(52 days)
The WALLSTENT RP Endoprosthesis Transhepatic Biliary and WALLSTENT Endoprosthesis Transhepatic Biliary are indicated for use in the treatment of biliary strictures produced by malignant neoplasms.
The WALLSTENTTM RP Endoprosthesis Transhepatic Biliary and WALLSTENTTM Endoprosthesis Transhepatic Biliary are comprised of two components: The implantable metallic stent and the Unistep Plus delivery system. The stent is composed of biomedical superalloy wire, braided in a tubular mesh configuration. This design configuration results in a stent that is flexible, compliant, and self-expanding. The delivery system consists in part of coaxial tubes. The exterior tube serves to constrain the stent until retracted during delivery. Radiopaque marker bands situated on the interior and exterior tubes aid in imaging during deployment. Small stent sizes (8 & 10mm) may have a radiopaque core to improve radiopacity. The interior tube of the coaxial system contains a central lumen that accommodates a 0.035in (0.89mm) guidewire.
This document does not contain information about an AI/ML medical device, but rather a medical device called the WALLSTENT RP Endoprosthesis Transhepatic Biliary and WALLSTENT Endoprosthesis Transhepatic Biliary, which is a self-expanding metallic stent used to treat biliary strictures produced by malignant neoplasms.
Therefore, I cannot answer the questions regarding acceptance criteria and the study that proves an AI/ML device meets the acceptance criteria, as the provided text does not describe such a device or study.
The document indicates that the device undergoes bench testing to support MR Conditional labeling, and this testing provides assurance of conformance to requirements for its intended use. However, these are not the types of studies typically conducted for AI/ML devices proving clinical performance with metrics like sensitivity, specificity, or reader improvement.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 20, 2015
Boston Scientific Corporation Carah Kucharski Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311-1566
Re: K152853
Trade/Device Name: WALLSTENT RP Endoprosthesis Transhepatic Biliary and WALLSTENT Endoprosthesis Transhepatic Biliary Regulation Number: 21 CFR§ 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: October 14, 2015 Received: October 15, 2015
Dear Carah Kucharski.
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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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/ResourcesforYou/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.
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 vours.
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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Indications for Use
510(k) Number (if known) K152853
Device Name
WALLSTENT RP Endoprosthesis Transhepatic Biliary and WALLSTENT Endoprosthesis Transhepatic Biliary
Indications for Use (Describe)
The WALLSTENT RP Endoprosthesis Transhepatic Biliary and WALLSTENT Endoprosthesis Transhepatic Biliary are indicated for use in the treatment of biliary strictures produced by malignant neoplasms.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510k Summary
Per 21 CFR §807.92
| Common or UsualName | Self-Expanding Biliary Stent |
|---|---|
| Trade Name(s) | WALLSTENT™ RP Endoprosthesis Transhepatic Biliary andWALLSTENT™ Endoprosthesis Transhepatic Biliary |
| Product Code | FGE— Catheter, Biliary, Diagnostic |
| Classification ofDevice | The WALLSTENT™ RP Endoprosthesis Transhepatic Biliary andWALLSTENT™ Endoprosthesis Transhepatic Biliary devices havebeen classified as Class II devices according to 21 CFR 876.5010 –Biliary Catheter and Accesories. |
| Submitter's Nameand Address | Boston Scientific CorporationOne Scimed PlaceMaple Grove, MN 55311-1566 |
| Contact Name andInformation | Carah KucharskiRegulatory Affairs SpecialistPhone: 763-494-1683Fax: 763-255-0738Email: carah.kucharski@bsci.com |
| EstablishmentRegistrationNumbers | Owner / Operator: Boston Scientific Corporation300 Boston Scientific WayMarlborough, MA 01752ERN: 3005099803 |
| ManufacturingFacility: Boston Scientific Ireland Ltd. (BSIL)Ballybrit Business ParkGalway, IrelandERN: 9681260 | |
| Predicate Devices | WALLSTENT™ Biliary Endoprosthesis with Unistep Plus DeliverySystem (Since changed to “WALLSTENT™ EndoprosthesisTranshepatic Biliary”) K993232 cleared September 24, 1999. |
| Intended Use/Indications for Use | The WALLSTENT™ RP Endoprosthesis Transhepatic Biliary andWALLSTENT™ Endoprosthesis Transhepatic Biliary are indicated foruse in the treatment of biliary strictures produced by malignantneoplasms. |
| Description ofDevice | The WALLSTENTTM RP Endoprosthesis Transhepatic Biliary andWALLSTENTTM Endoprosthesis Transhepatic Biliary are comprised oftwo components: The implantable metallic stent and the Unistep Plusdelivery system. The stent is composed of biomedical superalloy wire,braided in a tubular mesh configuration. This design configurationresults in a stent that is flexible, compliant, and self-expanding. Thedelivery system consists in part of coaxial tubes. The exterior tubeserves to constrain the stent until retracted during delivery.Radiopaque marker bands situated on the interior and exterior tubesaid in imaging during deployment. Small stent sizes (8 & 10mm) mayhave a radiopaque core to improve radiopacity. The interior tube of thecoaxial system contains a central lumen that accommodates a 0.035in(0.89mm) guidewire. |
| Comparison ofRequiredTechnologicalCharacteristics | The proposed WALLSTENTTM RP Endoprosthesis TranshepaticBiliary and WALLSTENTTM Endoprosthesis Transhepatic Biliary issubstantially equivalent to the existing WALLSTENTTM BiliaryEndoprosthesis with Unistep Plus Delivery System cleared by FDAunder premarket notification K993232 (September 24, 1999).WALLSTENTTM RP Endoprosthesis Transhepatic Biliary andWALLSTENTTM Endoprosthesis Transhepatic Biliary have the sameintended use, scientific technology, design, sterilization method, andpackaging as the applicable predicate device. The only difference is tothe MR Safety labeling information within the Directions for Use.Bench testing in accordance with current FDA guidance supports alabeling as MR Conditional. |
| Summary of Non-Clinical TestSummary | Bench testing was performed in accordance with FDA guidancedocument Establishing Safety and Compatibility of Passive Implants inthe Magnetic Resonance (MR) Environment , dated December 11,2014) to support labeling as MR Conditional. The results of thesetests provide reasonable assurance that the proposed device hasbeen designed and tested to assure conformance to the requirementsfor its intended use. No new safety or performance issues wereraised during the device testing. |
| Conclusion | Based on the indications for use, technological characteristics, andsafety and performance testing, the proposed WALLSTENTTM RPEndoprosthesis Transhepatic Biliary and WALLSTENTTMEndoprosthesis Transhepatic Biliary has been shown to beappropriate for its intended use and is considered to be substantiallyequivalent to the WALLSTENTTM Biliary Endoprosthesis with UnistepPlus Delivery System (K993232). |
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§ 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.