Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter

K180182 · Cook Incorporated · EYB · Sep 14, 2018 · Gastroenterology, Urology

Device Facts

• Record ID: K180182
• Device Name: Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter
• Applicant: Cook Incorporated
• Product Code: EYB · Gastroenterology, Urology
• Decision Date: Sep 14, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

This device is intended for injection of contrast medium and/or safety wire guide placement during percutaneous and transurethral access. The catheters that are 24 cm and 40 cm in length can be used in pediatric patients 12 years and over.

Device Story

Dual-lumen ureteral access catheter; used for contrast medium injection and safety wire guide placement during percutaneous and transurethral access. Constructed from polyurethane tubing with manifold and extension tubes; distal tip notched to expose one lumen; Flexi-Tip variant includes bonded flexible polyurethane tip. Available in 24, 40, and 50 cm lengths; 10.0 Fr outer diameter; 0.050-inch inner lumen diameter. Optional hydrophilic coating and radiopaque tungsten marker. Used in clinical settings by physicians; provides access conduit for urological procedures. Benefits include facilitated wire placement and contrast delivery. Single-use; ethylene oxide sterilized.

Clinical Evidence

Bench testing only. Testing included biocompatibility, sterilization validation, dimensional analysis, lumen patency, blockage and leakage, radiopacity, kinking, dynamic friction force, tensile strength, and accelerated aging.

Technological Characteristics

Dual-lumen polyurethane tubing; 10.0 Fr outer diameter; 0.050-inch inner lumen diameter. Features include optional hydrophilic coating, radiopaque tungsten marker, and flexible polyurethane tip. Sterilized via ethylene oxide. Single-use. No software or electronic components.

Indications for Use

Indicated for injection of contrast medium and/or safety wire guide placement during percutaneous and transurethral access in adults and pediatric patients 12 years and older (for 24 cm and 40 cm lengths).

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

• Dual Lumen Catheter (K043581)

Submission Summary (Full Text)

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September 14, 2018

Cook Incorporated Samuel Engelman Regulatory Affairs Specialist 750 Daniels Way Bloomington, IN 47404

Re: K180182

Trade/Device Name: Dual Lumen Ureteral Access Catheter, Flexi-Tip® Dual Lumen Ureteral Access Catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EYB Dated: August 13, 2018 Received: August 14, 2018

Dear Samuel Engelman:

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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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,

Glenn B. Bell -S 2018.09.14 10:17:38 -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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### Indications for Use

510(k) Number (if known) K180182

#### Device Name

Dual Lumen Ureteral Access Catheter Flexi-tip® Dual Lumen Ureteral Access Catheter

#### Indications for Use (Describe)

This device is intended for injection of contrast medium and/or safety wire guide placement during percutaneous and transurethral access. The catheters that are 24 cm in length can be used in pediatric patients 12 years and over.

| 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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Image /page/3/Picture/0 description: The image shows the Cook Medical logo. The logo consists of the word "COOK" in white, uppercase letters on a red background. Below the word "COOK" is the word "MEDICAL" in smaller, white, uppercase letters. The logo is simple and clean, with a focus on the company name.

#### 510(k) Summary

K180182 Page 1 of 4

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### Dual Lumen Ureteral Access Catheter and Flexi-Tip® Dual Lumen Ureteral Access Catheter 21 CFR §876.5130 Date Prepared: September 13, 2018

### Submitted By:

Submission: Applicant: Primary Contact: Applicant Address:

Primary Contact Phone: Contact Fax:

# Device Information:

Trade Name:

Common Name: Classification Name: Regulation Number: Product Code: Device Class: Review Panel:

## Predicate Device:

Traditional 510(k) Premarket Notification Cook Incorporated Karthik Pillai, Ph.D. Cook Incorporated 750 Daniels Way Bloomington, IN 47404 [phone] x104929 [phone]

Dual Lumen Ureteral Access Catheter and Flexi-Tip® Dual Lumen Ureteral Access Catheter Catheter, Ureteral, Gastro-Urology Urological catheter and accessories 21 CFR §876.5130 EYB Class II Gastroenterology/Urology

The predicate device is ACMI Corporation's Dual Lumen Catheter cleared under 510(k) Premarket Notification number K043581.

## Device Description:

The Dual Lumen Ureteral Access Catheter is constructed from a dual-lumen, polyurethane tubing with ink marks and a tubing manifold with extension tubes. The catheter has a working length of 50 cm. The outer diameter of the catheter is 10.0 Fr and both lumens' inner diameter is 0.050 inches. The distal tip is notched to expose one lumen and create a 5.0 Fr tip with the other lumen. This device is manufactured both with and without a hydrophilic coating.

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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 large, white, sans-serif font, and below it is the word "MEDICAL" in a smaller, white, sans-serif font.

K180182 Page 2 of 4

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The Flexi-Tip® Dual Lumen Ureteral Access Catheter is constructed from a dual-lumen, polyurethane tubing with ink marks and a tubing manifold with extension tubes. The catheter is available in lengths of 24, 40, and 50 cm. The outer diameter of the catheter is 10.0 Fr and both lumens' inner diameter is 0.050 inches. The distal tip is notched to expose one lumen and a flexible polyurethane tip is bonded to the tip of the other lumen. The Flexi-Tip® Dual Lumen Ureteral Access Catheter is available with hydrophilic coating and a radiopaque urethane tungsten marker. The Dual Lumen Ureteral Access Catheter and the Flex-Tip® Dual Lumen Ureteral Access catheters are sterilized by ethylene oxide and are packaged in peel-open pouches for single use.

### Indications for Use:

This device is intended for injection of contrast medium and/or safety wire guide placement during percutaneous and transurethral access. The catheters that are 24 cm and 40 cm in length can be used in pediatric patients 12 years and over.

### Comparison to Predicate Device:

The subject devices have similar indications for use, methods of operation, and fundamental technological characteristics as the predicate device. Differences between the subject devices and the predicate device include a difference in indications for use, patient population, dimensions, and materials. Characteristics of the subject devices that differ from the predicate device are supported by testing and analysis.

| | Predicate Device | Subject Device |
|------------------------|----------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| | Dual Lumen Catheter | Dual Lumen Ureteral Access Catheter<br>and Flexi-Tip® Dual Lumen Ureteral<br>Access Catheter |
| 510(k) Number | K043581 | K180182 |
| Manufacturer | ACMI Corporation (acquired by<br>Olympus) | Cook Incorporated |
| Regulation<br>Number | 21 CFR §876.5130 Urological catheter<br>and accessories. | Identical |
| Product<br>Code | EYB | Identical |
| Classification<br>Name | Urological catheter and accessories | Identical |
| Device Class | II | II |
| Indications for<br>Use | The dual lumen ureteral catheter is<br>designed for percutaneous and | This device is intended for injection of<br>contrast medium and/or safety wire guide |

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COOK INCORPORATED 750 DANIELS WAY BLOOMINGTON, IN 47404 USA 9.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM

Radiopaque Polyurethane Tubing

Image /page/5/Picture/1 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is in white, bold, sans-serif font in the upper portion of the logo. Below "COOK" is the word "MEDICAL" in white, bold, sans-serif font.

| | Predicate Device | Subject Device |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Dual Lumen Catheter | Dual Lumen Ureteral Access Catheter<br>and Flexi-Tip® Dual Lumen Ureteral<br>Access Catheter |
| | transurethral access and is indicated as a<br>conduit for multiple uses including, but<br>not limited to, ureteral dilation, stone<br>displacement, delivery of contrast<br>material/anesthetic agents and guidewire<br>placement. | placement during percutaneous and<br>transurethral access. The catheters that<br>are 24 cm and 40 cm in length can be<br>used in pediatric patients 12 years and<br>over. |
| Patient<br>Population | Unknown | Adult, and Pediatric 12 years and over |
| Single- Use<br>Only | Single- Use Only | Identical |
| Sterile | Yes | Yes |
| Sterilization<br>Method | Not known | Ethylene Oxide |
| Flexible Tip | Yes | Available |
| Catheter Tip<br>Diameter (Fr) | 6.0 | 5.0, 6.0 |
| Catheter<br>Lumens | Two | Two |
| Lumen size<br>(in) | .045 | .050 |
| Catheter<br>Diameter (Fr) | 10.0 | 10.0 |
| Working<br>Length (cm) | 60 | 24, 40, 50 |
| Radiopacity | Radiopaque Catheter | Radiopaque Catheter Shaft, Flexible Tip<br>and Marker |
| Materials | | |
| Hydrophilic<br>Coating | Not known | Available (Surmodics) |

Performance Data:

Catheter

Material

The following testing was performed in order to demonstrate that the proposed Dual Lumen Ureteral Access Catheter and Flexi-Tip® Dual Lumen Ureteral Access Catheter met applicable design and performance requirements.

Radiopaque Polyethylene Tubing

- Biocompatibility
- י Sterilization
- Dimensional
- Lumen Patency '

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Image /page/6/Picture/0 description: The image shows the Cook Medical logo. The word "COOK" is in white, bold, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in white, sans-serif font on a red background that is shaped like a banner.

K180182 Page 4 of 4

- ব
- Blockage and Leakage .
- Radiopacity
- I Kinking
- Dynamic Friction Force .
- Tensile ■
- " Accelerated Age

#### Conclusion:

The results of these tests provide reasonable assurance that the Dual Lumen Ureteral Access Catheter and Flexi-Tip® Dual Lumen Ureteral Access Catheter will function as intended. The subject devices do not raise new questions of safety or effectiveness as compared to the predicate device.