ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM

K091816 · Boston Scientific Corporation · ESW · Jul 1, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K091816
• Device Name: ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
• Applicant: Boston Scientific Corporation
• Product Code: ESW · General, Plastic Surgery
• Decision Date: Jul 1, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3610
• Device Class: Class 2
• Attributes: Therapeutic

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. 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 Story

Self-expanding metallic stent system for esophageal luminal patency. System comprises flexible delivery catheter preloaded with bare or covered stent. Stent placement performed by physician (gastroenterologist/surgeon) via fluoroscopic guidance using radiopaque markers or endoscopic guidance using visual markers on delivery catheter. Device maintains patency in malignant strictures; covered version additionally occludes esophageal fistulae. Changes from predicate include two adhesive material modifications and addition of visual marker on two models. Benefits include restoration of esophageal patency and fistula management.

Clinical Evidence

Bench testing only. In-vitro testing performed on all components and subassemblies to verify compliance with specifications.

Technological Characteristics

Self-expanding metallic stent; bare or covered configurations. Delivery system includes flexible catheter with proximal or distal release mechanisms. Features radiopaque markers for fluoroscopic guidance and visual markers for endoscopic placement. Adhesive materials modified from predicate. No software or electronic components.

Indications for Use

Indicated for patients with esophageal strictures caused by intrinsic or extrinsic malignant tumors. Covered version also indicated for occlusion of concurrent esophageal fistula.

Regulatory Classification

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.

Special Controls

The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”

Predicate Devices

• UltraflexTM Esophageal NG Stent System (K032930)

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

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:

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.

#### 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.

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.

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).

# 000014

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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 [phone] or [phone] 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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000012

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

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.

#### 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)

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(Division Sign-Off)

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

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