(195 days)
No
The device description and performance studies focus on the mechanical properties and deployment of a stent, with no mention of AI or ML.
Yes
The device is intended for "treatment of biliary strictures produced by malignant neoplasms," which directly addresses a disease state.
No
The device is a stent intended for treatment of biliary strictures, not for diagnosis.
No
The device description clearly states it is a physical, self-expanding prosthesis constructed of biomedical superalloy and an elastomeric polymer, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The WALLSTENT® Biliary Endoprosthesis is a physical device implanted within the body to treat a medical condition (biliary strictures).
- The intended use describes a therapeutic intervention. The device is intended to "increase or maintain the inner lumenal diameter of the biliary duct," which is a treatment, not a diagnostic test performed on a sample.
- The device description details a physical implant and delivery system. This is consistent with a medical device used for treatment, not a reagent, instrument, or kit used for in vitro testing.
Therefore, the WALLSTENT® Biliary Endoprosthesis falls under the category of a medical device used for treatment, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The WALLSTENT® Biliary Endoprosthesis is intended for use in the 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 and an elastomeric polymer. The prosthesis is a braided wire structure. The outward radial force along with the ends of the device serve to stabilize the prosthesis after implanted. The stent's purpose is to increase or maintain the inner lumenal diameter of the biliary duct. The stent is placed by means of a delivery system. The delivery system is a coaxial tubing assembly which constrains the prosthesis until it is released in a controlled manner. The release of the stent is accomplished by retracting the outer sheath. The prosthesis is packaged constrained on the delivery system ready for placement. The system is sterile and intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary strictures, biliary duct
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)
in vitro and in vivo deployment testing which demonstrate that deployment forces and handling characteristics are comparable to the current delivery system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K911292, K914227, K923993, K961262
Reference Device(s)
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
remarket Notification for the WALLSTENT® Biliary Endonmothesis
ਕਾਰਨ
ਸੀ।
510(k) SUMMARY 16. General Information
September 26, 1996 Date Prepared Class II Classification WALLSTENT® Biliary Transhepatic Endoprosthesis Trade Name WALLSTENT® Biliary Endoscopic Endoprosthesis Biliary Stent Common Name Schneider (USA) Inc Submitter 5905 Nathan Lane Minneapolis, MN 55442 (612) 550-5848 Cathy Yohnk Contact Senior Regulatory Affairs Associate WALLSTENT® Biliary Transhepatic Endoprosthesis Predicate Device WALLSTENT® Biliary Endoscopic Endoprosthesis K911292, K914227, K923993, K961262 Device Description
The WALLSTENT® Biliary Endoprosthesis is a self-expanding prosthesis constructed of biomedical superalloy and an elastomeric polymer. The prosthesis is a braided wire structure. The outward radial force along with the ends of the device serve to stabilize the prosthesis after implanted. The stent's purpose is to increase or maintain the inner lumenal diameter of the biliary duct.
1
The delivery system is a The stent is placed by means of a delivery system. coaxial tubing assembly which constrains the prosthesis until it is released in a controlled manner. The release of the stent is accomplished by retracting the outer sheath. The prosthesis is packaged constrained on the delivery system ready for placement. The system is sterile and intended for single use only.
Indication
The WALLSTENT® Biliary Endoprosthesis is intended for use in the treatment of biliary strictures produced by malignant neoplasms.
Technological Characteristics
The purpose of this 510(k) is to allow an alternate delivery system which allows the user to partially deploy and then reconstrain the stent to facilitate placement. This feature is presently available in the Esophageal delivery system (K940396).
The alternate delivery system can be found substantially equivalent based on the results of in vitro and in vivo deployment testing which demonstrate that deployment forces and handling characteristics are comparable to the current delivery system.
Summary
In summary Schneider (USA) Inc believes the alternate delivery system is substantially equivalent based on design, test results, and indications for use.