The Ureteral Introducer Sets is a bundle of two Ureteral Introducer Sets, composed of the Cook® 810 Set and Desilets-Hoffman Introducer Set. The Cook 810 Set is composed of a dilator and a delivery sheath, which is used for retrograde or antegrade ureteral access and to facilitate wire guide exchange. To use this device, antegrade (i.e., through a percutaneous tract) or retrograde (i.e., transurethral) access is achieved using a wire guide up to 0.038 inches in outer diameter, using standard access techniques. Next, the dilator is inserted over the wire guide and used to dilate the ureter/ureteral orifice. The physician would then place the delivery sheath over the dilator to dilate the anatomy to 10 French before placing the tip of the sheath into the desired anatomical location. The dilator is withdrawn while maintaining the position of the introducer sheath. Wires may then be placed/exchanged through the sheath, and the delivery sheath is subsequently removed from the patient. The dilator is an outer diameter of 8 French and 88 centimeters (cm) in length. Both ends of the dilator have smooth round tips and both tips are tapered at 5 millimeters (mm) as well. The sheath is an outer diameter of 8.5 French and 30 or 50 cm in length, depending on the selected set.

The Desilets-Hoffman Introducer Set is used for retrograde or antegrade ureteral access and to facilitate wire guide exchange. The Desilets-Hoffman Introducer Set includes a delivery sheath and dilator. The delivery sheath is 10 French and 30 cm in length. The dilator is 8 French and available in 70 or 88 cm in length. One of the sets ("RB" version) has a radiopaque band on the delivery sheath to aid in fluoroscopic visualization during placement.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device and thus does not contain the detailed information necessary to fully answer all aspects of your request regarding a stand-alone study with acceptance criteria and device performance. A 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting a comprehensive standalone validation study report with detailed performance metrics against pre-defined acceptance criteria.

However, I can extract the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "All predetermined acceptance criteria were met." However, it does not provide a table with specific numerical acceptance criteria or the corresponding numerical device performance results. Instead, it lists the types of tests performed.

Acceptance Criteria Category (Implied)	Reported Device Performance Summary
Dimensional Accuracy	All predetermined acceptance criteria were met.
Tensile Strength	All predetermined acceptance criteria were met.
Assembly After Kinking	All predetermined acceptance criteria were met.
Dilator Tip Rollback	All predetermined acceptance criteria were met.
Radiopacity	All predetermined acceptance criteria were met.
Biocompatibility (Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Material-mediated Pyrogenicity)	All evaluation criteria were met; conforms to biocompatibility requirements based on intended use.
Sterilization	All predetermined acceptance criteria were met.
Package Integrity and Stability	All predetermined acceptance criteria were met.
Shelf-life	All predetermined acceptance criteria were met.

Missing Information: Specific numerical acceptance thresholds (e.g., "tensile strength > X N") and specific numerical results for each test (e.g., "tensile strength = Y N").

2. Sample Size Used for the Test Set and the Data Provenance:

The document does not specify the sample sizes for each of the performance tests conducted. It also does not discuss data provenance in terms of country of origin or whether the data was retrospective or prospective, as these tests are typically bench and lab-based rather than clinical human data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

Since the performed tests are primarily bench, mechanical, material, and biological (biocompatibility) tests, the concept of "experts establishing ground truth" in the context of clinical interpretation (like radiologists for image analysis) does not apply. The "ground truth" for these types of tests would be established by validated test methods and reference standards.

4. Adjudication Method for the Test Set:

Not applicable, as this refers to adjudication of expert opinions or clinical outcomes, which are not detailed in the context of these engineering and biocompatibility tests.

5. 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:

Not applicable. This device is a ureteral introducer set, a physical medical device, not an AI-powered diagnostic tool requiring MRMC studies for human reader performance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

The performance tests listed are standalone tests of the device itself (e.g., tensile strength, biocompatibility), which can be considered "algorithm only" in the sense that they evaluate the device's inherent properties without active human intervention in its function during the test. There is no "human-in-the-loop" aspect to these specific performance validations as they are not AI/diagnostic tools.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the performance tests described, the "ground truth" would be based on:
* Validated test methods and industry standards: For dimensional testing, tensile strength, kinking, rollback, radiopacity, sterilization, package integrity, and shelf-life, results are compared against predefined engineering specifications and relevant ISO or ASTM standards.
* Established biological safety standards: For biocompatibility, the tests (cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity) results are compared against criteria outlined in ISO 10993 standards.

8. The sample size for the training set:

Not applicable. This device is a physical medical device, not an AI algorithm that requires a "training set" of data.

9. How the ground truth for the training set was established:

Not applicable. As above, there is no "training set" for this type of device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 2, 2018

Cook Incorporated Carly Powell Regulatory Affairs Specialist 750 Daniels Way Bloomington, IN 47404

Re: K180028

Trade/Device Name: Cook 810 Set, Desilets-Hoffman Introducer Set Regulation Number: 21 CFR§ 876.5470 Regulation Name: Ureteral Dilator Regulatory Class: II Product Code: EZN Dated: March 27, 2018 Received: March 28, 2018

Dear Carly Powell:

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.

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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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

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) K180028

Device Name

Cook 810 Set, Desilets-Hoffman Introducer Set

Indications for Use (Describe)

The Cook 810 Set is used for retrograde or antegrade ureteral access and to facilitate wire guide exchange.

The Desilets-Hoffman Introducer Set is used for retrograde or antegrade ureteral access and to facilitate wire guide exchange.

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)

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Image /page/3/Picture/1 description: The image shows the Cook Medical logo, which is a red square with the word "COOK" in white letters. Below the word "COOK" is the word "MEDICAL" in smaller white letters. Below the logo is the text "2.0 510(k) Summary" in black letters. The text is left-aligned and appears to be the title of a document or section.

cook incorporated 750 DANIELS WAY, P.O. BOX 489 MINGTON IN 47402-0489 II S A WW.COOKMEDICAL.COM

Ureteral Introducer Sets As required by 21 CFR 807.92 Date Prepared: May 1, 2018

Submitted By:

Submission: Applicant: Contact:

Applicant Address:

Contact Phone: Contact Fax:

Device Information:

Trade Name: Common Name: Classification Name: Regulation, Class: Product Code, Panel:

Predicate Device:

Traditional 510(k) Premarket Notification Cook Incorporated Carly Powell Andrew Breidenbach Cook Incorporated 750 Daniels Way Bloomington, IN 47404 (812) 335-3575 x104913 (812) 332-0281

Cook 810 Set, Desilets-Hoffman Introducer Set Ureteral dilator Ureteral dilator 21 CFR §876.5470, Class II EZN, Gastroenterology/Urology

Boston Scientific's 8/10 Dilator/Sheath Set, cleared for commercial distribution under ● 510(k) number K851144

Device Description:

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centimeters (cm) in length. Both ends of the dilator have smooth round tips and both tips are tapered at 5 millimeters (mm) as well. The sheath is an outer diameter of 8.5 French and 30 or 50 cm in length, depending on the selected set.

Indications for Use:

Ureteral Introducer Sets are indicated as follows:

The Cook 810 Set is used for retrograde or antegrade ureteral access and to facilitate wire guide exchange.
The Desilets-Hoffman Introducer Set is used for retrograde or antegrade ureteral access ● and to facilitate wire guide exchange.

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 slight dimensional variations and variations in materials. Characteristics of the subject devices that differ from the predicate device are supported by testing. These differences do not raise any new questions of safety and/or effectiveness.

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Performance Data:

The subject devices underwent the applicable testing listed below to ensure reliable design and performance under the testing parameters. Performance and biocompatibility testing were conducted in accordance with applicable performance standards and FDA guidance documents to confirm the reliable performance of critical device characteristics.

Dimensional Testing ●
Tensile Strength
Assembly After Kinking Testing
Dilator Tip Rollback Testing ●
Radiopacity Testing ●
Biocompatibility Testing shows that the subject devices conform to the ● biocompatibility requirements based on its intended use. All evaluation criteria were met. The following biological effects were evaluated:
- o Cytotoxicity
- Sensitization o
- Irritation/Intracutaneous Reactivity о
- Acute Systemic Toxicity o
- o Material-mediated Pyrogenicity
Sterilization
Package integrity and stability ●
Shelf-life .

All predetermined acceptance criteria were met.

Conclusion:

The data included in this submission indicate that the subject devices do not raise new questions of safety or effectiveness compared to the predicate device (K851144), which supports a determination of substantial equivalence.

Regulation Number and Section

§ 876.5470 Ureteral dilator.

(a)
Identification. A ureteral dilator is a device that consists of a specially shaped catheter or bougie and is used to dilate the ureter at the place where a stone has become lodged or to dilate a ureteral stricture.(b)
Classification. Class II (performance standards).