BARD CONFORMEXX BILIARY STENT AND DELIVERY SYSTEM

K021994 · C.R. Bard, Inc. · FGE · Jan 2, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K021994
• Device Name: BARD CONFORMEXX BILIARY STENT AND DELIVERY SYSTEM
• Applicant: C.R. Bard, Inc.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Jan 2, 2003
• Decision: SESU
• Submission Type: Abbreviated
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Bard® CONFORMEXX™ Biliary Stent and Delivery System is indicated for use in the treatment of biliary strictures resulting from malignant neoplasms.

Device Story

The Bard® CONFORMEXX™ Biliary Stent and Delivery System is a self-expanding nitinol metal mesh stent pre-loaded on a 6 Fr delivery system. It is used to maintain patency in biliary ducts obstructed by malignant neoplasms. The device is operated by a clinician in a clinical setting. The stent is deployed via the delivery system, which is compatible with 0.018" to 0.035" guidewires and 6 Fr introducers. The delivery system is designed for trackability through tortuous anatomy to ensure accurate stent placement. By expanding within the stricture, the stent restores bile flow, potentially alleviating symptoms associated with biliary obstruction. The device is not indicated for vascular use.

Clinical Evidence

Bench testing only. Performance data confirmed that the stent tracks through tortuous paths, achieves accurate placement, and exhibits expansion and compression forces comparable to predicate devices. Corrosion resistance in bile was verified. Delivery system bond joint tensile strengths were tested and found comparable to predicates.

Technological Characteristics

Self-expanding metal mesh stent constructed of nitinol. Stent geometry consists of laser-cut rhombi. Delivery system is 6 Fr, 135cm length, compatible with 0.018"-0.035" guidewires. Mechanical device; no software or energy source.

Indications for Use

Indicated for patients with biliary strictures caused by malignant neoplasms.

Regulatory Classification

Identification

A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.

Special Controls

*Classification.* Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Predicate Devices

• Bard® memotherm-FLEXX™ Biliary Stent
• Bard® memotherm Transhepatic Biliary Endoprosthesis
• Bard® LUMINEXX™ 6 Fr Delivery System

Submission Summary (Full Text)

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KO21994

IMPRA A Subsidiary of C. R. Bard, Inc. 1625 West 3rd Street P.O. Box 1740 Tempe. AZ 85280-1740 TEL: [phone] FAX: [phone]

JAN 0 2 2003

IMPA

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENES INFORMATION

Submitter Information: A.

> Impra, Inc. Submitter's Name: Submitter's Address: 1625 West 3rd Street Tempe, AZ 85281 Contact Person: Aymee Berry Contact Person's Telephone Number: [phone] [phone] Contact Person's FAX Number: Date of Preparation: June 12, 2002

- Device Name: B.
Bard® CONFORMEXX™ Biliary Stent and Delivery System

- C. Predicate Device:
Bard® memotherm-FLEXX™ Biliary Stent Bard® memotherm Transhepatic Biliary Endoprosthesis Bard® LUMINEXX™ 6 Fr Delivery System

- D. Device Description:
The Bard® CONFORMEXX™ Biliary Stent and Delivery System is a stenting device designed to maintain the patency of biliary ducts obstructed by malignant neoplasms. The device includes the self-expanding Bard® CONFORMEXX™ Biliary Stent pre-loaded on a unique delivery system. The stent is available in a variety of diameters and lengths.

The 6 Fr delivery system is compatible with a 6 Fr introducer and accepts a 0.018" to 0.035" guidewire. The delivery systems is 135cm in length.

Image /page/0/Picture/14 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, with a white fill. The word is slightly distorted, with some of the letters appearing to be slightly tilted or skewed. The overall effect is a somewhat rough or textured appearance.

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- E. Intended Use:
The Bard® CONFORMEXX™ Biliary Stent and Delivery System is indicated for use in the treatment of biliary strictures resulting from malignant neoplasms.

- Technological Characteristics Summary: F.
The Bard® CONFORMEXX™ Biliary Stent is a metal mesh stent constructed of nitinol. The nitinol tube is laser cut into a series of rhombi.

The flexibility of the Bard® CONFORMEXX™ Delivery System allows for smooth trackability and accurate stent placement.

- Performance Data: G.
The Bard® CONFORMEXX™ Biliary Stent tracks easily from the delivery system, even in a tortuous path. Accuracy of placement, expansion and compression force test results are comparable to those of the predicate devices. The stent is resistant to corrosion by bile.

The delivery system bond joint tensile strengths vary depending on the bond location but are comparable to those of the predicate device.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image contains the words "Public Health Service". The words are stacked on top of each other. The text is in a simple, sans-serif font.

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized design featuring three curved shapes, resembling a bird or abstract symbol. The image is in black and white.

JAN 2 - 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Aymee R. Berry Senior Regulatory Affairs Specialist C.R. Bard, Inc., Division of IMPRA, Inc 1625 West 3rd Street TEMPE AZ 85281

Re: K021994

Trade/Device Name: Bard® CONFORMEXX™ Biliary Stent and Delivery System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: October 2, 2002 Received: October 3, 2002

Dear Ms. Berry:

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 and the limitations described below. 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.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:

The safety and effectiveness of this device for use in the vascular system have not been established.

Furthermore, the indication for biliary use must be prominently displayed in all labeling, including pouch, box, and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.

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## Page. 2 - Ms. Avmee R. Berry

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.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement above is added to your labeling, as described.

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801 and additionally Part 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 Part 807.97). 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.qov/cdrh/dsma/dsmamain.html.

Sincerely yours,

David C. Sabol, M.D.

Daniel G. Schultz, M.D. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page

510(k) Number (if known): K021994

Device Name: Bard® CONFORMEXX™ Biliary Stent and Delivery System

FDA's Statement of the Indications For Use for device:

The Bard® CONFORMEXX™ Biliary Stent and Delivery System is indicated for use in the treatment of biliary strictures resulting from malignant neoplasms.

Prescription Use ✓ OR (Per 21 CFR 801.109)

Over-The-Counter Use_

Nancy C Brogdon

510(k) Num