The WallFlex™ Enteral Colonic Stent with Anchor Lock Delivery System is indicated for palliative treatment of colonic strictures caused by malignant neoplasms.

Device Description

The proposed WallFlex™ Enteral Stent with Anchor Lock Delivery System consists of two components: an implantable metal stent and a delivery system. The proposed stent is two components: an insplantaoffered in two diameters: 25mm body with a 30mm flare, mandracetal or over with a 27mm flare. Each diameter is offered in three lengths, 6cm, 9cm, and 12cm. The proposed Anchor Lock delivery 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

Here's an analysis of the provided text regarding the acceptance criteria and study for the WallFlex™ Enteral Colonic Stent:

It's important to note that the provided document is a 510(k) summary for a premarket notification, not a full clinical study report. Therefore, it focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel device. The "performance data" mentioned here refers to engineering and bench testing, not clinical studies in humans.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance (Summary)
Mechanical/Physical Equivalence
Dimensional Evaluation	Performance/results are comparable to predicate devices.
Fatigue Testing	Performance/results are comparable to predicate devices.
Radial Force Comparison	Performance/results are comparable to predicate devices.
Deployment and Reconstrainment Force	Performance/results are comparable to predicate devices.
Bond Integrity	Performance/results are comparable to predicate devices.
Material/Safety Compatibility
MRI Compatibility	Performance/results are comparable to predicate devices.
Overall Conclusion	"WallFlex Enteral Colonic Stent with Anchor Lock Delivery system is substantially equivalent to Boston Scientific Corporation's currently marketed Ultraflex™ Precision™ Colonic Stent and the Wallstent Enteral Endoprosthesis with Unistep Plus Delivery System."

Note: The document does not provide specific numerical acceptance criteria (e.g., "radial force must be > X Newtons") or detailed numerical results for the WallFlex™ stent. Instead, it states that the performance for these categories was compared and found to be substantially equivalent to predicate devices.

Study Details

Sample size used for the test set and the data provenance:
This document describes bench testing (mechanical, physical, and material compatibility tests), not a clinical test set involving human patients. Therefore, terms like "sample size for the test set" (in a clinical sense) and "data provenance (e.g. country of origin of the data, retrospective or prospective)" are not applicable here. The tests were likely conducted in a laboratory setting, and the "samples" would be individual stents/delivery systems.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable. Ground truth, in the clinical sense, refers to confirmed diagnoses or outcomes. The "ground truth" for the engineering performance tests would be the established engineering standards or the performance of the predicate devices, against which the new device's performance was compared. This would be evaluated by engineers or scientists performing the tests.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable as it pertains to clinical data interpretation or consensus. Bench testing results are typically quantifiable and do not require expert adjudication in the same manner.
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:
This is not applicable. MRMC studies are for evaluating diagnostic tools, often involving AI, and human reader performance. This document concerns a medical device (a stent) and its mechanical/physical equivalence, not an AI-powered diagnostic.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This is not applicable. This document describes a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the engineering performance tests, the "ground truth" was the established performance characteristics of the predicate devices and/or relevant engineering standards. The goal was to demonstrate that the WallFlex™ stent performed similarly or met the same benchmarks as the already approved predicate devices.
The sample size for the training set:
This is not applicable. There is no "training set" in the context of this device's engineering performance testing. This concept applies to machine learning algorithms.
How the ground truth for the training set was established:
This is not applicable for the same reason as above.

Summary of what the document does provide:

Type of Study: Comparative performance testing (bench testing) and comparison to predicate devices, not clinical trials.
Purpose: To establish substantial equivalence of the WallFlex™ Enteral Colonic Stent with Anchor Lock Delivery System to two named predicate devices (Ultraflex™ Precision™ Colonic Stent System, K030769 and Wallstent Enteral Endoprosthesis with Unistep Plus Delivery System, K000281) for 510(k) clearance.
Evaluated Characteristics: Dimensional evaluation, fatigue testing, radial force comparison, deployment and reconstrainment force, bond integrity, and MRI compatibility.
Conclusion: The device was found to be substantially equivalent based on these comparative tests.

Summary

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Endoscopy

SECTION 10 510(K) SUMMARY

510(K) SUMMARY

1. Submitter:

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

Contact: Kathleen Morahan, RAC Regulatory Affairs Manager Date Prepared: July 30, 2004

2. Device:

Trade Name: WallFlex™ Enteral Colonic Stent with Anchor Lock Delivery System Common Name: Expandable, metal colonic stent Classification Name: Stent, colonic, metallic, expandable Product Code: MQR Classification: Class II

3. Predicate Device:

Boston Scientific Corporation's Ultraflex™ Precision™ Colonic Stent System, K030769.

Boston Scientific Corporation's Wallstent Enteral Endoprosthesis and Unistep Plus Delivery System, K000281.

4. Device Description:

5. Intended Use:

The proposed WallFlex™ Enteral Colonic Stent with Anchor Lock Delivery System is indicated for palliative treatment of colonic strictures caused by malignant neoplasms.

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

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6. Technological Characteristics:

Essentially, the proposed WallFlex™ Enteral Colonic Stent with Anchor Lock Delivery System has the same technological characteristics as the predicate devices. The proposed stent combines the design features of the Ultraflex™ Precision™ Colonic stent and the Wallstent Enteral stent, yielding a self-expanding Nitinol stent. The proposed Anchor Lock delivery 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, like the predicate Wallstent Unistep Plus delivery system.

7. Performance Data:

Comparative performance testing was performed to establish substantial equivalence between the proposed WallFlex™ Enteral Colonic Stent with Anchor Lock Delivery System, and the predicate Ultraflex Precision Colonic Stent System, and the Wallstent Enteral Endoprothesis with Unistep Plus Delivery System. This testing included but was not limited to a dimensional evaluation, fatigue testing, radial force comparison, deployment and reconstrainment force, bond integrity and MRI.

8. Conclusion:

Boston Scientific Corporation has demonstrated that WallFlex Enteral Colonic Stent with Anchor Lock Delivery system is substantially equivalent to Boston Scientific Corporation's currently marketed Ultraflex™ Precision™ Colonic Stent and the Wallstent Enteral Endoprosthesis with Unistep Plus Delivery System.

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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 stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 3 0 2004

Ms. Kathleen Morahan Regulatory Affairs Manager Boston Scientific Corporation Endoscopy Division One Boston Scientific Place NATICK MA 01760

Re: K042065

K 042065
Trade/Device Name: WallFlex™ Enteral Colonic Stent and Anchor Lock Delivery System 25mm and 22mm x 90mm, -120mm, and -60mm Regulation Number: 21 CFR §878.3610 Regulation Name: Esophageal prosthesis Regulatory Class: II Product Code: 78 MQR Dated: July 30, 2004 Received: August 12, 2004

Dear Ms. Morahan:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your bector 310(a) fee 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 connine.cc proc to may 20, 1978, as eccordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). alle Cosmette Act (110) market the device, subject to the general controls provisions of the Act. The I ou may, therefore, market the act include requirements for annual registration, listing of general controls provisions of ractice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), IT your device is classified (600 above) a Existing major regulations affecting your device can be It may be subject to additions, Title 21, Parts 800 to 898. In addition, FDA may round in the Ood of Pressiants concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Picase oe advised that 1 277 5 155aates or our device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of any Federal Statues and roganders including, but not limited to: registration and listing Comply with an the Ace 3 requirements) xxxxl 801); good manufacturing practice requirements as set (21 CFR Part 607), laborning (21 CFR Part 820); and if applicable, the electronic Iorni in the quality by tions (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin marketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your premarket notification. The FD7A inding of substantial equivation of 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
r the regulation If you desire specific advice for your device on one of the following numbers, based on the regulation number at the top of the letter:

8xx. 1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on the pronocol and and the regulation entitled, "Mashranding
Office of Compliance at (301) 594-4639. Other of Compliance at (501) 594-057. Tax (207.97) you may obtain. Other general by reference to premarket notification (21 cc 1 c = 0 +7 joed from the Division of Small
information on your responsibilities under the Act may be obtained from the (800) 63 information on your responsibilities under the research its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assiss assessed instal Manufacturers, International and Collisation in and Collectives and Collectives and manufacturers.

Sincerely yours,

Nancy C. Brogdon

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 3 INDICATIONS FOR USE

Indications for Use:

510(k) Number (if known): Fo-Be Determined 5 0420 (se

Device Name: WallFlex™ Enteral Colonic Stent with Anchor Lock Delivery System

Indications For Use:

The WallFlex™ Enteral Colonic Stent with Anchor Lock Delivery System is indicated The Wall'Iex - Encrai-Colonic strictures 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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

et Notification, WallFlex Enteral Colonic Stent with Anchor Lock Delivery System
mproprietary and Confidential Information of Boston Scientific Corporation

04206

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number

00000:3

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.”