(120 days)
Not Found
No
The summary describes a physical medical device (a stent and delivery system) and its intended use for treating biliary strictures. There is no mention of software, algorithms, image processing, AI, ML, or data sets, which are typically associated with AI/ML-enabled devices.
Yes
The device is indicated for the "palliative treatment of biliary strictures produced by malignant neoplasms," which describes a therapeutic purpose.
No
The device is described as a stent system used for the palliative treatment of biliary strictures, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it consists of a self-expanding metal stent and a delivery system, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "palliative treatment of biliary strictures produced by malignant neoplasms." This describes a therapeutic intervention performed within the body to treat a medical condition.
- Device Description: The device is a "self-expanding metal stent and a delivery system" designed to be implanted in the biliary tract. This is a medical device used for treatment, not for analyzing samples in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (like blood, urine, tissue, etc.) to diagnose, monitor, or screen for diseases.
IVD devices are specifically designed to be used in vitro to examine specimens derived from the human body. This device is designed to be used in vivo (within the body) for treatment.
N/A
Intended Use / Indications for Use
The WallFlex Biliary RX Fully Covered Stent System is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms.
Product codes
FGE
Device Description
The WallFlex Biliary RX Fully Covered Stent System consists of a self-expanding metal stent and a delivery system. The stent is fully covered with Permalume coating and includes a retrieval loop at the proximal end of the stent to aid in removal during the initial stent placement procedure. The stent is mounted onto a sheath delivery system. The delivery system is a coaxial tubing assembly that constrains the stent onto the delivery system shaft until the stent is released by retracting the exterior tube.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Biliary
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
In-vitro, in-vivo, and clinical testing have been performed, and all components, subassemblies, and/or full devices met the required specifications for the completed tests.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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KOB3627 g10f2
SECTION 5 510(k) SUMMARY
510(k) SUMMARY
1. Submitter:
APR - 7 2009
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01760 Telephone: 508-683-4454 Fax: 508-683-5939
Contact: Marybeth Gamber Manager, Regulatory Affairs Date Prepared: December 5, 2008
2. Device:
Trade Name: WallFlex® Biliary RX Fully Covered Stent System Common Name: Biliary Stent Classification Name: Biliary Catheter and Accessories Regulation Number: 876.5010 Product Code: FGE Classification: Class II
3. Predicate Device:
WallStent™ RX Biliary Endoprosthesis Manufactured by Boston Scientific. Inc. WallFlex® Biliary RX Stent System Manufactured by Boston Scientific, Inc. · K012752, K030107
4. Device Description:
The WallFlex Biliary RX Fully Covered Stent System consists of a self-expanding metal stent and a delivery system. The stent is fully covered with Permalume coating and includes a retrieval loop at the proximal end of the stent to aid in removal during the initial stent placement procedure. The stent is mounted onto a sheath delivery system. The delivery system is a coaxial tubing assembly that constrains the stent onto the delivery system shaft until the stent is released by retracting the exterior tube.
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1
5. Intended Use:
The WallFlex Biliary RX Fully Covered Stent System is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms.
6. Technological Characteristics:
The WallFlex Biliary RX Fully Covered Stent System has the same technological characteristics as the currently marketed WallFlex Biliary RX Uncovered Stent System (K061231) and the Wallstent™ RX Biliary Endoprosthesis (K012752, K030107).
7. Performance Data:
In-vitro, in-vivo, and clinical testing have been performed, and all components, subassemblies, and/or full devices met the required specifications for the completed tests.
8. Conclusion:
Boston Scientific Corporation has demonstrated that the proposed WallFlex Biliary RX Fully Covered Stent System is substantially equivalent to Boston Scientific Corporation's currently marketed WallFlex Biliary RX Stent System (K061231) and Wallstent RX Biliary Endoprosthesis (K012752, K030107).
ર્ટર્
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, surrounded by a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written along the border of the seal. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Marybeth Gamber Manager, Regulatory Affairs Boston Scientific Corporation 100 Boston Scientific Way MARLBOROUGH MA 01752 .
APR - 7 2009
Re: K083627
Trade/Device Name: WallFlex® Biliary RX Fully Covered Stent System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: March 16, 2009 Received: March 31, 2009
Dear Ms. Gamber:
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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:
The safety and effectiveness of this device for use in the vascular system have not been established.
Furthermore, the indication for biliary use must be prominently displayed in all labeling, including pouch, box, and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.
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Page 2 - Ms. Marybeth Gamber
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.
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); 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 information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Voetman
Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 4 INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
This application K083627
WallFlex® Biliary RX Fully Covered Stent System
Indications for Use:
Device Name:
The WallFlex Biliary RX Fully Covered Stent System is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
QSTN
(DNision Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 68362 510(k) Number,
Premarket Notification, WallFiex® Biliary RX Fully Covered Stent System