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.

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.

AI/ML Overview

This document describes the Advanix™ Double Pigtail Biliary Stent, a Class II medical device intended for drainage of the bile ducts, splinting, or providing patency in strictures or past stones. The device is constructed of Styrene Butadiene Styrene material and is offered in 7Fr and 10Fr diameters and 3cm-15cm lengths. The stent is substantially equivalent to the predicate devices, Microvasive® Drainage Stent (K834468) and Microvasive® Biliary Stent and Delivery System (K965147).

Acceptance Criteria and Device Performance:

The provided document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format for specific functional benchmarks. Instead, it broadly states that "all components, subassemblies, and/or full devices met the required specifications for the completed tests" and "all device bench test results were acceptable."

However, based on the tests conducted, the implicit acceptance criteria would be that the device performs within established engineering and biocompatibility standards for biliary stents. The reported performance is that the device met these implied requirements.

Here is a summarized table based on the information provided:

Acceptance Criteria Category	Specific Tests Performed	Reported Device Performance
Biocompatibility	Cytotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity (Acute Systemic Toxicity, Subacute Toxicity - Intravenous and Intraperitoneal), Genotoxicity (Ames Assay and Mouse Lymphoma), Implantation, USP Physicochemical (all conducted in accordance with EN ISO 10993-1:2009)	All biocompatibility tests passed; the device is considered biocompatible for its intended use.
Device Bench Testing	Drainage Lumen ID, Stent Length, Stent OD, Stent Shape, Deployment Force, Trackability Force, Duodenoscope Compatibility, Barb Flap Cover Compatibility	All device bench test results were acceptable; the device sufficiently meets design specifications and is suitable for intended use.
Substantial Equivalence	Comparison to predicate devices (Microvasive® Drainage Stent (K834668) and Microvasive® Biliary Stent and Delivery System (K965147)) regarding intended use, technological characteristics (same methodology, similar pigtail shape and material, same functioning for biliary drainage).	The device is demonstrated to be substantially equivalent to the predicate devices in intended use, technological characteristics, and methodology.

Study Details:

Sample Size Used for the Test Set and Data Provenance:
- The document does not specify a sample size for the test set used in the performance or biocompatibility studies. It refers to "components, subassemblies, and/or full devices."
- The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective). Given the nature of bench and in-vitro testing, it is generally conducted in a controlled laboratory environment.
Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- This information is not provided in the document. The tests performed are primarily engineering and laboratory-based, not involving human expert assessment for "ground truth" in the way a diagnostic imaging study would.
Adjudication Method for the Test Set:
- This information is not applicable as the tests are objective, laboratory-based evaluations against specifications, not subjective human assessments requiring adjudication.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not conducted. This type of study is typically relevant for diagnostic imaging devices or algorithms that involve human interpretation. This device is a therapeutic stent.
Standalone Device Performance (Algorithm Only without Human-in-the-Loop):
- Yes, the performance data detailed ("Performance Data: In-vitro testing," "All biocompatibility tests," "All device bench test results") represents standalone performance of the physical device. There is no "algorithm" in the context of this device that would involve a human-in-the-loop interaction for performance evaluation.
Type of Ground Truth Used:
- The "ground truth" for the performance evaluation was based on pre-defined design specifications, engineering standards, and established biocompatibility guidelines (EN ISO 10993-1:2009). For example, a stent length test would compare the measured length to the specified manufacturing tolerance.
Sample Size for the Training Set:
- This is not applicable as this is a physical medical device, not a machine learning algorithm that requires a "training set."
How Ground Truth for the Training Set Was Established:
- This is not applicable as there is no training set for this type of device.

Summary

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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 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

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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

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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

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- 510(k) Number (if known):

K101786

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

Regulation Number and Section

§ 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.