(52 days)
Not Found
No
The summary describes a metallic stent and its delivery system, with no mention of AI or ML capabilities. The performance studies focus on MR compatibility and bench testing, not algorithmic performance.
Yes
The device is a stent used to treat biliary strictures caused by malignant neoplasms, directly addressing a health condition.
No
This device is a stent used for treating biliary strictures, which is a therapeutic rather than a diagnostic function. While imaging is used during its deployment, the device itself does not perform diagnosis.
No
The device description clearly states it is comprised of two components: an implantable metallic stent and a delivery system, both of 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 for the treatment of biliary strictures produced by malignant neoplasms. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device is an implantable metallic stent and a delivery system. This is a medical device designed to be placed inside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used to perform tests in vitro (outside the body) on samples taken from a patient. This device is clearly designed for direct therapeutic use within the patient's body.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FGE
Device Description
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was performed in accordance with FDA guidance document Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment, dated December 11, 2014) to support labeling as MR Conditional. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the device testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure in profile, with three faces layered on top of each other.
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.
1
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 Usual
| Name | Self-Expanding Biliary Stent |
|---|---|
| Trade Name(s) | WALLSTENT™ RP Endoprosthesis Transhepatic Biliary and |
| WALLSTENT™ Endoprosthesis Transhepatic Biliary | |
| Product Code | FGE— Catheter, Biliary, Diagnostic |
| Classification of | |
| Device | The WALLSTENT™ RP Endoprosthesis Transhepatic Biliary and |
| WALLSTENT™ Endoprosthesis Transhepatic Biliary devices have | |
| been classified as Class II devices according to 21 CFR 876.5010 – | |
| Biliary Catheter and Accesories. | |
| Submitter's Name | |
| and Address | Boston Scientific Corporation |
| One Scimed Place | |
| Maple Grove, MN 55311-1566 | |
| Contact Name and | |
| Information | Carah Kucharski |
| Regulatory Affairs Specialist | |
| Phone: 763-494-1683 | |
| Fax: 763-255-0738 | |
| Email: carah.kucharski@bsci.com | |
| Establishment | |
| Registration | |
| Numbers | Owner / Operator: Boston Scientific Corporation |
| 300 Boston Scientific Way | |
| Marlborough, MA 01752 | |
| ERN: 3005099803 | |
| Manufacturing | |
| Facility: Boston Scientific Ireland Ltd. (BSIL) | |
| Ballybrit Business Park | |
| Galway, Ireland | |
| ERN: 9681260 | |
| Predicate Devices | WALLSTENT™ Biliary Endoprosthesis with Unistep Plus Delivery |
| System (Since changed to “WALLSTENT™ Endoprosthesis | |
| Transhepatic Biliary”) K993232 cleared September 24, 1999. | |
| Intended Use/ | |
| Indications for Use | 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. | |
| Description of | |
| Device | 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. | |
| Comparison of | |
| Required | |
| Technological | |
| Characteristics | The proposed WALLSTENTTM RP Endoprosthesis Transhepatic |
| Biliary and WALLSTENTTM Endoprosthesis Transhepatic Biliary is | |
| substantially equivalent to the existing WALLSTENTTM Biliary | |
| Endoprosthesis with Unistep Plus Delivery System cleared by FDA | |
| under premarket notification K993232 (September 24, 1999). | |
| WALLSTENTTM RP Endoprosthesis Transhepatic Biliary and | |
| WALLSTENTTM Endoprosthesis Transhepatic Biliary have the same | |
| intended use, scientific technology, design, sterilization method, and | |
| packaging as the applicable predicate device. The only difference is to | |
| the MR Safety labeling information within the Directions for Use. | |
| Bench testing in accordance with current FDA guidance supports a | |
| labeling as MR Conditional. | |
| Summary of Non- | |
| Clinical Test | |
| Summary | Bench testing was performed in accordance with FDA guidance |
| document Establishing Safety and Compatibility of Passive Implants in | |
| the Magnetic Resonance (MR) Environment , dated December 11, |
- to support labeling as MR Conditional. The results of these
tests provide reasonable assurance that the proposed device has
been designed and tested to assure conformance to the requirements
for its intended use. No new safety or performance issues were
raised during the device testing. |
| Conclusion | Based on the indications for use, technological characteristics, and
safety and performance testing, the proposed WALLSTENTTM RP
Endoprosthesis Transhepatic Biliary and WALLSTENTTM
Endoprosthesis Transhepatic Biliary has been shown to be
appropriate for its intended use and is considered to be substantially
equivalent to the WALLSTENTTM Biliary Endoprosthesis with Unistep
Plus Delivery System (K993232). |
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