BARDEX I.C 4-WAY FOLEY CATHETER MODEL 1865SIXX XX = 18,20,22,24

{0}------------------------------------------------ K9831.01 NOV C. R. Bard, Inc. 8195 Industrial Blvd. Covington, GA 30209 ## SECTION VI # 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: Address: Contact Person: Contact Person's Phone: Contact Person's Fax: Date of Preparation: C. R. Bard, Inc., Urological Division 8195 Industrial Blvd. Covington, Georgia 30014 Georgia C. Abernathy (770) 784-6454 રન્ડ જુ (770) 784-6419 8-31-98 - B. Device Name: Bardex I. C. 4-Way Foley Catheter Trade Name: Common / Usual Name: Antimicrobial Catheter Catheter, Urological (Antimicrobial) and Accessories Classification Name: - C. Predicate Device Names: | Trade Name: | Bard Latex Urinary Catheters | |-------------|--------------------------------------------| | Trade Name: | Bard Hydrogel/Silver-Coated Foley Catheter | #### D. Device Description: The Bardex I. C. 4-Way Foley Catheter is a new catheter design incorporating the addition of a fourth lumen for prostatic drainage and the addition of several prostatic drainage eyes proximal to the balloon. #### E. Intended Use: The Bardex I. C. 4-Way Foley Catheter is indicated for use in bladder/urinary tract drainage/irrigation and to assist in hemostasis and surgical site drainage following procedures such as transurethral resection of the prostate. # F. Technological Characteristics Summary: Table VI-1 provides a tabulated comparison summary of the technological characteristics of the Bardex I. C. 4-Way Foley Catheter versus the predicate device. {1}------------------------------------------------ | Table VI-1 | | | | | |-----------------------------------------------------|--|--|--|--| | Comparison Summary of Technological Characteristics | | | | | | Product<br>Characteristic | Bard 4-Way Catheter<br>(this 510(k)) | Bard Latex Urinary<br>Catheters<br>(Predicate device)<br>(#K922431) | Bard Hydrogel/Silver-<br>Coated Foley Catheter<br>(Predicate device)<br>(#K910318) | |-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications or<br>Intended Use | The Bardex I.C. 4-Way Foley<br>Catheter is indicated for use<br>in bladder/urinary tract<br>drainage/irrigation and to<br>assist in hemostasis and<br>surgical site drainage<br>following procedures such as<br>transurethral resection of the<br>prostate.* | Bard Catheters are intended<br>for use in the drainage and/or<br>collection and/or<br>measurement of urine and in<br>bladder/urinary tract irrigation<br>and to assist in hemostasis<br>following surgery such as<br>transurethral resection of the<br>prostate. | The Bard Hydrogel/Silver-<br>Coated Foley Catheter is<br>intended for use in the<br>drainage and/or collection<br>and/or measurement of urine<br>and in bladder/urinary tract<br>irrigation and to assist in<br>hemostasis following surgery<br>such as transurethral resection<br>of the prostate. | | Disposable | Yes | Yes | Yes | | Sterile | Yes | Yes | Yes | | Catheter Base<br>Material | Red Latex | Red Latex | Red Latex | | X-Ray Opaque | Yes | Yes | Yes | | Coating | Silver/Hydrogel | Hydrogel | Silver/Hydrogel | | Drainage Eyes<br>Proximal to<br>Balloon | 5 Drainage Eyes * | None | None | | Tip Type –<br>Drainage Eyes<br>Distal to<br>Balloon | Open Concave Tip<br>(Couvelaire) and 3 additional<br>eyes | Single Eye | Open Concave Tip<br>(Couvelaire) and 2 opposed<br>eyes | | Fr. Sizes<br>Available | 18-24 Fr. | 22-24 Fr. | 18-24 Fr. | | Foley Balloon<br>Size | 30cc | 30cc | 30cc | | Available<br>Packaged<br>Singly | Yes | Yes | Yes | | Tip Shape | Coude | Coude | Coude | | Number of<br>Lumens | 4 lumens* | 3 lumens | 3 lumens | | Catalog # of<br>example | 1865SIXX** | 6003LXX** | 1859SIXX** | * New feature(s) this 510(k) ** XX = French size (e.g., 1865SIXX = 1865SI18, 1865SI20, 1865SI22, 1865SI24) #### Performance Data Summary: G. The Bardex I. C. 4-Way Foley Catheter referenced in this submission is held to the same design, manufacture, and performance specifications as those catheters currently manufactured. Performance and functional testing standards are based on the "Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters" dated September 12, 1994. {2}------------------------------------------------ Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Image /page/2/Picture/3 description: The image shows the date November 3, 1998. The month is abbreviated as NOV. The number 3 is written in a simple, sans-serif font. The year 1998 is also written in a similar font. Ms. Georgia Abernathy Regulatory Affairs Associate C.R. Bard, Incorporated Medical Division 8195 Industrial Blvd. Covington, Georgia 30209 Re: K983101 Bardex I.C. 4-Way Foley Catheter Dated: October 22, 1998 Received: October 26, 1998 Regulatory Class: II 21 CFR §876.5130/Product Codes: 78 MJC Dear Ms. Abernathy: 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 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, 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 (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 requirement, 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 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 Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours William Yin Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## SECTION 1 - D # INDICATIONS FOR USE STATEMENT 510(k) Number (if known): ---------------------------------------------------------------------------------------------------------------------------------------------------- Device Name: Indications for Use: The Bardex I. C. 4-Way Foley Catheter is indicated for use in bladder/urinary tract drainage/irrigation and to assist in hemostasis and surgical site drainage following procedures 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) | Prescription Use (Per 21 CFR 801.109) | <div> <img alt="Checkmark" src="checkmark.png"/> </div> | |---------------------------------------|---------------------------------------------------------| | OR Over-The-Counter Use | | (Optional Format 1/2/96) (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices K983101