X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER

K051316 · C.R. Bard, Inc. · LJE · Jul 18, 2005 · GU

Device Facts

• Record ID: K051316
• Device Name: X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER
• Applicant: C.R. Bard, Inc.
• Product Code: LJE · GU
• Decision Date: Jul 18, 2005
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The Bard® X-Force™ Nephrostomy Balloon Dilation Catheter is recommended for use in the dilation of the nephrostomy tract and for placement of the working sheath.

Device Story

The Bard® X-Force™ Nephrostomy Balloon Dilation Catheter is a dual-lumen catheter featuring an inflatable dilation balloon at the distal end. It is used by clinicians in a clinical setting to dilate the nephrostomy tract and facilitate the placement of a working sheath. The device includes a radiopaque band for radiographic visualization during placement and a high-pressure stopcock on the inflation lumen to maintain balloon pressure. By dilating the tract, the device enables the subsequent insertion of instruments or sheaths necessary for urological procedures, benefiting the patient by providing a controlled access route to the kidney.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Dual-lumen catheter with inflation and guidewire lumens; distal dilation balloon; radiopaque band for visualization; high-pressure stopcock for pressure maintenance. Mechanical device; no software or electronic components.

Indications for Use

Indicated for dilation of the nephrostomy tract and placement of a working sheath in patients requiring percutaneous nephrostomy procedures.

Predicate Devices

• Cook® Ultraxx™ Nephrostomy Balloon Catheter

Submission Summary (Full Text)

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

K051316
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JUL 1 8 2005

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATIC

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

#### SUBMITTER INFORMATION: A.

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

John C. Knorpp Contact Person: 770-784-6451 Contact Person's Telephone Number: 770-784-6419 Contact Person's Fax: May 19, 2005 Date of Preparation:

#### B. DEVICE NAME:

| Trade Name(s): | Bard® X-Force™ Nephrostomy Balloon Dilation<br>Catheter |
|-----------------------|---------------------------------------------------------|
| Common/Usual Name: | Nephrostomy Balloon Dilation Catheter |
| Classification Names: | 78 LJE - Catheter, Nephrostomy |
| CFR Reference: | N/A - Unclassified |

#### C. PREDICATE DEVICE NAME:

Cook® Ultraxx™ Nephrostomy Balloon Catheter Trade Names:

#### Device Description: D.

The Bard® X-Force™ Nephrostomy 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 a radiopaque band which corresponds with the distal end of the balloon's working length to facilitate radiographic visualization and placement. A high pressure stopcock is used on the inflation lumen to maintain pressure after removal of the pressurization apparatus.

### E. Intended Use:

The Bard® X-Force™ Nephrostomy Balloon Dilation Catheter is recommended for use in the dilation of the nephrostomy tract and for placement of the working sheath.

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Ko 51316
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## Technological Characteristics Summary: F.

The subject Bard® X-Force™ Nephrostomy Balloon Dilation Catheter has the The subject Dard® X-F orce - Nophrootemy Balloon in the scientific technology as the predicate device.

### Performance Data Summary: G.

The appropriate testing to determine substantial equivalence was completed. This includes testing to accoming with Draft Guidance for the Content of This InCludes testing in deserations inal Balloon Dilation Catheters (January 24, 1992).

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUL 1 8 2005

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

Re: K051316

Trade/Device Name: Bard® X-Force™ Nephrostomy Balloon Dilation Catheter Regulation Number: None Regulatory Class: Unclassified Product Code: LJE Dated: May 19, 2005 Received: May 20, 2005

Dear Mr. Knorpp:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced in We have reviewed your Section 110(x) prematically equivalent (for the indications for use stated in
above and have determined the device is substantially equivales commerc above and have delemined the devices is substant in interstate commerce prior to a the enclosure) to legally marketco prodical Device Amendments, or to devices that have been May 28, 1976, the enactified in the Freded For the Federal Food, Drug, and Cosmetic Act (Act) that reclassitied in accordance with the provisions of and issues of the may, therefore, market the A do not require approval of a prematics approvide approvisions of the Act. The Actualisms provisions of the Act device, subject to the general controls of the real good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Ontrols) or class III (Prematket If your device is classified (see above) mio cideols. Existing major regulations affecting your Approval), it may be subject to such additions, Title 21, Pars 800 to 898. In addition, FDA
device can be found in the Code of Federal Regulations, Title 21, Paris 800 to 89 device can be Tound in the Code of Federal Register in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised that FDA s issualice of a substance requirements of the Act or any
FDA has made a determination that your device complex with other comply with all FDA has made a determination that your devices frail agencies. You must comply with all the Federal statutes and regulations administered of other in the first (2 CFR Part 807), labeling Act's requirements, including, but not mined to reguirements as set for in the quality systems (QS)
(21 CFR Part 801); good manufacturing practice requirements as set to prov (21 CFR Part 801); good manufacturing practice the electronic product radiation control provisions
regulation (21 CFR Part 820); and if applica 1950 (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) I his letter will anow you to begin manseting your antial equivalence of your device to a legally premarket notification. The PDA Inding of sacsantial of the report 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 If you desire spective advice for your dovies on our of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (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 Also, please note the regulation entitled, "Thiseration on your responsibilities under the Act from the 807.97). You may outlin other general micronal and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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® X-Force™ Off It Burd, The Particle Callation Catheter
Bard® X-Force™ Nephrostomy Balloon Dilation Catheter
Premarket Notification Premarket Notification [510(k)]

K051316

| 1.3 Indications for Use Statement | |
|-----------------------------------|------------------------------------------------------|
| 510(k) Number (if known): | K051316 |
| Device Name: | Bard® X-Force™ Nephrostomy Balloon Dilation Catheter |
| Indications for Use: | |

The Bard® X-Force™ Nephrostomy Balloon Dilation Catheter is recommended for use in the dilation of the nephrostomy tract and for placement of the working sheath.

| Prescription Use (Part 21 CFR 801 Subpart D) | X |
|----------------------------------------------|---|
|----------------------------------------------|---|

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)

| (Division Sign-Off) | <div style="text-align:left;">Nancy C Brogdon</div> |
|---------------------------------------------------------------|-----------------------------------------------------|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K051316 |

(Recommended Format 11/13/2003)

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