BARD UROFORCE BALLOON DILATION CATHETER

K993840 · C.R. Bard, Inc. · EZN · Jan 31, 2000 · Gastroenterology, Urology

Device Facts

• Record ID: K993840
• Device Name: BARD UROFORCE BALLOON DILATION CATHETER
• Applicant: C.R. Bard, Inc.
• Product Code: EZN · Gastroenterology, Urology
• Decision Date: Jan 31, 2000
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 876.5470
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Bard UroForce Balloon Dilation Catheter is indicated for dilation of the urinary tract.

Device Story

Dual-lumen balloon dilation catheter; features Nydex two-layer nylon balloon; two radiopaque markers for working length visualization. Input: 0.038" guidewire for tracking; balloon inflation via dedicated lumen; optional medication/contrast infusion or pressure monitoring via secondary lumen. Operation: Physician-operated in clinical setting; catheter advanced over guidewire to target site; balloon inflated to dilate urinary tract. Output: Mechanical dilation of urinary tract structures. Benefits: Facilitates treatment of urinary tract obstructions/strictures. Device includes stylet, balloon sheath, and attached stopcock.

Clinical Evidence

Bench testing only. Testing performed per FDA Draft Guidance for the Content of Premarket Notifications for Urological Balloon Dilatation Catheters (1992). Evaluated balloon burst strength, distensibility, inflation time, diameter, and profile. Results confirm device meets performance requirements and is equivalent to predicates.

Technological Characteristics

Dual-lumen catheter; Nydex two-layer nylon balloon; radiopaque markers; 6 Fr size; 4-8 mm diameter; 4-10 cm length; 10 atm operating pressure; 25 atm rated burst pressure; 0.038" guidewire compatibility; one-piece shaft with drawn-down tip; includes stylet, balloon sheath, and stopcock. Sterile, single-use.

Indications for Use

Indicated for dilation of the urinary tract in patients requiring such procedures. Prescription use only.

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

• Opti-Plast Centurion 5.5F PTA Catheter (K993840)
• Bard A-Trac Urological Balloon Dilation Catheter (K993840)

Submission Summary (Full Text)

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

K993840 0. 1083

BARD

### SECTION VI

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

A. Submitter Information:

> Submitter's Name: Address:

Contact Person: Contact Person's Phone: Contact Person's Fax: Date of Preparation:

C. R. Bard, Inc., Urological Division 8195 Industrial Blvd., Covington, GA 30014 Angela L. Bunn 770-784-6135 770-784-6419 November 10, 1999

- B. Device Name:
Trade Name: Common/Usual Name: Classification Name:

Bard® UroForce™ Balloon Dilation Catheter Balloon Dilation Catheter Dilator, Catheter, Ureteral

- C. Predicate Device Name(s):
Trade Name: Trade Name: Opti-Plast® Centurion™ 5.5F PTA Catheter Bard® A-Trac Urological Balloon Dilation Catheter

- D. Device Description:
The Bard UroForce Balloon Dilation Catheter is a dual-lumen catheter with a Nydex® two-layer nylon balloon mounted on its distal tip and with two radiopaque markers beneath the balloon that define the working length. The lumen labeled "balloon" is for balloon inflation. The additional lumen allows the catheter to track over a 0.038"(.97mm) guidewire and can be used for monitoring of pressure or infusion of medication and/or contrast medium.

- E. Intended Use:
180-06

The Bard UroForce Balloon Dilation Catheter is indicated for dilation of the urinary tract.

- F. Technological Characteristics Summary:
Table VI-1 provides a comparison summary of the technological characteristics of the Bard UroForce Balloon Dilation Catheter versus the predicate devices.

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K 993840

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Table VI-1 Bard® UroForce™ Balloon Dilation Catheter of the
Bard® UroForce™ Balloon Dilation Catheter to Predicate Devices

| Characteristics | UroForce Balloon<br>Dilation Catheter | Opti-Plast Centurion<br>PTA Catheter | A-Trac Urological<br>Catheter |
|-------------------------------------|------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For Use | The Bard UroForce<br>Balloon Dilation Catheter<br>is indicated for dilation of<br>the urinary tract. | The Opti-Plast Centurion<br>5.5F PTA Catheter is<br>recommended for use in the<br>Percutaneous Transluminal<br>Angioplasty (PTA) of the<br>Iliac, Femoral and Renal<br>arteries and for the<br>treatment of obstructive<br>lesions of native or<br>synthetic arteriovenous<br>dialysis fistulae. The<br>catheter is not for use in the<br>Coronary arteries. | The Bard A-Trac<br>Urological Balloon<br>Dilation Catheter is<br>indicated for use in the<br>dilation of the ureter or<br>urethra through the<br>working channel of an<br>endoscope. |
| Reuse Status | Disposable. For single<br>patient use only. | Disposable. For single<br>patient use only. | Disposable. For single<br>patient use only. |
| Sterile | Yes | Yes | Yes |
| Catheter Balloon Material | Nylon, 2 layers | Nylon, 2 layers | PET, Single layer |
| X-Ray Opaque | yes | yes | yes |
| Fr. Size | 6 | 5.5 | 5 |
| Balloon Lengths | 4, 6, 10 cm | 2, 4 cm | 4, 8, 10 cm |
| Balloon Diameters | 4, 5, 6, 7, 8 mm | 4, 5, 6, 7, 8, 9, 10 mm | 4, 5, 6, 7, 8 mm |
| Operating Pressure | 10 atm | 10 atm | 10 atm |
| Rated Burst Pressures | 25 atm (max.) | 17-20 atm | 12-15 atm |
| Overall Catheter Length | 89.5 cm | 86 cm** | 96 cm |
| Guidewire Lumen Length | 85.5 cm | 84.5 cm** | 95.5 cm |
| Active Shaft Length | 75 cm* | 75 cm** | 75 cm* |
| Guidewire Compatibility | 0.038" | 0.035" | 0.035" |
| Shaft/Tip Design<br>(under balloon) | one piece with drawn<br>down tip | two piece with bonded tip | two piece with bonded<br>tip |
| Stopcock Attached | Yes | No | No |
| Stylet | Yes | Yes | Yes |
| Balloon Sheath | Yes | Yes | Yes |

* Excludes strain relief

** Shorter and longer shaft lengths are available

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K993840

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#### G. Performance Data:

Performance and functional testing standards are based on the FDA "Draft Guidance for the Content of Premarket Notifications for Urological Balloon Dilatation Catheters," dated January 24, 1992. Bench testing was conducted for the following characteristics: balloon burst strength, balloon distensibility, balloon inflation time and balloon diameter and profile. The test results indicate that the Bard UroForce Balloon Dilation Catheter is substantially equivalent to the stated predicate device, that there are no new safety or effectiveness issues, and that the device can be utilized for its stated indication.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 31 2000

Ms. Angela L. Bunn Regulatory Affairs Associate C. R. Bard, Inc. 8195 Industrial Boulevard Covington, GA 30014

Re: K993840 Bard® UroForce™ Balloon Dilation Catheter Dated: November 10, 1999 Received: November 12, 1999 Regulatory Class: II 21 CFR §876.5470/Procode: 78 EZN

Dear Ms. Bunn:

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 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 (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 Compilance 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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### SECTION I - D

# INDICATIONS FOR USE STATEMENT

x993840 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: ___ Bard® UroForce™ Balloon Dilation Catheter

Indications for Use:

The Bard® UroForce™ Balloon Dilation Catheter is indicated for dilation of the urinary tract.

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

CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

Prescription Use V (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ OR

(Optional Format 1/2/96)

Stat

(Division Sign-Off) (Division of Reproductive, Abdominal, EN and Radiological Devi 510(k) Number