BARDEX LUBRI-SIL AND BARDEX LUBRI-SIL I.C. ANTI-INFECTIVE ALL-SILICONE FOLEY CATHETERS

K070558 · C.R. Bard, Inc. · EZL · Dec 7, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K070558
• Device Name: BARDEX LUBRI-SIL AND BARDEX LUBRI-SIL I.C. ANTI-INFECTIVE ALL-SILICONE FOLEY CATHETERS
• Applicant: C.R. Bard, Inc.
• Product Code: EZL · Gastroenterology, Urology
• Decision Date: Dec 7, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

Bardex® Lubri-Sil® 3-Way Foley Catheter, and the Bardex® Lubri-Sil® I.C. 3-Way Foley Catheter are indicated for use in the drainage and/or collection and/or measurement of urine. Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as a nephrostomy tract. Some Foley catheters, especially those with larger (30cc) balloons are used to assist in hemostatis following surgery such as transurethral resection of the prostate.

Device Story

Three-way Foley catheter consisting of a trifurcated silicone tube, silicone balloon, and two-way inflation/deflation valve. Three lumens provide separate channels for urinary drainage (to collection bag/meter), balloon inflation/deflation, and bladder irrigation. Available in 16-24 Fr shaft sizes with 5cc or 30cc balloons. Used in clinical settings for urine management and post-surgical hemostasis (e.g., following transurethral prostate resection). Operated by healthcare professionals. Device facilitates bladder drainage and irrigation; assists in maintaining hemostasis post-surgery.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing and functional performance standards, including ISO 10993-1 for biological evaluation and ASTM F623-99 for Foley catheter performance specifications.

Technological Characteristics

Materials: Silicone. Design: Trifurcated tube with three lumens (drainage, inflation, irrigation). Sizes: 16-24 Fr. Balloon volumes: 5cc or 30cc. Standards: ASTM F623-99, ISO 10993-1. Non-electronic, mechanical device.

Indications for Use

Indicated for patients requiring urinary drainage, collection, or measurement via urethral, suprapubic, or nephrostomy placement. Larger (30cc) balloon catheters are indicated to assist in hemostasis following surgeries such as transurethral resection of the prostate.

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® Lubri-Sil™ 3-Way Foley Catheter (K002868)
• Bard® Lubri-Sil™ I.C. 3-Way Foley Catheter (K002868)

Submission Summary (Full Text)

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K070558

# SECTION 5 BARDEX® LUBRI-SIL® 3-WAY FOLEY CATHETER AND BARDEX® LUBRI-SIL® I.C. 3-WAY FOLEY CATHETER 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.

#### SUBMITTER INFORMATION: A.

JEC 77 2007

| Submitter's Name | C.R. Bard, Inc.<br>Bard Medical Division<br>8195 Industrial Blvd.<br>Covington, GA 30014 |
|------------------------------------|------------------------------------------------------------------------------------------|
| Contact Person: | Skip Rimer |
| Contact Person's Telephone Number: | 770-784-6160 |

#### B. DEVICE NAME:

Contact Person's Fax: Date of Preparation:

| Trade Name(s): | Bardex® Lubri-Sil® 3-Way Foley Catheter,<br>Bardex® Lubri-Sil® I.C. Foley Catheter |
|------------------------------|------------------------------------------------------------------------------------|
| Common/Usual Name: | Urological Foley catheter |
| Classification Product Code: | EZL - Catheter, Retention Type, Balloon<br>21 CFR 876.5130 |
| Subsequent Product Code: | MJC - Catheter, Urological (Antimicrobial) and<br>Accessories<br>21 CFR 876.5130 |

770-784-6419

August 16, 2007

#### C. PREDICATE DEVICE NAME:

Trade Name(s): Bard® Lubri-Sil™ 3-Way Foley Catheter, Bard® Lubri-Sil™ I.C. 3-Way Foley Catheter

#### D. DEVICE DESCRIPTION:

The subject device three-way Foley catheter is composed of a trifurcated silicone tube, a silicone balloon and a two-way valve (a valve that upon activation permits flow in either of two directions, i.e., for inflation of the balloon). The three-way designation of the catheter refers to the number of lumens in the catheter tubing. The tube has three lumens, one lumen for urinary drainage which is to be connected to a urine collection container (drainage bag or urine meter), one lumen with a two-way valve for inflation/deflation of the Foley balloon, and one lumen for irrigation of the bladder. Catheters with either a 5cc or 30cc balloon will be available with 16 through 24 Fr. shafts (i.e., 16, 18, 20, 22, and 24).

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# SECTION 5 BARDEX® LUBRI-SIL® 3-WAY FOLEY CATHETER AND BARDEX® LUBRI-SIL® I.C. 3-WAY FOLEY CATHETER 510(K) SUMMARY OF SAFETY AND EFFECTIVENSS INFORMATION

#### E. INTENDED USE:

Bardex® Lubri-Sil® 3-Way Foley Catheter, and the Bardex® Lubri-Sil® I.C. 3-Way Foley Catheter are indicated for use in the drainage and/or collection and/or measurement of urine. Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as a nephrostomy tract.

Some Foley catheters, especially those with larger (30cc) balloons are used to assist in hemostatis following surgery such as transurethral resection of the prostate.

#### F. TECHNOLOGICAL CHARACTERISTICS SUMMARY:

The subject devices, Bardex® Lubri-Sil® 3-Way Foley Catheter and Bardex® Lubri-Sil® I.C. 3-Way Foley Catheter, have the same intended use, design and fundamental scientific technology as the predicate devices.

#### F. PERFORMANCE DATA SUMMARY:

The Bardex® Lubri-Sil® 3-Way Foley Catheter and Bardex® Lubri-Sil® I.C. 3-Way Foley Catheter referenced in this submission are held to the same design, manufacture, and performance specifications as the predicate (#K002868). Performance and functional testing standards are based on the FDA "Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters" dated September 12, 1994. ISO 10993-1, "Biological Evaluation of Medical Devices," and ASTM F623-99, "Standard Performance Specification for Foley Catheter."

,上海

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is a stylized graphic of three human figures in profile, with flowing lines representing movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC -7 2007

C.R. Bard, Inc. % Mr. Robert Mosenkis President Citech 5200 Butler Pike PLYMOUTH MEETING PA 19462-1298

Re: K070558

Trade/Device Name: Bardex® Lubri-Sil® 3-wav Foley Catheter, Bardex® Lubri-Sil® I.C. Foley Catheter

Regulation Number: 21 CFR 876.5130

Regulation Name: Urological catheter and accessories

Regulatory Class: II

Product Code: EZL

Dated: November 20, 2007

Received: November 21, 2007

Dear Mr. Mosenkis:

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 (MA), 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, isting 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 Registed.

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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (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.

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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### SECTION 4 BARDEX® ALL-SILICONE 3-WAY IRRIGATON FOLEY CATHETER INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K070558

### Device Name: Bardex® Lubri-Sil® All-Silicone Foley Catheter, and Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter

Indications for Use:

The Bardex® Lubri-Sil® All-Silicone Foley Catheter, and the Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter are indicated for use in the drainage and/or collection and/or measurement of urine. Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as a nephrostomy tract.

Some Foley catheters, especially those with larger (30cc) balloons are used to assist in hemostatis following surgery such as transurethral resection of the prostate.

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

### CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

OR

Prescription Use ﮯ۔ (Per 21 CFR 801.109) Over-The-Counter Use __

Nancy C brogdon

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

(Optional Format 1/2/96)

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