(28 days)
No
The summary describes a physical medical device (a biliary stent) and its material properties and performance testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is described as a "biliary stent" intended for "drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone," which directly aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device description and intended use indicate that the Advanix™ Double Pigtail Biliary Stent is used for drainage, splinting, and maintaining patency in bile ducts, which are therapeutic functions, not diagnostic ones. There is no mention of it being used to detect or identify a condition.
No
The device description clearly states it is a "biliary plastic stent" constructed of "Styrene Butadiene Styrene material," indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the drainage and splinting of bile ducts within the body. This is a therapeutic and interventional procedure performed directly on a patient.
- Device Description: The device is a physical stent designed to be implanted in the bile ducts.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze samples for diagnostic purposes. This device is used inside the body for a therapeutic purpose.
N/A
Intended Use / Indications for Use
Advanix™ Double Pigtail Biliary Stent is intended for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.
Advanix™ Double Pigtail Biliary Stent is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.
Product codes
FGE
Device Description
The proposed Advanix™ Double Pigtail Biliary Stent consists of a biliary plastic stent. The Advanix double pigtail stent will be sold in a single stent configuration. The double pigtail stent has proximal and distal pigtails, lateral drainage holes in the pigtails, and a tapered tip.
The Advanix Double Pigtail Stent will be offered in 7Fr and 10Fr. diameters. The stent lengths for each diameter vary from 3cm-15cm stent lengths. The Advanix Double Pigtail Stent is constructed of a Styrene Butadiene Styrene material.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary tract, bile 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)
In-vitro testing:
All components, subassemblies, and/or full devices met the required specifications for the completed tests.
Biocompatibility testing: evaluation in accordance with EN ISO 10993-1:2009.
The following tests were performed on the stent: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity -Acute Systemic Toxicity, Subacute Toxicity -Intravenous and Intraperitoneal, Genotoxicity - Ames Assay and Mouse Lymphoma, Implantation, and USP Physicochemical.
Results: All biocompatibility tests conducted on the Advanix™ Double Pigtail Biliary Stent passed. Therefore, the Advanix Double Pigtail Billiary Stent is considered biocompatible for its intended use.
Bench testing:
The following tests were conducted on the Advanix™ Double Pigtail Biliary Stent: Drainage Lumen ID, Stent Length, Stent OD, Stent Shape, Deployment Force, Trackability Force, Duodenoscope Compatibility, and Barb Flap Cover Compatibility.
Results: All device bench test results were acceptable. The data demonstrate that the Advanix Double Pigtail Biliary Stent sufficiently meets the design specifications and is suitable for the intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
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K101786
Page 1 of 2
SECTION 5 JUL 2 8 2010 510(k) SUMMARY
510(k) SUMMARY
1. Submitter:
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 ·
Contact: Elena Nieves Senior Regulatory Affairs Specialist Date Prepared: June 22, 2010
2. Proposed Device:
Trade Name: Advanix™ Double Pigtail Biliary Stent Classification Name: Biliary Catheters and Accessories Regulation Number: 876.5010 Product Code: FGE Classification: Class II
3. Predicate Device(s):
Trade Name: Microvasive® Biliary Stent and Delivery System Manufacturer and Clearance Number: Boston Scientific Corporation, K965147 Classification Name: Biliary Catheters and Accessories Regulation Number: 876.5010 Product Code: FGE Classification: Class II
Trade Name: Microvasive® Drainage Stent Manufacturer and Clearance Number: Boston Scientific Corporation, K834468 Classification Name: Biliary Catheters and Accessories Regulation Number: 876.5010 Product Code: FGE Classification: Class II
4. Proposed Device Description:
The proposed Advanix™ Double Pigtail Biliary Stent consists of a biliary plastic stent. The Advanix double pigtail stent will be sold in a single stent configuration. The double pigtail stent has proximal and distal pigtails, lateral drainage holes in the pigtails, and a tapered tip.
The Advanix Double Pigtail Stent will be offered in 7Fr and 10Fr. diameters. The stent lengths for each diameter vary from 3cm-15cm stent lengths. The Advanix Double Pigtail Stent is constructed of a Styrene Butadiene Styrene material.
Special 510(k) Premarket Notification, Advanix™ Double Pigtail Biliary Stent Proprietary and Confidential Information of Boston Scientific Corporation
1
5. Intended Use:
Advanix™ Double Pigtail Biliary Stent is intended for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.
6. Technological Characteristics:
The proposed Advanix™ Double Pigtail Biliary Stent has the same technological characteristics as the predicate Microvasive® Drainage Stent (K834468) and Microvasive® Biliary Stent and Delivery System (K965147).
The proposed device has the same intended use as the predicate Microvasive Biliary Stent and is placed using the same methodology as both of the predicate devices. Both the proposed and predicate devices function in the same manner allowing for biliary drainage through the lumen.
The pigtail shape and material for the Advanix Double Pigtail Biliary Stent are the same as the predicate Microvasive Drainage Stent.
7. Performance Data:
In-vitro testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests.
The proposed Advanix™ Double Pigtail Biliary Stent was evaluated in accordance with EN ISO 10993-1:2009. The following tests were performed on the stent: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity -Acute Systemic Toxicity, Subacute Toxicity -Intravenous and Intraperitoneal, Genotoxicity - Ames Assay and Mouse Lymphoma, Implantation, and USP Physicochemical.
The following tests were conducted on the Advanix™ Double Pigtail Biliary Stent: Drainage Lumen ID, Stent Length, Stent OD, Stent Shape, Deployment Force, Trackability Force, Duodenoscope Compatibility, and Barb Flap Cover Compatibility.
8. Conclusion:
All biocompatibility tests conducted on the Advanix™ Double Pigtail Biliary Stent passed. Therefore, the Advanix Double Pigtail Billiary Stent is considered biocompatible for its intended use.
All device bench test results were acceptable. The data demonstrate that the Advanix Double Pigtail Biliary Stent sufficiently meets the design specifications and is suitable for the intended use.
Boston Scientific Corporation has demonstrated that the proposed Advanix™ Double Pigtail Biliary Stent is substantially equivalent to Boston Scientific Corporation's currently marketed Microvasive® Drainage Stent (K834468) and Microvasive® Biliary Stent and Delivery System (K965147).
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Image /page/2/Picture/0 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" written around the edge. In the center of the seal is a stylized eagle with its wings spread. The image is black and white and appears to be a scan or photocopy of an official document.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ms. Elena Nieves Sr. Regulatory Affairs Specialist Boston Scientific Corporation 100 Boston Scientific Way MARLBOROUGH MA 01752
JUL 2 3 2010
Re: K101786
Trade/Device Name: Advanix™ Double Pigtail Biliary Regulation Number: 21 CFR§ 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: June 22, 2010 Received: June 25, 2010
Dear Ms. Nieves:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related
3
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adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the au vithe events (QS) regulation (21 CFR Part 820); and if applicable, the electronic product quality bybents (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you ucsire specific advise 101 your 2017 your 2017 inces/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please the Center for Devices and Radionageen nearth of (21CF) Party of the Party of Carly of Car note the regulation online of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
- 510(k) Number (if known):
Advanix™ Double Pigtail Biliary
Device Name:
Indications for Use:
Advanix™ Double Pigtail Biliary Stent is intended for delivery of the stent to the biliary tract for drainage of the
bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K101786