This device is intended to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts. Also, used for endoscopic removal of biliary stones.

Device Description

The Direct Peroral Cholangioscopy Balloon is a sterile, single use device used to gain access for direct peroral cholangioscopy. The device is placed through a duodenoscope with a minimum accessory of 2.0 mm. The latex balloon is then anchored within the pancreaticobiliary system to guide forward viewing endoscopes for diagnostic and therapeutic applications. It can also remove biliary stones.

AI/ML Overview

The provided document is a 510(k) summary for the "Direct Peroral Cholangioscopy Balloon." It describes the device, its intended use, and states that it met performance requirements through non-clinical bench testing. However, it does not contain the detailed information requested regarding acceptance criteria, specific performance metrics, or study characteristics like sample size, ground truth establishment, or expert involvement.

Here's a breakdown of what can be extracted and what is missing:

The device is a "Direct Peroral Cholangioscopy Balloon" used to guide optical and accessory devices in the pancreaticobiliary system and for endoscopic removal of biliary stones.

What's explicitly stated in the document:

Acceptance Criteria/Performance Data: The document states, "Performance testing consisting of non-clinical bench testing demonstrates that the Direct Peroral Cholangioscopy Balloon met the performance requirements of the expanded intended use." This is a general statement that performance requirements were met, but it does not specify what those requirements were or provide quantitative results.
Study Type: Non-clinical bench testing.

What is missing from the document (and therefore cannot be provided):

A table of acceptance criteria and the reported device performance: This information is not provided in the 510(k) summary. It only states that the device "met the performance requirements."
Sample sizes used for the test set and data provenance: No sample sizes are mentioned for the bench testing. Data provenance is not applicable as it's non-clinical bench testing, not human use data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for non-clinical bench testing.
Adjudication method for the test set: Not applicable for non-clinical bench testing.
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 medical instrument, not an AI or imaging diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a medical instrument, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For non-clinical bench testing, "ground truth" would typically refer to validated measurement standards or engineered specifications, but these specifics are not provided.
The sample size for the training set: Not applicable as it's not an AI model.
How the ground truth for the training set was established: Not applicable as it's not an AI model.

In summary, the provided document indicates that the device underwent non-clinical bench testing and met performance requirements. However, it does not offer the granular detail requested regarding specific acceptance criteria, quantitative performance results, or study design elements beyond identifying it as bench testing.

Summary

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K101095

COOK ENDOSCOPY 00 BETHANSA STATION ROAD NSTON-SALEM, NC 27105 U.S.A. 0157 TOLL FREE: 800.245.4707 WWW.COOKMEDICAL.COM

FDA CDRH DMC

JUL 1 9 2010

510(k) Summary

Cook Endoscopy

Name: Address:

Phone: Fax: Contact: Date:

Trade Name: Common Name: Classification Name:

Legally Marketed Devices:

Description of the Device:

Intended Use:

4900 Bethania Station Road APR 80 2010 Winston-Salem, North Carolina 27105 (336)744-0157 Regely and (336)201-5994 Scottie Fariole, Global Regulatory Affairs Specialist April 8, 2010 Direct Peroral Cholangioscopy Balloon

Balloon Catheter Mini Endoscope, Gastroenterology-Urology (21 CFR 876.1500, Product Code ODF) Catheter, biliary, surgical (21 CFR 876.5010, Product Code GCA)

SpyScope Access and Delivery Catheter (K090170) Fusion Quattro Extraction Balloon XL (K063677)

This device is intended to guide both optical and accessory Intended Use: devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts. Also, used for endoscopic removal of biliary stones.

Page 1 of 2

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510(k) Summary

Technological Characteristics: The Direct Peroral Cholangioscopy Balloon has similar technological characteristics to the to the Fusion Quattro Extraction Balloon XL (K063677) in terms of general design, materials and operation but differs in terms of dimensions, number of lumens, modifications to the proximal and distal ends of the device and extent of expansion.

101095

Performance Data:

Performance testing consisting of non-clinical bench testing demonstrates that the Direct Peroral Cholangioscopy Balloon met the performance requirements of the expanded intended use. The device will be substantially equivalent to currently cleared predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol of medicine and health. The caduceus is depicted with three lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G61 Silver Spring, MD 20993-0002

Mr. Scottie Fariole Global Regulatory Affairs Specialist Wilson-Cook Medical, Inc 4900 Bethania Station Road WINSTON-SALEM NC 27105

JUL 1 9 2010

Re: K101095

Trade/Device Name: Direct Peroral Cholangioscopy Balloon Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: Class II Product Code: FGE Dated: April 8, 2010 Received: April 20, 2010

Dear Mr. Fariole:

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 of medical device-related

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Page 2 -

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K/ 0 /0 95

Device Name: Direct Peroral Cholangioscopy Balloon

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Colun M. Pollard.

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number K / 0 / 0 9 5

Page 1 of 1

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.