Source: http://www.readbag.com/accessdata-fda-cdrh-docs-pdf5-k053589
Timestamp: 2019-10-16 11:51:45
Document Index: 542787730

Matched Legal Cases: ['art 1', 'art3', 'art 1', '§876', 'arts 800', 'art 807', 'art 807', 'art 801', 'art 820', 'art 807']

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Long-Term Hemodialysis Catheters with BioBlocTM Coating Traditional 510(k)
Section 5 Long-Term Hemodialysis Catheters with BioBIocTM Coating 510(k) Summary of Safety and Effectiveness 21 CFR 807.92(a)
General Information Submitter Name: Address: Telephone Number: Fax Number: Contact Person: Date of Preparation: Registration Number: Additional Registration Numbers: C.R. Bard: Bard Access Systems, Inc. (BAS) [Wholly owned Subsidiary of C. R. Bard, Inc.] 5425 W. Amelia Earhart Drive Salt Lake City, UT 84116 (801) 595-0700 ext. 5541 (801) 595-5425 Michaela Rivkowich April 12, 2006 1720496 2212754
Subject Device Information Device Name: Trade Name: Common/Usual Name: Classification Name: Long-Term Hemodialysis Catheters with BioBlocTm coating HemoSplit®, HemoStarTM, BioBlocTM Long-Term Hemodialysis Catheter 78 MSD - Catheter, Hemodialysis, Implanted 21 CFR 876.5540(b)(1) - Class III Implanted Blood Access Device Gastroenterology and Renal
Classification Panel: 5.3
Predicate Device Information Device Name: HemoSplit Long-Term Hemodialysis Catheter HemoStart Long-Term Hemodialysis Catheter HemoSplit , HemoStar Long-Term Heemodialysis Catheter 78 MSD - Catheter, Hemodialysis, Implanted 21 CFR 876.5540(b)(1) - Class III Implanted Blood Access Device Gastroenterology and Renal
Trade Name: Common/Usual Name: Classification Name:
Classification Panel:
.nceDate&lt;.t~k ~) .
HemoSplit Long-Term Hemodialysis Catheter HemoStar Long-Term Hemodialysis Catheter
K030020 K051748
6/16/2003 8/12/2005
The predicate device for the BioBIocTm coating is: Device Name: Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip® ARROWg+ard Blue® Catheter for High Volume Infusions
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Trade Name: Common/Usual Name: Classification Name: Classification Panel:
Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip® ARROWg+ard Blue® Catheter for High Volume Infusions Two-lumen, short-term central venous hemodialysis catheter 78 MIPB - Nonimplanted Blood Access Device 21 CFR 876.5540 - Class II Blood Access Device Gastroenterology and Renal
14 Fr Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip® ARROWg+ard Blue® Catheter for High Volume Infusions 5.4 Intended Use
K993933
The HemoSplit® and HemoStar&quot; catheters are recommended for use in attaining short-term or long-term vascular access for hemodialysis, apheresis, and hemoperfusion treatments. The performance of the BioBIocTm coating on the HemoSplit® and HemoStarTM catheters in reducing bacterial adhesion for 21 days was supported by in vitro testing. 5.5 Indications for Use
The HeroSplit® and HemoStarTM 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 T coating on the HemoSplit® and HemoStarTm catheters in M 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 m catheters incorporate a staggered distal lumen tip. The catheter shaft is the same for both designs. BioBlocT &quot; 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, Staphylococcu3s aureus, Pseudomonasaeruginosa, Candidaalbicans, Enterococcusfaecalis,and Escherichia coi. Catheters with BioBloc coating are not intended to be used as a treatment for existing infections.
Technological Comparison to Predicate Devices The technological characteristics of the HemoSplit and HemoStart m catheters with BioBloc&quot;' coating are substantially equivalent to those of the predicate HemoSplit , HemoStarTM and Blue FlexTip® ARROWg+ard Blue® Catheters in terms of intended use, application, user population, basic design, performance and labeling.
Long-Termr Hemodialysis Catheters with BioBloc TM Coating Traditional 510(1k)
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 HemoStart catheters have the same intended use and indications for use with the addition of intended use and indications for use for BioBlocTM coating. Do the differences alter the intended therapeutic/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 T 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 PremarketNotification [510(k)] Submissionfor Short-Term and Long-Term IntravascularCatheters, dated 3/16/95 ISO 10555-1:1997, Sterile, single-use intravascularcatheters, Part 1. Generalrequirements ISO 10555-1:1997, Sterile, single-use intravascularcatheters, Part Generalrequirements, ]. Amendment I ISO 10555-3:1997, Sterile, single-use intravascularcatheters, Part3. Centralvenous catheters AAMI/ANSI/ISO 11135:1994, Medical Devices - Validation andRoutine Control of Ethylene Oxide Sterilization AAMI/ANSI/ISO 10993-1:1997, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, and the FDA ModiftedISO 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, Pseudomonasaeruginosa,Candidaalbicans,Enterococcus faecalis, andEscherichiacoli. Catheters with BioBloc coating are not intended to be used as a treatment for existing infections
Performance data demonstrate equivalence? The HemoSplit and HemoStarT long-term hemodialysis catheters with BioBloc&quot; coating met performance criteria of the safety and effectiveness tests performed and, based on FDA's decision
tree, are substantially equivalent to the predicate HemoSplit® Long-Term Hemodialysis Catheter, K030020, concurrence date 6/16/2003, HemoStat 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, concUlence date 9/14/2000.
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 Hlemodialysis Catheters with BioBIOcTM 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. Please note: 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 11 (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.
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, &quot;Misbranding by reference to premarket notification&quot; (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/industrv/support/index.html. Sincerely yours,
&lt;Nancy
Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Long-Term Hemodialysis Catheters with BioBloc TM Coating Traditional 510(k)
Section 4 Indications for Use
k,05
Device Name: Long-Term Hemodialysis Catheters with BioBIoeTM Coating Indications for Use: HemoSplit® and HemoStarTM long-term hemodialysis catheters with BioBlocTM 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 BioBloCTM coating on the HemoSplit® and HemoStarTM catheters in reducing bacterial adhesion for 21 days was supported by in vitro testing.
Pe/OR
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological De t
'&quot; 510(k) Number__________ ?