The Cotton® Graduated Dilation Catheter, Fusion® Biliary Dilation Catheter, Soehendra® Biliary Dilation Catheters are used to dilate biliary strictures. These devices are indicated for adult use only.

The Geenen® Graduated Dilation Catheter is used to dilate stenotic minor papilla. These devices are indicated for adult use only.

Device Description

The subject devices consist of a catheter with a luer lock hub with a connecting cap fitting. The Fusion® Biliary Dilation Catheter is constructed with a double lumen, radiopaque catheter with a stylet wire that is removed prior to contrast or fluid injection. The subject devices are used by passing the device through an endoscope, over a pre-positioned wire guide. The device is then advanced under fluoroscopic monitoring; during advancement, the pre-positioned wire guide will exit the proximal (non-patient contacting) end of the catheter through the connecting cap and luer lock hub. The Fusion® Biliary Dilation Catheter includes an additional option which allows the wire guide to exit at the distal end of the device (patient contacting). The dilation catheter is advanced to the appropriate position where dilation of the stricture is completed.

The subject device consists of a catheter with a radiopaque marker band and a luer lock hub with a connecting cap fitting. The subject device is used by passing the device through an endoscope, over a prepositioned wire guide. The device is then advanced under fluoroscopic monitoring; during advancement, the pre-positioned wire guide will exit the proximal (non-patient contacting) end of the catheter through the connecting cap and luer lock adapter. The dilation catheter is advanced to the appropriate position where dilation of the stricture is performed.

AI/ML Overview

This document is a 510(k) premarket notification for Catheters for Biliary Dilation. It details the substantial equivalence of new devices (Cotton®, Fusion®, Soehendra® Biliary Dilation Catheters, and Geenen® Graduated Dilation Catheter) to previously cleared predicate devices.

Based on the provided text, there is no information about an AI/Algorithm-based device or a study proving its performance against specific acceptance criteria for diagnostic accuracy, sensitivity, or specificity. The document pertains to physical medical devices (catheters) and their non-clinical performance (bench testing, biocompatibility, shelf life, packaging).

Therefore, I cannot provide the requested information regarding acceptance criteria and performance of an AI/Algorithm-based device as it is not present in the provided text.

The information provided in the document focuses on:

Device Names and Intended Use: Dilation of biliary strictures and stenotic minor papilla.
Regulatory Information: 510(k) clearance, classification, and predicate devices.
Device Description: Physical characteristics and operation of the catheters.
Substantial Equivalence Justification: Minor changes from predicate devices and how these changes do not affect safety or effectiveness.
Performance Data (Non-clinical): Shelf life, packaging validation, and various bench tests (visual inspection, guidewire verification, endoscope channel compatibility, dilatation simulated removal, removal force, tensile strength) and biocompatibility.

To directly answer your specific questions based on the absence of this information in the document:

A table of acceptance criteria and the reported device performance: Not applicable for an AI device. The document reports non-clinical bench testing results to confirm the physical device performs as intended, but specific numerical acceptance criteria (e.g., minimum tensile strength) are not tabulated or explicitly stated beyond "met the performance requirements."
Sample size used for the test set and the data provenance: Not applicable for an AI device's test set. For the physical device bench testing, sample sizes are not specified, nor is data provenance in terms of "country of origin" as it relates to clinical data. It's lab-based testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no expert-based ground truth for diagnostic purposes is discussed for an AI model.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for an AI diagnostic study.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This document describes the clearance of physical catheters, not an AI-assisted diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No. This is not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for an AI diagnostic study. The "ground truth" for these physical devices is their ability to perform mechanical functions (e.g., dilate, withstand force, remain sterile) as demonstrated in engineering tests.
The sample size for the training set: Not applicable, as there is no AI model or training set discussed.
How the ground truth for the training set was established: Not applicable, as there is no AI model or training set discussed.

In summary, this FDA 510(k) clearance document is for physical medical devices (catheters) and does not contain any information related to AI/Algorithm performance, diagnostic accuracy studies, or clinical trial data of the kind you are asking about.

Summary

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October 12, 2017

Wilson-Cook Medical, Inc. Sierra Lowe Regulatory Affairs Specialist - 1 4900 Bethania Station Road Winston-Salem, NC 27105

Re: K171548

Trade/Device Name: Cotton® Graduated Dilation Catheter, Fusion® Biliary Dilation Catheter, Soehendra® Biliary Dilation Catheter, Geenen® Graduated Dilation Catheter Regulation Number: 21 CFR§ 876.5010 Regulation Name: Biliary Catheter and Accessories Regulatory Class: II Product Code: FGE Dated: August 18, 2017 Received: August 21, 2017

Dear Sierra Lowe:

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.

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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) 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,

Joyce M. Whang -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) K171548

Device Name

Cotton® Graduated Dilation Catheter, Fusion® Biliary Dilation Catheter, Soehendra® Bilary Dilation Catheter, Geenen® Graduated Dilation Catheter

Indications for Use (Describe)

The Geenen® Graduated Dilation Catheter is used to dilate stenotic minor papilla. These devices are indicated for adult use only.

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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COOK®
MEDICAL

COOK ENDOSCOPY 4900 BETHANIA STATION ROAD WINSTON-SALEM, NC 27105 U.S.A. PHONE: 336.744.0157 TOLL FREE: 800.245.4707 WWW.COOKMEDICAL.COM

510(k) Summary

Name:	Wilson-Cook Medical, Inc. /Cook Endoscopy
Address:	4900 Bethania Station RoadWinston-Salem, North Carolina 27105
Phone:	(336) 744-0157 (x396506)
Fax:	(336) 201-5994
Contact:	Sierra Lowe, Regulatory Affairs Specialist I
Date:	October 13, 2017
Trade Names:	Cotton® Graduated Dilation Catheter (CGDC)Fusion® Biliary Dilation Catheter (FS-BDC)Soehendra® Biliary Dilation Catheter (SBDC)Geenen® Graduated Dilation Catheter (GGDC)
Common Name:	Dilation Catheter
Classification Name:	Biliary Catheter and Accessories 21 CFR §876.5010; FGE Class II
Predicate Devices:	Soehendra® Biliary Dilation Catheter, K851960, cleared April 18, 1985Vennes® Pancreatic Dilation Set, K851956, cleared June 13, 1985

Intended Uses:

The Cotton® Graduated Dilation Catheter, Fusion® Biliary Dilation Catheter, Soehendra® Biliary Dilation Catheters are used to dilary strictures. These devices are indicated for adult use only.

The Geenen® Graduated Dilation Catheter is used to dilate stenotic minor papilla. These devices are indicated for adult use only.

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Description of the Devices:

Biliary Dilation Catheters

Dilation Catheter

Substantial Equivalence:

Biliary Dilation Catheter

Minor changes were made to the predicate dilation catheters cleared to market via K851960. Changes to the subject devices include: additional catheter lengths and diameters, additional tapered tip lengths and diameters, and the addition of tantalum radiopaque marker bands. For the Fusion® Biliary Dilation Catheter (FS-BDC), there was a change to the catheter material and the addition of a stylet wire.

Dilation Catheter

Minor changes have been made to the predicate dilation catheter cleared to market via (K851956). Changes to the subject device include: additional catheter lengths and diameters, additional tapered tip lengths and diameters, addition of tantalum radiopaque marker bands, exclusion of the wire guide that was previously supplied along with the device, and updated wire guide compatibility.

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Performance Data:

Performance testing consisting of non-clinical bench testing demonstrates that the subject devices met the performance requirements to fulfill their intended uses. The results of this testing provides reasonable assurance that the subject devices will function as intended. The subject devices do not raise new questions of safety or effectiveness as compared to their respective predicate devices.

Summary of non-clinical testing:

The following non-clinical testing was conducted to demonstrate the performance of the subject device and confirmed that the subject device performs as intended.

. Shelf Life Testing
Packaging Validation .
Non-clinical, bench testing of the subject devices methods included: visual inspection, pre-. position guidewire verification, endoscope channel compatibility, dilatation simulated removal, and removal force and tensile strength tests

Biocompatibility testing was performed in accordance with the FDA Guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices-Part I: Evaluation and testing within a risk management process."

Conclusion:

We believe that the subject devices are substantially equivalent to the predicate devices in terms of intended use, key operating principles, materials and technological characteristics. We consider the risks associated with the modifications to the subject devices to have been adequately addressed through our Design Control Processes and do not affect safety or effectiveness of the devices.

Regulation Number and Section

§ 876.5010 Biliary catheter and accessories.

(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.