(67 days)
Not Found
No
The device description focuses on the physical components and mechanical function of a stent and delivery system, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is indicated for the palliative treatment of biliary strictures produced by malignant neoplasms, which is a therapeutic purpose.
No.
The device is a Wallstent RX Biliary Endoprosthesis, indicated for the palliative treatment of biliary strictures produced by malignant neoplasms. It is a therapy device (a stent) used to open blockages, not to diagnose a condition.
No
The device description clearly outlines physical components: a stent (made of wire with a tantalum core) and a delivery catheter (coaxial tubing assembly with radiopaque markers). This indicates a hardware-based medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Device Function: The described device is a biliary stent and its delivery system. It is a physical implant designed to be placed inside the body (in vivo) to open up a blocked bile duct.
- Intended Use: The intended use is "palliative treatment of biliary strictures produced by malignant neoplasms." This is a therapeutic intervention performed directly on the patient's anatomy, not a diagnostic test on a sample.
- Device Description: The description details a physical stent and a delivery catheter, not reagents, test kits, or analytical instruments used for laboratory testing.
The device is a therapeutic medical device used for interventional procedures, not an IVD.
N/A
Intended Use / Indications for Use
The proposed 100mm Wallstent™ RX Biliary Endoprosthesis is indicated for palliative treatment of biliary strictures produced by malignant neoplasms.
Product codes (comma separated list FDA assigned to the subject device)
78 FGE
Device Description
The proposed Wallstent RX Biliary Endoprosthesis consists of a stent and a delivery catheter. The self-expanding metal stent is delivered endoscopically with the delivery catheter. The stent is a tubular mesh constructed from a biomedical super alloy wire with a tantalum core to allow for visibility under fluoroscopy. The stent is offered bare. The proposed delivery catheter consists of a coaxial tubing assembly that constrains the stent until it is released by retracting the exterior tube assembly. The interior tube of the coaxial system contains a central lumen to accommodate a 0.035" guidewire that exits near the tip of the delivery catheter. Radiopaque markers are located on the interior and exterior tubes to facilitate imaging during stent deployment. The device will be offered in 8mm & 10mm diameters and 100mm length.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopy
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 conducted to aid with the establishment of substantial equivalence of the proposed device to the predicate device.
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.
0
K030107
Page 1 of 2
510(K) SUMMARY
1. Submitter:
Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537
Contact: Jennifer Johnson Senior Regulatory Specialist Date Prepared: January 10, 2003
2. Device:
Trade Name: 100mm Wallstent™ RX Biliary Endoprosthesis Common Name: Biliary Stent Classification Name: Biliary Catheter & Accessories
3. Predicate Device:
BSC Wallstent RX Biliary Endoprosthesis - K012752
4. Device Description:
The proposed Wallstent RX Biliary Endoprosthesis consists of a stent and a delivery catheter. The self-expanding metal stent is delivered endoscopically with the delivery catheter. The stent is a tubular mesh constructed from a biomedical super alloy wire with a tantalum core to allow for visibility under fluoroscopy. The stent is offered bare. The proposed delivery catheter consists of a coaxial tubing assembly that constrains the stent until it is released by retracting the exterior tube assembly. The interior tube of the coaxial system contains a central lumen to accommodate a 0.035" guidewire that exits near the tip of the delivery catheter. Radiopaque markers are located on the interior and exterior tubes to facilitate imaging during stent deployment. The device will be offered in 8mm & 10mm diameters and 100mm length.
5. Intended Use:
The proposed 100mm Wallstent™ RX Biliary Endoprosthesis is indicated for palliative treatment of biliary strictures produced by malignant neoplasms.
6. Technological Characteristics:
The stent design and materials are identical to the predicate Wallstent™ RX Biliary Endoprosthesis that is currently marketed by BSC for the same indication.
7. Performance Data:
Bench testing was conducted to aid with the establishment of substantial equivalence of the proposed device to the predicate device.
Premarket Notification, 100mm Wallstent™ RX Biliary Endoprosthesis January 10, 2003 Proprietary and Confidential Information of Boston Scientific Corporation
MAR 2 1 2003
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Page 2 of 2
8. Conclusion:
BSC has demonstrated that the 100mm Wallstent™ RX Biliary Endoprosthesis is substantially equivalent to BSC's currently marketed Wallstent™ RX Biliary Endoprosthesis.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol. The logo is simple and recognizable, conveying the department's mission of promoting health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 1 2003
Ms. Jennifer Johnson Senior Regulatory Specialist Boston Scientific Corporation One Boston Scientific Place NATICK MA 01760
Re: K030107
Trade/Device Name: Wallstent™ RX Biliary Endoprosthesis – 100 mm length Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: February 14, 2003 Received: February 19, 2003
Dear Ms. Johnson:
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 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.
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
3
Page 2 – Ms. Jennifer Johnson
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 above is added to your labeling, as described.
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.
If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801 and additionally Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Daniel C. Schultz, M.D.
"Daniel G. Schultz, M.I Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): K030107
Device Name: Wallstent™ RX Biliary Endoprosthesis -- 100 mm Length
FDA's Statement of the Indications For Use for device:
The Wallstent™ RX Biliary Endoprosthesis is indicated for palliative treatment of biliary strictures produced by malignant neoplasms.
Prescription Use OR (Per 21 CFR 801.109)
Over-The-Counter Use_
David G. Hanson