(38 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and delivery system of a stent, with no mention of AI or ML.
Yes
The intended use statement explicitly states the device is "for treatment of biliary strictures produced by malignant neoplasms," indicating a therapeutic purpose.
No
This device is a prosthesis used for the treatment of biliary strictures, not for diagnosing them. It is designed to expand and hold open obstructed ducts.
No
The device description clearly states it is a physical prosthesis (stent) and a delivery system, both of which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for treatment of biliary strictures produced by malignant neoplasms." This describes a therapeutic intervention (treatment), not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a self-expanding prosthesis (a stent) designed to be implanted in the biliary tract. This is a medical device used for treatment, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening
This device is clearly a therapeutic medical device used for treating a specific condition within the body.
N/A
Intended Use / Indications for Use
"for treatment of biliary strictures produced by malignant neoplasms."
Product codes
Not Found
Device Description
The WALLSTENT® Biliary Endoprosthesis is a self-expanding prosthesis constructed of biomedical superalloy with a radiopaque core. The prosthesis is a braided wire structure allows for self expansion. Thi; premarket notification deals with the modification of the 12 mm diameter prosthesis to increase the radial force.
The delivery system is a coaxial tubing assembly which constrains the prosthesis until it is released in a controlled manner. The release of the prosthesis is accomplished by pulling the outer tube back, thus exposing the stent and allowing gradual release and expansion of the prosthesis. The prosthesis : packaged constrained on the delivery system ready for placement. The system is steri e and intended for single use only. The fully expanded stents are offered in sizes from 1 to 12 mm.
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)
The modified 12 mm diameter stent can be found substantially equivalent based on the results of axial fatigue and relative radial force testing which demonstrate that the fatigue life and relative radial force are comparable 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
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
lax 110. - 16125505806
ា K961262
MAY | 0 1996
510(k) SUMMARY
General Information
| Date Prepared | March 29, 1996 |
|---|---|
| Classification | Class II |
| Trade Name | WALLSTENT® Biliary Transhepatic Endoprosthesis |
| WALLSTENT® Biliary Endoscopic Endoprosthesis | |
| Common Name | Biliary Stent |
| Submitter | Schneider (USA) Inc |
| 5905 Nathan Lane | |
| Minneapolis, MN 55442 | |
| (612) 550-5848 | |
| Contact | Cathy Yohnk |
| Senior Regulatory Affairs Associate | |
| Predicate Device | WALLSTENT® Biliary Transhepatic Endoprosthesis |
| WALLSTENT® Biliary Endoscopic Endoprosthesis | |
| K911292, K914277, K923993 |
1
K961262
Device Description
The WALLSTENT® Biliary Endoprosthesis is a self-expanding prosthesis constructed of biomedical superalloy with a radiopaque core. The prosthesis is a braided wire structure allows for self expansion. Thi; premarket notification deals with the modification of the 12 mm diameter prosthesis to increase the radial force.
The delivery system is a coaxial tubing assembly which constrains the prosthesis until it is released in a controlled manner. The release of the prosthesis is accomplished by pulling the outer tube back, thus exposing the stent and allowing gradual release and expansion of the prosthesis. The prosthesis : packaged constrained on the delivery system ready for placement. The system is steri e and intended for single use only. The fully expanded stents are offered in sizes from 1 to 12 mm.
Intended Use
The indication for the use of the WALLSTENT® Endoprosthesis is "for treatment of biliary strictures produced by malignant neoplasms."
Technological Changes
This premarket notification deals with the modification of the 12 mm diameter prosthesis to standardize the relative radial force. This is accomplished by increased wire diameter and the number of wires used to fabricate the stent.
The modified 12 mm diameter stent can be found substantially equivalent based on the results of axial fatigue and relative radial force testing which demonstrate that the fatigue life and relative radial force are comparable to the predicate device.
Summary
In summary Schneider (USA) Inc believes the modified device is substantially equivalent based design, materials, methods of fabrication and indications for use.