The WallFlex™ Enteral Duodenal Stent with Anchor Lock Delivery System is indicated for the palliative treatment of gastroduodenal obstructions caused by malignant neoplasms.

Device Description

The proposed WallFlex™ Enteral Duodenal Stent with Anchor Lock Delivery System consists of two components: an implantable metal stent and a delivery system. The proposed stent is manufactured of Nitinol and has a 22mm body diameter with a 27mm distal flare diameter, and is offered in three lengths, 6cm, 9cm, and 12cm. The Anchor Lock Delivery System consists of a coaxial tubing assembly that constrains the stent on the delivery catheter shaft until the stent is released by retracting the exterior tube.

AI/ML Overview

The provided text is a 510(k) summary for the WallFlex™ Enteral Duodenal Stent System with Anchor Lock Delivery System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain detailed information about specific acceptance criteria or a dedicated study proving performance against such criteria.

The document states:

"Clinical data in support of the proposed indication for the WallFlex™ Enteral Duodenal Stent with Anchor Lock Delivery System has been included in this premarket notification."
"Boston Scientific Corporation has demonstrated that proposed WallFlex™ Enteral Duodenal Stent with Anchor Lock Delivery System is substantially equivalent to the currently marketed WallFlex™ Enteral Colonic Stent with Anchor Lock Delivery System and in terms of the proposed indication to Boston Scientific's Wallstent Enteral Endoprosthesis."

This indicates that the clinical data presented was likely used to demonstrate substantial equivalence to existing predicate devices, rather than a standalone study designed to meet specific quantitative acceptance criteria for a novel device performance.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer many of the specific questions about sample sizes, ground truth, expert qualifications, or MRMC studies, as this information is not present in the provided 510(k) summary.

Here's what can be inferred or stated based on the available text:

A table of acceptance criteria and the reported device performance:
- Not provided. The document focuses on substantial equivalence rather than a new device meeting pre-defined acceptance criteria.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. The document only states "Clinical data... has been included," without details on sample size or provenance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not provided. This information is generally not part of a 510(k) summary focused on substantial equivalence for a medical device like a stent.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not provided.
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 device is a medical implant (stent), not an AI-powered diagnostic tool engaging human "readers."
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a medical implant, not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not explicitly stated for the "clinical data" mentioned. For a medical device like a stent, ground truth would likely refer to clinical outcomes (e.g., successful stent placement, patency, complication rates, patient survival, symptom relief) verified through clinical follow-up, imaging, and potentially pathology if biopsies were taken. The document, however, does not detail how this "clinical data" was acquired or what specific endpoints it measured.
The sample size for the training set:
- Not applicable/Not provided. This device is hardware; there is no "training set" in the context of an AI algorithm. Clinical trials involve patient cohorts, but the size of any such cohort is not disclosed.
How the ground truth for the training set was established:
- Not applicable/Not provided.

Summary of what's present in the document:

The device is a WallFlex™ Enteral Duodenal Stent with Anchor Lock Delivery System.
Its intended use is for the palliative treatment of gastroduodenal obstructions caused by malignant neoplasms.
The submission is a 510(k) premarket notification claiming "substantial equivalence" to predicate devices (WallFlex™ Enteral Colonic Stent with Anchor Lock Delivery System and Wallstent Enteral Endoprosthesis).
Clinical data was included to support the proposed indication, but no details of the study (design, sample size, outcome measures) are provided in this summary.
The FDA's letter confirms the determination of substantial equivalence.

Summary

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UEL - 4 2006

SECTION 5 510(K) SUMMARY

510(K) SUMMARY

1. Submitter:

Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4356 Fax: 508-683-5939

Contact: Allyson Barford, RAC Regulatory Affairs Specialist Date Prepared: September 13, 2006

2. Device:

Trade Name: WallFlex™ Enteral Duodenal Stent System with Anchor Lock Delivery System Common Name: Esophageal prosthesis Classification Name: Expandable, metallic duodenal stent Regulation Number: 878.3610 Product Code: MUM Classification: Class II

3. Predicate Device:

WallFlex™ Enteral Colonic Stent System with Anchor Lock Delivery System, K042065 Wallstent Enteral Endoprosthesis, K000281 The predicate devices are class II devices per 21 CFR 878.3610

4. Device Description:

5. Intended Use:

The proposed WallFlex™ Enteral Duodenal Stent is indicated for the palliative treatment of gastroduodenal obstructions caused by malignant neoplasms.

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6. Technological Characteristics:

The proposed WallFlex Enteral Duodenal Stent with Anchor Lock Delivery System has the identical technological (materials, construction, processing) characteristics as the predicate WallFlex Enteral Colonic Stent with Anchor Lock Delivery System and has the identical indication statement as the predicate Wallstent Enteral Endoprosthesis.

7. Performance Data:

Clinical data in support of the proposed indication for the WallFlex™ Enteral Duodenal Stent with Anchor Lock Delivery System has been included in this premarket notification.

8. Conclusion:

Boston Scientific Corporation has demonstrated that proposed WallFlex™ Enteral Duodenal Stent with Anchor Lock Delivery System is substantially equivalent to the currently marketed WallFlex™ Enteral Colonic Stent with Anchor Lock Delivery System and in terms of the proposed indication to Boston Scientific's Wallstent Enteral Endoprosthesis.

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

DEC - 4 2006

Ms. Allyson Barford Regulatory Specialist Boston Scientific Corporation Endoscopy Division 100 Boston Scientific Way MARLBOROUGH MA 01752

Re: K062750

Trade/Device Name: WallFlex Enteral Duodenal Stent with Anchor Lock Delivery System Regulation Number: 21 CFR §878.3610 Regulation Name: Esophageal prosthesis Regulatory Class: II Product Code: MUM Dated: September 13, 2006 Received: September 14, 2006

Dear Ms. Barford:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have rotened 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 ass stated in the enerobare) to regarly than of the Medical Device Amendments, or to devices that prov to May 20, 1976, the onabilities and the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, Act (free) market the device, subject to the general controls provisions of the Act. The general therefore, manor the act include requirements for annual registration, listing of devices, good controls provisions or colors, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket n your device is oldsmired (000 as 11) diffinial controls. Existing major regulations affecting your Applovar, it may be saylor to outs Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/2/Picture/10 description: The image shows a logo with the text "FDA Centennial" and the years "1906-2006" inside a circular border. The logo features the letters "FDA" in a stylized font above the word "Centennial". There are three stars below the word "Centennial". The logo appears to be a commemorative emblem for the centennial of the Food and Drug Administration.

Protecting and Promoting Public Health

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Page 2 --

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.

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.litml.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SECTION 4 INDICATIONS FOR USE STATEMENT

Indications for Use:

510(k) Number (if known): To Be Determined - KO 6 2750

K062750

Device Name: WallFlex Enteral Duodenal Stent with Anchor Lock Delivery System

Indications For Use:

The WallFlex™ Enteral Duodenal Stent with Anchor Lock Delivery System is indicated for the palliative treatment of gastroduodenal obstructions caused by malignant neoplasms.

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)

Premarket Notification, WallFlex™ Enteral Duodenal Stent with Anchor Lock Delivery System Proprietary and Confidential Information of Boston Scientific Corporation

00009

Regulation Number and Section

§ 878.3610 Esophageal prosthesis.

(a)
Identification. An esophageal prosthesis is a rigid, flexible, or expandable tubular device made of a plastic, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the esophagus. The metal esophageal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.(b)
Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”