Directly aligns with the predicate's intended use and is demonstrated through non-clinical performance data and material similarity.)
	Facilitates placement/exchange of guidewires	"It may be used to facilitate placement and exchange of guidewires and other interventional devices." (Directly aligns with the predicate's intended use.)
	Delivers saline/contrast	"It may also be used to deliver saline/contrast." (Directly aligns with the predicate's intended use.)
Safety and Effectiveness (Overall Substantial Equivalence)	Comparison to Wildcat 7F Guidewire Support Catheter	"Based upon the product technical information, intended use, and performance data provided... the Avinger 6F catheter has been shown to be equivalent to the currently marketed Avinger 7F catheter." (This is the ultimate "acceptance criterion" for a 510(k) - demonstrating no new safety or effectiveness concerns compared to a legally marketed device, despite minor modifications like smaller profile, modified distal tip, and new working lengths.)

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

Sample Size: The document does not specify exact sample sizes for the "design verification testing" or "biocompatibility testing." It only states that "Design verification testing was conducted." For medical device non-clinical testing, sample sizes are typically determined by statistical methods or regulatory guidance to ensure robustness and often involve multiple units tested to destruction or specific performance thresholds.
Data Provenance: The data is generated from laboratory testing (design verification and biocompatibility testing). It is prospective in the sense that the tests were designed and executed to evaluate this specific device for regulatory submission. The country of origin for the data generation is not explicitly stated but would presumably be in the USA, where Avinger, Inc. is located.

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

Not Applicable / Not Specified. For non-clinical device performance and biocompatibility testing, "ground truth" is established by adherence to recognized standards (e.g., ISO 10555-1, EN ISO 10993-1) and internal product specifications. The "experts" involved would be the engineers, scientists, and technicians who perform and validate these tests, but their specific number or qualifications are not detailed in this summary. These are typically individuals with expertise in mechanical engineering, materials science, and biochemistry specific to medical devices.

4. Adjudication Method for the Test Set

Not Applicable. Since this involves laboratory testing against established specifications and standards, there isn't a "ground truth" requiring adjudications between human observers, as would be the case in a clinical trial or image interpretation study. The test results are objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This document describes non-clinical testing for a medical device. MRMC studies are typically performed for diagnostic imaging devices to evaluate the impact of AI assistance on human reader performance. This is not relevant to the Wildcat 6F Guidewire Support Catheter which is an interventional tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not Applicable. This is a physical medical device, not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm doesn't apply. The device's "standalone" performance is its ability to meet the non-clinical specifications independently.

7. The Type of Ground Truth Used

Engineering/Material Specifications and Recognized Standards: The ground truth for the non-clinical tests is based on:
- Pre-determined product specifications: Internal quality and performance requirements set by Avinger, Inc.
- External standard requirements: Adherence to established international standards such as ISO 10555-1 (for intravascular catheters) and EN ISO 10993-1 (for biocompatibility).
- Performance of the predicate device: The Wildcat 7F served as a benchmark for demonstrating substantial equivalence.

8. The Sample Size for the Training Set

Not Applicable. This is not a machine learning or AI device that employs a "training set."

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

Not Applicable. (See point 8).

Summary

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K102022 page 1 of

6 2010

AVINGER, INC.

Section 2: 510(k) Summary (21 CFR § 807.92)

Submitter:	Avinger, Inc.400 Chesapeake Drive
	Redwood City, CA 94063
Contact:	Himanshu PatelChief Technology Officer	AUG
Date Summary Prepared:	15 July 2010
Device Trade Name:	Wildcat 6F Guidewire Support Catheter
Common Name:	Guidewire Support Catheter
Classification Name:	Percutaneous Catheter (21 CFR § 870.1250)
Product Code:	DQY
Cleared Device:	Wildcat 7F Guidewire Support Catheter (K083313)

Device Description:

Intended Use:

Nonclinical Performance Data:

Design verification testing was conducted. Such testing confirms that the Wildcat 6F device performs according to the stated intended use. Device evaluation consisted of laboratory testing specified in 10555-1 "Sterile, single-use intravascular catheters – Part 1 – General Requirements" and included tensile, torque strength, coating integrity and device compatibility. Biocompatibility testing was

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conducted according to EN ISO 10993-1 "Biological Evaluation of Medical Devices". All data fell well within pre-determined product specifications and external standard requirements.

Comparison with Cleared Device:

The Avinger 6F catheter is very similar to the Avinger 7F catheter. Both devices are intended for use with steerable guidewires to access discrete regions of the peripheral vasculature. Additionally, both devices may be used to facilitate placement and exchange of conventional guidewires and to deliver saline or contrast. Both devices are comprised of similar materials and function according to similar operating parameters. There are three primary differences between the modified and cleared devices. First, the modified device has a smaller profile (6F as opposed to 7F) as compared to the cleared device. Second, the distal tip has been modified to allow for articulation. Lastly, the 6rd clevice will be offered in two working lengths to accommodate various access procedures.

Summary:

Based upon the product technical information, intended use, and performance data provided in this premarket notification, the Avinger 6F catheter has been shown to be equivalent to the currently marketed Avinger 7F catheter.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The logo is in black and white.

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

AUG - 6 2010

Avinger. Inc c/o Mr. Himanshu Patel Chief Technology Officer 400 Chesapeake Drive Redwood City, CA 94063

Re: K102022

Trade/Device Name: Wildcat 6F Guidewire Support Catheter Regulation Number: 21 CFR§ 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: July 16, 2010 Received: July 19, 2010

Dear Mr Patel:

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.

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Page 2 - Mr. Himanshu Patel

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/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.

una R. Laline

Image /page/3/Picture/7 description: The image shows a handwritten symbol or character. It appears to be a stylized or cursive letter, possibly a 'W' or a similar shape. The character is drawn with a single, continuous stroke, featuring a curved line that forms two peaks and a loop at the bottom.

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

Enclosure

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AVINGER, INC.

Section 1: Statement of Indications for Use

510(k) Number if known: TBD KIO 2022

Device Name: Wildcat 6F Guidewire Support Catheter

AUG - 6 2010

Indications for Use:

Prescription Use: (Σ (Per 21 CFR § 801, Subpart D)

AND/OR

Over-the-Counter Use (Per 21 CFR §807, Subpart C)

(Please DO NOT WRITE BELOW THIS LINE ~ Continue on another page if needed)

Concurrence of CDRH, Office of 욕ூர்ட்டி நடிப்பூர்மடும்

(Division Sign-Off)

CONFIDENTIAL

DIVISION OF OCT OF Childing Security Devisor

Page 2

510(k) Number K 102022

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).