ULTRAFLEX PRECISION COLONIC STENT

K030769 · Boston Scientific Corp · MQR · Jul 14, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K030769
• Device Name: ULTRAFLEX PRECISION COLONIC STENT
• Applicant: Boston Scientific Corp
• Product Code: MQR · General, Plastic Surgery
• Decision Date: Jul 14, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3610
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ultraflex ™Precision™ Colonic Stent is indicated for palliative treatment of colonic strictures in the descending colon, sigmoid colon and rectum caused by malignant neoplasms.

Device Story

Ultraflex Precision Colonic Stent System consists of self-expanding Nitinol wire stent and delivery catheter; used for palliative treatment of malignant colorectal strictures. Stent features cylindrical body with flared distal section; compressed onto tapered delivery catheter shaft; secured with braided nylon suture using crochet stitch. Deployment involves holding handle stationary and pulling ring to unravel suture. Device used by physicians in clinical setting. Stent provides mechanical support to maintain patency of strictured colon, alleviating obstruction and improving patient quality of life.

Clinical Evidence

Literature documents use of self-expanding metal stents for malignant colorectal strictures. Performance established via comparative bench testing against predicate and in vivo testing demonstrating safety and effectiveness.

Technological Characteristics

Nitinol self-expanding stent; 25mm body diameter, 30mm flared distal section; 6cm, 9cm, 12cm lengths. Delivery system uses braided nylon suture crochet stitch release mechanism. Non-software device.

Indications for Use

Indicated for palliative treatment of malignant colonic strictures in the descending colon, sigmoid colon, and rectum.

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

• C.R. Bard Memotherm® Colorectal Stent

Submission Summary (Full Text)

{0}------------------------------------------------

KO30769

JUL 1 4 2003

Microvasive Endoscopy Boston Sommi · Corporation One Boston Scientific Place Natick, MA J7769 1537 508-650-8000

www.bsci.com

## SECTION 11 510(K) SUMMARY

### 510(K) SUMMARY

#### 1. Submitter:

Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537

Contact: Kathleen Morahan, RAC Regulatory Affairs Manager Date Prepared: March 10, 2003

#### 2. Device:

Trade Name: Ultraflex™ Precision™ Colonic Stent System Common Name: Expandable, metallic colonic stent Classification Name: Not classified

## 3. Predicate Device:

C.R. Bard Memotherm® Colorectal Stent

# 4. Device Description:

The proposed Ultraflex™ Precision™ Colonic Stent System consists of a self-expanding metal stent and a delivery catheter. The proposed stent consists of Nitinol wires wound together to form a cylinder with a flared distal section. The proposed stent is mounted on a delivery catheter. The stent is compressed onto the tapered delivery catheter shaft and bound with braided nylon suture using a crochet stitch. The stent is deployed by holding the handle stationary and pulling a ring to unravel the crochet stitch.

{1}------------------------------------------------

### 6. Technological Characteristics:

The proposed Ultraflex™ Precision™ Colonic Stent System is a Nitinol, self-expanding stent mounted on a delivery catheter. The proposed stent diameter is 25mm along the body and 30mm at the flared distal section; the lengths are 6cm, 9cm, and 12cm.

The Ultraflex™ Precision™ Colonic Stent System is substantially equivalent to C.R. Bard's Memotherm Colorectal Stent. The devices have intended use and are both self-expanding stents constructed of Nitinol. Both stents are mounted on a delivery catheter, however the delivery catheter designs differ. The proposed Ultraflex™ Precision™ Colonic stent is bound onto the delivery catheter shaft with braided nylon suture using a crochet stitch. The predicate Memotherm Colorectal stent delivery catheter utilizes a co-axial tube and the stent is constrained onto the delivery catheter shaft by the outer sheath.

## 7. Performance Data:

The use of self-expanding metal stents for palliation of malignant colorectal strictures is well documented in the literature.

Comparative performance testing was performed, where appropriate, between the proposed Ultraflex Precision Colonic Stent System and the Bard Memotherm Colorectal Stent System to establish substantial equivalence. Additional performance data, such as tensile strength, fatigue, and corrosion resistance testing was also performed.

In vivo testing of the proposed Ultraflex Precision Colonic Stent System demonstrates that the device is safe and effective for its intended use.

#### 8. Conclusion:

BSC has demonstrated that Ultraflex Precision Colonic Stent System is substantially equivalent to C.R. Bard's currently marketed Memotherm® Colorectal Stent.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 4 2003

Ms. Kathleen Morahan Manager Regulatory Affairs Boston Scientific Corporation One Boston Scientific Place NATICK MA 01760

Re: K030769

Trade/Device Name: Ultraflex Precision Colonic Stent System Regulation Number: 21 CFR 878.3610 Regulation Name: Esophageal prosthesis Regulatory Class: II Product Code: 78 MQR Dated: June 12, 2003 Received: June 16, 2003

Dear Ms. Morahan:

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. Drue, 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); 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.

{3}------------------------------------------------

This letter will allow you to begin 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 one of the following numbers, based on the regulation number at the top of the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, 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 may be obtained 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,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# SECTION 3 INDICATIONS FOR USE

510(k) Number:

To Be Determined

Ko30769

Device Name:

Ultraflex ™Precision™ Colonic Stent

Indication for Use:

The Ultraflex ™Precision™ Colonic Stent is indicated for palliative treatment of colonic strictures in the descending colon, sigmoid colon and rectum caused by malignant neoplasms.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use 1 (Per 21 CFR 801.1091) (Optional Format 1-2-96)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Daniel A. Jepson

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number K030769

Premarket Notification, Ultraflex™ Precision Colonic Stent System Proprietary and Confidential Information of Boston Scientific Corporation