CRE DITATATION BALLON

K112994 · Boston Scientific Corporation · FGE · Feb 10, 2012 · Gastroenterology, Urology

Device Facts

• Record ID: K112994
• Device Name: CRE DITATATION BALLON
• Applicant: Boston Scientific Corporation
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Feb 10, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CRE™ Wireguided Balloon Dilatation Catheter is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy.

Device Story

The CRE Wireguided Balloon Dilatation Catheter is a medical device used by physicians during endoscopic procedures to dilate strictures in the alimentary tract and the Sphincter of Oddi. The device features a balloon capable of three distinct, progressively larger diameters via controlled radial expansion. It is designed to pass through the working channel of an endoscope or duodenoscope and accommodates a 0.035-inch guidewire. The catheter includes a preloaded guidewire and an integrated guidewire locking device to secure the wire position during use. By inflating the balloon within a stricture, the device mechanically expands the narrowed area, potentially improving patient outcomes by restoring patency to the alimentary or biliary passages.

Clinical Evidence

No clinical trials were conducted. Evidence consists of in-vitro bench testing confirming component and device specifications, and a clinical literature search supporting the safety and effectiveness of the device for dilation of biliary tree strictures and the Sphincter of Oddi.

Technological Characteristics

Wireguided balloon dilatation catheter; features controlled radial expansion to three distinct diameters. Compatible with 0.035-inch guidewires. Includes integrated guidewire locking mechanism. Designed for passage through endoscope/duodenoscope working channels. Identical materials and design to predicate K110833.

Indications for Use

Indicated for adult and adolescent populations for endoscopic dilation of alimentary tract strictures; also indicated for adults for endoscopic dilation of the Sphincter of Oddi, with or without prior sphincterotomy.

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

• CRE Dilatation Balloon (K110833)
• Hurricane RX Biliary Balloon Dilatation Catheter (K001338)
• Maxforce Biliary (K910931)

Submission Summary (Full Text)

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K112994.
pg. 1 of 2

FEB 1 0 2012

### 510(k) SUMMARY

### 1. Submitter

Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: [phone] Fax: [phone]

Contact: Janis F. Taranto M.S., RAC Regulatory Affairs Specialist Date Prepared: October 9, 2011

# 2. Device

Trade Name: CRE Dilatation Balloon Common Name: CRE Wireguided Dilatation Balloon Classification Name: 1) Endoscope and/or accessories, 2) dilator, esophageal, 3) Catheter, Biliary, Diagnostic Regulation Number: 1) 876.5010, 2) 876.5365, 3) 876.5010 Product Code: 1) KOG, 2) KNQ, 3) FGE Classification: Class II

#### 3. Predicate Devices

Trade Name: CRE Dilatation Balloon Manufacturer and Clearance Number: Boston Scientific Corporation, K110833 Classification Name: 1) Endoscope and/or accessories, 2) dilator, esophageal Regulation Number: 1) 876.5010, 2) 876.5365 Product Code: 1) KOG, 2) KNQ Classification: Class II

Trade Name: Hurricane RX Biliary Balloon Dilatation Catheter Manufacturer and Clearance Number: Boston Scientific Corporation K001338 Classification Name: Catheter, Biliary, Diagnostic Regulation Number: 876.5010 Product Code: FGE Classification: II

Trade Name: Maxforce Biliary Manufacturer and Clearance Number: Boston Scientific Corporation, K910931 Classification Name: Catheter, Biliary, Diagnostic Regulation Number: 876.5010 Product Code: FGE Classification: II

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K.112994
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# 4. Device Description

The CRE™ Wireguided Balloon Dilatation Catheter is capable of 3 distinct and progressively larger size diameters via controlled radial expansion. Specific balloon sizes are printed on each package and hub label.

The CRETM Wireguided Balloon Dilatation Catheter is designed to pass through a 2,8mm or greater working channel of an endoscope and a 3.2 or 4.2 mm (depending on the balloon) or greater working channel of a duodenoscope. It will also accept a 0.035 in (0.89 mm) guidewire through its guidewire lumen. This catheter comes packaged with a 0.035 in (0.89 mm), floppy tip guidewire preloaded in the guidewire lumen. The guidewire is 25 cm longer than the balloon catheter with the excess length extending from the hub end of the catheter.

A guidewire locking device is attached to the guidewire hub of the catheter. The locking device will be packaged in the "OFF" or unlocked position. The guidewire may only be advanced or removed from the catheter when the switch on the locking device is in the "OFF" position. The guidewire may be held in place within the catheter by moving the switch to the "ON" position.

## 5. Indication for Use:

The CRETM Wireguided Balloon Dilatation Catheter is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy.

## 6. Technological Characteristics:

The proposed CRE™ Wireguided Balloon Dilatation Catheter is identical in design, materials, and manufacturing processes to the predicate CRE™ Wireguided Balloon Dilatation Catheter (K110833).

#### 7. Performance Data:

In-vitro testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests.

A clinical literature search was conducted and the resulting data supports the safety and effectiveness of the CRE™ Wireguided Balloon Dilatation Catheter for dilation of strictures of the biliary tree and the Sphincter of Oddi with or without prior sphincterotomy.

#### 8. Conclusion:

Boston Scientific Corporation has demonstrated that the proposed CRETM Wireguided Balloon Dilatation Catheter is substantially equivalent to Boston Scientific Corporation's currently marketed CRE™ Wireguided Balloon Dilatation Catheter (K110833), Hurricane RX Biliary Balloon Dilatation Catheter (K001338) and Maxforce Biliary Balloon Dilatation Catheter (K910931).

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Janis F. Taranto, M.S. RAC Regulatory Affairs Specialist Boston Scientific Corporation Endoscopy 100 Boston Scientific Way MARLBOROUGH MA 01752

FEB 1 0 2012

K112994 Re:

Trade Name: CRE™ Wireguided Balloon Dilatation Catheter Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: February 9, 2012 Received: February 10, 2012

Dear Ms. Taranto:

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 r read or at hose 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 (reporting of medical

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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 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,

Benjamin R. Civiletti

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

### STATEMENT

#### 510(k) Number (if known): K112994

Device Name: CRETM Wireguided Balloon Dilatation Catheter

Indications for Use:

The CRE™ Wireguided Balloon Dilatation Catheter is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy.

Prescription Use _ X (Part 21 CFR 801 Part D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Carolyn Y Newland for Herb Lenner

Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K112994