(299 days)
Not Found
No
The description focuses on the physical characteristics of the stent and delivery system, with no mention of AI or ML.
Yes.
The device is used for "palliative treatment of patients with malignant biliary strictures" which is a therapeutic purpose.
No
The device is a stent system used for palliative treatment of malignant biliary strictures, which is a therapeutic function, not diagnostic.
No
The device description clearly states it is a "biliary stent system" made of Nitinol and includes details about its physical dimensions and delivery system, indicating it is a physical medical device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. This includes tests performed on blood, urine, tissue, etc.
- Device Description and Intended Use: The Ultraflex™ Diamond Biliary Stent System is a therapeutic device designed to be implanted directly into the biliary duct to treat malignant strictures. It is a physical device used within the body, not a test performed on a sample outside the body.
Therefore, based on the provided information, the Ultraflex™ Diamond Biliary Stent System is a medical device, but not an IVD.
N/A
Intended Use / Indications for Use
The Ultraflex™ Diamond Biliary Stent System is indicated for palliative treatment of patients with malignant biliary strictures.
Product codes
78 FGE
Device Description
Not Found
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
Laboratory testing regarding characteristics was performed on Ultraflex™ Diamond Biliary Stem System to verify its safety and performance. A biocompatibility assessment was performed on the patient- and fluid-contact materials of the Ultraflex™ Diamond Biliary Stent System with satisfactory results.
Key Metrics
Not Found
Predicate Device(s)
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 20 K
ATTACHMENT 10 510(K) SUMMARY
FOI RELEASABLE
Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation is required to submit with this Premarket Notification " ... adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Boston Scientific Corporation chooses to submit a summary of information respecting safety and effectiveness.
- Biliary Stent, Biliary Stent System > Common/Usual Names:
-
Trade/PropRietary Name: Ultraflex™ Diamond
| > Classification Name &
| DEVICE CLASSIFICATION: | Class II | ||
|---|---|---|---|
| Name | Number | 21 CFR Ref. | |
| Biliary Catheter and Accessories 78 FGE | 876.5010 | ||
| > Device Panel/Branch: | Gastroenterology-Urology (GU) | ||
| Gastro-Renal (GRDB) | |||
| > Owner/Operator: | Boston Scientific Corporation | ||
| One Boston Scientific Place | |||
| Natick, MA 01760 | |||
| Owner/Operator No. 9912058 | |||
| > Contact Person: | Daniel J. Dillon, Senior Regulatory Affairs Specialist |
INDICATIONS FOR USE
The Ultraflex™ Diamond Biliary Stent System is indicated for palliative treatment of patients with malignant biliary strictures.
CONTRAINDICATIONS
The Ultraflex™ Diamond Biliary Stent System is contraindicated for biliary duct strictures of benign etiology; biliary obstruction preventing either endoscopic or perculaneous cholangiography; concurrent perforated bile duct, those patients for whom endoscopic or perculaneous procedures are contraindicated; any use other than those specifically outlined under Indications for Use.
POTENTIAL COMPLICATIONS
The following complications have been reported in the literature for plastic and metal biliary stent placement. Procedural: infection, bleeding, perforation of the duct, pain, aspiration, oxygen desaturation related to sedation, stent misplacement, pancreatitis, Post-Stent Placement: stent migration, stent occlusion due to sludge formation, stent occlusion due to turnor ingrowth, stent occlusion due to tumor overgrowth of stent ends, stent occlusion due to excessive hyperplastic tissue ingrowth, recurrent obstructive jaundice related to stent occlusion, infection, bleeding, bile duct ulceration and/or perforation
1
DESCRIPTIVE AND TECHNOLOGICAL CHARACTERISTICS OF PROPOSED AND PREDICATE DEVICES
Boston Scientific Corporation believes that the Ultraflex™ Diamond Biliary Stent System is substantially equivalent to the currently-marketed Schneider Wallstent® Endoscopic Biliary Endoprosthesis. Table 10-1 compares the descriptive characteristics of these products.
PERFORMANCE CHARACTERISTICS
Laboratory testing regarding characteristics was performed on Ultraflex™ Diamond Biliary Stem System to verify its safety and performance. A biocompatibility assessment was performed on the patient- and fluid-contact materials of the Ultraflex™ Diamond Biliary Stent System with satisfactory results.
PACKAGING, STERILIZATION, AND PYROGENICITY
The Ultraflex™ Diamond Biliary Stent System will be packaged in a TyvelyPolyester-polyethylene pouch. The Ultraflex™ Diamond Billiary Stent System will be sterilized using ethylene oxide gas using the AAMI protocol for ethylene oxide sterilization. Pyrogenicity testing will be performed on a periodic basis to monitor bacterial endotoxin levels.
CONCLUSION
Boston Scientific Corporation believes that Ultraflex™ Diamond Biliary Stent System is substantially equivalent to the currently-marketed Ultraflex™ Diamond Biliary Stent System. Table 10-1 compares the descriptive characteristics of these products. As demonstrated in Table 10-1, the Ultrallex™ Diamond Biliary Stent System is equivalent in its indications for use, while being very similar in design and materials. In addition, Boston Scientific Corporation has presented laboratory testing and biocompatibility information. The information presented provides assurance that the Ultraflex™ Diamond Biliary Stent System will meet the minimum requirements that are considered acceptable for its intended use.
962899
2
Table 10-1:
SIMILARITIES AND DIFFERENCES BETWEEN ULTRAFLEX™ DIAMOND BILIARY STENT SYSTEM AND Schneider Wallstent® Endoscopic Billary Endoprosthesis
| Ultraflex Diamond Biliary
Stent System
(This 510(k)) | Schneider Wallstent®
Endoscopic Biliary
Endoprosthesis |
|------------------------------------------------------------|--------------------------------------------------------------|
| | (K925406) |
USE
|
| Indication | Malignant Billiary Strictures | «- Same |
|---|---|---|
| Route of Administration | ||
| Company of Concession of Children Company of Children Company | ||
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Company of the contribution of a minimal commens and consideration and the collection of the collection of the collection of the collection of the collection of the collectio | |
| Endoscopic | - Same |
STENT
| Overall OD | 10 mm | 8 - 12 mm | |
|---|---|---|---|
| Overall Length | 40 -80 mm | «- Same | |
| Material | Nitinol | Stainless Steel | |
| Construction Method | Monofilament, Twisted | Monofilament, Braided | |
| Expansion Mode | Self-Expanding | «-- Same | |
| RO Marker Location | Stent and Delivery System | Delivery System |
DELIVERY SYSTEM
| Design | Sliding Sheath |