The WallFlex Biliary RX Fully Covered Stent System is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms.

Device Description

The WallFlex Biliary RX Fully Covered Stent System consists of a self-expanding metal stent and a delivery system. The stent is fully covered with Permalume coating and includes a retrieval loop at the proximal end of the stent to aid in removal during the initial stent placement procedure. The stent is mounted onto a sheath delivery system. The delivery system is a coaxial tubing assembly that constrains the stent onto the delivery system shaft until the stent is released by retracting the exterior tube.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the WallFlex® Biliary RX Fully Covered Stent System:

Summary of Acceptance Criteria and Device Performance for WallFlex® Biliary RX Fully Covered Stent System

The provided document is a 510(k) summary for a medical device (a stent). For such devices, acceptance criteria and performance are typically established through comparisons to predicate devices, demonstrating substantial equivalence rather than explicit, numerical performance metrics in the same way one might for diagnostic software.

No explicit quantitative acceptance criteria or detailed device performance metrics are provided in the text. The submission primarily relies on demonstrating substantial equivalence to existing, legally marketed predicate devices.

Here's what can be inferred from the document:

Acceptance Criteria (Implied)	Reported Device Performance
Safety: Device is safe for its intended use.	"In-vitro, in-vivo, and clinical testing have been performed, and all components, subassemblies, and/or full devices met the required specifications for the completed tests.""The safety and effectiveness of this device for use in the vascular system have not been established." (FDA Caution)
Effectiveness: Device is effective for its intended use.	"In-vitro, in-vivo, and clinical testing have been performed, and all components, subassemblies, and/or full devices met the required specifications for the completed tests."
Technological Characteristics: Similar to predicate devices.	"The WallFlex Biliary RX Fully Covered Stent System has the same technological characteristics as the currently marketed WallFlex Biliary RX Uncovered Stent System (K061231) and the Wallstent™ RX Biliary Endoprosthesis (K012752, K030107)."
Intended Use: Matches or is within the scope of predicate devices.	"The WallFlex Biliary RX Fully Covered Stent System is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms." (This is the same as the predicate devices' likely intended use).
Substantial Equivalence: Demonstrate equivalence to predicates.	"Boston Scientific Corporation has demonstrated that the proposed WallFlex Biliary RX Fully Covered Stent System is substantially equivalent to Boston Scientific Corporation's currently marketed WallFlex Biliary RX Stent System (K061231) and Wallstent RX Biliary Endoprosthesis (K012752, K030107)."

Detailed Analysis of the Study and Ground Truth:

The document describes the regulatory submission for a medical device, not a typical diagnostic AI study. Therefore, many of the requested categories (like sample size for test/training sets, experts for ground truth, MRMC studies, etc.) are not applicable or not explicitly detailed in this type of submission.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified. The document states "In-vitro, in-vivo, and clinical testing have been performed." It does not provide specific numbers for patients or samples used in these tests for equivalence demonstration.
- Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the studies were retrospective or prospective. "In-vivo" and "clinical testing" generally imply prospective human studies, but details are absent.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable/Not Specified. In a 510(k) submission for a physical device like a stent, "ground truth" isn't established by expert consensus on images or diagnoses in the way it would be for an AI algorithm. Instead, the "truth" is related to the device's physical performance, safety, and effectiveness measured through engineering tests, animal studies, and clinical trials. The document does not detail how "ground truth" was established for these tests, nor does it mention specific experts.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable/Not Specified. This concept of adjudication is relevant for diagnostic accuracy studies involving human readers or AI outputs. For a physical device's performance testing (in-vitro, in-vivo), this type of adjudication method is not typically used or reported in this format.
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:
- Not Applicable. This is a physical medical device (stent), not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device (stent), not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Implied through performance metrics and clinical outcomes. For a stent, "ground truth" for its performance would be derived from:
  - In-vitro testing: Engineering specifications, material properties, mechanical integrity, expansion force, durability, etc.
  - In-vivo (animal) testing: Biocompatibility, stent patency, tissue response, animal survival.
  - Clinical testing: Patient outcomes such as stent patency, complication rates (e.g., migration, occlusion, perforation), effectiveness in palliating strictures, patient survival, and adverse event reporting.
- The document states "all components, subassemblies, and/or full devices met the required specifications for the completed tests," implying that the ground truth for these tests was adherence to pre-defined engineering and clinical performance standards.
The sample size for the training set:
- Not Applicable/Not Specified. This is a physical device, not a machine learning algorithm. Therefore, there is no "training set" in the computational sense.
- If interpreted broadly as data used to develop the device, that information is not provided.
How the ground truth for the training set was established:
- Not Applicable/Not Specified. As there's no training set for an AI algorithm, this question is not relevant.

In conclusion, this 510(k) summary demonstrates substantial equivalence for a physical medical device (stent) based on in-vitro, in-vivo, and clinical testing, rather than presenting detailed performance metrics or "ground truth" assessments characteristic of AI or diagnostic imaging studies. The FDA's acceptance is based on this claim of substantial equivalence to predicate devices, with added labeling limitations regarding its use in the vascular system.

Summary

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KOB3627 g10f2

SECTION 5 510(k) SUMMARY

510(k) SUMMARY

1. Submitter:

APR - 7 2009

Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01760 Telephone: 508-683-4454 Fax: 508-683-5939

Contact: Marybeth Gamber Manager, Regulatory Affairs Date Prepared: December 5, 2008

2. Device:

Trade Name: WallFlex® Biliary RX Fully Covered Stent System Common Name: Biliary Stent Classification Name: Biliary Catheter and Accessories Regulation Number: 876.5010 Product Code: FGE Classification: Class II

3. Predicate Device:

WallStent™ RX Biliary Endoprosthesis Manufactured by Boston Scientific. Inc. WallFlex® Biliary RX Stent System Manufactured by Boston Scientific, Inc. · K012752, K030107

K061231

4. Device Description:

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5. Intended Use:

The WallFlex Biliary RX Fully Covered Stent System is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms.

6. Technological Characteristics:

The WallFlex Biliary RX Fully Covered Stent System has the same technological characteristics as the currently marketed WallFlex Biliary RX Uncovered Stent System (K061231) and the Wallstent™ RX Biliary Endoprosthesis (K012752, K030107).

7. Performance Data:

In-vitro, in-vivo, and clinical testing have been performed, and all components, subassemblies, and/or full devices met the required specifications for the completed tests.

8. Conclusion:

Boston Scientific Corporation has demonstrated that the proposed WallFlex Biliary RX Fully Covered Stent System is substantially equivalent to Boston Scientific Corporation's currently marketed WallFlex Biliary RX Stent System (K061231) and Wallstent RX Biliary Endoprosthesis (K012752, K030107).

ર્ટર્

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, surrounded by a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written along the border of the seal. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Marybeth Gamber Manager, Regulatory Affairs Boston Scientific Corporation 100 Boston Scientific Way MARLBOROUGH MA 01752 .

APR - 7 2009

Re: K083627

Trade/Device Name: WallFlex® Biliary RX Fully Covered Stent System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: March 16, 2009 Received: March 31, 2009

Dear Ms. Gamber:

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). 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. Marybeth Gamber

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); 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 information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Voetman

Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SECTION 4 INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

This application K083627

WallFlex® Biliary RX Fully Covered Stent System

Indications for Use:

Device Name:

The WallFlex Biliary RX Fully Covered Stent System is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

చెప్ప

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

QSTN

(DNision Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 68362 510(k) Number,

Premarket Notification, WallFiex® Biliary RX Fully Covered Stent System

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.