DIRECT PERORAL CHOLANGIOSCOPY BALLOON

K101095 · Wilson-Cook Medical, Inc. · FGE · Jul 19, 2010 · Gastroenterology, Urology

Device Facts

• Record ID: K101095
• Device Name: DIRECT PERORAL CHOLANGIOSCOPY BALLOON
• Applicant: Wilson-Cook Medical, Inc.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Jul 19, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Direct Peroral Cholangioscopy Balloon is a sterile, single-use catheter; inserted through a duodenoscope (minimum 2.0 mm accessory channel) into the pancreaticobiliary system. Device features a latex balloon; inflated to anchor within the system. Primary function: guide forward-viewing endoscopes and accessory devices to target sites; secondary function: endoscopic removal of biliary stones. Used in clinical settings by physicians; provides mechanical stabilization for endoscopic access. Benefits include improved navigation and therapeutic access to hepatic ducts and biliary stone management.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Sterile, single-use balloon catheter. Features a latex balloon for anchoring. Dimensions, lumen count, and proximal/distal end configurations are specific to the device design. Operates via mechanical inflation. No software or electronic components.

Indications for Use

Indicated for patients undergoing endoscopic procedures in the pancreaticobiliary system, including hepatic ducts, requiring guidance of optical or accessory devices for diagnostic/therapeutic applications or removal of biliary stones.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

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

Submission Summary (Full Text)

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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 [phone] Regely and [phone] 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)

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.

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.

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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

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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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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 [phone] or [phone] 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:

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.

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

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