(73 days)
Not Found
No
The document describes a physical medical device (a stent) and its delivery system. There is no mention of software, algorithms, or data processing that would suggest the use of AI or ML.
Yes
The device is described as treating biliary strictures and obstruction caused by malignant neoplasms, which is a therapeutic purpose.
No
The device is a stent used for treatment (palliative care and relief of obstruction), not for diagnosing conditions.
No
The device description clearly states it is an implantable biliary self-expanding metal stent pre-loaded onto a delivery system, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the palliative treatment of biliary strictures and relief of malignant biliary obstruction. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device is an implantable self-expanding metal stent delivered endoscopically into the biliary system. This is a medical device used for treatment, not for testing samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is mechanical support and drainage.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The WallFlex "11 Biliary RX Stent System is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms, and relief of malignant biliary obstruction prior to surgery.
Product codes
FGE
Device Description
The WallFlexTM Biliary RX Stent System is an implantable biliary self-expanding metal stent that is pre-loaded onto a Delivery System with a working length of 194mm, which allows delivery of the stent into the Biliary system endoscopically. The self-expanding metal stent consists of Platinum cored Nitinol wires wound together to form a cylinder including flares on both the proximal end and distal end. The WallFlex "M Biliary RX Stent is available uncovered, partially covered, or fully covered with a Permalume 199 covering.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Biliary system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
No performance data was required for this submission.
Boston Scientific used published clinical results of stents used for pre-operative biliary drainage. The conclusion from this review demonstrates that the WallFlex Biliary Stent System can be safely and effectively used as a relief of biliary obstruction prior to surgery.
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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MAY 2 3 2014
K140630 Page 1 of 2
SECTION 5 510(k) SUMMARY
510(k) SUMMARY
1. Submitter:
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4454 Fax: 508-683-5939
Contact: Thomas Hirte Senior Manager, Regulatory Affairs Date Prepared: March 7, 2014
2. Proposed Device:
| Trade Name: | WallFlex TM Biliary RX Stent System |
|---|---|
| Classification Name: | Catheter, Biliary, Diagnostic |
| Regulation Number: | 876.5010 |
| Product Code: | FGE |
| Classification: | Class II |
3. Predicate Device:
| Trade Name: | WallFlex™ Biliary RX Stent System |
|---|---|
| 510(k) Number: | K122072 |
| Classification Name: | Catheter, Biliary, Diagnostic |
| Regulation Number: | 876.5010 |
| Product Code: | FGE |
| Classification: | Class II |
Advanix Biliary Stent With Naviflex RX Delivery System Trade Name: 510(k) Number: K101314 Classification Name: Catheter, Biliary, Diagnostic Regulation Number: 876.5010 Product Code: FGE Classification: Class II
4. Proposed Device Description:
The WallFlexTM Biliary RX Stent System is an implantable biliary self-expanding metal stent that is pre-loaded onto a Delivery System with a working length of 194mm, which allows delivery of the stent into the Biliary system endoscopically. The self-expanding metal stent consists of Platinum cored Nitinol wires wound together to form a cylinder including flares on both the proximal end and distal end. The WallFlex "M Biliary RX Stent is available uncovered, partially covered, or fully covered with a Permalume 199 covering.
1
5. Indications for Use:
The WallFlex "11 Biliary RX Stent System is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms, and relief of malignant biliary obstruction prior to surgery.
6. Technological Characteristics:
There are no differences in the technological characteristics between the proposed device and the predicate WallFlex Biliary RX Stent System (K122072). The purpose of this Traditional 510(k) is to request an expanded indication for the proposed WallFlex "M Biliary RX Stent System. The physical devices will remain unchanged from the predicate K 122072, but the expanded indication requires a change to the product labeling. All other design specifications remain unchanged.
7. Performance Data:
No performance data was required for this submission.
Boston Scientific used published clinical results of stents used for pre-operative biliary drainage. The conclusion from this review demonstrates that the WallFlex Biliary Stent System can be safely and effectively used as a relief of biliary obstruction prior to surgery.
8. Conclusion:
Boston Scientific Corporation has demonstrated that the proposed WallFlex™ Biliary RX Stent System can be safely and effectively used for its proposed expanded indication.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized depiction of an eagle with three lines representing its wings and tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 23, 2014
Boston Scientific Thomas Hirte Sr. Manager, Regulatory Affairs 100 Boston Scientific Way Marlborough, MA 01752
Re: K140630
Trade/Device Name: WallFlex™ Biliary RX Stent System Regulation Number: 21 CFR§ 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: April 1, 2014 Received: April 2, 2014
Dear Thomas Hirte,
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 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. 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.
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.
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Page 2 - Thomas Hirte
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.
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 SIO(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); medical device reporting (reporting of medical 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
4
Page 3 - Thomas Hirte
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Christy L. Foreman -S
Christy Foreman Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
SECTION 4 INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name:
Indications For Use:
WallFlex™ Biliary RX Stent System
The WallFlex™ Biliary RX Stents are indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery.
Prescription Use X (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)