The Heavy Double Flexible Tipped Wire Guide is constructed of stainless steel coils surrounding a stainless steel mandril. It is a 0.032 inch diameter, 60 cm long wire guide with two flexible tips and four sets of centimeter markings etched at 10 cm intervals along the wire shaft. The device is supplied sterile, packaged within a Tyvek peel pouch.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Heavy Double Flexible Tipped Wire Guide." It does not describe an AI/ML powered device, therefore the requested information for acceptance criteria and study proving the device meets the criteria is not applicable in the context of AI/ML.

The document discusses various performance tests conducted for the wire guide and states that predetermined acceptance criteria for each test were met. However, it does not provide the specific numerical acceptance criteria or detailed results in a table format as requested for an AI/ML device.

Here's a breakdown of what is available in the document, framed as close as possible to the request, but acknowledging the device type:

Device Type: Medical device (Catheter Guide Wire), not an AI/ML powered device.

1. Table of acceptance criteria and reported device performance:

Test Name	Acceptance Criterion (General Statement)	Reported Device Performance
Fracture Testing	No signs of fracture after manipulation (excluding region of fixation and first turn).	Met the predetermined acceptance criterion.
Tensile Testing	No sign of loosening of any unions after appropriate force per ISO 11070:1999.	Met the predetermined acceptance criterion.
Corrosion Resistance	No signs of corrosion affecting functional performance or biocompatibility.	Met the predetermined acceptance criterion.
Flex Testing	No signs of defects or damage after repeated flexing.	Met the predetermined acceptance criterion.
Acute Performance Evaluation	Rated as acceptable for normal clinical practice for performance parameters evaluated.	Met the predetermined acceptance criterion.
Bubble Leak (Packaging)	No pinholes or imperfect seals (no bubbles from pressurized air leaking).	Met the predetermined acceptance criterion.
Seal Strength (Packaging)	Mean seal force exceeds 0.50 lbf.	Met the predetermined acceptance criterion.
Biocompatibility Testing	Deemed acceptable per ISO 10993-1:2009 (cytotoxicity, sensitization, irritation/intracutaneous reactivity, systemic toxicity, hemocompatibility).	Deemed acceptable; met the predetermined acceptance criterion.

Regarding the requested details that are specific to AI/ML studies, none of these are applicable to this document:

Sample sized used for the test set and the data provenance: Not applicable to a physical device performance study. The "test set" would be the physical samples of the wire guide subjected to the tests.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's mechanical and material properties is established through standardized testing procedures and measurements, not expert consensus on interpretations.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a physical device, ground truth is based on objective measurements and adherence to specified physical and material properties.
The sample size for the training set: Not applicable (no "training set" for physical device testing).
How the ground truth for the training set was established: Not applicable.

In conclusion, this document details the performance testing of a conventional medical device, not an AI/ML product. Therefore, many of the specific questions related to AI/ML acceptance criteria and studies are not relevant. The document states that the device successfully met its predetermined acceptance criteria for various physical and mechanical tests.

Summary

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Public Health Service

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

May 28, 2015

Cook, Inc. Ms. Julia Ferguson Regulatory Affairs Specialist 750 Daniels Way Bloomington, IN 47404

Re: K150802

Trade/Device Name: Heavy Double Flexible Tipped Wire Guide Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: March 25, 2015 Received: March 26, 2015

Dear Ms. Ferguson:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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,

Kenneth J. Cavanaugh -S

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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Indications for Use

510(k) Number (if known) K150802

Device Name

Heavy Double Flexible Tipped Wire Guide

Indications for Use (Describe)

The Heavy Double Flexible Tipped Wire Guide is intended to facilitate placement of devices used during diagnostic and interventional procedures.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Heavy Double Flexible Tipped Wire Guide 21 CFR §870.1310 Date Prepared: May 26, 2015

Submitted By:

Applicant:	Cook Incorporated
Contact:	Julia Ferguson
Applicant Address:	Cook Incorporated750 Daniels WayBloomington, IN 47404
Contact Phone Number:	(812) 335-3575 x104554
Contact Fax Number:	(812) 332-0281

Device Information:

Trade Name:	Heavy Double Flexible Tipped Wire Guide
Common Name:	Catheter Wire Guide
Classification Name:	Wire, Guide, Catheter
Regulation:	21 CFR §870.1330
Product Code:	DQX

Predicate Device:

The predicate device is the Cardiovascular Spring Guides (Lake Region Mfg., Inc., K770977).

Device Description:

Intended Use:

The Heavy Double Flexible Tipped Wire Guide is intended to facilitate placement of devices used during diagnostic and interventional procedures.

Comparison to Predicates:

Cook Incorporated's Heavy Double Flexible Tipped Wire Guide is substantially equivalent to the predicate device, the Cardiovascular Spring Guides (K770977), in that these devices have identical designs, methods of construction and operation, and indications for use.

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Technological Characteristics:

The following tests have been conducted to ensure reliable design and performance under the specified design requirements.

Fracture Testing: Testing verified that there will be no signs of fracture after . manipulation, excluding the region of fixation and the first turn. The predetermined acceptance criterion was met.
Tensile Testing: Testing verified that there will be no sign of loosening of any unions . after an appropriate level of force defined by ISO 11070:1999 is applied. The predetermined acceptance criterion was met.
Corrosion Resistance: Testing verified that there will be no signs of corrosion that will . affect the functional performance or biocompatibility of the wire guide. The predetermined acceptance criterion was met.
Flex Testing: Testing verified that there will be no signs of defects or damage when the . wire guide is subjected to repeated flexing. The predetermined acceptance criterion was met.
. Acute Performance Evaluation: The testing confirmed that the wire guide is rated as acceptable for normal clinical practice for the performance parameters evaluated. The predetermined acceptance criterion was met.
Bubble Leak (Packaging): The package shall show no signs of pin holes or imperfect . seals indicated by bubbles created from the pressurized air leaking into the surrounding solution. The predetermined acceptance criterion was met.
Seal Strength (Packaging): All specimens must have a mean seal force that exceeds 0.50 . lbf. The predetermined acceptance criterion was met.
Biocompatibility Testing: Per ISO 10993-1:2009, the subject devices are categorized as . external communicating devices in contact with circulating blood for a limited (≤24 hours) duration. The following tests were completed and the biocompatibility was deemed acceptable: cytotoxicity, sensitization, irritation/intracutaneous reactivity, systemic toxicity, and hemocompatibility.

Conclusion:

The results of these tests support a conclusion that the Cook Incorporated Heavy Double Flexible Tipped Wire Guide met the design input requirements based on its intended use. The results also support the conclusion that these devices do not raise new questions of safety or effectiveness and are substantially equivalent to the predicate device, the Cardiovascular Spring Guides (K770977).

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.