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 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 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 also incorporates two adhesive material changes and the addition of a visual marker on two models.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the Ultraflex™ Esophageal NG Stent System. This submission is a "Special 510(k)," which typically means minor changes have been made to a previously cleared device. As such, the emphasis is on demonstrating substantial equivalence to the predicate device rather than presenting new clinical performance data for acceptance criteria and a detailed study proving performance.

Here's an analysis based on the provided text, addressing your points:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated as quantitative acceptance criteria for clinical performance. The submission focuses on substantial equivalence to the predicate device, implying that the new device should perform at least as well as the predicate.	* "In-vitro testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests." (Section 7)

Rationale: The 510(k) summary (Section 7) states that "In-vitro testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests." This confirms that the device meets its internal design specifications and performance requirements for in-vitro tests, which are used to demonstrate substantial equivalence, especially for a Special 510(k). However, specific acceptance criteria for clinical outcomes (e.g., success rates, complication rates) are not provided, as this type of submission usually relies on the predicate device's established clinical profile. The "acceptance criteria" here are implicitly that the device performs equivalently to the predicate in all relevant aspects, supported by in-vitro testing for the changes made.

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

Sample Size for Test Set: Not applicable / Not provided.
Data Provenance: The performance data described is "In-vitro testing." This suggests laboratory-based testing rather than patient-derived data (e.g., retrospective or prospective clinical studies). Therefore, there is no country of origin for patient data.

Rationale: The submission explicitly states "In-vitro testing." This means the testing was likely conducted in a lab environment using physical devices or models, not on a patient population. Consequently, there's no patient data, sample size for test sets (in a clinical sense), or data provenance from a geographical perspective.

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

Number of Experts: Not applicable.
Qualifications of Experts: Not applicable.

Rationale: Since the performance data is derived from "in-vitro testing" and not clinical studies involving diagnostic accuracy or treatment efficacy evaluated by experts, there is no need for experts to establish ground truth in the context of this submission. The "ground truth" for in-vitro tests is typically defined by engineering specifications and objective measurements.

4. Adjudication method for the test set

Adjudication Method: Not applicable.

Rationale: As there are no human-interpreted results or clinical outcomes requiring independent review or consensus, an adjudication method is not relevant to "in-vitro 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

MRMC Study: No, an MRMC study was not done.
Effect Size: Not applicable.

Rationale: This device is an esophageal stent system, which is a physical medical device, not an AI or imaging diagnostic tool. Therefore, MRMC studies and concepts of human reader improvement with AI assistance are not applicable.

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

Standalone Performance Study: Not applicable.

Rationale: This device is a physical stent system and does not involve an algorithm. Therefore, "standalone" algorithm performance is not relevant.

7. The type of ground truth used

Type of Ground Truth: Engineering specifications and objective measurements for in-vitro performance.

Rationale: For "in-vitro testing," the ground truth is typically established by predetermined performance specifications, material properties, and objective measurements (e.g., mechanical strength, deployment characteristics, fatigue resistance) that the device must meet.

8. The sample size for the training set

Sample Size for Training Set: Not applicable.

Rationale: There is no mention of "training" in the context of an algorithm or statistical model. The testing described is performance testing of a physical device.

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

How Ground Truth for Training Set was Established: Not applicable.

Rationale: As there is no "training set" in the context of an algorithm, the concept of establishing ground truth for it does not apply.

In summary:

This 510(k) submission for the Ultraflex™ Esophageal NG Stent System is a "Special 510(k)," indicating minor changes to a previously cleared device. The primary method of demonstrating performance and substantial equivalence relies on in-vitro testing to show that the modified device's components and full systems meet all required specifications. The submission does not present clinical performance data (e.g., patient-based studies, expert evaluation, or AI algorithm performance) to establish acceptance criteria or prove effectiveness in the way one might expect for a novel device or an AI/diagnostic software product. The "acceptance criteria" are implicitly met by showing the new device performs identically to or within acceptable limits of the predicate device through laboratory testing.

Summary

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K091816
162

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: June 16, 2009

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: UltraflexTM Esophageal NG Stent System Manufacturer and Clearance Number: Boston Scientific Corporation, K032930 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 (non-covered) is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors only.

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

JUL - 1 2009

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6. Technological Characteristics:

The proposed Ultraflex™ Esophageal NG Stent System is nearly identical in design, materials, and manufacturing processes to the predicate Ultraflex™ Esophageal NG Stent System (K032930).

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.

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 (K032930).

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle's head is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 1 2009

Ms. Janis Taranto Regulatory Affairs Specialist Boston Scientific Corporation Endoscopy Division 100 Boston Scientific Way MARLBOROUGH MA 01752

K091816 Re:

119-1010 Regulation Number: 21 CFR §878.3610 Regulation Name: Esophageal prosthesis Regulatory Class: II Product Code: ESW Dated: June 16, 2009 Received: June 18, 2009

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 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 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 of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Janine M. Morris Acting 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

510(k) Number (if known):

Device Name:

Indications for Use:

Fo Be Determined

Ultraflex™ Esophageal NG Stent System

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.

K091816

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)

.
(Division Sign-Off)

Division of Reproductive, Abdominal and Radiological Devices K091816 510(k) Number _

Special 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.”