The Cook MicroWire Wire Guide is manufactured using a nitinol mandril with a PTFE coating and a stainless steel and palladium distal tip. The maximum outside diameter is 0.0142-inch and will be available in 135, 190 and 300 cm lengths. It will be supplied sterile, intended for one-time use.

AI/ML Overview

The provided text describes a Special 510(k) Premarket Notification for the Cook MicroWire Wire Guide. This type of regulatory submission is for medical devices and focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive clinical trial data or detailed performance metrics against specific quantitative acceptance criteria in the same way modern AI/software as a medical device (SaMD) submissions might.

Therefore, many of the requested categories for acceptance criteria and study details are not applicable or directly available in this document. The submission focuses on physical and material properties and safety, reflecting the nature of a hardware device.

Here's an analysis based on the provided text, highlighting what is available and what is not:

Acceptance Criteria and Device Performance for Cook MicroWire Wire Guide

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (Not explicitly stated as quantitative thresholds in the document, but implied successful completion)	Reported Device Performance
Tensile Test	Device maintains integrity under tensile force, meets design specifications.	Performed; results provide reasonable assurance of conformance.
Tip Flexibility Test	Tip maintains appropriate flexibility for intended use without breaking or deforming adversely.	Performed; results provide reasonable assurance of conformance.
Fracture Test	Device does not fracture under specified conditions.	Performed; results provide reasonable assurance of conformance.
Flexing Test	Device withstands repeated flexing without degradation.	Performed; results provide reasonable assurance of conformance.
Torque Strength Test	Device withstands specified torque without damage or failure.	Performed; results provide reasonable assurance of conformance.
Torque Response Test	Device transmits torque effectively and predictably.	Performed; results provide reasonable assurance of conformance.
Biocompatibility Testing	Device materials are biocompatible (e.g., non-toxic, non-irritating, non-sensitizing).	Performed; results provide reasonable assurance of conformance.
Bioburden Testing	Device meets specified microbial load limits.	Performed; results provide reasonable assurance of conformance.
Endotoxin Testing	Device meets specified endotoxin limits.	Performed; results provide reasonable assurance of conformance.
EtO Residual Testing	Device meets specified limits for Ethylene Oxide residuals (if EtO sterilized).	Performed; results provide reasonable assurance of conformance.

Note: The document states that "The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a wire guide." This implies that the device met its internal acceptance criteria for each test, but the specific numerical thresholds for these criteria are not disclosed in this summary.

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

Sample Size: Not explicitly stated for any of the tests. The testing typically involves a representative number of units to demonstrate product consistency and performance.
Data Provenance: Not applicable in the context of "country of origin of the data" or "retrospective or prospective" as these tests are laboratory-based, pre-market engineering and safety assessments of a manufactured medical device, not clinical data sets. The testing was conducted internally by Cook Incorporated.

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

Not Applicable. This device is a physical medical instrument, not an AI or diagnostic tool that relies on expert interpretation of data to establish ground truth for performance. The "ground truth" for these engineering tests is based on established scientific and engineering principles, material specifications, and regulatory standards.

4. Adjudication Method for the Test Set

Not Applicable. See point 3. The tests are objective measurements of physical properties, not subjective interpretations requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance.

Not Applicable. This is a hardware device (wire guide), not an AI or software product. MRMC studies are used for evaluating diagnostic performance of AI or imaging technologies in conjunction with human readers.

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

Not Applicable. See point 5.

7. The Type of Ground Truth Used

Device-Specific Engineering and Material Specifications, and Regulatory Standards: The "ground truth" for the tests (Tensile, Flexibility, Fracture, etc.) is based on meeting the defined engineering parameters and safety standards relevant to a guide wire for cardiovascular use. For biocompatibility, bioburden, endotoxin, and EtO residuals, the ground truth is defined by established international standards (e.g., ISO) and regulatory limits for patient safety.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" in the context of this traditional hardware medical device. Training sets are relevant for machine learning algorithms.

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

Not Applicable. See point 8.

Summary

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Special 510(k) Premarket Nutification Cook MicroWire Wire Guide COOK INCORPORATED

510(k) Summary

Submitted By:

Karen Bradburn, RAC Senior Regulatory Affairs Specialist Cook Incorporated 750 Daniels Way, PO Box 489 Bloomington, IN 47402 812-339-2235

Device:

Trade Name: Proposed Classification:

Cook MicroWire Wire Guide Wire, Guide, Catheter 21 CFR §870.1330

Indications for Use:

The Cook MicroWire Wire Guide is indicated for use in facilitating delivery of percutaneous catheters into the cardiovascular system.

Predicate Devices:

The Cook MicroWire Wire Guide is similar in terms of intended use, materials of construction and technological characteristics to predicate devices reviewed as devices for facilitating delivery of percutaneous catheters into the cardiovascular system.

Device Description:

Substantial Equivalence:

The Cook MicroWire Wire Guide is similar to many devices in commercial distribution for facilitating delivery of percutaneous catheters into the cardiovascular system. The identical indications for use, principles of operations, similar materials of construction and technological characteristics of the wire guide support a determination of substantial equivalency.

K070410

APR 2 7 2007

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Test Data:

The Cook MicroWire Wire Guide was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:

1. Tensile Test
1. Tip Flexibility Test
1. Fracture Test
1. Flexing Test
1. Torque Strength Test
ર. Torque Response Test
Biocompatibility Testing 7.
1. Bioburden Testing
1. Endotoxin Testing
1. EtO Residual Testing

The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a wire guide.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cook Incorporated c/o Ms. Karen Bradburn Senior Regulatory Affairs Specialist 750 Daniels Way, P.O. Box 489 Bloominton, IN 47402

APR 2 7 2007

Re: K070410 Cook MicroWire Wire Guide Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: II (two) Product Code: DOX Dated: April 6, 2007 Received: April 9, 2007

Dear Ms. Bradburn:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 -- Ms. Karen Bradburn

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

R. haines

Image /page/3/Picture/5 description: The image contains a signature and the words "Br" and "Di" to the right of the signature. The signature is a stylized loop with a line extending from the bottom left. The letters "Br" and "Di" are stacked vertically, with "Br" on top of "Di".

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 Cook MicroWire Wire Guide COOK INCORPORATED

510(k) Number (if known):

Device Name: Cook MicroWire Wire Guide

Indications for Use:

Indicated for use in facilitating delivery of percutaneous catheters into the cardiovascular system.

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)

sumer 2. VC. une (Division Sign-Off)

Division of Cardiovascular De

510(k) Number Ko 70410

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.