The One-Step Suprapubic Introducer is comprised of a stainless steel trocar stylet needle and a dilator with a peel-away sheath. The trocar stylet needle is 20 centimeters (cm) long with a trocar beveled tip at the distal end of the device. The dilator is 14-22 French (Fr) and 18-19 cm in length. The peel-away sheath is 14-22 Fr and 17 cm in length. The three components are designed to fit together to form a single assembly.

AI/ML Overview

This document describes the Cook Incorporated One-Step Suprapubic Introducer (K182709) and its claim of substantial equivalence to a predicate device. The information provided focuses on the device's technical specifications and the performance tests conducted, rather than a clinical study involving human patients or AI systems. Therefore, many of the requested categories related to clinical studies, AI performance, and human reader effect sizes cannot be populated from the provided text.

Here's the breakdown of the information available:

1. A table of acceptance criteria and the reported device performance

The document broadly states, "All predetermined acceptance criteria were met" for all listed tests. Specific quantitative acceptance criteria are not provided.

Acceptance Criteria (Quantitative/Qualitative)	Reported Device Performance
Specific criteria not detailed in document	All predetermined acceptance criteria were met.
For Biocompatibility:
- Cytotoxicity	Conforms to biocompatibility requirements
- Sensitization	Conforms to biocompatibility requirements
- Irritation/Intracutaneous Reactivity	Conforms to biocompatibility requirements
- Acute Systemic Toxicity	Conforms to biocompatibility requirements
For other listed tests (Radiopacity, Peel-Away Shaft Tensile, Dilator Shaft Tensile, Peel Force, Rollback, Dilator Hub-to-Shaft Tensile, Dimensional, Sterilization, Package integrity and stability, Shelf-life)	All predetermined acceptance criteria were met.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for any of the performance tests. The data provenance is Cook Incorporated, based in Bloomington, Indiana, U.S.A. The testing described appears to be prospective lab/bench testing, not clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable as the document describes technical performance testing of a physical medical device, not a diagnostic device requiring expert interpretation or ground truth establishment in a clinical context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable for the same reasons as #3.

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

This question is not applicable. The device is a physical suprapubic introducer, not an AI system or a diagnostic tool that would be evaluated with an MRMC study comparing human readers with and without AI assistance.

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

This question is not applicable as the device is not an algorithm or an AI system.

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

This question is not applicable for the type of device and testing described. The "ground truth" for these engineering and biocompatibility tests would be the established test standards and specifications against which the device's performance is measured.

8. The sample size for the training set

This question is not applicable as the device is not an AI system that requires a training set.

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

This question is not applicable for the same reasons as #8.

Summary

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Image /page/0/Picture/0 description: The image shows 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.

December 26, 2018

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

Re: K182709

Trade/Device Name: One-Step Suprapubic Introducer Regulation Number: 21 CFR 876.5090 Regulation Name: Suprapubic Urological Catheter and Accessories Regulatory Class: Class II Product Code: KOB Dated: September 26, 2018 Received: September 27, 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. 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. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or post-marketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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,

Glenn B. Bell -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

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Indications for Use

510(k) Number (if known)

K182709

Device Name One-Step Suprapubic Introducer

Indications for Use (Describe)

The One-Step Suprapubic Introducer is used for introducing a drainage catheter suprapubically into the bladder.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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K182709 Page 1 of 3

Image /page/3/Picture/1 description: The image shows the logo for Cook Medical. The logo is a red rectangle with the word "COOK" in white, sans-serif font on the top half of the rectangle. Below the word "COOK" is the word "MEDICAL" in a smaller, white, sans-serif font. The bottom left corner of the rectangle is cut off at an angle.

COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 BLOOMINGTON, IN 47402-0489 U.S.A 12.339.2235 TOLLESEE: 800.457.4 WWW.COOKMEDICAL.CO

One-Step Suprapubic Introducer 21 CFR §876.5090 Date Prepared: December 26, 2018

Submitted By:	Traditional 510(k) Premarket Notification
Submission:	Cook Incorporated
Applicant:	Carly Powell
Primary Contact:	Karthik Pillai, Ph.D.
Secondary Contact:	Cook Incorporated
Applicant Address:	750 Daniels Way

	Contact Phone Number:
Contact Fax Number:	(812) 332-0281
Device Information:
Trade Names:	One-Step Suprapubic Introducer
Common Name:	Catheter, Suprapubic
Classification Name:	Suprapubic urological catheter and accessories
Regulation:	21 CFR §876.5090
Product Code:	KOB
Review Panel:	Class II, Gastroenterology/Urology

Predicate device:

The One-Step Suprapubic Introducer is substantially equivalent to the following device:

Predicate device: Supra-Foley Suprapubic Catheter Introducer cleared under K884061

Device Description:

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Intended Use:

The One-Step Suprapubic Introducer is intended for introducing a drainage catheter suprapubically into the bladder.

Comparison to Predicate:

The subject and predicate device, Supra-Foley Suprapubic Catheter Introducer, are substantially equivalent in that these devices are similar in indications for use and method of placement. Additionally, the subject device has a similar design and technological characteristics as the predicate device. The differences between the subject device and the predicate device include materials, dimensions, and components. Characteristics of the subject device that differ from the predicate device are supported by testing and do not raise any new questions of safety and effectiveness.

Performance Data:

The subject device, the One-Step Suprapubic Introducer, was subjected to applicable testing to assure reliable design and performance under the testing parameters. The following tests have been conducted to ensure reliable design and performance under the specified testing parameters:

. Radiopacity Testing
Peel-Away Shaft Tensile Test ●
Dilator Shaft Tensile Test ●
Peel Force ●
Rollback Testing ●
Dilator Hub-to-Shaft Tensile Test .
Dimensional Testing ●
Biocompatibility Testing shows that the subject device conforms 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 o
- Acute Systemic Toxicity O
Sterilization ●
Package integrity and stability
Shelf-life ●

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All predetermined acceptance criteria were met.

Conclusion:

The data included in this submission indicate that the subject device does not raise new questions of safety or effectiveness compared to the predicate device, the Supra-Foley Suprapubic Catheter Introducer (K884061), which supports a determination of substantial equivalence.

Regulation Number and Section

§ 876.5090 Suprapubic urological catheter and accessories.

(a)
Identification. A suprapubic urological catheter and accessories is a flexible tubular device that is inserted through the abdominal wall into the urinary bladder with the aid of a trocar and cannula. The device is used to pass fluids to and from the urinary tract. This generic type of device includes the suprapubic catheter and tube, Malecot catheter, catheter punch instrument, suprapubic drainage tube, and the suprapubic cannula and trocar.(b)
Classification. (1) Class II (performance standards).(2) Class I for the catheter punch instrument, nondisposable cannula and trocar, and gastro-urological trocar. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.