MAXFORCE BILIARY DILATATION CATHETER AND HURRICANE RX BILIARY CATHETER

K130484 · Boston Scientific Corp · FGE · Aug 9, 2013 · Gastroenterology, Urology

Device Facts

• Record ID: K130484
• Device Name: MAXFORCE BILIARY DILATATION CATHETER AND HURRICANE RX BILIARY CATHETER
• Applicant: Boston Scientific Corp
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Aug 9, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MaxForce Biliary Dilatation Catheter: The MaxForce Biliary Balloon Dilatation Catheters are recommended for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. Hurricane RX Biliary Balloon Dilatation Catheter: The Hurricane RX Biliary Balloon Dilatation Catheter is recommended for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. The Hurricane RX Biliary Balloon Dilatation Catheter may be used for injection of contrast medium for fluoroscopic visualization of the bile ducts.

Device Story

Double lumen catheters with non-compliant (MaxForce) or standard (Hurricane RX) balloons at distal tip; used for endoscopic dilatation of biliary strictures and Sphincter of Oddi; Hurricane RX allows contrast medium injection for fluoroscopic visualization. Operated by physicians in endoscopic procedures. Radial force exerted by balloon inflation dilates narrow duct segments. Benefit: restoration of biliary duct patency.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included guidewire compatibility, multiple inflation, proximal balloon bond tensile, wing tool removal force, shaft lap weld tensile strength, balloon rated burst pressure, and biocompatibility testing. All tests passed.

Technological Characteristics

Double lumen catheter with distal balloon. Modification involves replacement of catheter tip resin with a similar material. Mechanical operation via inflation. Biocompatibility testing performed.

Indications for Use

Indicated for endoscopic dilatation of biliary tree and Sphincter of Oddi strictures. Hurricane RX also indicated for contrast medium injection for fluoroscopic visualization of bile ducts.

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

• MaxForce Biliary Balloon Dilatation Catheter (K910931)
• Hurricane RX Biliary Balloon Dilatation Catheter (K001338)

Submission Summary (Full Text)

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# SECTION 6 510(k) SUMMARY

## 510(k) SUMMARY

## 1. Submitter:

Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752

Contact: Andrew Nguyen Regulatory Affairs Specialist Tel: [phone] Fax: [phone]

Secondary Contact: Ashley Santos Regulatory Affairs Manager Tel: [phone] Fax: [phone]

Date Prepared: February 22, 2013

### 2. Proposed Device:

Trade Name: MaxForce Biliary Balloon Dilatation Catheter Classification Name: Catheter, Biliary, Diagnostic Regulation Number: 876.5010 Product Code: FGE Classification: Class II

Trade Name: Hurricane RX Biliary Balloon Dilatation Catheter Classification Name: Catheter, Biliary, Diagnostic Regulation Number: 876.5010 Product Code: FGE Classification: Class II

#### 3. Predicate Device:

Trade Name: MaxForce Biliary Balloon Dilatation Catheter (K910931) Classification Name: Catheter, Biliary, Diagnostic Regulation Number: 876.5010 Product Code: FGE Classification: Class II

Trade Name: Hurricane RX Biliary Balloon Dilatation Catheter (K001338) Classification Name: Catheter, Biliary, Diagnostic Regulation Number: 876.5010 Product Code: FGE Classification: Class II

Special 510(k) Premarket Notification, MaxForce Biljary Dilatation Catheter and Hurricane RX Dilatation Catheter Proprietary and Confidential Information of Boston Scientific Corporation

AUG 09 2013

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#### 4. Device Description:

MaxForce Biliary Balloon Dilatation Catheter: The MaxForce Biliary balloon dilatation catheter, styled after the Gruntzig technique, is a double lumen catheter with a non-compliant balloon mounted at the distal tip. Dilatation balloon catheters are used to exert radial force to dilate narrow duct segments as well as the Sphincter of Oddi.

Hurricane RX Biliary Balloon Dilatation Catheter: The Hurricane RX Biliary Balloon Dilatation Catheter is a double lumen catheter with a balloon mounted at the distal tip. Dilatation balloon catheters are used to exert radial force to dilate narrow duct segments, as well as the Sphincter of Oddi.

#### 5. Indications for Use:

MaxForce Biliary Dilatation Catheter: The MaxForce Biliary Balloon Dilatation' Catheters are recommended for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi.

Hurricane RX Biliary Balloon Dilatation Catheter: The Hurricane RX Biliary Balloon Dilatation Catheter is recommended for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. The Hurricane RX Biliary Balloon Dilatation Catheter may be used for injection of contrast medium for fluoroscopic visualization of the bile ducts.

### 6. Technological Characteristics:

The resin of the "catheter tip" component of the MaxForce Biliary and Hurricane RX products are being slightly modified. The current resin is being discontinued by the supplier and will be replaced with a similar resin.

#### 7. Performance Data:

Technical assessments were performed to demonstrate that the performances of the two resins are equivalent. The following tests were conducted:

- Guidewire Compatibility .
- Multiple Inflation .
- Proximal Balloon Bond Tensile .
- Wing Tool Removal Force ●
- Shaft Lap Weld Tensile Strength .
- Balloon Rated Burst Pressure ●
- � Biocompatibility Testing

All tests had passing results.

#### 8. Conclusion:

Boston Scientific Corporation has demonstrated that the proposed "catheter tip" resin is substantially equivalent to the "catheter tip" resin of the currently cleared MaxForce Biliary (K910931) and Hurricane RX Biliary Catheter (K001338) devices.

Special 510(k) Premarket Notification, MaxForce Biliary Dilatation Catheter and Hurricane RX Dilatation Catheter Proprietary and Confidential Information of Boston Scientific Corporation

000072

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Public Health Service

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

August 9, 2013

Boston Scientific Corporation % Andrew Nguyen Regulatory Affairs Specialist 100 Boston Scientific Way Marlborough, MA 01752

Re: K130484

Trade/Device Name: MaxForce Biliary Dilatation Catheter Hurricane RX Biliary Catheter Regulation Number: 21 CFR§ 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: July 5, 2013 Received: July 10, 2013

Dear Andrew Nguyen:

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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Page 2 - Andrew Nguyen

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/ucm | 15809.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/ReportalProblem/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,

Herbert P. Lerner -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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## SECTION 5 INDICATIONS FOR USE STATEMENT

K130484 510(k) Number (if known):

MaxForce Biliary Dilatation Catheter Device Name: Hurricane RX Biliary Catheter

MaxForce Biliary Dilatation Catheter: The MaxForce Indications for Use: Biliary Balloon Dilatation Catheters are recommended for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi.

> Hurricane RX Biliary Balloon Dilatation Catheter: The Hurricane RX Biliary Balloon Dilatation Catheter is recommended for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. The Hurricane RX Biliary Balloon Dilatation Catheter may be used for injection of contrast medium for fluoroscopic visualization of the bile ducts.

Prescription Use × (Part 21 CFR 801 Subpart 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)

# Herbert P. Lerner -S

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K130484 510(k) Number _

Special 510(k) Premarket Notification, MaxForce Biliary Dilatation Catheter and Hurricane RX Dilatation Catheter Proprietary and Confidential Information of Boston Scientific Corporation