Universa Firm Ureteral Stents and Stent Sets

K161236 · Cook Incorporated · FAD · Jan 27, 2017 · Gastroenterology, Urology

Device Facts

• Record ID: K161236
• Device Name: Universa Firm Ureteral Stents and Stent Sets
• Applicant: Cook Incorporated
• Product Code: FAD · Gastroenterology, Urology
• Decision Date: Jan 27, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4620
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Universa® Firm Ureteral Stent Sets are intended for temporary internal drainage from the ureteropelvic junction to the bladder. Ureteral stents have been used to relieve obstruction in a variety of benign, malignant, and post-traumatic conditions. The stents may be placed using endoscopic, percutaneous, or open surgical techniques.

Device Story

Sterile, single-use ureteral stents; provide temporary internal drainage from ureteropelvic junction to bladder. Constructed of radiopaque polycarbonate-based polyurethane with hydrophilic coating; feature sideports and pigtail loops for securement. Includes pigtail straightener for placement over wire guide; optional sets include stent positioner and stainless steel wire guide. Placed by physicians via endoscopic, percutaneous, or open surgical techniques. Graduation marks assist visualization during advancement. Tether on proximal pigtail allows for repositioning/removal; tether removal recommended after 14 days; 12-month indwell time. Benefits include relief of urinary obstruction.

Clinical Evidence

Bench testing only. Tests included sterility, packaging, biocompatibility, ink adherence, curl retention strength, break/tensile strength, dynamic friction, flow rate, MRI compatibility, and radiopacity.

Technological Characteristics

Radiopaque polycarbonate-based polyurethane material; hydrophilic coating. Dimensions: 5.0 to 8.0 French diameter, 18.0 to 32.0 cm length. Mechanical fixation via pigtail loops. Sterile, single-use. No software or energy source.

Indications for Use

Indicated for patients requiring temporary internal drainage from the ureteropelvic junction to the bladder to relieve obstruction caused by benign, malignant, or post-traumatic conditions.

Regulatory Classification

Identification

A ureteral stent is a tube-like implanted device that is inserted into the ureter to provide ureteral rigidity and allow the passage of urine. The device may have finger-like protrusions or hooked ends to keep the tube in place. It is used in the treatment of ureteral injuries and ureteral obstruction.

Predicate Devices

• Universa® Soft Ureteral Stents and Stent Sets (K151051)
• Bard® InLayOptima™ Ureteral Stent with Suture (K043193)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is an emblem featuring a stylized depiction of three human profiles facing right, layered on top of each other to create a sense of depth and unity.

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

January 27, 2017

Cook Incorporated Jamie Ridner Regulatory Affairs Team Lead 750 Daniels Way Bloomington, IN 47404

Re: K161236

Trade/Device Name: Universa Firm Ureteral Stents and Stent Sets Regulation Number: 21 CFR 876.4620 Regulation Name: Ureteral Stent Regulatory Class: Class II Product Code: FAD Dated: December 13, 2016 Received: December 14, 2016

Dear Jamie Ridner,

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 [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 yours,

# Benjamin R. Fisher -S

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)

#### K161236

Device Name Universa® Firm Ureteral Stents and Stent Sets

#### Indications for Use (Describe)

The Universa® Firm Ureteral Stent Sets are intended for temporary internal drainage from the ureteropelvic junction to the bladder. Ureteral stents have been used to relieve obstruction in a variety of benign, malignant, and post-traumatic conditions. The stents may be placed using endoscopic, percutaneous, or open surgical techniques.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

The burden time for this collection of information 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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EF

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

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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, stacked on top of the word "MEDICAL" in smaller, white, block letters. The background behind the text is a solid, dark red color. The registered trademark symbol is located to the right of the word "COOK".

# 2. 510(k) Summary

#### COOK INCORPORATED 750 DANIELS WAY BLOOMINGTON, IN 47404 USA HONE: 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM

# Universa® Firm Ureteral Stents and Stent Sets 21 CFR 8876.4620

# Date Prepared: April 29, 2016

# Submitted By:

Submission: Applicant: Contact Name: Applicant Address:

Traditional 510(k) Premarket Notification Cook Incorporated Jamie Ridner Cook Incorporated 750 Daniels Way Bloomington, IN 47404 Phone: [phone] x102834 Fax: [phone]

Contact Phone Number: Contact Fax Number:

#### Device Information:

Trade Name: Universa® Firm Ureteral Stents and Stent Sets Stent, Ureteral Common Name: 21 CFR §876.4620 Classification Regulation: Device Class: Class II Product Code: FAD Classification Panel: Gastroenterology/Urology Devices

# Predicate Device:

The predicate devices are:

- . Universa® Soft Ureteral Stents and Stent Sets cleared under 510(k) K151051 on January 11, 2016
- Bard® InLayOptima™ Ureteral Stent with Suture cleared under 510(k) K043193 on ● December 07, 2004

# Device Description:

The Universa® Firm Ureteral Stents and Stent Sets are sterile, single-use devices. The stents are available in 5.0 to 8.0 French (Fr) diameter, with lengths ranging from 18.0 to 32.0 centimeters (cm). The stents are constructed of radiopaque polycarbonate-based polyurethane material and include a hydrophilic coating. Sideports extend along the body of the stent as well as on the pigtails to provide drainage. The stents are secured in the urinary tract with pigtail loops on the proximal and distal ends. A braided or monofilament tether for repositioning and removal of the device is located on the proximal pigtail (bladder end) of the stent. Along the stent are graduation marks to provide visualization during stent advancement and placement. The Universa® Firm Ureteral Stent includes a pigtail straightener, a small polymer tube to aid in placement over a wire guide. The pigtail straightener is removed prior to use. The stent and

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Image /page/4/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in large, white, sans-serif font, with a registered trademark symbol to the right of the word. Below "COOK" is the word "MEDICAL" in a smaller, white, sans-serif font. The background is a solid red color.

COOK INCORPORATED 750 DANIELS WAY BLOOMINGTON, IN 47404 USA E: 812,339,2235 TOLL FREE: 800,457,4500 WWW.COOKMEDICAL.COM

pigtail straightener can be sold as a set with a stent positioner and stainless steel wire guide. The positioner and the wire guide are available for sale separately. The Universa Firm Ureteral Stents and Stent Sets are labeled for a 12-month indwell time; however, the tether should be removed after 14 days.

#### Intended Use:

The Universa Firm Ureteral Stents and Stent Sets are intended for temporary internal drainage from the ureteropelvic junction to the bladder. Ureteral stents have been used to relieve obstruction in a variety of benign, malignant, and post-traumatic conditions. The stents may be placed using endoscopic, percutaneous, or open surgical techniques.

#### Comparison to Predicate Device:

The Universa Firm Ureteral Stents and Stent Sets are similar in design and functional characteristics to the predicate devices Universa Soft Ureteral Stents and Stent Sets (K151051) and Bard® InLayOptima" Ureteral Stent with Suture (K043193). The characteristic differences from the proposed device and the predicate devices are pigtail curl diameter and stent material.

# Test Data:

The Universa Firm Ureteral Stent Sets were subjected to the following tests to assure design and performance under the specified testing parameters:

- Sterility .
- Packaging .
- Biocompatibility .
- . Ink Adherence
- Curl Retention Strength .
- Break Strength/Tensile Strength ●
- Dynamic Friction/Coefficient of Friction 0
- Flow Rate .
- MRI Testing 0
- Radiopacity .

#### Conclusion:

The results of the testing provide reasonable assurance that the Universa Firm Ureteral Stents and Stent Sets have been designed such that they it will function as intended. The proposed devices do not raise new questions of safety or effectiveness as compared to the predicate devices.