The Ultraflex™ Esophageal NG Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors and, for occlusion of concurrent esophageal fistula (for covered stents only).

The Ultraflex™ Esophageal NG Stent System (non-covered) is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors only.

The Covered Ultraflex™ Esophageal NG Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors only, and occlusion of concurrent esophageal fistula.

Device Description

The proposed Ultraflex™ Esophageal NG Stent System consists of a self-expanding metal stent preloaded on a flexible delivery catheter. The stent is offered either bare or covered and with either a proximal release or distal release delivery system.

The stent may be placed flouroscopically using radiopaque markers as a guide or endoscopically using the visual marker on the delivery catheter. To deploy the stent, hold the handle hub in the palm of one hand, and grasp the finger ring with the other hand. As the finger ring is retracted, the suture crochet knots are unraveled in a circular manner along the length of the stent, gradually deploying the stent. When the stent is completely released, the delivery catheter is removed.

AI/ML Overview

This section describes the performance data and acceptance criteria for the Ultraflex™ Esophageal NG Stent System.

1. Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Reported Device Performance
Technological Characteristics	The technological characteristics of the proposed device are unchanged from the predicate device, except for: - A modified crochet suture pattern on the delivery catheter to create a 10mm "visual marker" (for proximal release product codes only). - Modified suture material threaded around the circumference of each stent end.
Impact on Device Performance	These modifications have not impacted the device performance as demonstrated by bench testing.

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated as a numerical value for a "test set" in the context of clinical data. The performance was demonstrated through "bench testing."
Data Provenance: The document implies that the "bench testing" was conducted internally by Boston Scientific Corporation. The data provenance is presumed to be internal laboratory testing rather than human subject data with country of origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The "ground truth" for this submission was based on engineering bench testing, not expert clinical interpretation of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No clinical adjudication method was used for this bench testing.

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:

Not applicable. This submission pertains to a medical device (stent system) and its mechanical performance, not an AI or imaging diagnostic tool that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is not an algorithm. Bench testing was performed on the device itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" was established through bench testing to assess the mechanical and functional characteristics of the device, primarily focused on ensuring that the stated modifications did not negatively impact performance compared to the predicate device. This would likely involve measurements of physical properties, deployment mechanics, and other relevant engineering parameters.

8. The sample size for the training set:

Not applicable. This submission describes bench testing for a physical device, not an AI model that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. No training set was used.

Summary

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OCT 2 3 2003

Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537 508.650.8000 www.bsci.com

510(K) Summary

1. Submitter:

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

Contact: Kathleen Morahan Regulatory Affairs Manager Date Prepared: September 17, 2003

2. Device:

Trade Name: Ultraflex™ Esophageal NG Stent System Common Name: Esophageal Stent Classification Name: Esophageal Prosthesis

3. Predicate Device:

BSC UltraflexTM Esophageal Stent System - K955347

4. Device Description:

5. Intended Use:

The UltraflexTM Esophageal NG Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors and, for occlusion of concurrent esophageal fistula (for covered stents only).

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6. Technological Characteristics:

The technological characteristics of the proposed and predicate devices are unchanged. The crochet suture pattern on the delivery catheter was modified to create a 10mm "visual marker" on the delivery system (for proximal release product codes only) to assist with endoscopic stent placement. The suture material threaded around the circumference of each stent end was also modifications have not impacted the device performance as demonstrated by bench testing.

7. Performance Data:

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

8. Conclusion:

BSC has demonstrated that the Ultraflex™ Esophageal NG Stent System is substantially equivalent to BSC's currently marketed Ultraflex™ Esophageal Stent System.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three horizontal lines above it, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

OCT 2 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Kathleen Morahan Manager, Regulatory Affairs Microvasive Endoscopy Boston Scientific Corporation One Boston Scientific Place NATICK MA 01760-1537

Re: K032930

Trade/Device Name: Ultraflex " Esophageal Next Generation (NG) Stent System Noncovered and Covered, Distal Release; Noncovered and Covered, Proximal Release Regulation Number: 21 CFR §878.3610 Regulation Name: Esophageal prosthesis Regulatory Class: II Product Code: 79 ESW Dated: September 18, 2003 Received: September 23, 2003

Dear Ms. Morahan:

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) 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. 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.

If vour 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.

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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 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 Office of Compliance at (301) 594-4639. 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 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,

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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510(K) Number:

To Be Determined K032930.

Device Name:

Ultraflex™ Esophageal NG Stent System

Indications for Use:

The Ultraflex™ Esophageal NG Stent System (non-covered) is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.1091)
(Optional Format 1-2-96)
(Division Sign-Off)
OR
Over-The-Counter Use _
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number _ K032930

Special 510(k) for the Ultraflex™ Esophageal NG Stent System, September 17, 2003 Proprietary and Confidential Information of Boston Scientific Corporation

000017

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.”