Ultraflex™ Esophageal NG Stent System (covered) 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 allows for the placement of a selfexpanding metallic stent within the esophagus. The systems consist of a flexible delivery catheter preloaded with an expandable stent. The stent is offered covered with either a proximal release or distal release delivery system. The stent may be placed fluoroscopically using radiopaque markers as a guide or endoscopically using the visual marker on the delivery catheter. The proposed device incorporates a material formulation change for the stent covering and covering adhesive material.

AI/ML Overview

The provided text does not contain information about acceptance criteria and a study proving a device meets them in the context of an AI/ML-based medical device. Instead, the document describes a 510(k) summary for a medical device called the "Ultraflex™ Esophageal NG Stent System."

This submission is a Special 510(k) Premarket Notification for a device that is substantially equivalent to a previously cleared device. The key difference in the proposed device is a material formulation change for the stent covering and covering adhesive material.

Therefore, the "performance data" section focuses on in-vitro testing to demonstrate that this material change does not negatively impact the device's performance. There is no mention of an AI/ML component, diagnostic performance metrics (like sensitivity, specificity, accuracy), or any studies involving human readers or ground truth establishment relevant to AI.

Here's why the requested information cannot be extracted:

No AI/ML Component: The device is a physical medical implant (stent) and does not involve artificial intelligence or machine learning for diagnostic or assistive purposes.
Performance Data Type: The "Performance Data" mentioned (dimensional, tensile strength, integrity, exposure resistance, chemical analysis, and biocompatibility) are typical for material changes in medical devices, not for evaluating AI algorithms.
Comparison to Predicate: The entire submission is built on demonstrating substantial equivalence to a legally marketed predicate device, primarily through in-vitro testing for the material change.

Therefore, I cannot provide the requested table and details because the provided input document describes a traditional medical device submission (a stent with a material change), not an AI/ML device.

Summary

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MAY - 2 2012

SECTION 5 510(k) SUMMARY

510(k) SUMMARY

1. Submitter:

Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4560 Fax: 508-683-5939

Contact: Janis F. Taranto, M.S., RAC Regulatory Affairs Specialist Date Prepared: March 30, 2012

2. Proposed Device:

Trade Name: UltraflexTM Esophageal NG Stent System Classification Name: Esophageal Prosthesis Regulation Number: 878.3610 Product Code: ESW Classification: Class II

3. Predicate Device:

Trade Name: UltraflexTM Esophageal NG Stent System Manufacturer and Clearance Number: Boston Scientific Corporation, K091816 Classification Name: Esophageal Prosthesis Regulation Number: 878.3610 Product Code: ESW Classification: Class II

4. Proposed Device Description:

5. Intended Use:

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

Special 510(k) Premarket Notification, Ultraflex™ Esophageal NG Stent System

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6. Technological Characteristics:

The proposed Ultraflex™ Esophageal NG Stent System is identical in design and manufacturing processes to the predicate Ultraflex™ Esophageal NG Stent System (K091816) while incorporating a minor formulation change to the stent covering and covering adhesive material.

7. Performance Data:

In-vitro testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests including: dimensional, tensile strength, integrity, exposure resistance, chemical analysis and biocompatibility.

8. Conclusion:

Boston Scientific Corporation has demonstrated that the proposed Ultraflex™ Esophageal NG Stent System is substantially equivalent to Boston Scientific Corporation's currently marketed Ultraflex™ Esophageal NG Stent System (K091816).

Special 510(k) Premarket Notification, Ultraflex™ Esophageal NG Stent System

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MAY 2 2012

Ms. Janis F. Taranto, M.S., RAC Regulatory Affairs Specialist Boston Scientific Corporation 100 Boston Scientific Way, M-11 MARLBOROUGH MA 01752

K120983 Re:

Trade/Device Name: Ultraflex™ Esophageal NG Stent System Regulation Number: 21 CFR§ 878.3610 Regulation Name: Esophageal prosthesis Regulatory Class: II Product Code: ESW Dated: March 30, 2012 Received: April 2, 2012

Dear Ms. Taranto:

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 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); 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 advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourceforYou/Industry/default.htm.

Sincerely yours,

Benjamin R. Twitchell

Doctor of Philosophy, Ph.D.

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K120982

SECTION 4 INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

To Be Determined K120983

Device Name:

Indications for Use:

Ultraflex™ Esophageal NG Stent System

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)

Hild Leen

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K120983

Special 510(k) Premarket Notification, Ultraflex™ Esophageal NG Stent System

000012

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.”