WALLFLEX ENTERNAL COLONIC STENT AND ANCHOR LOCK DELIVERY SYSTEM

K042065 · Boston Scientific Corp · MQR · Sep 30, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K042065
• Device Name: WALLFLEX ENTERNAL COLONIC STENT AND ANCHOR LOCK DELIVERY SYSTEM
• Applicant: Boston Scientific Corp
• Product Code: MQR · General, Plastic Surgery
• Decision Date: Sep 30, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3610
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The proposed WallFlex™ Enteral Colonic Stent with Anchor Lock Delivery System is indicated for palliative treatment of colonic strictures caused by malignant neoplasms.

Device Story

WallFlex Enteral Colonic Stent with Anchor Lock Delivery System is a self-expanding Nitinol stent used for palliative treatment of malignant colonic strictures. The device consists of an implantable metal stent and a coaxial tubing delivery system. The stent is deployed by retracting an exterior tube on the delivery catheter. Used by clinicians in a clinical setting to maintain patency in obstructed colons; the device provides mechanical support to the stricture site, relieving obstruction and improving patient quality of life.

Clinical Evidence

Bench testing only. Comparative performance testing included dimensional evaluation, fatigue testing, radial force comparison, deployment and reconstrainment force, bond integrity, and MRI compatibility testing.

Technological Characteristics

Self-expanding Nitinol stent; coaxial tubing delivery system; available in 25mm and 22mm diameters with 6cm, 9cm, and 12cm lengths. Mechanical deployment via retraction of exterior tube.

Indications for Use

Indicated for palliative treatment of colonic strictures caused by malignant neoplasms in adult patients.

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 Endoprosthesis and Unistep Plus Delivery System (K000281)

Submission Summary (Full Text)

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Endoscopy

SECTION 10 510(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: July 30, 2004

#### 2. Device:

Trade Name: WallFlex™ Enteral Colonic Stent with Anchor Lock Delivery System Common Name: Expandable, metal colonic stent Classification Name: Stent, colonic, metallic, expandable Product Code: MQR Classification: Class II

# 3. Predicate Device:

Boston Scientific Corporation's Ultraflex™ Precision™ Colonic Stent System, K030769.

Boston Scientific Corporation's Wallstent Enteral Endoprosthesis and Unistep Plus Delivery System, K000281.

#### 4. Device Description:

The proposed WallFlex™ Enteral Stent with Anchor Lock Delivery System consists of two components: an implantable metal stent and a delivery system. The proposed stent is two components: an insplantaoffered in two diameters: 25mm body with a 30mm flare, mandracetal or over with a 27mm flare. Each diameter is offered in three lengths, 6cm, 9cm, and 12cm. The proposed Anchor Lock delivery consists of a coaxial tubing assembly that constrains the stent on the delivery catheter shaft until the stent is released by retracting the exterior tube.

#### 5. Intended Use:

The proposed WallFlex™ Enteral Colonic Stent with Anchor Lock Delivery System is indicated for palliative treatment of colonic strictures caused by malignant neoplasms.

Premarket Notification, WallFlex Enteral Colonic Stent with Anchor Lock Delivery System Proprietary and Confidential Information of Boston Scientific Corporation

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# 6. Technological Characteristics:

Essentially, the proposed WallFlex™ Enteral Colonic Stent with Anchor Lock Delivery System has the same technological characteristics as the predicate devices. The proposed stent combines the design features of the Ultraflex™ Precision™ Colonic stent and the Wallstent Enteral stent, yielding a self-expanding Nitinol stent. The proposed Anchor Lock delivery consists of a coaxial tubing assembly that constrains the stent on the delivery catheter shaft until the stent is released by retracting the exterior tube, like the predicate Wallstent Unistep Plus delivery system.

## 7. Performance Data:

Comparative performance testing was performed to establish substantial equivalence between the proposed WallFlex™ Enteral Colonic Stent with Anchor Lock Delivery System, and the predicate Ultraflex Precision Colonic Stent System, and the Wallstent Enteral Endoprothesis with Unistep Plus Delivery System. This testing included but was not limited to a dimensional evaluation, fatigue testing, radial force comparison, deployment and reconstrainment force, bond integrity and MRI.

## 8. Conclusion:

Boston Scientific Corporation has demonstrated that WallFlex Enteral Colonic Stent with Anchor Lock Delivery system is substantially equivalent to Boston Scientific Corporation's currently marketed Ultraflex™ Precision™ Colonic Stent and the Wallstent Enteral Endoprosthesis with Unistep Plus Delivery System.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 3 0 2004

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

Re: K042065

K 042065
Trade/Device Name: WallFlex™ Enteral Colonic Stent and Anchor Lock Delivery System 25mm and 22mm x 90mm, -120mm, and -60mm Regulation Number: 21 CFR §878.3610 Regulation Name: Esophageal prosthesis Regulatory Class: II Product Code: 78 MQR Dated: July 30, 2004 Received: August 12, 2004

Dear Ms. Morahan:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your bector 310(a) fee 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 connine.cc proc to may 20, 1978, as eccordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). alle Cosmette Act (110) market the device, subject to the general controls provisions of the Act. The I ou may, therefore, market the act include requirements for annual registration, listing of general controls provisions of ractice, 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 your device is classified (600 above) a Existing major regulations affecting your device can be It may be subject to additions, Title 21, Parts 800 to 898. In addition, FDA may round in the Ood of Pressiants concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Picase oe advised that 1 277 5 155aates or our device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of any Federal Statues and roganders including, but not limited to: registration and listing Comply with an the Ace 3 requirements) xxxxl 801); good manufacturing practice requirements as set (21 CFR Part 607), laborning (21 CFR Part 820); and if applicable, the electronic Iorni in the quality by tions (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin marketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your premarket notification. The FD7A inding of substantial equivation of 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
r the regulation If you desire specific advice for your device on 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 Additionally, for questions on the pronocol and and the regulation entitled, "Mashranding
Office of Compliance at [phone]. Other of Compliance at (501) 594-057. Tax (207.97) you may obtain. Other general by reference to premarket notification (21 cc 1 c = 0 +7 joed from the Division of Small
information on your responsibilities under the Act may be obtained from the (800) 63 information on your responsibilities under the research its toll-free number [phone] or
Manufacturers, International and Consumer Assiss assessed instal Manufacturers, International and Collisation in and Collectives and Collectives and manufacturers.

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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# SECTION 3 INDICATIONS FOR USE

Indications for Use:

510(k) Number (if known): Fo-Be Determined 5 0420 (se

Device Name: WallFlex™ Enteral Colonic Stent with Anchor Lock Delivery System

Indications For Use:

The WallFlex™ Enteral Colonic Stent with Anchor Lock Delivery System is indicated The Wall'Iex - Encrai-Colonic strictures caused by malignant neoplasms.

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)

et Notification, WallFlex Enteral Colonic Stent with Anchor Lock Delivery System
mproprietary and Confidential Information of Boston Scientific Corporation

04206

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number

00000:3