X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER

K080944 · C.R. Bard, Inc. · LJE · Oct 23, 2008 · GU

Device Facts

• Record ID: K080944
• Device Name: X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER
• Applicant: C.R. Bard, Inc.
• Product Code: LJE · GU
• Decision Date: Oct 23, 2008
• Decision: SESE
• Submission Type: Special
• 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 X-Force™ N30 Nephrostomy Balloon Dilation Catheter is a medical device used by clinicians to dilate the nephrostomy tract and facilitate the placement of a working sheath. The device consists of a dual-lumen shaft featuring an inflation lumen and a guidewire lumen, with a dilation balloon located at the distal end. A radiopaque band is positioned at the distal end of the balloon's working length to assist with radiographic visualization and accurate placement during the procedure. A high-pressure stopcock is attached to the inflation lumen to maintain balloon pressure after the pressurization apparatus is removed. The device is intended for prescription use.

Clinical Evidence

Bench testing only. The device was subjected to design verification and validation activities to confirm it meets established performance specifications.

Technological Characteristics

Dual-lumen shaft (inflation and guidewire lumens); dilation balloon; radiopaque band for visualization; high-pressure stopcock for pressure maintenance. No software or electronic components.

Indications for Use

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

Predicate Devices

• X-Force™ N30 Nephrostomy Balloon Dilation Catheter (K051316)
• X-Force™ N30 Nephrostomy Balloon Dilation Catheter (K063632)

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's Information:

| Submitter's Name: | C. R. Bard, Inc., Urological Division |
|-------------------------|-----------------------------------------------|
| Address: | 13183 Harland Dr.<br>Covington, Georgia 30014 |
| Contact Person: | Terri Morris |
| Contact Person's Phone: | [phone] |
| Contact Person's Fax: | [phone] |
| Date of Preparation: | March 19, 2008 |

#### B. Device Name:

| Trade Name: | X-Force™ N30 Nephrostomy Balloon Dilation Catheter |
|----------------------|----------------------------------------------------|
| Common / Usual Name: | Nephrostomy Balloon Dilation Catheter |
| Classification Name: | 78 LJE— Catheter, Nephrostomy |
| CFR Reference: | N/A - Unclassified |

- C. Predicate Device Name:
Trade Name:

X-Force™ N30 Nephrostomy Balloon Dilation Catheter # K051316 and K063632

- D. Device Description:
The Bard X-Force™ Nephrostomy 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 band which corresponds with the distal end of the balloon's working length to radiopaque 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.

- F. Technological Characteristics Summary:
The modified device has the same intended use, general design and fundamental scientific technology as the predicate device.

- G. Performance Data Summary:
The X-Force™ N30 Nephrostomy Balloon Dilation Catheter referenced in this submission is held to the same design, manufacture, and performance specifications as those catheters currently manufactured by Bard. The appropriate design verification and validation activities for the modifications to the device were conducted.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes representing the three branches of government. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Terri Morris Regulatory Affairs Specialist II Bard Urological Division C. R. Bard, Inc. 8195 Industrial Blvd. COVINGTON GA 30014

OCT 2 3 2008

Re: K080944

Trade/Device Name: X-Force™ N30 Nephrostomy Balloon Dilation Catheter Regulation Number: None Regulatory Class: Unclassified Product Code: LJE Dated: September 26, 2008 Received: October 1, 2008

Dear Ms. Morris:

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 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.

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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.

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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html.

Sincerely yours,

loque M. Whang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Bard Urological Division, C.R. Bard, Inc. X-Force™ N30 Nephrostomy Balloon Dilation Catheter Premarket Notification [510(k)]

Indications for Use Statement 1.3

510(k) Number (if known): __ Ko 80944 4_______________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

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.

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

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

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(Recommended Format 11/13/2003)

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