The van Andel Dilatation Catheter is intended to facilitate percutaneous introduction of guide wires, and other devices into the femoral, popliteal, and infrapopliteal arteries during diagnostic and interventional procedures.

Device Description

The van Andel Dilatation Catheter are intravascular dilation catheters comprised of polytetrafluoroethylene, designed for use in diagnostic and interventional procedures. The van Andel Dilatation Catheters are provided sterile and are meant for single use only. The van Andel Dilatation Catheter is available in 5.0, 6.3, 7.0, 8.0, and 9.0 French diameters and is manufactured in lengths of 60, 80, and 100 centimeters.

AI/ML Overview

The provided text describes the 510(k) summary for the van Andel Dilatation Catheter. This document focuses on demonstrating substantial equivalence to predicate devices through various performance tests, not through clinical studies involving human readers or AI. Therefore, numerous requested sections related to AI performance, reader studies, and ground truth establishment are not applicable.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Biocompatibility Testing	Predetermined acceptance criteria as per ANSI AAMI ISO 10993-1:2009(R)2013 for cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, pyrogenicity, hemocompatibility, complement activation, and partial thromboplastin time.	The device is biocompatible. The predetermined acceptance criteria were met.
Tensile Testing of the Hub to Shaft Bond	Withstand peak load values specified in BS EN ISO 10555-1:2013 – Section 4.6 during proper clinical use.	The hub-to-shaft connection is expected to withstand peak load values. The predetermined acceptance criterion was met.
Liquid Leakage Testing	No liquid leakage during proper clinical use, as per BS EN ISO 10555-1:2013 - Section 4.7.1.	There shall be no liquid leakage. The predetermined acceptance criterion was met.
Dimensional Verification Testing	Outer diameter, inner diameter, taper length, and overall length of the device are within a specified tolerance.	The dimensions are within a specified tolerance. The predetermined acceptance criteria were met.
Exterior Surface Condition Testing and Distal Tip Inspection	Exterior surface of the device is smooth and free from any process defects.	The exterior surface was smooth and free from any process defects. The predetermined acceptance criteria were met.
Radiopacity Testing	Device is visible under fluoroscopic imaging in simulated clinical conditions.	The device would be visible under fluoroscopic imaging. The predetermined acceptance criterion was met.
Kink Radius Testing	Device would not kink under clinical conditions.	The device would not kink under clinical condition. The predetermined acceptance criteria were met.
Simulated Use Testing	Performance parameters are acceptable for clinical use.	The performance parameters were acceptable for clinical use. The predetermined acceptance criteria were met.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for each of the listed tests.
The data provenance is not specified beyond being "applicable testing" conducted by the manufacturer, Cook Incorporated, in Bloomington, IN, USA. These are laboratory/bench tests, not clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The tests conducted are physical and material property tests (e.g., tensile strength, leakage, dimensions, biocompatibility), not diagnostic interpretations requiring expert radiologists or similar medical professionals to establish ground truth.

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

Not applicable. These are objective engineering and material tests, not subjective interpretations requiring adjudication.

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

Not applicable. This is a medical device (catheter), not an AI-powered diagnostic or assistive tool.

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

Not applicable. This is a medical device (catheter), not an AI algorithm.

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

The "ground truth" for the tests performed are established engineering and material standards and specifications (e.g., BS EN ISO 10555-1:2013, ANSI AAMI ISO 10993-1:2009(R)2013). These are objective criteria against which the device's physical properties and performance are measured.

8. The sample size for the training set

Not applicable. This is a medical device, not a machine learning model; therefore, there is no "training set."

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

Not applicable. As there is no training set, this question is not relevant.

Summary

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Public Health Service

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April 28, 2017

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

Cook Incorporated Daniel Corbin Regulatory Affairs Specialist 750 Daniels Wav Bloomington, IN 47404

Re: K170616

Trade/Device Name: Van Andel Dilatation Catheter Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel Dilator For Percutaneous Catheterization Regulatory Class: Class II Product Code: DRE Dated: February 28, 2017 Received: March 1, 2017

Dear Mr. Daniel Corbin:

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 of medical device

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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 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,

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) K170616

Device Name van Andel Dilatation Catheter

Indications for Use (Describe)

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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510(k) SUMMARY

van Andel Dilatation Catheter Traditional 510(k) Summary 21 CFR §807.92

Submitter Information

Applicant:	Cook Incorporated
Address:	750 Daniels Way
	Bloomington, IN 47404
Contact:	Daniel J. Corbin
Email:	RegSubmissions@cookmedical.com
Contact Phone Number:	812-335-3575 ext. 104018
Contact Fax Number:	812-332-0281
Date Prepared:	April 12, 2017
Device Information
Trade Name:	van Andel Dilatation Catheter
Common Name:	Dilator, Vessel, For Percutaneous Catheterization
Classification Name:	Vessel dilator for percutaneous catheterization
	DRE (21 CFR §870.1310)

Predicate Device

The van Andel Dilatation Catheter is substantially equivalent to the Lawmax Dilator, cleared under K123842, and the Fortress Introducer Sheath System, cleared under K153197.

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Image /page/4/Picture/0 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is in white, sans-serif, uppercase letters. Below "COOK" is the word "MEDICAL" in white, sans-serif, uppercase letters.

COOK INCORPORATED
750 DANIELS WAY, P.O. BOX 489
BLOOMINGTON, IN 47402-0489 U.S.A.
PHONE: 812.339.2235 TOLL FREE: 800.457.4500
WWW.COOKMEDICAL.COM

Comparison to Predicate Device

It has been demonstrated that the van Andel Dilatation Catheter and the predicate devices are substantially equivalent in terms of intended use, duration of use, principles of operation, fundamental technological characteristics, and insertion method. The design, dimensions, indications for use, duration of use, and materials of the subject device is similar to the attributes of the predicate devices. The predicate devices are available in 4.0 - 24.0 French diameters, 26 - 100 centimeter lengths, and are compatible with a 0.035 or 0.038 inch wire guide; the subject device is available in 5.0, 6.3, 7.0, 8.0, and 9.0 French diameters, 60 - 100 centimeter lengths, and is compatible with a 0.035 or 0.038 inch wire guide. Therefore, the specifications of the subject device fall within the range of specifications of the predicate device in terms of French size, catheter length, and wire guide compatibility. This, combined with the provided testing, supports a determination of substantial equivalence between the predicate and subject devices.

Device Description

Intended Use

The van Andel Dilatation Catheter is intended to facilitate percutaneous introduction of guide wires, catheters, and other devices into the femoral, popliteal, and infrapopliteal arteries during diagnostic and interventional procedures.

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Image /page/5/Picture/0 description: The image shows the Cook Medical logo. The logo consists of the word "COOK" in white, block letters on a red background. Below the word "COOK" is the word "MEDICAL" in smaller, white block letters. The red background is a rectangle shape.

COOK INCORPORATED
750 DANIELS WAY, P.O. BOX 489
BLOOMINGTON, IN 47402-0489 U.S.A.
PHONE: 812.339.2235 TOLL FREE: 800.457.4500
WWW.COOKMEDICAL.COM

Test Data

The van Andel Dilatation Catheter, subject of this submission, was subjected to applicable testing to assure reliable design and performance under the testing parameters. The following tests were conducted to ensure reliable design and performance:

. Biocompatibility testing - Testing (i.e., cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, pyrogenicity, hemocompatibility, complement activation, and partial thromboplastin time) demonstrated that the device is biocompatible. In conformance with the applicable sections of ANSI AAMI ISO 10993-1:2009(R)2013, the predetermined acceptance criteria were met.
Tensile Testing of the Hub to Shaft Bond Testing verified that under proper ● clinical use of the catheter, the hub-to-shaft connection is expected to withstand peak load values specified in BS EN ISO 10555-1:2013 – Section 4.6. The predetermined acceptance criterion was met.
Liquid Leakage Testing Testing in accordance with BS EN ISO 10555-1:2013 -. Section 4.7.1.verified that under proper clinical use of the catheter, there shall be no liquid leakage. The predetermined acceptance criterion was met.
Dimensional Verification Testing Testing verified that the outer diameter, inner . diameter, taper length and overall length of the device are within a specified tolerance. The predetermined acceptance criteria were met.
Exterior Surface Condition Testing and Distal Tip Inspection – Testing verified that exterior surface of the device was smooth and free from any process defects. The predetermined acceptance criteria were met.
. Radiopacity Testing – Testing verified that the device would be visible under fluoroscopic imaging in simulated clinical conditions. The predetermined acceptance criterion was met.
Kink Radius Testing – Testing verified that the device would not kink under clinical condition in which the test is expected to be used. The predetermined acceptance criteria were met.

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Image /page/6/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in large, white, sans-serif font, stacked on top of the word "MEDICAL" in a smaller, white, sans-serif font. Both words are set against a solid red background. The "COOK" has a registered trademark symbol after it.

Simulated Use Testing verified the performance parameters were acceptable for . clinical use. The predetermined acceptance criteria were met.
In conclusion, the results of these tests support a determination of substantial equivalence to the predicate device.

Regulation Number and Section

§ 870.1310 Vessel dilator for percutaneous catheterization.

(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).