(224 days)
Schneider Wallstent
Not Found
No
The description focuses on the mechanical properties and delivery system of a metal stent, with no mention of AI or ML capabilities.
Yes
The device is a stent used to maintain the patency of bile ducts, treating strictures caused by malignant neoplasms.
No
The device is described as a "stenting device designed to maintain the patency of biliary ducts obstructed by malignant neoplasms," indicating its therapeutic purpose rather than a diagnostic one.
No
The device description clearly details a physical stenting device made of nitinol and a delivery system, indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Bard Memotherm Transhepatic Biliary Endoprosthesis is a stenting device designed to be implanted within the biliary ducts to maintain their patency. It is a physical device used for treatment, not a test performed on a sample outside the body.
The information provided clearly describes a medical device used for a therapeutic intervention, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Bard Memotherm Transhepatic Biliary Endoprosthesis is indicated for use in the treatment of biliary strictures resulting from malignant neoplasms.
Product codes
Not Found
Device Description
The Bard Memotherm Transhepatic Endoprosthesis is a stenting device designed to maintain the patency of biliary ducts obstructed by malignant neoplasms. The device includes the self-expanding Bard Memotherm Transhepatic Biliary Endoprosthesis pre-loaded on a unique delivery system. This 7 Fr. delivery system is compatible with a 7 Fr. introducer and accepts a .035" guidewire. The Bard Memotherm Transhepatic Biliary Endoprosthesis is available in various diameters and lengths.
The Bard Memotherm Transhepatic Biliary Endoprosthesis is a metal mesh stent constructed of biocompatible nitinol. It is self-expanding and is packaged pre-mounted on a disposable delivery system. It will be available in expanded diameters of 7, 8, 9, 10 and 12mm and in lengths from 30mm to 110mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary ducts
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 Bard Memotherm Transhepatic Biliary Endoprosthesis deploys easily from the delivery system even in a tortuous path. The delivery system withstands pull test forces in excess of 5 lbs for the shaft-tohandle joint and in excess of 2 lbs for the tip-to-shaft joint. Elastic properties of the Memotherm stent are comparable to those for the The stent is resistant to corrosion by bile and to predicate device. compressive forces expected to be encountered within the biliary system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Schneider Wallstent
Reference Device(s)
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
IRANIRO
111
MAY - 2 1997
SECTION VI
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
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A. Submitter Information:
Submitter's Name: C. R. Bard, Inc., Radiology Division Submitter's Address: 13183 Harland Drive., Covington, GA 30209 Contact Person: Donna J. Wilson Contact Person's Address: 8195 Industrial Blvd., Covington, GA 30209 Contact Person's Telephone Number: 770-784-6135 Contact Person's FAX Number 770-784-6419 Date of Preparation: September 16, 1996 -
B. Device Name:
Bard® Memotherm® Transhepatic Biliary Endoprosthesis -
C. Predicate Device Name:
Schneider Wallstent -
D. Device Description
The Bard Memotherm Transhepatic Endoprosthesis is a stenting device designed to maintain the patency of biliary ducts obstructed by malignant neoplasms. The device includes the self-expanding Bard Memotherm Transhepatic Biliary Endoprosthesis pre-loaded on a unique delivery system. This 7 Fr. delivery system is compatible with a 7 Fr. introducer and accepts a .035" guidewire. The Bard Memotherm Transhepatic Biliary Endoprosthesis is available in various diameters and lengths.
1
z (1)
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E. Intended Use:
The Bard Memotherm Transhepatic Biliary Endoprosthesis is indicated for use in the treatment of biliary strictures resulting from malignant neoplasms. -
F. Technological Characteristics Summary:
The Bard Memotherm Transhepatic Biliary Endoprosthesis is a metal mesh stent constructed of biocompatible nitinol. It is self-expanding and is packaged pre-mounted on a disposable delivery system. It will be available in expanded diameters of 7, 8, 9, 10 and 12mm and in lengths from 30mm to 110mm.
G. Performance Data:
The Bard Memotherm Transhepatic Biliary Endoprosthesis deploys easily from the delivery system even in a tortuous path. The delivery system withstands pull test forces in excess of 5 lbs for the shaft-tohandle joint and in excess of 2 lbs for the tip-to-shaft joint. Elastic properties of the Memotherm stent are comparable to those for the The stent is resistant to corrosion by bile and to predicate device. compressive forces expected to be encountered within the biliary system.