(142 days)
Not Found
No
The device description and summary of performance studies focus on the physical characteristics and mechanical performance of a metallic stent, with no mention of AI or ML technologies.
Yes
The device is a stent used to maintain the patency of a bile duct obstructed by malignant neoplasms, which is a therapeutic intervention.
No
The device is described as a stent used to maintain patency of a bile duct, which is a therapeutic function, not a diagnostic one. Its purpose is to treat an obstruction, not to identify or characterize a medical condition.
No
The device description clearly states it is a physical stent made of Tantalum, supplied mounted on a balloon catheter delivery system. This indicates a hardware medical device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "maintain patency of a bile duct which is obstructed from malignant neoplasms." This describes a therapeutic intervention performed within the body to treat a medical condition.
- Device Description: The device is a "helical coil made of flexible radiopaque 5400 Grade Tantalum (Ta)" that is "supplied mounted and crimped onto a balloon catheter delivery system." This is a physical implant designed to be placed inside the body.
- IVD Definition: In Vitro Diagnostics (IVDs) are tests performed on samples taken from the human body (such as blood, urine, or tissue) to detect diseases, conditions, or infections.
This device is clearly a medical device used for treatment, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The Cordis Biliary Stent intended ↓se is to maintain patency of a bile duct which is obstructed from malignant neoplasms.
Product codes
Not Found
Device Description
The Cordis Biliary Stent is a helical coil made of flexible radiopaque 5400 Grade Tantalum (Ta). The stent is available in 7.0 mm diameter size. The nominal expanded length of the stent is 1.5 cm and 3.0 cm. The stent is supplied mounted and crimped onto a balloon catheter delivery system, the size of which determines the delivered diameter of the stent.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bile 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 testing was conducted to support substantial equivalence to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K905720, K911581, K885180, K896163, K911292, K914277, K921191, K903858, K882610
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
MAY
-8 1996
SUMMARY OF SAFETY AND EFFECTIVENESS
General Provisions -
Biliary Stents Common or Usual Name:
Cordis Biliary Stent Proprietary Name:
11. Name of Predicate Devices
Classification lll.
Class II, 21CFR 876.5010, Biliary Catheters and Accessories.
IV. Performance Standards
Performance standards have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act.
V. Intended Use and Device Description
The Cordis Biliary Stent intended ↓se is to maintain patency of a bile duct which is obstructed from malignant neoplasms.
The Cordis Biliary Stent is a helical coil made of flexible radiopaque 5400 Grade Tantalum (Ta). The stent is available in 7.0 mm diameter size. The nominal expanded length of the stent is 1.5 cm and 3.0 cm. The stent is supplied mounted and crimped onto a balloon catheter delivery system, the size of which determines the delivered diameter of the stent.
VI. Biocompatibility
All appropriate biocompatibility tests as specified by ISO 10993 Part 1 - Biological Evaluation of Medical Devices, were successfully performed on the Cordis Biliary Stent.
1
VII. Summary of Substantial Equivalence
The Cordis Biliary Stent is similar in its basic design, construction, indication for use and performance characteristics to other commercially available biliary stents. In-vitro and in-vivo testing was conducted to support substantial equivalence to the predicate devices.
ALLARIA