The Express LD Biliary Premounted Stent System consists of: A 316L surgical grade stainless steel balloon expandable stent. The stent is premounted on an over the wire Stent Delivery System (SDS) equipped with a non-compliant balloon. The SDS balloon catheter has two radiopaque markers embedded in the shaft to aid in the placement of the stent. The SDS is compatible with 0.035 in (0.89 mm) guidewires. The SDS balloon has a maximum inflation pressure of 12 atm (1216 kPa) that can be used for initial stent placement and post stent dilatation. The Premounted Stent System is available in a variety of stent lengths with SDS balloons that expand them from 5 mm to 10 mm in diameter. The SDS balloon catheter is also offered in two shaft lengths.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called the "Express LD Biliary Premounted Stent System." It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.

Based on the content, the study conducted is focused on bench testing and biocompatibility to demonstrate that the new device has similar performance and safety characteristics to previously cleared devices. It is not a study that involves AI, human readers, or image interpretation. Therefore, many of the requested categories related to AI performance metrics cannot be found or are not applicable.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding reported device performance in the typical pass/fail or quantitative metric sense for a clinical or image-based AI study. Instead, it lists the types of tests performed to demonstrate substantial equivalence to predicate devices. The "performance" is implied by the successful completion of these tests, confirming that the new device is "appropriate for its intended use" and "substantially equivalent."

Test Category	Reported Device Performance/Conclusion
Bench Testing
Balloon Deflation Time	Performed, results led to a conclusion of substantial equivalence.
Guidewire Compatibility	Performed, results led to a conclusion of substantial equivalence.
Multiple Balloon Inflations	Performed, results led to a conclusion of substantial equivalence.
Rated Burst Pressure (RBP)	Performed, results led to a conclusion of substantial equivalence.
RO Marker Location/RO Markers	Performed, results led to a conclusion of substantial equivalence.
Biocompatibility Testing
MEM Elution Cytotoxicity	Performed, results led to a conclusion of substantial equivalence.
Hemocompatibility Hemolysis (Direct)	Performed, results led to a conclusion of substantial equivalence.
USP Physicochemical	Performed, results led to a conclusion of substantial equivalence.
Overall Conclusion	"No new safety or performance issues were raised during the testing." and "considered to be substantially equivalent to Express LD Biliary Premounted Stent System (K021630, K024048, and K032360)."

Study Details

Given the nature of the device (a physical stent system) and the regulatory submission (510(k) for substantial equivalence), the "study" described is a series of engineering bench tests and biocompatibility assessments, not an AI or clinical performance study.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not specified in terms of number of units or test replicates for each specific bench test. The document states "Bench testing and biocompatibility were performed," implying an engineering validation rather than a statistical clinical trial.
Data Provenance: Not applicable in the context of clinical data provenance (e.g., country of origin). The data is generated from laboratory testing (bench and biocompatibility tests) of the physical device. The tests are for design validation and do not involve patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Number of Experts: Not applicable. Ground truth for these types of tests are typically established by engineering specifications, international standards (e.g., ISO), and material science principles, not expert consensus on medical images or diagnoses.
Qualifications of Experts: N/A

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:

Adjudication Method: Not applicable. This refers to the resolution of disagreements among human readers, which is not relevant to bench testing or biocompatibility assessment of a physical medical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

MRMC Study: No. This is a comparison of a physical medical device to its predicates, not an AI system.
Effect Size: Not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Standalone Performance: Not applicable. The device is a physical stent, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

Type of Ground Truth: For the "bench testing" and "biocompatibility" studies, the "ground truth" would be the pre-defined engineering specifications, performance standards, and biological safety criteria that the device must meet to function as intended and be considered safe and effective, similar to the predicate devices. This is based on established scientific and engineering principles for medical device design and manufacturing.

8. The Sample Size for the Training Set:

Sample Size: Not applicable. The stent system is a physical device, and this document does not describe the development or training of an AI model.

9. How the Ground Truth for the Training Set Was Established:

Ground Truth Establishment: Not applicable. As there is no AI training set, there is no ground truth to establish for it.

In summary: The provided document describes a regulatory submission (510(k)) for a physical medical device (a stent system) based on "substantial equivalence" to existing predicate devices. The "study" refers to bench testing and biocompatibility assessments performed to ensure the new device functions similarly and safely. The request's questions are heavily geared towards the evaluation of Artificial Intelligence (AI) or image-based diagnostic devices, which do not align with the nature of this particular submission.

Summary

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Attachment 5

510(k) Summary

Submitter	Boston Scientific CorporationOne Scimed Place Maple Grove, MN 55311
Contact Person	Renee Mitchell
Phone Number	763-494-1405
Fax Number	763-494-1643
Date Prepared	September 27, 2013
Device Trade Name	Express LD Biliary Premounted Stent System
Common Name	Biliary Premounted Stent
Device Classification	Class II devices by the Gastroenterology/Urology DevicesPanel according to 21 CFR Part 876.5010.

Product Code FGE

Predicate Device Express LD Biliary Premounted Stent System

Device Description

Indications for Use

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

Substantial Equivalence

The proposed Express LD Biliary Premounted Stent System is substantially equivalent to the predicate Express LD Biliary Premounted Stent System which was cleared by FDA under premarket notification K021630 (October 25, 2002). The proposed Express LD Biliary Premounted Stent System has the same intended use and device performance as the predicates Express LD Biliary Premounted Stent System (K021630, K024048, and K032360),

JUL 0 2 2014

Confidential

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Comparison of Technological Characteristics

The proposed Express LD Biliary Premounted Stent System incorporates existing device materials, sterilization EO methods, and design characteristics as the predicate BSC device (Express LD Biliary Premounted Stent System) and similar materials as BSC reference device Renegade microcatheter (K100892).

Characteristic	Express LD Biliary Premounted Stent SystemPredicates (K021630, K024048, and K032360)
Stent	Same design and function
Stent Delivery System
Materials
Balloon	Same balloon material, design, and function
Catheter Shaft	Same catheter shaft material, design, and function
Catheter Tip	Minor resin formulation difference. Same Tip design.Same Function
RO Markers	Same RO marker material, design, and function
Catheter Shaft Coatings	Same catheter shaft coating material, design, andfunction
Balloon Adhesives	Minor formulation differences in both adhesivesSame function
Sterilization
Sterilization Method	Same sterilization method
SAL	Same level of assurance
Design Characteristics
Balloon Diameters	Same Catheter Diameters serving same function
Balloon Lengths	Same catheter length ranges serving same functionLengths
Rated Burst Pressure (RBP)	Same rated burst pressure
Usable CatheterLengths	Same useable catheter lengths serving same function
Intended use	Same intended use
Packaging	Same design and function

Comparison to Predicate Device

Performance Data

Bench testing and biocompatibility were performed to support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing.

Testing Completed:

. Balloon deflation time
Guidewire Compatibility ●
Multiple Balloon Inflations .
. Rated Burst Pressure
RO Marker Location/RO Markers .
MEM Elution Cytotoxicity .
Hemocompatibility Hemolysis (Direct) .
USP Physicochemical .

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Conclusion:

Based on the indications for use, technological characteristics, and safety and performance testing, the proposed Express LD Biliary Premounted Stent System has been shown to be appropriate for its intended use and is considered to be substantially equivalent to Express LD Biliary Premounted Stent System (K021630, K024048, and K032360).

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Public Health Service

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

July 2, 2014

Boston Scientific Corporation Renec Mitchell Senior Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311

Re: K133110

Trade/Device Name: Express® LD Biliary Premounted Stent System Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: June 9, 2014 Received: June 10, 2014

Dear Rence Mitchell.

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 10 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 and the limitations described below. 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.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following . limitation must appear in the Warnings section of the device's labeling:

The safety and effectiveness of this device for use in the vascular system have not been established.

Image /page/3/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles a bird or a person with outstretched arms. The symbol is made up of three curved lines that are stacked on top of each other.

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Page 2 - Renee Mitchell

Furthermore, the indication for biliary use must be prominently displayed in all labeling, including pouch box, and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

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 (reporting of medical devicerelated 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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.

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Page 3 - Renee Mitchell

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,

Christy L. Foreman -S

Christy Foreman Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment 2

Indications for Use

510(k) Number (if known): K133110

Express® LD Biliary Premounted Stent System Device Name:

Indications for Use:

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

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Benjamin '00' 2014.06.24 09

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.