LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATING

{0}------------------------------------------------ K053589 page 1 of 4 # 478 1 8 2006 ### Section 5 Long-Term Hemodialysis Catheters with BioBloc™ Coating 510(k) Summary of Safety and Effectiveness 21 CFR 807.92(a) ### 5.1 General Information | Submitter Name: | Bard Access Systems, Inc. (BAS)<br>[Wholly owned Subsidiary of C. R. Bard, Inc.] | |----------------------------------|----------------------------------------------------------------------------------| | Address: | 5425 W. Amelia Earhart Drive<br>Salt Lake City, UT 84116 | | Telephone Number: | (801) 595-0700 ext. 5541 | | Fax Number: | (801) 595-5425 | | Contact Person: | Michaela Rivkowich | | Date of Preparation: | April 12, 2006 | | Registration Number: | 1720496 | | Additional Registration Numbers: | | | C.R. Bard: | 2212754 | ### 5.2 Subject Device Information | Device Name: | Long-Term Hemodialysis Catheters with BioBloc™ coating | |-----------------------|------------------------------------------------------------------------------------------------------------------| | Trade Name: | HemoSplit®, HemoStar™, BioBloc™ | | Common/Usual Name: | Long-Term Hemodialysis Catheter | | Classification Name: | 78 MSD - Catheter, Hemodialysis, Implanted<br>21 CFR 876.5540(b)(1) - Class III<br>Implanted Blood Access Device | | Classification Panel: | Gastroenterology and Renal | ### 5.3 Predicate Device Information | Device Name: | HemoSplit® Long-Term Hemodialysis Catheter<br>HemoStar™ Long-Term Hemodialysis Catheter | |-----------------------|------------------------------------------------------------------------------------------------------------------| | Trade Name: | HemoSplit®, HemoStar™ | | Common/Usual Name: | Long-Term Hemodialysis Catheter | | Classification Name: | 78 MSD – Catheter, Hemodialysis, Implanted<br>21 CFR 876.5540(b)(1) – Class III<br>Implanted Blood Access Device | | Classification Panel: | Gastroenterology and Renal | | Predicate Device Name (Catheter Design) | 510(k) | Clearance Date | |--------------------------------------------|---------|----------------| | HemoSplit® Long-Term Hemodialysis Catheter | K030020 | 6/16/2003 | | HemoStar™ Long-Term Hemodialysis Catheter | K051748 | 8/12/2005 | The predicate device for the BioBloc™ coating is: Device Name: Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip® ARROWg+ard Blue® Catheter for High Volume Infusions {1}------------------------------------------------ | Trade Name: | Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip®<br>ARROWg+ard Blue® Catheter for High Volume Infusions | |-----------------------|----------------------------------------------------------------------------------------------------------------------| | Common/Usual Name: | Two-lumen, short-term central venous hemodialysis catheter | | Classification Name: | 78 MPB – Nonimplanted Blood Access Device<br>21 CFR 876.5540 - Class II<br>Blood Access Device | | Classification Panel: | Gastroenterology and Renal | | Predicate Device Name(Coating) | 510(k) | Clearance Date | |-------------------------------------------------------------------------------------------------------------------------------|---------|----------------| | 14 Fr Two-Lumen Hemodialysis Catheterization Kit with<br>Blue FlexTip® ARROWg+ard Blue® Catheter for High<br>Volume Infusions | K993933 | 9/14/2000 | #### 5.4 Intended Use The HemoSplit® and HemoStar" catheters are recommended for use in attaining short-term or long-term vascular access for hemodialysis, apheresis, and hemoperfusion treatments. The performance of the BioBloc™ coating on the HemoStar™ catheters in reducing bacterial adhesion for 21 days was supported by in vitro testing. #### ર્ફ્ર ર Indications for Use The HemoSplit® and HemoStar™ long-term hemodialysis catheters with BioBloc™ coating are indicated for use in attaining short-term or long-term vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, external jugular vein, subclavian vein, or femoral vein. Catheters greater than 40 cm are intended for femoral vein insertion. The performance of the BioBloc™ coating on the HemoSplit® and HemoStar™ catheters in reducing bacterial adhesion for 21 days was supported by in vitro testing. #### 5.7 Device Description The HemoSplit and HemoStar" catheters with BioBloc" coating are dual lumen long-term hemodialysis catheters. Both catheters have a dual lumen, double-D cross-sectional design. The HemoSplit® catheters are designed with a split distal tip whereas the HemoStar™ catheters incorporate a staggered distal lumen tip. The catheter shaft is the same for both designs. BioBloc" coating is present on the tunnel portion of the catheter shaft tubing. BioBloc" coating reduces bacterial adhesion to the catheter by 99.9% in the catheter tunnel for a period of 21 days as tested in an in-vitro model against Staphylococcus epidermidis. Staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans, Enterococcus faecalis, and Escherichia coli. Catheters with BioBloc coating are not intended to be used as a treatment for existing infections. #### Technological Comparison to Predicate Devices 5.8 The technological characteristics of the HemoSplit® and HemoStar™ catheters with BioBloc™ coating are substantially equivalent to those of the predicate HemoSplit", HemoStar™ and Blue FlexTip® ARROWg+ard Blue® Catheters in terms of intended use, application, user population, basic design, performance and labeling. {2}------------------------------------------------ #### ਦ ਹੈ. 9 510(k) Substantial Equivalence Decision Tree New device is compared to Marketed Device? Yes. Does the new device have the same indication statement and intended use as the predicate? The HemoSplit® and HemoStar" catheters have the same intended use and indications for use with the addition of intended use and indications for use for BioBloc™ coating. Do the differences alter the intended therapentic/diagnostic/etc. effect (i.e. deciding may consider impact on safety and effectiveness)? No, the differences do not alter the intended use of the device. Does the new device have the same technological characteristics, e.g. design, materials, etc.? Not in all regards. The principles of operation and basic design are the same as the predicate devices. The main change in design comprises of the addition of BioBloc" coating to the shaft of the HemoSplit® and HemoStar" catheters. There is precedence in the market for a coated dialysis catheter (Blue FlexTip® ARROWg+ard Blue® Antimicrobial Catheter, K993933). ### Could the new characteristics affect safety or effectiveness? Yes. The design changes may affect safety or effectiveness of the device. Do the new characteristics raise new types of safety and effectiveness questions? No. Safety and effectiveness questions are the same as for the predicate devices. Do accepted scientific methods exist for assessing effects of the new characteristics? Yes. Testing was based on FDA guidance document and recognized standards to evaluate the devices' performance: - Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term . Intravascular Catheters, dated 3/16/95 - ISO 10555-1:1997, Sterile, single-use intravascular catheters, Part 1. General requirements t - ISO 10555-1:1997, Sterile, single-use intravascular catheters, Part 1. General requirements, . Amendment I - . ISO 10555-3:1997, Sterile, single-use intravascular catheters, Part 3, Central venous catheters - � AAMI/ANSI/ISO 11135:1994, Medical Devices -- Validation and Routine Control of Ethylene Oxide Sterilization - AAMI/ANSI/ISO 10993-1:1997, Biological Evaluation of Medical Devices Part 1: Evaluation ● and Testing, and the FDA Modified ISO 10993 Test Profile # Are performance data available to assess effects of new characteristics? Yes. Bench testing was based on the above referenced guidance document and standards. The testing demonstrated that BioBloc™ coating reduces bacterial adhesion to the catheter by 99.9% in the catheter tunnel for a period of 21 days as tested in an in-vitro model against Staphylococcus epidermidis, Staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans, Enterococcus ephall mials, Blaphytooocus aureas, I seadomonas del agmost, Canada dolcums, Entervecoccus treatment for existing infections ## Performance data demonstrate equivalence? The HemoSplit® and HemoStar™ long-term hemodialysis catheters with BioBloc™ coating met performance criteria of the safety and effectiveness tests performed and, based on FDA's decision {3}------------------------------------------------ KASSA M tree, are substantially equivalent to the predicate HemoSplit® Long-Term Hemodialysis Catheter, K030020, concurrence date 6/16/2003, HemoStar™ Long-Term Hemodialysis Catheter, K051748, concurrence date 8/12/2005, and 14 Fr Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip® ARROWg+ard Blue® Catheter for High Volume Infusions, K993933, concurrence date 9/14/2000. Page 12 of 66 {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines above two wavy lines. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR 1 3 2006 Ms. Michaela Rivkowich Sr. Regulatory Affairs Specialist Bard Access Systems, Inc. 5425 W. Amelia Earhart Drive SALT LAKE CITY UT 84116 Re: K053589 Trade/Device Name: Long-Term Hemodialysis Catheters with BioBloc™ Coating Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: III Product Code: MSD Dated: March 28, 2006 Received: March 29, 2006 Dear Ms. Rivkowich: 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 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. {5}------------------------------------------------ # Page 2 - Ms. Michaela Rivkowich 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 (21 CFR Part 807); 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 the labeling regulation, please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 (800) 638-2041 or (301) 443-6597, or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely vours, David A. Nygren fr Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ Section 4 Indications for Use 510(k) Number (if known): K053589 Device Name: Long-Term Hemodialysis Catheters with BioBloc™ Coating Indications for Use: HemoSplit® and HemoStar™ long-term hemodialysis catheters with BioBloc™ coating are indicated for use in attaining short-term or long-term vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, external jugular vein, subclavian vein, or femoral vein. Catheters greater than 40 cm are intended for femoral vein insertion. The performance of the BioBloc™ coating on the HemoStar™ catheters in reducing bacterial adhesion for 21 days was supported by in vitro testing. Prescription Use X (Part 21 CFR 801 Subpart D) ND/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 (ODF) David A. Lynam (Division Sign-Off) (Division Sign-Off) Division of Reproductive, Abdominal and Radiological Dev 510(k) Number