(165 days)
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.
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.
The provided document describes a Special 510(k) Premarket Notification for a modification to existing medical devices, specifically the MaxForce Biliary Balloon Dilatation Catheter and the Hurricane RX Biliary Balloon Dilatation Catheter. The primary change is the replacement of a catheter tip resin due to the discontinuation of the original material. The acceptance criteria and the study performed are focused on demonstrating that the performance of the new resin is equivalent to the old one.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria / Test Performed | Reported Device Performance |
|---|---|
| Guidewire Compatibility | Passing results |
| Multiple Inflation | Passing results |
| Proximal Balloon Bond Tensile | Passing results |
| Wing Tool Removal Force | Passing results |
| Shaft Lap Weld Tensile Strength | Passing results |
| Balloon Rated Burst Pressure | Passing results |
| Biocompatibility Testing | Passing results |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample sizes used for each test. The study appears to be a bench-top engineering study rather than one involving patient data. Therefore, data provenance in terms of country of origin or retrospective/prospective clinical data is not applicable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The study involved engineering tests and measurements, not subjective expert evaluation to establish ground truth from clinical data.
4. Adjudication Method for the Test Set:
Not applicable. There was no need for adjudication as the tests were objective, quantitative engineering measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. This type of study is typically done for diagnostic imaging devices involving human interpretation. This document describes a physical device modification and associated engineering performance tests, not an AI or imaging device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
No. This is not an algorithm-based device. The tests performed are inherent to the physical characteristics and performance of the catheter.
7. Type of Ground Truth Used:
The "ground truth" for this study was established using engineering specifications and established test methods to assess the physical performance characteristics of the catheter (e.g., tensile strength, burst pressure, compatibility).
8. Sample Size for the Training Set:
Not applicable. This device is not an AI/ML algorithm that requires a training set. The study focuses on verifying the physical performance of the device with a new material.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
{0}------------------------------------------------
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: 508-683-6496 Fax: 508-683-5939
Secondary Contact: Ashley Santos Regulatory Affairs Manager Tel: 508-683-4359 Fax: 508-683-5939
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
{1}------------------------------------------------
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
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
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.
{3}------------------------------------------------
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 (800) 638-2041 or (301) 796-7100 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
{4}------------------------------------------------
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
§ 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.