The proposed Wallstent RX Biliary Endoprostheses consists of a stent and a delivery catheter. The self-expanding metal stent is delivered endoscopically with the delivery catheter. The stent is a tubular mesh constructed from a biomedical super alloy wire with a tantalum core to allow for visibility under fluoroscopy. The stent is offered bare or covered. The proposed delivery catheter consists of a coaxial tubing assembly that constrains the stent until it is released by retracting the exterior tube assembly. The interior tube of the coaxial system contains a central lumen to accommodate a 0.035" guidewire that exits near the tip of the delivery catheter. Radiopaque markers are located on the interior and exterior tubes to facilitate imaging during stent deployment. The device will be offered in 8mm & 10mm diameters and 40mm, 60mm & 80mm lengths.

AI/ML Overview

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to Predicate Device (BSC Wallstent Biliary Endoprostheses - K000308, K982184, K964119, & K961262)	Demonstrated Aided by Bench Testing

Note: The provided document does not explicitly state quantitative acceptance criteria or specific numerical performance metrics. The primary acceptance criterion for this 510(k) submission is the demonstration of "substantial equivalence" to a predicate device.

Sample Size for the Test Set and Data Provenance:

Sample Size: Not specified. The document states "Bench testing was conducted."
Data Provenance: Not specified, but generally, bench testing involves in vitro or ex vivo laboratory evaluations. It does not typically involve human patient data from a specific country or a retrospective/prospective study design in the same way clinical trials do.

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

This information is not applicable. Bench testing, as described here, typically involves engineering or laboratory testing against defined specifications or predicate device characteristics, not expert-derived ground truth as would be used in an AI/imaging device.

Adjudication Method for the Test Set:

This information is not applicable. As stated above, bench testing does not involve human expert adjudication in the context of establishing ground truth for a test set.

Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. The device is a physical medical device (a stent and delivery catheter), not an AI-assisted diagnostic tool for human readers.

Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

This information is not applicable. The device is a physical medical device, not a standalone algorithm.

The Type of Ground Truth Used:

"Ground truth" in the traditional sense of human expert consensus or pathology is not directly applicable here. For bench testing of a physical device, the "ground truth" would be the established performance characteristics, specifications, and design of the already-marketed predicate device. The performance of the new device would be compared against these known attributes.

Sample Size for the Training Set:

This information is not applicable. The device is a physical medical device, not an AI algorithm requiring a training set.

How the Ground Truth for the Training Set Was Established:

This information is not applicable for the reasons stated above.

Summary

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K012752
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Image /page/0/Picture/1 description: The image shows the logo for Boston Scientific Microvasive. The words "Boston Scientific" are stacked on top of each other in a serif font. Underneath the words "Boston Scientific" is the word "MICROVASIVE" in a bold, sans-serif font.

NOV 1 5 2001

Microvasive Endoscop Boston Scientific Cornoratio One Boston Scientific Place Natick, MA 01760-153 508-650-8000 www.bsci.com

SECTION 10 510(K) SUMMARY

510(K) SUMMARY

1. Submitter:

Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537

Contact: Kathleen Morahan Principal Regulatory Specialist Date Prepared: August 6,2001

2. Device:

Trade Name: Wallstent RX Biliary Endoprostheses Common Name: Biliary Stent Classification Name: Biliary Catheter & Accessories

3. Predicate Device:

BSC Wallstent Biliary Endoprostheses - K000308, K982184, K964119, & K961262

4. Device Description:

Premarket Notification, Wallstent RX Biliary Endoprostheses August 15, 2001 Proprietary and Confidential Information of Boston Scientific Corporation

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K012752
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5. Intended Use:

The proposed Wallstent RX Biliary Endoprostheses is indicated for palliative treatment of biliary strictures produced by malignant neoplasms.

6. Technological Characteristics:

The stent design and materials are identical to the predicate Wallstent Biliary Endoprostheses that is currently marketed by BSC for the same indication. The primary difference between the proposed and predicate devices is in the design of the delivery catheter. In the predicate device the guidewire runs through the entire length of the delivery catheter whereas in the proposed device the guidewire exits through a lumen near the tip of the delivery catheter. This modification allows for a single operator exchange technique.

7. Performance Data:

Bench testing was conducted to aid with the establishment of substantial equivalence of the proposed device to the predicate device.

8. Conclusion:

BSC has demonstrated that the Wallstent™ RX Biliary Endoprostheses is substantially equivalent to BSC's currently marketed Wallstent™ Biliary Endoprostheses.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

NOV 1 5 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Kathleen Morahan Principal Regulatory Specialist Boston Scientific Corporation Microvasive Endoscopy One Boston Scientific Place NATICK MA 01760-1537

Re: K012752

Trade/Device Name: Wallstent™ RX Biliary Endoprosthesis Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary Catheter and Accessories Regulatory Class: II Product Code: 78 FGE Dated: August 15, 2001 Received: August 16, 2001

Dear Ms. Morahan:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.

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.

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.

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Page 2 - Ms. Kathleen Morahan

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); 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.

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 510(k) premarket notification if the limitation statement above is added to your labeling, as described.

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.

If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Bernard E. Statland, M.D., Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health

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NOV 1 5 2001

Page 1 of 1

510(k) Number (if known): K012752

Device Name: Wallstent™ RX Biliary Endoprosthesis

FDA's Statement of the Indications For Use for device:

The Wallstent™ RX Biliary Endoprosthesis is indicated for palliative treatment of biliary strictures produced by malignant neoplasms.

Prescription Use v OR (Per 21 CFR 801.109)

Over-The-Counter Use __

Nancyl. Broadin

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.