(275 days)
Wallstent® Transhepatic Biliary Endoprosthesis with UnistepTM Delivery System
Not Found
No
The description focuses on the mechanical components and function of a stent and delivery system, with no mention of AI or ML.
Yes
The device is designed for the "treatment of biliary strictures produced by malignant neoplasms," which directly indicates its therapeutic purpose.
No
The device description and intended use clearly state that it is for the treatment of biliary strictures by maintaining luminal patency, not for their diagnosis.
No
The device description clearly states it is a two-part system consisting of a self-expanding stent and a flexible delivery catheter, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing is done outside the body (in vitro).
- Device Description: The description clearly states this is a stent and delivery system designed to be implanted within the biliary tree to maintain luminal patency. This is an in vivo (within the body) device used for treatment, not for testing specimens outside the body.
- Intended Use: The intended use is for the treatment of biliary strictures, not for diagnostic testing.
Therefore, based on the provided information, this device is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
For use in the treatment of biliary strictures produced by malignant neoplasms.
Product codes
78 FGE
Device Description
The proposed Symphony™ Nitinol Stent Transhepatic Biliary System is a two-part system consisting of a self-expanding stent and a flexible delivery catheter. The delivery catheter is designed to facilitate transhepatic access to the biliary tree and the stent is designed to maintain luminal patency of biliary strictures produced by malignant neoplasms.
The proposed Symphony™ Nitinol Stent will be provided bre-loaded by Boston Scientific Corporation onto the delivery catheter. The stent is mounted on the catheter shaft and an outer sheath is positioned over the stent/catheter subassembly. The delivery catheter is compatible with 7F introducer systems and the multi-lumen design provides a priming lumen and accomodates a .035" guidewire.
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
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
Functional and integrity bench testing and Biocompatibility testing(according to the FDA guidance document, ODE Blue Book Memorandum #G95-1, May 1, 1995, Use of International Standard ISO-10993, "Biological Evelyation of Medical Devices Part 1: Evaluation and Testing" ) were performed, and the data supported the substantial equivalence of the Symphony™ Nitinol Stent Transhepatic Biliary System to the Wallstent® Transhepatic Biliary Endoprosthesis with Unistep™ Delivery System.
Key Metrics
Not Found
Predicate Device(s)
Wallstent® Transhepatic Biliary Endoprosthesis with UnistepTM Delivery System
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.
0
Boston
Scientific
Corporation
One Boston Scientific Place Natick, MA 01760-1537 508-650-8000
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Pursuant to §513(1)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation is required to submit with this Premarket Notification" ... adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Boston Scientific Corporation chooses to submit a summary of information respecting safety and effectiveness. According to §513(0)(3)(B), " Any summary under subparagraph (A) respecting a device shall contain detailed information regarding data conceming adverse health effects..."
The summary regarding the adverse heath effects of the proposed Symphony™ Nitinol Stent Transhepatic Biliary System is as follows:
| Trade Name: | SymphonyTM Nitinol Stent Transhepatic Biliary System |
|---|---|
| Manufacturer: | Boston Scientific Corporation |
| 480 Pleasant Street | |
| Watertown, MA 02172 | |
| Device Generic Name: | Biliary Stent |
| Classification: | According to Section 513 of the Federal Food, Drug and Cosmetic |
| Act, the device classification is Class II, Performance Standards | |
| (CFR 876.5010). | |
| Predicate Device: | Wallstent® Transhepatic Biliary Endoprosthesis with |
| UnistepTM Delivery System |
Device Description:
The proposed Symphony™ Nitinol Stent Transhepatic Biliary System is a two-part system consisting of a self-expanding stent and a flexible delivery catheter. The delivery catheter is designed to facilitate transhepatic access to the biliary tree and the stent is designed to maintain luminal patency of biliary strictures produced by malignant neoplasms.
The proposed Symphony™ Nitinol Stent will be provided bre-loaded by Boston Scientific Corporation onto the delivery catheter. The stent is mounted on the catheter shaft and an outer sheath is positioned over the stent/catheter subassembly. The delivery catheter is compatible with 7F introducer systems and the multi-lumen design provides a priming lumen and accomodates a .035" guidewire.
Indications For Use:
For use in the treatment of biliary strictures produced by malignant neoplasms.
1
Image /page/1/Picture/0 description: The image shows the logo for Boston Scientific Corporation. The logo is composed of three lines of text, with each line containing one or two words. The words are stacked vertically, with "Boston" on the top line, "Scientific" on the second line, and "Corporation" on the third line. The font is a serif typeface, and the text is black.
Safety and Performance:
Functional and integrity bench testing and Biocompatibility testing(according to the FDA guidance document, ODE Blue Book Memorandum #G95-1, May 1, 1995, Use of International Standard ISO-10993, "Biological Evelyation of Medical Devices Part 1: Evaluation and Testing" ) were performed, and the data supported the substantial equivalence of the Symphony™ Nitinol Stent Transhepatic Biliary System to the Wallstent® Transhepatic Biliary Endoprosthesis with Unistep™ Delivery System.
Conclusion:
Based on the indications for use, technological characteristics, and safety and performance testing, the Symphony™ Nitinol Stent Transhepatic Biliary System has been shown to be safe and effective for its intended use.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 1 1997
Ms. Laura Mondano Project Manager, Regulatory Affairs Boston Scientific Corporation One Boston Scientific Place Natick, Massachusetts 01760-1537
Re: K963254
Symphony™ Nitinol Stent Transhepatic Biliary System Dated: February 19, 1997 Received: February 20, 1997 Regulatory Class: II 21 CFR 876.5010/Procode: 78 FGE
Dear Ms. Mondano:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Willian Yi, Ph.D.
Lillian Yin, Ph.D Director, Division of Reproduc Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of . 1
INDICATION FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Symphony™ Nitinol Stent Transhepatic Biliary System Device Name: _____
Indications for Use:
. . .
For Use in the treatment of biliary strictures produced by malignant neoplasms.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Weber R. Nothing
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K963254
Prescription Use
OR
Over-The-Counter Use_
(Per 21 CFR 801.109)
(Option Format 1-2-96)
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