MEMOTHERM COLORECTAL STENT

K990504 · C.R. Bard, Inc. · MQR · Mar 16, 2000 · General, Plastic Surgery

Device Facts

• Record ID: K990504
• Device Name: MEMOTHERM COLORECTAL STENT
• Applicant: C.R. Bard, Inc.
• Product Code: MQR · General, Plastic Surgery
• Decision Date: Mar 16, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3610
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The proposed stent is indicated for the palliative treatment of colonic strictures and obstruction caused by malignant neoplasms in the rectum, sigmoid colon and descending colon.

Device Story

Memotherm Colorectal Stent is a self-expanding nitinol metal stent with flared ends; used for palliative treatment of malignant colonic strictures/obstructions. Device includes stent and coaxial delivery system with inner catheter, outer sheath, and pistol-grip handle. Physician positions device under fluoroscopic guidance after guidewire placement via colonoscope. Stent expands upon release from delivery system, exerting radial force to maintain lumen patency. Benefits include relief from partial or complete obstructions caused by colon cancer.

Clinical Evidence

No clinical data. Evidence based on published scientific literature regarding in vivo use of self-expanding metal stents for palliative treatment of colon cancer, supplemented by comparative bench testing (tensile, dimensional, trackability, deployment, expansion/compression) against the predicate device.

Technological Characteristics

Biocompatible nitinol self-expanding stent; coaxial delivery system with uni-directional pistol grip handle; radiopaque markers for positioning; available in 20-30mm diameters and 60-100mm lengths.

Indications for Use

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

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

• WALLSTENT® Enteral Endoprosthesis

Submission Summary (Full Text)

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## MAR 1 6 2000

K 990504 1083

Bard Interventional Products Division C.R. Bard, Inc. 129 Concord Road P.O. Box 7031 Billerica, MA 01821-7031 978-663-8989

BARD

## VI 510(k) SUMMARY SAFETY AND EFFECTIVENESS INFORMATION

As required by the Safe Medical Devices Act of 1990, codified under Section 513, Part (i)(3)(A) of the Food Drug and Cosmetic Act, a summary of the safety and effectiveness information upon which substantial equivalence determination is based follows.

- A. Submitter Information

| Submitter's Name: | Bard Interventional Products Division<br>C.R. Bard, Inc. |
|----------------------|----------------------------------------------------------|
| Address: | 129 Concord Road, Bldg. #3<br>Billerica, MA 01821 |
| Phone: | 978 - 262 - 4867 |
| Fax: | 978 - 262 - 4878 |
| Contact Person: | Marion Gordon, R.A.C. |
| Date of Preparation: | December 11, 1998 |

- B. Device Name

| Trade Name: | Memotherm® Colorectal Stent |
|----------------------|------------------------------------|
| Common/Usual Name: | Expandable, metallic colonic stent |
| Classification Name: | FDA has not classified to date |

- C. Predicate Device Name
Trade Name:

WALLSTENT® Enteral Endoprosthesis Schneider (USA), Inc.

- D. Device Description:
The Memotherm® Colorectal Stent comprised of two components - a self-expanding implantable metal stent and the delivery device. The stent is a nitinol grid-like cylinder with flared ends, available in 20 and 30mm

25

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diameters and 60, 80, and 100mm lengths. While mounted on the deployment system the stent is compressed. Upon release of the stent from the deployment system the nitinol cylinder expands. The coaxial deployment system consists of an inner catheter, an outer sheath and an ergonomically shaped handgrip. Female luer injection ports are included on the back of the handgrip and ratchet carriage. Two radiopaque markers are positioned on the deployment system to mark both ends of the stent.

- Intended Use: ن
The proposed stent is indicated for the palliative treatment of colonic strictures and obstruction caused by malignant neoplasms in the rectum, sigmoid colon and descending colon.

- Technological Characteristics Summary: F.
The Memotherm® Colorectal Stent is a metal stent constructed of biocompatible nitinol. The self-expanding stent is packaged pre-mounted on a disposable delivery system that utilizes an uni-directional, pistol grip handle release mechanism.

The Memotherm® Colorectal Stent is substantially equivalent to the Schneider WALLSTENT® Enteral Endoprosthesis. Both devices are manufactured with a delivery system that implants a self-expanding metal stent over a guidewire using a coaxial, interfacing catheter/sheath (tubes). While each manufacturer's metal stents are made from different materials, both allow for self-expanding deployment using radial force to expand the inner colon lumen. The WALLSTENT can be placed via the colonoscope's working channel, while the Memotherm is positioned using fluoroscopy after the guidewire has been inserted using the colonoscope. Both manufacturers have the same intended use for the device and have stents within the same range of diameters and lengths.

- G. Performance Data
Safe and effective in vivo use of self-expanding, metal stents in the colon

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has been demonstrated in relevant published, scientific, literature. Metal stents have been shown to be effective, in palliative treatment of colon cancers, and give the patients relief from partial or complete obstructions caused by the disease.

Comparative performance testing was done, where appropriate, between the Memotherm and WALLSTENT. In addition to testing various tensile and dimensional verifications, other bench data included trackability, deployment and stent expansion/compression were completed. The stent is resistant to corrosion within the intended anatomical environment based on Bard's experience with other metal stents. All data was within the anticipated results.

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Image /page/3/Picture/2 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 representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

MAR 1 6 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Marion Gordon, R.A.C. Senior Regulatory Affairs Coordinator Bard Interventional Products Division C.R. Bard, Inc. 129 Concord Road, Bldg. #3 P.O. Box 7031 Billerica. MA 01821-7031

Re: K990504 Memotherm® Colorectal Stent

Dated: October 8, 1999 Received: October 12, 1999 Regulatory Class: III 21 CFR 878.3610/Procode: 78 MQR

Dear Ms. Gordon:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls of the Act indude 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| 510(k) Number (if known): | TBD K090504 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Memotherm Colorectal Stent |
| Indications For Use: | The Memotherm colorectal stent is indicated for the palliative treatment of colonic strictures and obstruction caused by malignant neoplasms in the rectum, sigmoid colon and descending colon. |

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| Prescription Use | <div style="text-align:left;"> <div style="display:inline-block; vertical-align:middle;"></div> </div> | OR | Over-The-Counter Use | <div style="text-align:left;"> <div style="display:inline-block; vertical-align:middle;"></div> </div> |
|----------------------|--------------------------------------------------------------------------------------------------------|----|--------------------------|--------------------------------------------------------------------------------------------------------|
| (Per 21 CFR 801.109) | | | (Optional Format 1-2-96) | |

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT,

and Radiological Devices

| 510(k) Number | K990504/5002 |
|---------------|--------------|
|---------------|--------------|

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