U-BALLOON DILATION CATHETER

K050875 · C.R. Bard, Inc. · EZN · May 26, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K050875
• Device Name: U-BALLOON DILATION CATHETER
• Applicant: C.R. Bard, Inc.
• Product Code: EZN · Gastroenterology, Urology
• Decision Date: May 26, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Bard® U-Balloon Dilation Catheter is used for dilation of the urinary tract.

Device Story

Bard U-Balloon Dilation Catheter is a mechanical device used for urinary tract dilation. It consists of a dual-lumen shaft (inflation and guidewire lumens) with a distal dilation balloon. Two radiopaque bands facilitate radiographic visualization and placement; a high-pressure stopcock is attached to the inflation lumen. The device is used by clinicians in a medical setting to perform dilation procedures. It functions via mechanical inflation of the balloon to expand the urinary tract, aiding in clinical interventions.

Clinical Evidence

Bench testing only.

Technological Characteristics

Dual-lumen catheter shaft with distal dilation balloon; includes two radiopaque bands for visualization and a high-pressure stopcock. Mechanical dilation principle. No software or electronic components.

Indications for Use

Indicated for dilation of the urinary tract. Patient population not specified.

Regulatory Classification

Identification

A ureteral dilator is a device that consists of a specially shaped catheter or bougie and is used to dilate the ureter at the place where a stone has become lodged or to dilate a ureteral stricture.

Predicate Devices

• Bard® UroForce™ Balloon Dilation Catheter

Submission Summary (Full Text)

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K050875

Bard Urological Division

C. R. Bard, Inc. 8195 Industrial Blvd. Covington, GA 30014

MAY 2 6 2005

Image /page/0/Picture/4 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 letters are closely spaced together, creating a compact and unified visual element. The overall design is simple and impactful.

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

#### A. SUBMITTER INFORMATION:

| Submitter's Name: | C. R. Bard, Inc.<br>Bard Urological Division |
|-------------------|----------------------------------------------|
| Address: | 8195 Industrial Blvd.<br>Covington, GA 30014 |

| Contact Person: | John C. Knorpp |
|------------------------------------|----------------|
| Contact Person's Telephone Number: | 770-784-6451 |
| Contact Person's Fax: | 770-784-6419 |
| Date of Preparation: | April 5, 2005 |

#### B. Device Name:

| Trade Name(s): | Bard® U-Balloon Dilation Catheter |
|-----------------------|--------------------------------------|
| Common/Usual Name: | Balloon Dilation Catheter |
| Classification Names: | 78 EZN – Dilator, Catheter, Ureteral |
| CFR Reference: | 21 CFR 876.5470 |

#### C. PREDICATE DEVICE NAME:

Trade Names: Bard® UroForce™ Balloon Dilation Catheter

#### D. Device Description:

The Bard® U-Balloon Dilation Catheter is composed of a dual lumen shaft with inflation and guidewire lumens and a dilation balloon on the distal end, The catheter has two radiopaque bands which define the balloon working length and facilitate radiographic visualization and placement. A high pressure stopcock is attached to the inflation lumen.

#### ட். INTENDED USE:

The Bard® U-Balloon Dilation Catheter is used for dilation of the urinary tract.

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## F. TECHNOLOGICAL CHARACTERISTICS SUMMARY:

The subject Bard® U-Balloon Dilation Catheter has the same intended use, general design and fundamental scientific technology as the predicate device.

### G. Performance Data Summary:

The appropriate testing to determine substantial equivalence was completed in accordance with Draft Guidance for the Content of Premarket Notifications for Urological Balloon Dilation Catheters (January 24, 1992),

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Image /page/2/Picture/12 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular fashion around the bird figure.

MAY 2 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. John C. Knorpp Manager, Regulatory Projects Bard Urological Division C. R. Bard, Inc. 8195 Industrial Blvd. COVINGTON GA 30014-2655

Re: K050875

Trade/Device Name: Bard U-Balloon Dilation Catheter Regulation Number: 21 CFR §876.5470 Regulation Name: Ureteral dilator Regulatory Class: II Product Code: EZN Dated: April 5, 2005 Received: April 6, 2005

Dear Mr. Knorpp:

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, al tile Are 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.

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 nust comply with 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 radion control provisions (2 (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) 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), 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.xxxxx | (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/dsmadsmam.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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C.R. Bard, Inc., Bard Urological Division Bard® U-Balloon Dilation Catheter Premarket Notification [510(k)]

1.3 Indications for Use Statement

0-70874 510(k) Number (if known):

Bard® U-Balloon Dilation Catheter Device Name:

Indications for Use:

The Bard® U-Balloon Dilation Catheter is indicated for dilation of the urinary tract.

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

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

David h. lyon

(Division Sign-O Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

(Recommended Format 11/13/2003)