The device is intended for temporary internal drainage from the ureteropelvic junction to the bladder following dilation and or incision of a stricture. Double pigtail ureteral stents have been used to relieve obstruction in a variety of benign, malignant, and post-traumatic conditions. These stents may be placed using endoscopic, percutaneous, or open surgical techniques.

Device Description

The Ultrathane Endoureterotomy Stent Set is comprised of a double pigtail endoureterotomy stent and coaxial positioner. The endoureterotomy stent body has a dual diameter design with a larger diameter section tapered to a smaller diameter section. This dual diameter option is available with a 9.5 French to 6.0 French taper or a 14.0 French to 7.0 French taper. The small diameter section has drainage holes along the stent body. The stent body working length is available in 18 to 30 centimeters. Sideports are located along the curl to allow for drainage. The stent (stent body and pigtails) is made of radiopaque polyurethane elastomer.

The coaxial positioner consists of a release sleeve and a stent positioner. The release sleeve is made of radiopaque tetrafluoroethylene. The release sleeve has a 10.0 French outer diameter and a 38 centimeter working length. The release sleeve is able to lock into the stent positioner via a compression fitting consisting of a connector cap and luer lock adapter. The stent positioner is made of polyethylene and has a distal stainless steel marker. The stent positioner has a 7.0 French outer diameter and a 46.1 centimeter working length. The stent positioner accepts a 0.038 inch wire guide.

The set will be supplied sterile and is intended for one-time use. The set is packaged in a peelopen pouch with a three-year shelf life.

AI/ML Overview

This document is a 510(k) summary for the Ultrathane Endoureterotomy Stent Set. It describes the device, its intended use, and performance testing conducted to demonstrate its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (Implicit)	Reported Device Performance
Tensile Strength	Tensile force during proper clinical use should not fracture the Ultrathane Endoureterotomy Stent Set materials and bonds.	"All predetermined acceptance criteria were met."
Curl Retention (stent only)	(1) Curl retention during proper clinical use should retain the Ultrathane Endoureterotomy Stent within the intended anatomy. (2) Curl retention strength must allow for removal of the Ultrathane Endoureterotomy Stent within the intended anatomy.	"All predetermined acceptance criteria were met."
Magnetic Resonance (MR) Compatibility	The device should be MR conditional under defined conditions.	"All predetermined acceptance criteria were met." (Device is MR conditional based on defined, tested conditions.)
Biocompatibility	The device should conform with biocompatibility requirements based on its intended use.	"All predetermined acceptance criteria were met."

Note: The document explicitly states "All predetermined acceptance criteria were met" for all categories, but it does not provide the specific numerical thresholds for these criteria. For example, it doesn't say "Tensile strength must be >X Newtons" or "Curl retention force must be between Y and Z Newtons."

Study Information

Sample size used for the test set and the data provenance:
The document does not specify general "test set" sample sizes or data provenance (e.g., country of origin, retrospective/prospective). The performance data section describes types of testing performed (Tensile Strength, Curl Retention, MR, Biocompatibility), which likely involved specific test articles or samples for each test. However, the exact number of units or samples tested for each criterion is not provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The testing described appears to be primarily engineering/materials performance testing (tensile strength, curl retention, MR compatibility) and biocompatibility testing, rather than a clinical study requiring expert assessment of "ground truth" for patient outcomes or diagnostic accuracy.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable/provided as the described testing does not involve clinical judgment or adjudication of a test set in the way a diagnostic AI device would.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No, an MRMC comparative effectiveness study was not done and is not applicable to an endoureterotomy stent. This device is a physical medical device, not a diagnostic AI tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This pertains to a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
As mentioned, the testing seems to involve physical and chemical property measurements against predefined engineering and regulatory standards, rather than "ground truth" in a clinical diagnostic sense. For example:
- Tensile Strength & Curl Retention: Ground truth would be the physical measurement of these properties compared to required specifications.
- MR Compatibility: Ground truth would be the demonstration that the device performs safely and as intended in an MR environment, likely through controlled laboratory testing.
- Biocompatibility: Ground truth is established through standardized biological testing (e.g., cytotoxicity, sensitization, irritation) against ISO standards.
The sample size for the training set:
Not applicable. This device is not an AI/ML algorithm that requires a training set.
How the ground truth for the training set was established:
Not applicable. This device is not an AI/ML algorithm that requires a training set.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, often associated with medicine and healthcare. The seal is black and white.

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

June 24, 2016

Cook Incorporated Kara Kanorr Regulatory Affairs Specialist 750 Daniels Way Bloomington, IN 47404

Re: K160891

Trade/Device Name: Ultrathane Endoureterotomy Stent Set Regulation Number: 21 CFR 876.4620 Regulation Name: Ureteral Stent Regulatory Class: Class II Product Code: FAD Dated: March 30, 2016 Received: March 31, 2016

Dear Kara Kanorr,

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

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

510(k) Number (if known)

K160891

Device Name

Ultrathane Endoureterotomy Stent Set

Indications for Use (Describe)

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

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

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."

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2.0 510(k) Summary

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

Ultrathane Endoureterotomy Stent Set 21 CFR $807.92 Date Prepared: March 30, 2016

Submitted By:

Submission: Applicant: Contact: Applicant Address:

Contact Phone: Contact Fax:

Device Information:

Trade Name: Common Name: Classification Name: Classification Regulation: Device Class/Classification Panel: Traditional 510(k) Premarket Notification Cook Incorporated Kara Kanorr Cook Incorporated 750 Daniels Way Bloomington, IN 47404 (812) 339-2235 x104072 (812) 332-0281

Ultrathane® Endoureterotomy Stent Set Stent, Ureteral Ureteral Stent 21 CFR §876.4620, Product Code FAD Class II. Gastroenterology/Urology

Predicate Device:

The predicate device is the Retromax™ Plus Endopyelotomy Stent cleared under 510(k) K924608.

Device Description:

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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 white, uppercase letters, with a trademark symbol next to it. Below the word "COOK" is the word "MEDICAL" in smaller, white, uppercase letters. The background of the logo is a solid red color.

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

inch wire guide.

The set will be supplied sterile and is intended for one-time use. The set is packaged in a peelopen pouch with a three-year shelf life.

Indications for Use:

The device is intended for temporary internal drainage from the ureteropelvic junction to the bladder following dilation and/or incision of a stricture. Double pigtail ureteral stents have been used to relieve obstruction in a variety of benign, malignant, and post-traumatic conditions. These stents may be placed using endoscopic, percutaneous, or open surgical techniques.

Comparison to Predicate Device:

The proposed device has similar indications for use, methods of operation, and fundamental technological characteristics as the predicate device. Differences between the proposed device and the predicate device include dimensional variations, inclusion of a release sleeve, and material. Characteristics of the proposed device that differ from the predicate device are supported by testing.

Performance Data:

The following testing was performed in order to demonstrate that the proposed Ultrathane® Endoureterotomy Stent Set met applicable design and performance requirements.

. Tensile Strength - Testing shows the tensile force during proper clinical use should not fracture the Ultrathane Endoureterotomy Stent Set materials and bonds. All predetermined acceptance criteria were met.
. Curl Retention (stent only) - Testing shows the curl retention during proper clinical use should retain the Ultrathane Endoureterotomy Stent within the intended anatomy. Testing also shows the curl retention strength must allow for removal of the Ultrathane® Endoureterotomy Stent within the intended anatomy. All predetermined acceptance criteria were met.
Magnetic Resonance (MR) - Testing shows that the proposed device is MR conditional based on defined, tested conditions. All predetermined acceptance criteria were met.
Biocompatibility - Testing shows that the proposed device conforms with the biocompatibility requirements based on its intended use. All predetermined acceptance criteria were met.

Conclusion:

The results of these tests provide reasonable assurance that the Ultrathane® Endoureterotomy Stent Set will function as intended. The proposed device does not raise new questions of safety or effectiveness as compared to the predicate device.

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).