Universa Soft Ureteral Stents and Stent Sets

• K Number: K151051
• Device Name: Universa Soft Ureteral Stents and Stent Sets
• Manufacturer: COOK INCORPORATED
• Date Cleared: 2016-01-11 ( 266 days)
• Product Code: FAD
• Regulation Number: 876.4620

Intended Use

Used 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 Description

The Universa" Soft Ureteral Stents and Stent Sets are flexible, tubular double pigtail stents composed of radiopaque polyurethane. The devices may include a positioner with a radiopaque band, a pigtail straightener, or a wire guide. Alternatively, these sets may include only a positioner and a pigtail straightener. The Universa" Soft Ureteral Stents and Stent Sets are 5.0 to 8.0 Fr in diameter and from 8.0 to 30.0 cm in specified length. The stents are also available in expandable multi-length versions, with diameters of 5.0 to 8.0 Fr and can accommodate ureter lengths ranging from 22.0 to 32.0 cm.

Predicate Devices

K961446, K043193

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical medical device (ureteral stent) and its performance testing, with no mention of software, algorithms, or AI/ML capabilities.

Therapeutic

Yes
The device is used for temporary internal drainage and to relieve obstruction in the ureter, which directly treats a medical condition.

Diagnostic

No

Explanation: The device is a ureteral stent, which is used for temporary internal drainage to relieve obstruction. It is a therapeutic device, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a flexible, tubular double pigtail stent composed of radiopaque polyurethane, and the performance studies involve physical tests like tensile testing, break strength, and flow rate testing, indicating it is a physical medical device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states it's for "temporary internal drainage from the ureteropelvic junction to the bladder." This describes a device used within the body for a therapeutic purpose (drainage), not for testing samples outside the body to diagnose a condition.
• Device Description: The description details a physical, implantable device (a stent) made of polyurethane, designed to be placed within the ureter. This is consistent with a medical device used for treatment or support, not for diagnostic testing.
• Lack of IVD Characteristics: The description and performance studies do not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information. IVDs typically involve reagents, assays, or analytical methods.

In summary, this device is a medical device used for internal drainage, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Used 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.

Product codes (comma separated list FDA assigned to the subject device)

FAD

Device Description

The Universa" Soft Ureteral Stents and Stent Sets are flexible, tubular double pigtail stents composed of radiopaque polyurethane. The devices may include a positioner with a radiopaque band, a pigtail straightener, or a wire guide. Alternatively, these sets may include only a positioner and a pigtail straightener. The Universa" Soft Ureteral Stents and Stent Sets are 5.0 to 8.0 Fr in diameter and from 8.0 to 30.0 cm in specified length. The stents are also available in expandable multi-length versions, with diameters of 5.0 to 8.0 Fr and can accommodate ureter lengths ranging from 22.0 to 32.0 cm.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

ureteropelvic junction to the bladder

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

1. Tensile testing (tether)
2. Break strength of stent
3. Biocompatibility testing
4. Curl retention testing (pigtails)
5. Flow rate testing
6. Ink adherence testing
7. Dynamic frictional force testing
8. Radiopacity testing
9. MRI testing
   In conclusion, the results of these tests support a determination of substantial equivalence to the predicate devices, the AQ Hydrophilic Stents (Cook Inc., K961446) and the Bard® InLayOptima™ Ureteral Stent with Suture (C. R. Bard, Inc., K043193).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K961446, K043193

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 876.4620 Ureteral stent.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

0

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 stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and are connected by a flowing line. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the image.

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

January 11, 2016

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

Re: K151051

Trade/Device Name: Universa Soft Ureteral Stents and Stent Sets Regulation Number: 21 CFR 876.4620 Regulation Name: Ureteral Stent Regulatory Class: Class II Product Code: FAD Dated: December 10, 2015 Received: December 11, 2015

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

1

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

2

Indications for Use

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

510(k) Number (if known) K151051

Device Name

UniversaTM Soft Ureteral Stents and Stent Sets

Indications for Use (Describe)

Used 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)
-------------------------------------------------	--

XJ Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

Image /page/3/Picture/0 description: The image shows the logo for Cook Medical. The logo is white text on a red background. The word "COOK" is in large, bold letters at the top of the logo, with the registered trademark symbol to the right. Below that, the word "MEDICAL" is in smaller, bold letters.

COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 OMINGTON IN 47402-0489 II 9 VWW.COOKMEDICAL.COM

5. 510(k) Summary

Cook Incorporated Universa™ Soft Ureteral Stents and Stent Sets 510(k) Summary 21 CFR § 807.92 Date Prepared: December 10, 2015

Submitter Information
Applicant:
Address:

Phone Number: Fax Number: Contact: Contact Address: Cook Incorporated (Cook) 750 Daniels Way P.O. Box 489 Bloomington, IN 47402 [phone] ext. 102834 [phone] Jamie Ridner Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47402 [phone] ext. 102834 [phone]

Contact Phone Number: Contact Fax Number:

1. Device Information

Trade Name:	UniversaTM Soft Ureteral Stents and Stent Set
Common Name:	Stent, Ureteral
Classification:	Class II
Regulation:	21 CFR § 876.4620
Panel:	Gastroenterology/Urology Devices
Product Code:	FAD

2. Predicate Devices:

• AQ Hydrophilic Stents (Cook Inc., K961446) ●
• Bard® InLayOptima™ Ureteral Stent with Suture (C. R. Bard, Inc., K043193) 0

3. Comparison to Predicate:

The technological characteristics of the Universa™ Soft Ureteral Stents and Stent Sets are substantially equivalent to the predicate AQ Hydrophilic Stents in regards to intended use, design, materials, and construction.

4

Cook Incorporated Traditional 510(k) K151051 Universa™ Soft Ureteral Stents and Stent Sets December 10, 2015

The Universa"" Soft Stents and Stent Sets are substantially equivalent to the Bard®
InLayOptima"" Ureteral Stent in regards to intended use, basic design, and function.

4. Device Description

The Universa" Soft Ureteral Stents and Stent Sets are flexible, tubular double pigtail stents composed of radiopaque polyurethane. The devices may include a positioner with a radiopaque band, a pigtail straightener, or a wire guide. Alternatively, these sets may include only a positioner and a pigtail straightener. The Universa" Soft Ureteral Stents and Stent Sets are 5.0 to 8.0 Fr in diameter and from 8.0 to 30.0 cm in specified length. The stents are also available in expandable multi-length versions, with diameters of 5.0 to 8.0 Fr and can accommodate ureter lengths ranging from 22.0 to 32.0 cm.

5. Intended Use

The Universa™ Soft Ureteral Stents and Stent Sets are used 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.

6. Technological Characteristics

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

• 1. Tensile testing (tether)
• 2. Break strength of stent
• 3. Biocompatibility testing
• 4. Curl retention testing (pigtails)
• 5. Flow rate testing
• 6. Ink adherence testing
• 7. Dynamic frictional force testing
• Radiopacity testing 8.
• 9. MRI testing

In conclusion, the results of these tests support a determination of substantial equivalence to the predicate devices, the AQ Hydrophilic Stents (Cook Inc., K961446) and the Bard® InLayOptima™ Ureteral Stent with Suture (C. R. Bard, Inc., K043193).