Alight™ 16 Superselective Microwire Guides are 0.016 inches (0.41 mm) in diameter and are available in a variety of lengths and configurations. The core mandril of the Alight Superselective Microwire Guides is made of nitinol with a polymer coating and spans the entire length of the device to help facilitate flexibility and torqueability. The distal length of the device is covered with a hydrophilic coating.

AI/ML Overview

This document describes the testing and acceptance criteria for the Alight™ 16 Superselective Microwire Guides.

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Torque Response	Predetermined acceptance criteria were met. (Specific criteria not detailed in the provided text, but implied to be related to successful rotational response testing.)	All test articles were successfully subjected to rotational response testing and met the predetermined acceptance criteria.
Hydrated Lubricity	Peak force of all test articles was less than the predetermined acceptance criteria. (Specific criteria not detailed in the provided text, but implied to be a maximum force value.)	The peak force of all test articles was less than the predetermined acceptance criteria.
Flexing Evaluation	No flaking witnessed after testing. Predetermined acceptance criteria were met. (Specific criteria not detailed in the provided text, but implied to be related to structural integrity after flexing.)	No flaking was witnessed after testing. The predetermined acceptance criteria were met.
Fracture Evaluation	All test articles underwent bending testing without showing signs of fracture. Predetermined acceptance criteria were met. (Specific criteria not detailed in the provided text, but implied to be related to structural integrity after bending.)	All test articles underwent bending testing without showing signs of fracture. The predetermined acceptance criteria were met.
Torque Strength Evaluation	Device is sufficiently strong to withstand normal rotational loading for intended use. Predetermined acceptance criteria were met. (Specific criteria not detailed in the provided text, but implied to be a minimum torque resistance.)	Testing verifies that the device is sufficiently strong to withstand normal rotational loading for intended use. The predetermined acceptance criteria were met.
Tensile Evaluation	Wire guide is sufficiently strong to withstand normal tensile loading for intended use in accordance with ISO 11070:2009. Predetermined acceptance criteria were met. (Specific criteria not detailed in the provided text, but implied to be a minimum tensile strength according to the ISO standard.)	Testing verifies that the wire guide is sufficiently strong to withstand normal tensile loading for intended use in accordance with ISO 11070:2009. The predetermined acceptance criteria were met.
Tip Flexibility Evaluation	N/A (Tested for characterization purposes only, without a set acceptance criterion.)	The testing showed that the wire guide is sufficiently strong to withstand normal tensile loading for its intended use.
Biocompatibility Testing	Conformance with applicable sections of ISO 10993-1. Predetermined acceptance criteria were met. (Specific criteria not detailed in the provided text, but implied to be acceptable results for cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, pyrogen, hemocompatibility, complement activation, partial thromboplastin time, and thromboresistance.)	Device is biocompatible. In conformance with the applicable sections of ISO 10993-1, the predetermined acceptance criteria were met.

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

The provided document does not explicitly state the numerical sample size used for the test set for each individual test. It consistently refers to "all test articles" being subjected to the tests, implying that the entire batch of samples prepared for testing was used without presenting specific numerical counts.
The data provenance (country of origin, retrospective/prospective) is not mentioned in the provided text. It can be inferred that the testing was prospective as it was conducted specifically for this premarket notification.

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

The provided text describes performance testing of a medical device (microwire guide). For such physical and biocompatibility testing, "ground truth" is typically established through adherence to standardized testing protocols and validated measurement techniques, rather than expert consensus on interpretive data. There is no mention of experts being used to establish a "ground truth" in the way that would apply to interpretative diagnostic studies (e.g., radiologists interpreting images). The "ground truth" here is the physical measurement against set engineering and biocompatibility standards.

4. Adjudication Method for the Test Set

Not applicable. As described above, the tests are primarily objective performance measurements against predetermined engineering and biocompatibility criteria, not subjective interpretations requiring adjudication.

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

No. The provided document relates to the premarket notification for a medical device (microwire guide), not a diagnostic or interpretative AI system. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or described.

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

Yes, in a sense. The testing described is entirely "standalone" in that it assesses the device's inherent physical and biological performance characteristics without integration into a human workflow or requiring human interpretation for its primary function. The device's performance is evaluated intrinsically.

7. The Type of Ground Truth Used

The ground truth for the performance tests described (Torque Response, Lubricity, Flexing, Fracture, Torque Strength, Tensile, Biocompatibility) is based on:

Engineering Specifications and Predetermined Acceptance Criteria: These are set values or conditions that the device must meet, derived from design requirements, industry standards (e.g., ISO 11070:2009 for tensile evaluation, ISO 10993-1 for biocompatibility), and internal quality controls.
Objective Measurements: Laboratory instruments and standardized procedures are used to objectively measure the device's physical properties (e.g., rotational response, peak force, absence of flaking/fracture, tensile strength).
Standardized Biocompatibility Assays: Established biological tests (e.g., for cytotoxicity, sensitization) with predefined positive and negative controls and interpretation criteria.

8. The Sample Size for the Training Set

Not applicable. This document describes the evaluation of a physical medical device. There is no mention of a "training set" as would be used for machine learning or AI algorithms. The device's design and manufacturing processes are refined through engineering and material science, not through AI training on data.

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

Not applicable, as there is no training set for this type of device.

Summary

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K123707
p. 1 of 2

Page 22

FEB 2 8 2013

Special 510(K) Premarket Notification Alight" 16 Superselective Microwire Guides Cook Incorporated 30 November 2012

510(k) Summary

Submitted By:

David Lehr Cook Incorporated 750 Daniels Way Bloomington, IN 47404

Device:

Trade Name: Proposed Classification:

Alight™ 16 Superselective Microwire Guides Wire, Guide, Catheter DQX (21 CFR §870.1330)

Indications for Use:

Alight" 16 Superselective Microwire Guides are intended for use in facilitating delivery of percutaneous catheters into the peripheral vasculature.

Predicate Device:

Cook Incorporated's Alight™ 16 Superselective Microwire Guide is identical in terms of intended use and similar in terms of principles of operation, materials of construction, and technological characteristics to the predicate device, subject of this submission, is substantially equivalent to the Roadrunner UniGlide Hydrophilic Wire Guide, manufactured by Cook Incorporated, which is cleared under 510(k) number K110009 (February 2, 2011).

Comparison to Predicate Device:

It has been demonstrated that the Alight™ 16 Superselective Microwire Guide is comparable to its predicate device in terms of design, intended use, materials, fundamental technology, and principle of operation.

Device Description:

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K123707
P. 2 of 2

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Special 510(K) Premarket Notification . Alight™ 16 Superselective Microwire Guides Cook Incorporated 30 November 2012

Test Data:

The Alight" 16 Superselective Microwire Guide was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:

Torque Response ~ Testing shows that all test articles were successfully subjected to 1 . rotational response testing. The predetermined acceptance criteria were met.
Hydrated Lubricity Testing shows that the peak force of all test articles was less 2. than the predetermined acceptance criteria.
Flexing Evaluation No flaking was witnessed after testing. The predetermined 3. acceptance criteria were met.
1. Fracture Evaluation - Testing shows that all test articles underwent bending testing without showing signs of fracture. The predetermined acceptance criteria were met.
Torque Strength Evaluation Testing verifies that the device is sufficiently strong to న. withstand normal rotational loading for intended use. The predetermined acceptance criteria were met.
Tensile Evaluation Testing verifies that the wire guide is sufficiently strong to 6. withstand normal tensile loading for intended use in accordance with ISO 11070:2009. The predetermined acceptance criteria were met.
Tip Flexibility Evaluation Testing was completed for characterization purposes only 7. and therefore did not have a set acceptance criterion. The testing showed that the wire guide is sufficiently strong to withstand normal tensile loading for its intended use.
Biocompatibility Testing (i.e., cytotoxicity, sensitization, intracutaneous reactivity, 8. systemic toxicity, pyrogen, hemocompatibility, complement activation, partial thromboplastin time, and thromboresistance) shows the device is biocompatible. In conformance with the applicable sections of ISO 10993-1, the predetermined acceptance criteria were met.

In conclusion, the results of these tests provide reasonable assurance that the device is as safe and effective as the predicate device and support a determination of substantial equivalence.

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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 graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.

February 28. 2013

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

Public Health Service

Cook Incorporated c/o Mr. David Lehr, Regulatory Affairs Specialist 750 Daniels Way Bloomington, IN 47404

Re: K123707

Trade Name: Alight™ 16 Superselective Microwire Guides Regulation Number: 21 CFR 870.1330 Regulation Name: Wire, Guide, Catheter Regulatory Class: Class II Product Code: DOX Dated: January 31, 2013 Received: February 4, 2013

Dear Mr. Lehr:

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 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.

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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/CDRH0ffices/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,

Matthew G¶레illebrenner

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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Special 510(K) Premarket Notification Alight™ 16 Superselective Microwire Guides Cook Incorporated 30 November 2012

510(k) Number (if known):

Device Name: Alight™ 16 Superselective Microwire Guides

Indications for Use:

Alight™ 16 Superselective Microwire Guides are intended for use in facilitating delivery of percutaneous catheters into the peripheral vasculature.

Prescription Use X (Per 21 CFR 801 Subpart D) OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Matthew G퀘訓lebrenner

Regulation Number and Section

§ 870.1330 Catheter guide wire.

(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.