The Sof-Flex Ureteral Stent Set is intended for temporary internal drainage from the ureteropelvic junction to the bladder. Sof-Flex ureteral stents have been employed 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. The 3 French stents are indicated for pediatric patients.

Device Description

The Sof-Flex Ureteral Stent is a single-lumen ureteral stent indicated for endoscopic, percutaneous, or open surgical techniques in order to provide temporary internal drainage from the ureteropelvic junction to the bladder. This ureteral stent is a long-term indwelling device not to exceed 6 months in the body. The Sof-Flex Ureteral Stent Set is composed of a Sof-Flex Ureteral Stent, positioner, and wire guide. The Sof-Flex Ureteral Stents may be sold in sets or as standalone devices. The Sof-Flex stent is constructed from radiopaque polyurethane and is available in multiple sizes. The stent sizes range from 3 to 12 Fr in outer diameter with a length between 4 to 32 cm. The stents are available in a specified-length or multi-length configuration. The set will be supplied sterile and is intended for one-time use. The set is packaged in a peel-open pouch with a three-year shelf life.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the Sof-Flex® Ureteral Stent Set, a medical device. It focuses on the substantial equivalence determination based on performance testing and biocompatibility. However, the document does not describe an AI/ML-driven medical device, nor does it detail a study involving human readers, AI assistance, or the establishment of ground truth for an AI model.

Therefore, most of the information requested in your prompt (especially points 2, 3, 4, 5, 6, 7, 8, and 9, which relate to AI model evaluation) cannot be extracted from this document, as it pertains to a traditional medical device (a ureteral stent) and not an AI/ML diagnostic or therapeutic system.

I can, however, provide the acceptance criteria and performance data for the physical device based on the provided text, if you'd like.

Based on the provided document, here's what can be extracted regarding the physical device's acceptance criteria and performance, not an AI/ML system:

The document describes the testing performed on the Sof-Flex® Ureteral Stent Set, a physical medical device. It does not mention any AI/ML components or studies related to AI performance.

1. Table of Acceptance Criteria and Reported Device Performance

Test Type	Acceptance Criteria (for physical device)	Reported Device Performance
Tensile Strength & Retention	Retention strength: ≥ 0.03 N but ≤ 3.9 N	The acceptance criteria were met.
Strength (Time Zero & Aged)	Minimum break strength: > 3.9 N	The acceptance criteria were met.
Flow Rate (Time Zero)	No acceptance criteria (for characterization purposes only)	Measurements performed for characterization purposes only.
Radiopacity (Time Zero)	Evaluated by comparative fluoroscopic evaluation (in accordance with ASTM F640-12)	The acceptance criterion was met.
Magnetic Resonance (MR) Imaging Safety	Performed in accordance with ASTM F2503-13, ASTM F2052-14, ASTM F2213-06(2011), and ASTM F2119-07(2013)	Testing performed. (Implicitly met, no explicit failure stated)
Biocompatibility	Conformance with ISO 10993-1(2009) and FDA guidance for various toxicities	Performed to ensure biocompatibility of the subject device.
Leachable Studies	Toxicological equivalence to reference device (Kwart Retro-Inject Ureteral Stent K162109)	Presented to support toxicological equivalence.

Information Not Applicable to This Document (Relates to AI/ML Performance)

The following points are central to describing an AI/ML study but are not present in this documentation because the Sof-Flex® Ureteral Stent Set is a traditional physical medical device, not an AI/ML diagnostic or therapeutic system.

2. Sample size used for the test set and the data provenance: Not applicable. Performance testing was on the physical stent material and design, not a dataset for an AI model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no "ground truth" to establish for an AI model in this context. Expert review would relate to clinical performance Post-market, not the manufacturing/design verification and validation described here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This refers to comparing AI-assisted human performance to unassisted human performance, which is irrelevant for a physical stent.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable. There is no AI model to train.
9. How the ground truth for the training set was established: Not applicable.

Conclusion from document: All predetermined acceptance criteria for the physical device testing were reportedly met, supporting its intended performance and substantial equivalence to predicate devices.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

September 13, 2018

Cook Incorporated Minjin Choi Regulatory Affairs Specialist 750 Daniels Way Bloomington, IN 47404

Re: K180053

Trade/Device Name: Sof-Flex® Ureteral Stent Set Regulation Number: 21 CFR& 876.4620 Regulation Name: Ureteral stent Regulatory Class: II Product Code: FAD Dated: August 13, 2018 Received: August 14, 2018

Dear Minjin Choi:

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. Although this letter refers to your product as a device, please be aware 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.

{1}------------------------------------------------

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Mark R. Kreitz -S

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

{2}------------------------------------------------

DEPARTMENT OF HEALTH ANDHUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K180053

Device Name Sof-Flex® Ureteral Stent Set

Indications for Use (Describe)

The Sof-Flex Ureteral Stent Set is intended for temporary internal drainage from the bladder. Sof-Flex ureteral stents have been employed to relieve obstruction in a variety of beingn, and post-traunations. These stents may be placed using endoscopic, percutaneous, or open surgical techniques.

The 3 French stents are indicated for pediatric patients.

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)

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 ADDRE SS 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."

FORM FDA 3881 (8/14)

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

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the Cook Medical logo. 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, set against a darker red background.

2.0 510(k) Summary

Sof-Flex® Ureteral Stent Set 21 CFR §807.92 Date Prepared: January 05, 2018

Submitted By:

Submission:	Traditional 510(k) Premarket Notification
Applicant:	Cook Incorporated
Primary Contact:	Minjin Choi
Secondary Contact:	Andrew Breidenbach
Applicant Address:	Cook Incorporated750 Daniels WayBloomington, IN 47404
Primary Contact Phone:	(812) 335-3575 x104901
Contact Fax:	(812) 332-0281

Device Information:

Trade Name:	Sof-Flex® Ureteral Stent Set
Regulation Name:	Stent, Ureteral
Classification Regulation:	21 CFR §876.4620, Primary Product Code FAD
Device Class/Classification Panel:	Class II, Gastroenterology/Urology

Predicate Devices:

Primary predicate device: ●
Universa™ Soft Ureteral Stents and Stent Sets (K151051)
Secondary predicate device: ●
C-Flex® Ureteral Stent Set (K162104)

Reference Device:

Kwart Retro-Inject Ureteral Stent (K162109) .

{4}------------------------------------------------

Device Description:

The Sof-Flex Ureteral Stent Set is composed of a Sof-Flex Ureteral Stent, positioner, and wire guide. The Sof-Flex Ureteral Stents may be sold in sets or as standalone devices. The Sof-Flex stent is constructed from radiopaque polyurethane and is available in multiple sizes. The stent sizes range from 3 to 12 Fr in outer diameter with a length between 4 to 32 cm. The stents are available in a specified-length or multi-length configuration.

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

Indications for Use:

Comparison to Predicate Devices:

The Sof-Flex Ureteral Stent Set and the primary predicate device, Universa Soft Ureteral Stents and Stent Sets (K151051), are substantially equivalent in that they have an identical intended use. Furthermore, the devices have a similar method of operation, design, and dimensions. The Universa Soft Ureteral Stent Set (K151051) was chosen as the primary predicate device because it shares the most similar indications for use and technological characteristics to the device under review. The modifications from the predicate device includes:

. Indication for Use
Stent Dimensions 트

{5}------------------------------------------------

. Stent Material

The Sof-Flex Ureteral Stent Set also has an identical intended use to the secondary predicate device, C-Flex Ureteral Stent Set (K162104). Furthermore, the devices have a similar method of operation, design, dimensions, and pediatric indications. This secondary predicate device was used to support the pediatric indications and dimensions of the 3 Fr. Sof-Flex stents. Modifications between the subject device and the predicate device include:

. Indication for Use
. Stent Dimensions
. Stent Material

Differences between the characteristics of the subject device and the predicate devices are supported by testing.

Technological Characteristics:

The subject device, Sof-Flex Ureteral Stent Set, was subjected to the following applicable testing to assure reliable design and performance under the specified testing parameters:

Performance Testing:

Tensile Strength and Retention Strength Testing (Time Zero and Aged) The . retention strength shall be ≥ 0.03 N but ≤ 3.9 N. The minimum break strength shall be > 3.9 N. The acceptance criteria were met.
. Flow Rate (Time Zero) – Gravity flow rate measurements were performed for characterization purposes only and therefore there was no acceptance criteria.
Radiopacity Testing (Time Zero) The radiopacity of the subject device was . evaluated by subjecting it to a comparative fluoroscopic evaluation and performed in accordance with ASTM F640-12. The acceptance criterion was met.
Magnetic Resonance (MR) Imaging Safety Testing Performed in accordance . with ASTM F2503-13, ASTM F2052-14, ASTM F2213-06(2011), and ASTM F2119-07(2013)

Biocompatibility Testing:

Per ISO 10993-1(2009) and FDA guidance for cytotoxicity, sensitization, . intracutaneous reactivity, acute systemic toxicity, material-mediated pyrogenicity,

{6}------------------------------------------------

subacute/subchronic toxicity, genotoxicity, chronic toxicity, and implantation were performed to ensure the biocompatibility of the subject device set.

. A reference device, Kwart Retro-Inject Ureteral Stent (K162109), has identical stent configurations (specified- and multi-length) and similar stent materials as some of the subject device configurations. Comparative leachable studies of the Sof-Flex Ureteral Stent and Kwart Retro-Inject Ureteral Stent were presented to support the toxicological equivalence of the subject and reference devices.

Conclusion:

All predetermined acceptance criteria for the testing were met. Therefore, the results of these tests support a conclusion that the Sof-Flex Ureteral Stent will perform as intended and support a determination of substantial equivalence to the predicate devices.

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).