The Express® SD Biliary Monorail® Premounted Stent System (Express SD Biliary) is a traditional Monorail catheter with a balloon near the distal tip. Express SD Biliary consists of a delivery system and a stent that is balloon expandable intended to maintain patency of biliary strictures produced by malignant neoplasms.

AI/ML Overview

This document is a 510(k) summary for the Express® SD Biliary Monorail® Premounted Stent System. It's a premarket notification to the FDA to demonstrate substantial equivalence to an already marketed device, not a study proving the device meets acceptance criteria for a new clinical claim or an AI algorithm.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth, and training sets is not applicable to this type of document.

This 510(k) pertains to a medical device (a stent system), not an AI/ML powered device. The "study" mentioned here refers to non-clinical tests (first article, shaft, and bond burst testing) to ensure the physical properties of the device (specifically a modified corewire) are equivalent to the predicate device, not clinical performance studies against specific acceptance criteria for a diagnostic or prognostic claim.

Here's why some of the requested information cannot be found:

Acceptance Criteria & Device Performance Table: This document discusses substantial equivalence to a predicate device based on similar design, materials, and non-clinical testing. It does not provide specific performance metrics or acceptance criteria in the way an AI/ML device submission would (e.g., sensitivity, specificity thresholds).
Sample Size (Test Set) & Data Provenance: Non-clinical testing of physical components doesn't typically involve "test sets" of patient data or data provenance in the context of clinical AI/ML studies.
Number of Experts & Qualifications / Adjudication: This is relevant for establishing ground truth in clinical studies, particularly for imaging or diagnostic AI. It's not part of a non-clinical device equivalence assessment.
MRMC Study / Standalone Performance: These are specific to AI/ML powered diagnostic or screening devices to assess their impact on human readers or their performance without human intervention. This device is a physical stent system.
Type of Ground Truth: Ground truth (e.g., pathology, clinical outcomes) is established in clinical studies for diagnostic or prognostic purposes. The "ground truth" for this device is its physical integrity and performance as determined by engineering tests (e.g., burst pressure, stiffness).
Sample Size (Training Set) & Ground Truth for Training Set: These concepts are specific to the development and validation of AI/ML models. This document describes a physical medical device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 12, 2016

Boston Scientific Corporation Ka Zoua Xiong Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311-1566

Re: K162404

Trade/Device Name: Express® SD Biliary Monorail® Premounted Stent System Regulation Number: 21 CFR§ 876.5010 Regulation Name: Biliary Catheter and Accessories Regulatory Class: II Product Code: FGE Dated: August 26, 2016 Received: August 29, 2016

Dear Ka Zoua Xiong:

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.

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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting 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 Industry and Consumer Education 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,

Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K162404

Device Name

Express® SD Biliary Monorail® Premounted Stent System

Indications for Use (Describe)

The Express SD Biliary Monorail Premounted Stent System is indicated for palliation of malignant neoplasms in the biliary tree.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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| X Prescription Use (Part 21 CFR 801 Subpart D)

|__ | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary Per 21 CFR §807.92

Common or Usual Name	Biliary Stent and Balloon Dilatation Catheter
Trade Name(s)	Express® SD Biliary Monorail® Premounted Stent System
Product Code	FGE -Catheter, Biliary, Diagnostic
Classification of Device	Class II - 21 CFR 876.5010
Submitter's Name and Address	Boston Scientific CorporationOne Scimed PlaceMaple Grove, MN 55311-1566
Contact Name and Information	Ka Zoua XiongRegulatory Affairs SpecialistPhone: 763-494-2970Fax: 763-494-2222Email: Kazoua.Xiong@bsci.com
Date Prepared	11 October 2016
Section 514 of the ActPerformance Standards	Currently no FDA mandated or voluntary performancestandards exist for this device.
Establishment Registration Numbers	Owner/Operator:Boston Scientific Corporation300 Boston Scientific WayMarlborough, MA 01752ERN: 9912058Manufacturing Facility:Boston Scientific CorporationTwo Scimed PlaceMaple Grove, MN 55311ERN: 2134265Sterilization Facilities:BSC Coventry8 Industrial DriveCoventry, RI 02816USASynergy Health (Tullamore)IDA Business & Technology ParkTullamoreCounty OffalyIreland

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PredicateDevices	K152607 - Express® SD Biliary Monorail® Premounted StentSystem, cleared 27 October 2015
DeviceDescription	The Express® SD Biliary Monorail® Premounted Stent System(Express SD Biliary) is a traditional Monorail catheter with aballoon near the distal tip. Express SD Biliary consists of adelivery system and a stent that is balloon expandableintended to maintain patency of biliary strictures produced bymalignant neoplasms.
Intended Use/Indications forUse	The Express SD Biliary Monorail Premounted Stent System isindicated for palliation of malignant neoplasms in the biliarytree.
Comparison ofRequiredTechnologicalCharacteristics	The proposed Express SD Biliary is substantially equivalent tothe existing Express SD Biliary cleared by FDA underpremarket notification K152607 (27Oct2015). Express SDBiliary has the same intended use, scientific technology,design (with the exception of the corewire design), materials,sterilization method, and packaging materials as theapplicable predicate device.
Summary ofNon-Clinical TestSummary	First article and shaft and bond burst testing were performedto support a determination of substantial equivalence. Theresults of these tests provide reasonable assurance that theproposed device with the modified corewire have beendesigned and tested to assure conformance to therequirements for its intended use. No new safety orperformance issues were raised during the device testing.
Conclusion	Based on the indications for use, technological characteristics,and safety and performance testing, the proposed ExpressSD Biliary with the modified corewire has been shown to beappropriate for its intended use and is considered to besubstantially equivalent to its predicate (K152607).

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.