ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380

K060323 · Boston Scientific Corporation · MQR · May 12, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K060323
• Device Name: ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380
• Applicant: Boston Scientific Corporation
• Product Code: MQR · General, Plastic Surgery
• Decision Date: May 12, 2006
• 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 and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.

Device Story

Self-expanding metallic stent system for colonic strictures. Device consists of Nitinol wire cylinder with flared distal section mounted on tapered delivery catheter. Stent compressed onto catheter and secured with braided nylon suture using crochet stitch. Deployment achieved by holding handle stationary and pulling ring to unravel suture. Used by clinicians in clinical setting to provide mechanical patency in obstructed colon. Benefits include palliative symptom relief and bowel decompression prior to surgical intervention.

Clinical Evidence

Clinical data provided in support of the proposed indication. No new bench testing performed as design and materials are identical to the predicate.

Technological Characteristics

Self-expanding metallic stent; Nitinol wire construction; delivery catheter with braided nylon suture release mechanism; flared distal section. No changes to materials or design from predicate.

Indications for Use

Indicated for patients with malignant neoplasms causing colonic strictures in the descending colon, sigmoid colon, or rectum. Used for palliative treatment or to relieve large bowel obstruction prior to colectomy.

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™ Precision™ Colonic Stent System (K030769)
• Wallstent Enteral Stent (K000281)

Submission Summary (Full Text)

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K060323
page 1 of 2

MAY 12 2006

# SECTION 5 510(K) SUMMARY

#### 510(K) SUMMARY

### 1. Submitter:

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

Contact: Jennifer A. Kimball, RAC Principal Regulatory Affairs Specialist Date Prepared: February 8, 2006

#### 2. Device:

Trade Name: Ultraflex™ Precision™ Colonic Stent System Common Name: Expandable, metallic colonic stent Classification Name: Stent, colonic, metallic, expandable Regulation Number: 878.3610 Product Code: MOR Classification: Class II

#### 3. Predicate Device:

Boston Scientific Corporation's Ultraflex™ Precision™ Colonic Stent System, K030769 Boston Scientific Corporation's Wallstent Enteral Stent, K000281 Both predicates are class II devices per 21 CFR 878.3610

## 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.

### 5. 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 and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.

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## 6. Technological Characteristics:

The proposed Ultraflex Precision Colonic Stent has the identical technological characteristics (materials, construction, manufacturing processes) as the currently marketed Ultraflex Precision Colonic Stent.

## 7. Performance Data:

As this is a request for an additional indication and introduces no new materials or design changes the performance testing presented in K030769 was not repeated. Clinical data in support of the proposed indication has been collected and is presented within this submission.

# 8. Conclusion:

Boston Scientific Corporation has demonstrated that the proposed Ultraflex™ Precision™ Colonic Stent is substantially equivalent to Boston Scientific Corporation's currently marketed Ultraflex™ Precision™ Colonic Stent and, in terms of the proposed indication to Boston Scientific Corporation's Wallstent Enteral Stent.

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

**MAY 12 2006**

Ms. Jennifer Kimball Principal Regulatory Specialist Boston Scientific Corporation Endoscopy Division 100 Boston Scientific Way MARLBOROUGH MA 01752

Re: K060323

Trade/Device Name: Ultraflex™ Precision™ Colonic Stent System Regulation Number: 21 CFR §878.3610 Regulation Name: Esophageal prosthesis Regulatory Class: II Product Code: MQR Dated: February 8, 2006 Received: February 13, 2006

#### Dear Ms. Kimball:

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 (Premarket Approval), it may be subject to such 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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I lease of advanced 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.

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 promated novice 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 this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology). | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/industry/support/index.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

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Indications for Use:

510(k) Number (if known): To Be Determined K 0 (e 0322

Device Name: Ultraflex™ Precision™ Colonic Stent System

Indications 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 and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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(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)**
Premarket Notification, Ultraflex™ Precision™ Colonic Stent System
proprietary and Confidential Information of Boston Scientific Corporation

ivision of Reproductive. Abdominal, and Radiological Devic

510(k) Number