BARD CONFORMEXX BILIARY STENT WITH THE PERFORMAXX GRIP

K052114 · Bard Peripheral Vascular, Inc. · FGE · Aug 25, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K052114
• Device Name: BARD CONFORMEXX BILIARY STENT WITH THE PERFORMAXX GRIP
• Applicant: Bard Peripheral Vascular, Inc.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Aug 25, 2005
• Decision: SESU
• Submission Type: Special
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Bard® CONFORMEXX™ Biliary Stent with the PerforMAXX™ Grip is intended for palliation of malignant strictures in the biliary tree.

Device Story

Self-expanding Nitinol biliary stent preloaded on BARD S.A.F.E. delivery system; features PerforMAXX™ grip for deployment. Used for palliation of malignant biliary strictures. Operated by physicians in clinical settings. Device maintains duct patency via radial force. Modifications from predicate include addition of PerforMAXX™ grip, additional delivery system lengths, and packaging changes. Output is physical stent placement to relieve obstruction. Benefits include improved biliary drainage and symptom management for patients with malignant neoplasms.

Clinical Evidence

Bench testing only. Design verification and validation performed in accordance with FDA guidance 'Content of Premarket Notifications for Metal Expandable Biliary Stents' (1998). All test results confirmed substantial equivalence to the predicate device.

Technological Characteristics

Self-expanding Nitinol stent; preloaded on flexible delivery system. Available in various diameters and lengths. Sterilization method consistent with predicate. No software or electronic components.

Indications for Use

Indicated for the treatment of biliary strictures resulting from malignant neoplasms in patients requiring biliary stenting.

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

• CONFORMEXX™ Biliary Stent and Delivery System (K021994)

Submission Summary (Full Text)

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K052114
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# CONFORMEXX™ Biliary Stent with the PerforMAXX™ Grip 510(k) Summary of Safety and Effectiveness 21 CFR 807.92(a).

As required by the Safe Medical Devices Act of 1990, coded 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 as follows:

#### General Information:

| Submitter Name: | Bard Peripheral Vascular, Inc. |
|---------------------|---------------------------------------------------------------|
| Address: | 1625 W. Third Street<br>P.O. BOX 1740<br>Tempe, AZ 85280-1740 |
| Telephone Number: | [phone] |
| Fax Number: | [phone] |
| Contact Person: | Dennis Salzmann, Ph.D.<br>Manager, Regulatory Affairs |
| Device Information: | |
| Device Trade Name: | CONFORMEXX™ Biliary Stent with the PerforMAXX™ Grip |

Common/Usual Name: Biliary Stent Class II Classification:

Classification Panel: Gastroenterology/Urology

# Predicate Device:

CONFORMEXX™ Biliary Stent and Delivery System (K021994, cleared January 2, 2003)

# Summary of Change:

The design modifications to the CONFORMEXX™ Biliary Stent and Delivery System are addition of the PerforMAXX™ Grip, an additional delivery system length, and modification of the packaging. These changes result in a subject device that provides more deployment methods and delivery system length options for physicians. All other aspects of the subject device remain the same as the predicate devices.

Image /page/0/Picture/14 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, giving them a distinct and prominent appearance. The font style is consistent throughout the word, creating a unified and recognizable logo or brand name.

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#### Device Description:

The Bard® CONFORMEXX™ Biliary Stent with the PerforMAXX™ Grip is a stenting device designed to maintain the patency of biliary ducts obstructed by malignant neoplasms. The device includes the self-expanding Nitino! CONFORMEXX™ Stent preloaded on a flexible, multifunctional stent deployment system, the BARD S.A.F.E. ™ Delivery System with the PerforMAXX™ Grip. It is preloaded into the delivery system and is available in two delivery system lengths, and various device diameters and lengths.

#### Intended Use of Device:

The Bard® CONFORMEXX™ Biliary Stent with the PerforMAXXT™ Grip is intended for palliation of malignant strictures in the biliary tree.

# Technological Comparison to Predicate Device:

The technological characteristics of the Bard® CONFORMEXX™ Biliary Stent with the PerforMAXX™ Grip are substantially equivalent to those of the predicate Bard® CONFORMEXX™ Biliary Stent and Delivery System in terms of intended use, application, user population, basic design, performance, labeling, and sterilization method.

# Non-Clinical Performance Data:

Design verification and validation of the modified device was done with conformance to or evaluated based on the following FDA guidance document:

Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents, February 5, 1998.

All test results confirm the modified device to be substantially equivalent to the predicate devices.

Image /page/1/Picture/15 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are all capitalized and appear to be outlined in black. The letter "A" is stylized with a horizontal line through the middle, resembling the Greek letter lambda.

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#### Conclusions:

The Bard® CONFORMEXX™ Biliary Stent with the PerforMAXX™ Grip met all the predetermined performance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs. The Bard® CONFORMEXX™ Biliary Stent with the PerforMAXX™ Grip is substantially equivalent to the legally marketed predicate device, the Bard® CONFORMEXX™ Biliary Stent and Delivery System.

TRADE SECRET/CONFIDENTIAL INFORMATION Notify CR Bard Before Releasing this Document.

Image /page/2/Picture/7 description: The image shows the word "BARD" in a bold, outlined font. The letters are all capitalized and evenly spaced. The font is simple and geometric, with straight lines and sharp angles. The outline gives the word a three-dimensional effect.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 5 2005

Dennis Salzmann, Ph.D. Manager, Regulatory Affairs Bard Peripheral Vascular, Inc. 1625 W. Third Street P.O. Box 1740 TEMPE AZ 85280-1740

Re: K052114 Trade/Device Name: Bard® CONFORMEXXTM Biliary Stent with the PerforMAXXTM Grip Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: August 2, 2005 Received: August 4, 2005

Dear Dr. Salzmann:

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 for use stated in the Merces, 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 and Cosmette Her (1 to) (1 to) provisions of the 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 The Office 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 - Dennis Salzmann, Ph.D.

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Please note that the above labeling innitations are modified in any way or removed from the device's labeling.

The FDA finding of substantial equivalence of your device to a legally marketed predicate I he FDA iniding of substantial equirales is your device and permits your device to proceed to the device results in a classification for your device as described in your Section market. This letter will anow you to evigation statement described above is added to your labeling.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), if your device is classified (\$cc above) into enas regulations affecting your device can be If may be subject to additional controls. Linking majors 800 to 898. In addition, FDA may found in the Code of reactive concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dris Issualloo or our device complies with other requirements of the Act that FDA has made a decermination administered by other Federal agencies. You must of any Federal Statutes and regulations daminitives but not limited to: registration and listing (21 comply with an the Act 3 requirements, merces and manufacturing practice requirements as set CFR Part 807), labeling (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific information about the application of other labeling requirements to your II you desire specific information accuracy as a compliance at [phone]. Also,
device (21 CFR Part 801), please contact the Office of Compliance at [phone]. Al device (21 CFR Part 001); picuse containg by reference to premarket notification" (21) please note the regulation onlined, "Miorraneans of formation on your responsibilities under the CFK Fall 807.77). Pourmay South other gener gener gener Assistance at its Act from the Dryiblem [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Donna-Bea Tillman, Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K052114

Device Name: Bard® CONFORMEXX™ Biliary Stent with the PerforMAXX™ Grip

Indications For Use:

The Bard® CONFORMEXX™ Biliary Stent with the PerforMAXX™ Grip is indicated The Bard® CONFORETER
for the treatment of biliary strictures resulting from malignant neoplasms.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive

\$10(k) Number K052114

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