BARD DUAL LUMEN URETERAL CATHETER

K032521 · C.R. Bard, Inc. · EYB · Nov 14, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K032521
• Device Name: BARD DUAL LUMEN URETERAL CATHETER
• Applicant: C.R. Bard, Inc.
• Product Code: EYB · Gastroenterology, Urology
• Decision Date: Nov 14, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2

Intended Use

The Bard® Dual Lumen Ureteral Catheter is intended to facilitate drainage and retrograde pyelogram of the upper urinary tract. This catheter will allow access to and navigation of a torturous ureter using standard endoscopic techniques.

Device Story

Bifurcated ureteral catheter; 10 Fr size with 6 Fr tapered tip; 50 cm working length. Features two lumens: one for guidewire passage, one for fluid injection/drainage. Each lumen terminates in a 'Y' extension with a female luer lock for syringe connection. Used by clinicians during endoscopic procedures to access and navigate tortuous ureters. Facilitates upper urinary tract drainage and retrograde pyelogram imaging. Benefits include improved access to difficult anatomy during urological interventions.

Clinical Evidence

Bench testing only; no clinical data provided. Device performance found equivalent to predicate.

Technological Characteristics

Polyurethane construction; bifurcated dual-lumen design; 10 Fr diameter with 6 Fr tapered tip; 50 cm length; female luer lock fittings. Non-powered, mechanical device.

Indications for Use

Indicated for patients requiring drainage or retrograde pyelogram of the upper urinary tract, including navigation of tortuous ureters via standard endoscopic techniques.

Regulatory Classification

Identification

A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).

Predicate Devices

• Bard® Dual Lumen Ureteral Catheter (K032521)

Submission Summary (Full Text)

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# 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:

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

Contact Person: Contact Person's Telephone Number: Contact Person's Fax: Date of Preparation:

Frances E. Harrison, RAC 770-784-6257 770-784-6419 August 7. 2003

# B. Device Name:

| Trade Name: | Bard® Dual Lumen Ureteral Catheter |
|----------------------|-------------------------------------|
| Common / Usual Name: | Ureteral Catheter |
| Classification Name: | Ureteral Catheter (21 CFR 876.5130) |

#### C. PREDICATE DEVICE NAME:

Bard® Dual Lumen Ureteral Catheter Trade Name:

# D. DEVICE DESCRIPTION:

The Dual Lumen Ureteral Catheter is a bifurcated catheter with one lumen used for the passage of a quidewire and the other lumen used to inject or drain fluids. Each "Y" extension employs a female luer lock fitting used for connection to a syringe. The Dual Lumen is available in 10 Fr. with the catheter tip tapered to approximately 6 Fr. The working length of the catheter is 50 cm.

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K032521
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# Intended Use: ய்

The Bard® Dual Lumen Ureteral Catheter is intended to facilitate drainage and retrograde pyelogram of the upper urinary tract. This catheter will allow access to and navigation of a torturous ureter using standard endoscopic techniques.

#### F. TECHNOLOGICAL CHARACTERISTICS SUMMARY:

The Bard® Dual Lumen Ureteral Catheter is constructed of polyurethane. It has the same intended use, general design and is manufactured from the same biocompatible materials as the predicate devices.

### Performance Data Summary: G.

The Bard® Dual Lumen Ureteral Catheter is constructed with biocompatible materials and has been tested for performance and found equivalent to the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Frances E. Harrison, RAC Director, Regulatory Affairs C.R.Bard, Incorporated 8195 Industrial Boulevard COVINGTON GA 30014

NOV 1 4 2003

Re: K032521

Trade/Device Name: Bard® Dual Lumen Ureteral Catheter Regulation Number: 21 CFR& 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II

Product Code: 78 EYB Dated: August 7, 2003 Received: August 18, 2003

Dear Ms. Harrison

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, 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 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.

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Page 2

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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this 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 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.gov/cdrh/dsma/dsmamain.html.

Sincerely vours.

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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K0.3 2521

# INDICATIONS FOR USE STATEMENT

| 510(k) Number (if known): | K032521 |
|---------------------------|---------|
|---------------------------|---------|

Device Name:

Indications for Use:

The Bard® Dual Lumen Ureteral Catheter is intended to facilitate drainage and retrograde pyelogram of the upper urinary tract. This catheter will allow access to and navigation of a torturous ureter using standard endoscopic techniques.

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

CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---------------------------------------|----|----------------------|
|---------------------------------------|----|----------------------|

| (Division Sign-Off) | | (Optional Format 1/2/96) |
|---------------------------------------------------------------|---------|--------------------------|
| Division of Reproductive, Abdominal, and Radiological Devices | | |
| 510(k) Number | K032521 | |