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.

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

Device Description

The proposed Ultraflex Esophageal NG Stent System allows for the placement of a self-expanding metallic stent within the esophagus. The systems consist of a flexible delivery catheter preloaded with an expandable stent. The stent is offered either bare or covered and 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 an updated Magnetic Resonance (MR) Conditional statement in the Directions for Use.

AI/ML Overview

The Ultraflex™ Esophageal NG Stent System (K130004) is substantially equivalent to its predicates because it has identical design and materials, and the only change is an updated MR Conditional statement in the Directions for Use (DFU). This updated statement ensures compatibility with 1.5 and 3.0 Tesla MRI use, aligning with ASTM standard F 2503-08.

Here's a breakdown of the information:

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
MR Conditional Labeling per ASTM F 2503-08	Meets requirements for MR Conditional labeling per ASTM F 2503-08 for 1.5 and 3.0 Tesla use.

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated as a "test set" in the context of human data. The performance data section refers to "Magnetic Resonance testing."
- Data Provenance: The document does not specify the country of origin or whether the data was retrospective or prospective. It implies laboratory testing rather than human clinical data.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. The "ground truth" here is defined by the technical standard ASTM F 2503-08 for MR Conditional labeling, not by expert medical opinion on a patient dataset.
Adjudication Method for the Test Set:
- Not applicable. The evaluation is based on adherence to a technical standard and laboratory testing, not on human adjudication of cases.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. This study is focused on the MR safety labeling of a medical device, not on diagnostic performance or the effectiveness of human readers with or without AI assistance.
If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Not applicable. This device is a stent, not an AI algorithm. The performance evaluation relates to its physical properties and interaction with an MR environment.
The Type of Ground Truth Used:
- Technical Standard Compliance: The "ground truth" for the device's MR compatibility is established by adherence to the ASTM F 2503-08 standard for MR Conditional labeling.
The Sample Size for the Training Set:
- Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.
How the Ground Truth for the Training Set Was Established:
- Not applicable. There is no training set for this device.

Summary

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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: December 31, 2012

DEC 0 6 2013

2. Proposed Device:

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

3. Predicate Device:

Trade Name: Ultratlex™ Esophageal NG Stent System Manufacturer and Clearance Number: Boston Scientific Corporation, K091816, K120983 Classification Name: Esophageal Prosthesis Regulation Number: 878.3610 Product Code: ESW Classification: Class II

Trade Name: Ultraflex™ Tracheobronchial Stent System Manufacturer and Clearance Number: Boston Scientific Corporation, K121048 Classification Name: Prosthesis, Tracheal, Expandable Regulation Number: 878.3720 Product Code: JCT Classification: Class II

4. Proposed Device Description:

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5. Indications for Use:

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

6. Technological Characteristics:

The proposed Ultraflex™ Esophageal NG Stent System is identical in design and materials to the predicate Ultraflex™ Esophageal NG Stent System (K091816, K120983) while incorporating an updated MR Conditional statement in the Directions for Use stating compatibility with 1.5 and 3.0 Tesla use. This MR Conditional statement is identical to the statement used in the Ultrallex™ Tracheobronchial Stent System (K121048) DFU.

7. Performance Data:

Magnetic Resonance testing has been performed for the Ultraflex™ Esophageal NG Stent. The Directions for Use meet the requirements for MR Conditional labeling per ASTM standard F 2503-08.

8. Conclusion:

Boston Scientific Corporation has demonstrated that the proposed Ultraflex™ Esophageal NG Stent System with the minor labeling change to update the MR Conditional statement in the DFU, is substantially equivalent to Boston Scientific Corporation's currently marketed Ultraflex™ Esophageal NG Stent System (K091816. K120983) and UltraflexTM Tracheobronchial Stent System (K121048).

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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 features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.

Public I lealth Service

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

December 6, 2013

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

Re: K130004

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: November 7, 2013 Received: November 8, 2013

Dear Janis F. 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 general controls provisions of the Act include requirements for annual registration. Ilisting 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

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Page 2 - Janis F. Taranto, M.S., RAC

medical 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher -S

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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SECTION 4 INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K130004

Device Name:

て、どちらないから、「トバ

Ultraflex™ Esophageal NG Stent System

Indications for Use:

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)

Benjamin R. Fisher -S 2013.12.09 20:05:46 -05'00'

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

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SECTION 4 INDICATIONS FOR USE STATEMENT

510(k) Number (if known): KI30004

Device Name:

Ultraflex™ Esophageal NG Stent System

Indications for Use:

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.

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

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)

Benjamin R. Fisher -S 2013.12.09 20:06:40 -05'00'

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

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.”