ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM

K012883 · Boston Scientific Corp · ESW · Oct 12, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K012883
• Device Name: ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM
• Applicant: Boston Scientific Corp
• Product Code: ESW · General, Plastic Surgery
• Decision Date: Oct 12, 2001
• Decision: SESU
• Submission Type: Special
• Regulation: 21 CFR 878.3610
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The proposed Ultraflex Esophageal Stent System is intended for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors. The proposed Ultraflex Diamond Biliary Stent System is indicated for palliative treament of patients with malignant biliary strictures. The proposed Ultraflex Tracheobronchial Stent System is intended for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.

Device Story

Ultraflex Stent Systems consist of metallic expandable stents mounted on flexible delivery catheters; used for esophageal, biliary, and tracheobronchial strictures caused by malignant tumors. Delivery catheter placed over guidewire through endoscope working channel; stent deployed to maintain patency. Used in clinical settings by physicians. Device provides mechanical support to strictured anatomy to improve patient quality of life by relieving obstruction. Subject of 510(k) is to establish MRI safety and compatibility.

Clinical Evidence

Bench testing only; no clinical data provided. Testing conducted to support MRI safety and compatibility claims.

Technological Characteristics

Metallic expandable stent; flexible delivery catheter; available in various diameters and lengths. MRI safe and compatible.

Indications for Use

Indicated for patients with malignant esophageal strictures (intrinsic/extrinsic), malignant biliary strictures (palliative), or malignant tracheobronchial strictures.

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

• Ultraflex Esophageal Stent System (K940838)
• Ultraflex Diamond Biliary Stent System (K962899)
• Ultraflex Tracheobronchial Stent System (K963241)

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a stylized image of an eagle. The eagle is depicted with three profiles, representing the department's focus on health, human services, and well-being. The seal is simple and monochromatic.

# AUG 15 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Boston Scientific Corporation % Ms. Angela Byland Manager, Regulatory Affairs Cardiovascular Two Scimed Place Maple Grove, Minnesota 55311

Re: K012883

Trade/Device Name: Ultraflex Stent Systems (i.e., Ultraflex Esophageal Stent System, Ultraflex Diamond Biliary Stent System, and Ultraflex Tracheobronchial Stent System) Regulation Number: 21 CFR 878.3610, 21 CFR 876.5010. and 21 CFR 878.3720

Regulation Name: Prosthesis, tracheal, expandable Regulatory Class: II Product Code: ESW, FGE, and JCT Dated: October 1, 2001 Received: October 2, 2001

Dear Ms. Byland:

This letter corrects our substantially equivalent letter of October 12, 2001.

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 (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

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Page 2 - Ms. Angela Byland

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.

This letter will allow you to continue 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 [phone]. 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 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/dsma/dsmamain.html

Sincerely yours,

Hubert Lermus

Mark N. Melkerson Director

Division of General, Restorative and Neurological Devices Office of Device Evaluatin Center for Devices and Radiological Devices

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# Indications for Use

K012883 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Ultraflex Diamond Biliary Stent

Indications For Use:

The Ultraflex Diamond Biliary Stent is indicated for palliative treatment of patients with malignant biliary strictures.

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

Over-The-Counter Use (21 CFR 801 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 General, Restorative, and Neurological Devices Page 1 of _

6012883 510(k) Number_

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# Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Ultraflex Esophageal Stent System Device Name:

Indications For Use:

The Ultraflex Esophageal Stent System is indicated for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors.

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evalyation (ODE)

Hule Leun

(Division Sign-Division of General, I Restor and Neurological Devices

1012883 510(k) Number_

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# Indications for Use

510(k) Number (if known): K012883

Ultraflex™ Tracheobronchial Stent System Device Name:

Indications for Use:

The Ultraflex Tracheobronchial Stent System is indicated for treatment of tracheobronchial strictures produced by malignant neoplasms.

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

Over-The-Counter Use (21 CFR 801 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 General, Restorative, Page 1 of 1
and Neurological Devices

510(k) Number K012883

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D12883 p. 1 of 2

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## 510(K) SUMMARY K012883

### 1. Submitter:

Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01545 Telephone: [phone] Fax: [phone]

Contact: Kathleen Morahan Director Regulatory Affairs Original Date Prepared: August 6, 2001 Revision Date: July 14, 2006

#### . 2. Device:

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

Trade Name: Ultraflex™ Diamond Biliary Stent System Common Name: Biliary Stent Classification Name: Biliary Catheter and Accessories Regulation Number: 876.5010 Product Code: FGE Classification: Class II

Trade Name: Ultraflex™ Tracheobronchial Stent System Common Name: Tracheal Prosthesis Classification Name: Tracheal Prosthesis Regulation Number: 878.3720 Product Code: JCT Classification: Class II

#### 3. Predicate Device:

Boston Scientific Corporation's Ultraflex™ Esophageal Stent System, K940838 Boston Scientific Corporation's Ultraflex™ Diamond Biliary Stent System, K962899 Boston Scientific Corporation's Ultraflex™ Tracheobronchial Stent System, K963241

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012883 p. 2 of 2

### 4. Device Description:

The proposed Esophageal, Biliary and Tracheobronchial Ultraflex stents are comprised of two components, a metallic expandable stent and a flexible delivery catheter. The stents are mounted on a delivery catheter. The delivery catheter is placed over a guidewire and through the working channel of an endoscope to deliver the stents are available in a variety of diameters and lengths.

### 5. Intended Use:

The proposed Ultraflex Esophageal Stent System is intended for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors.

The proposed Ultraflex Diamond Biliary Stent System is indicated for palliative treament of patients with malignant biliary strictures.

The proposed Ultraflex Tracheobronchial Stent System is intended for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.

#### 6. Technological Characteristics:

There are no differences in the technological characteristics between the proposed and predicate devices. The purpose of this Special 510(k) is to request a labeling claim that the Ultraflex stents are MRI safe and MRI compatible.

#### 7. Performance Data:

Bench testing was conducted to support the MRI safety and compatibility claim.

#### 8. Conclusion:

Boston Scientific Corporation has demonstrated that the proposed Esophageal, Biliary and Tracheobronchial Ultraflex stents are substantially equivalent to Boston Scientific Corporation's currently marketed Esophageal, Biliary and Tracheobronchial Ultraflex stents.