van Andel Dilatation Catheter

K170616 · Cook Incorporated · DRE · Apr 28, 2017 · Cardiovascular

Device Facts

• Record ID: K170616
• Device Name: van Andel Dilatation Catheter
• Applicant: Cook Incorporated
• Product Code: DRE · Cardiovascular
• Decision Date: Apr 28, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1310
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Intravascular dilatation catheter; facilitates percutaneous introduction of guide wires, catheters, and other devices into femoral, popliteal, and infrapopliteal arteries. Used during diagnostic and interventional procedures. Operated by clinicians in clinical settings. Device consists of PTFE catheter; provides pathway for interventional tools. Benefits patient by enabling minimally invasive access to peripheral vasculature. Output is physical access/dilatation of vessel entry site; clinician uses fluoroscopic imaging to guide placement. Single-use, sterile device.

Clinical Evidence

Bench testing only. Testing included biocompatibility (ISO 10993-1), tensile strength (BS EN ISO 10555-1), liquid leakage, dimensional verification, surface inspection, radiopacity, kink radius, and simulated use. All tests met predetermined acceptance criteria.

Technological Characteristics

Material: Polytetrafluoroethylene (PTFE). Dimensions: 5.0, 6.3, 7.0, 8.0, 9.0 French diameters; 60, 80, 100 cm lengths. Compatibility: 0.035 or 0.038 inch wire guides. Standards: ANSI AAMI ISO 10993-1:2009(R)2013 (biocompatibility), BS EN ISO 10555-1:2013 (tensile/leakage). Sterilization: Sterile, single-use.

Indications for Use

Indicated for patients requiring percutaneous introduction of guide wires, catheters, or other devices into femoral, popliteal, or infrapopliteal arteries during diagnostic or interventional procedures.

Regulatory Classification

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.

Predicate Devices

• Lawmax Dilator (K123842)
• Fortress Introducer Sheath System (K153197)

Submission Summary (Full Text)

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Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three stylized human profiles facing to the right, stacked on top of each other.

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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------|------------------------------------------------------|
| <div> <span> <input type="checkbox"/> </span> </div> | <div> <span> <input type="checkbox"/> </span> </div> |

|X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, block letters on a red background. Below the word "COOK" is the word "MEDICAL" in white, block letters on a red background. The logo is simple and modern.

## 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: | [e-mail] | |
| 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: [phone] 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

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.

#### 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: [phone] 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.