Angled Tip Ureteral Catheter

K181144 · Cook Incorporated · KOD · Jun 28, 2018 · Gastroenterology, Urology

Device Facts

• Record ID: K181144
• Device Name: Angled Tip Ureteral Catheter
• Applicant: Cook Incorporated
• Product Code: KOD · Gastroenterology, Urology
• Decision Date: Jun 28, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2

Intended Use

These devices are intended for access and catheterization of the urinary tract, including the following applications: - Delivery of contrast media - Navigation of a tortuous ureter - Access, advancement, or exchange of wire guides

Device Story

Angled Tip Ureteral Catheter facilitates urinary tract access and catheterization. Device consists of polyurethane tubing with 20° angled distal tip, sideports, taper, and female Luer lock adapter (polyamide). Includes 0.035-inch PTFE-coated stainless steel wire guide. Used by clinicians in clinical settings to navigate tortuous ureters, deliver contrast media, or manage wire guide exchange. Device provides mechanical access to urinary tract; output is physical placement/navigation. Benefits include improved maneuverability in complex anatomy.

Clinical Evidence

Bench testing only. Performance evaluated at time-zero and post-accelerated aging. Testing included biocompatibility, sterilization, dimensional/compatibility, radiopacity, kink radius, tensile strength, and blockage/leakage assessments.

Technological Characteristics

Polyurethane tubing; polyamide female Luer lock adapter; PTFE-coated stainless steel wire guide (0.035 inch diameter, 145 cm length). 5 and 6 French diameters; 70 cm length. Distal tip features 20° angle, sideports, and taper. Non-powered, mechanical device.

Indications for Use

Indicated for access and catheterization of the urinary tract in patients requiring contrast media delivery, navigation of tortuous ureters, or wire guide manipulation.

Regulatory Classification

Identification

A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).

Predicate Devices

• Kumpe Access Catheter (K171600)

Reference Devices

• Imager™ II Catheter (K102527)
• Renal Access Cobra Catheter (K171600)
• Ureteral Catheter (K171662)

Submission Summary (Full Text)

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June 28, 2018

Cook Incorporated Chelsea Woods Regulatory Affairs Specialist 750 Daniels Way, P.O. Box 489 Bloomington, IN 47404

Re: K181144

> Trade/Device Name: Angled Tip Ureteral Catheter Regulation Number: 21 CFR& 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: KOD Dated: April 30, 2018 Received: May 1, 2018

Dear Chelsea Woods:

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.

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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-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.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Mark R. Kreitz -S 2018.06.28 11:28:42 -04'00'

for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

2

510(k) Number (if known)

#### K181144

Device Name Angled Tip Ureteral Catheter

Indications for Use (Describe)

These devices are intended for access and catheterization of the urinary tract, including the following applications:

- Delivery of contrast media ●
- Navigation of a tortuous ureter
- . Access, advancement, or exchange of wire guides

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

V Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

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#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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Image /page/3/Picture/1 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is written in white, sans-serif font in the upper portion of the logo. Below the word "COOK" is the word "MEDICAL" in a smaller, white, sans-serif font.

750 DANIELS WAY, P.O. LOOMINGTON, IN 47402

#### 2.0 510(k) Summary

# Angled Tip Ureteral Catheter 21 CFR §807.92 Date Prepared: April 30, 2018

#### Submitted By:

Submission: Applicant: Primary Contact: Secondary Contact: Applicant Address:

Traditional 510(k) Premarket Notification Cook Incorporated Chelsea Woods Karthik Pillai Cook Incorporated 750 Daniels Way Bloomington, IN 47404 [phone] x104707 [phone]

Contact Phone: Contact Fax:

### Device Information:

Trade Name: Angled Tip Ureteral Catheter Common Name: Urological Catheter Classification Name: Urological Catheter and Accessories Classification Regulation: 21 CFR §876.5130, Product Code KOD Device Class/Classification Panel: Class II, Gastroenterology/Urology

### Predicate Device:

- Kumpe Access Catheter (K171600)
### Reference Device:

- Imager™ II Catheter (K102527)
- Renal Access Cobra Catheter (K171600)
- Ureteral Catheter (K171662)

### Device Description:

The Angled Tip Ureteral Catheter is constructed from polyurethane tubing and is designed with a female Luer lock adapter. The catheter is available in 5 and 6 French diameters and a length of 70 centimeters. The distal tip of the catheter has an angle of 20°, sideports, and a taper. The female Luer lock adapter is constructed from polyamide. The subject device

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Image /page/4/Picture/22 description: The image shows the Cook Medical logo. The word "COOK" is in white, bold letters on a red background. Below the word "COOK" is the word "MEDICAL" in white, bold letters on a red background.

also includes a stainless steel wire guide coated with PTFE. The wire guide diameter is 0.035 inches and the length is 145 centimeters

# Indications for Use:

These devices are intended for access and catheterization of the urinary tract, including the following applications:

- Delivery of contrast media ●
- Navigation of a tortuous ureter ●
- . Access, advancement, or exchange of wire guides

# Comparison to Predicate Device:

The subject device has the same indications for use, methods of operation, and fundamental technological characteristics as the predicate device. Differences between the subject device and the predicate device include design and materials. Characteristics of the subject device that differ from the predicate device are supported by testing and analysis.

# Performance Data:

The following testing was performed at time-zero and following accelerated aging in order to demonstrate that the subject device Angled Tip Ureteral Catheter met applicable design and performance requirements.

- . Biocompatibility
- o Sterilization
- Dimensional and Compatibility ●
- Radiopacity ●
- Kink Radius ●
- Tensile
- Blockage and leakage ●

# Conclusion:

The results of these tests support a conclusion that the Angled Tip Ureteral Catheter will perform as intended. The subject device does not raise new questions of safety and/or effectiveness when compared to the predicate device.

K181144