K Number
K053589
Device Name
LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATING
Date Cleared
2006-04-13

(111 days)

Product Code
Regulation Number
876.5540
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
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.
More Information

Not Found

No
The summary describes a physical medical device (hemodialysis catheter) with a coating to reduce bacterial adhesion. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.

No.
A therapeutic device is one that treats a disease or condition. This device is used to assist in therapies like hemodialysis, hemoperfusion, or apheresis, but it does not directly treat a disease itself. It serves as a means of vascular access for these procedures.

No

Explanation: The device is indicated for vascular access for therapies like hemodialysis, hemoperfusion, or apheresis, and it features a coating to reduce bacterial adhesion. Its function is to facilitate treatment, not to diagnose a condition.

No

The device description clearly details physical components (catheters, lumens, coating) and their material properties and performance, indicating it is a hardware medical device.

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

  • Intended Use: The intended use is for "attaining short-term or long-term vascular access for hemodialysis, hemoperfusion or apheresis therapy." This is a direct medical intervention on a patient, not a test performed on a sample taken from a patient.
  • Device Description: The device is a catheter designed to be inserted into a vein. This is a medical device used for treatment/therapy, not for diagnostic testing.
  • IVD Definition: An IVD is a medical device used to perform tests on samples (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform such tests.
  • In Vitro Testing Mention: While the description mentions "in vitro testing" to support the performance of the BioBloc™ coating, this refers to laboratory testing of the device's properties (bacterial adhesion) outside of a living organism. This is not the same as the device itself being an IVD.

Therefore, the HemoSplit® and HemoStar™ long-term hemodialysis catheters are medical devices used for therapeutic purposes, not for in vitro diagnostic testing.

N/A

Intended Use / Indications for 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.

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.

Product codes

MSD

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

internal jugular vein, external jugular vein, subclavian vein, or femoral vein

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Bench testing was based on the 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, 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.

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 faecalis, and Escherichia coli.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

bacterial adhesion reduced by 99.9%

Predicate Device(s)

K030020, K051748, K993933

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 876.5540 Blood access device and accessories.

(a)
Identification. A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices.(1) The implanted blood access device is a prescription device and consists of various flexible or rigid tubes, such as catheters, or cannulae, which are surgically implanted in appropriate blood vessels, may come through the skin, and are intended to remain in the body for 30 days or more. This generic type of device includes various catheters, shunts, and connectors specifically designed to provide access to blood. Examples include single and double lumen catheters with cuff(s), fully subcutaneous port-catheter systems, and A-V shunt cannulae (with vessel tips). The implanted blood access device may also contain coatings or additives which may provide additional functionality to the device.
(2) The nonimplanted blood access device consists of various flexible or rigid tubes, such as catheters, cannulae or hollow needles, which are inserted into appropriate blood vessels or a vascular graft prosthesis (§§ 870.3450 and 870.3460), and are intended to remain in the body for less than 30 days. This generic type of device includes fistula needles, the single needle dialysis set (coaxial flow needle), and the single needle dialysis set (alternating flow needle).
(3) Accessories common to either type include the shunt adaptor, cannula clamp, shunt connector, shunt stabilizer, vessel dilator, disconnect forceps, shunt guard, crimp plier, tube plier, crimp ring, joint ring, fistula adaptor, and declotting tray (including contents).
(b)
Classification. (1) Class II (special controls) for the implanted blood access device. The special controls for this device are:(i) Components of the device that come into human contact must be demonstrated to be biocompatible. Material names and specific designation numbers must be provided.
(ii) Performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(A) Pressure versus flow rates for both arterial and venous lumens, from the minimum flow rate to the maximum flow rate in 100 milliliter per minute increments, must be established. The fluid and its viscosity used during testing must be stated.
(B) Recirculation rates for both forward and reverse flow configurations must be established, along with the protocol used to perform the assay, which must be provided.
(C) Priming volumes must be established.
(D) Tensile testing of joints and materials must be conducted. The minimum acceptance criteria must be adequate for its intended use.
(E) Air leakage testing and liquid leakage testing must be conducted.
(F) Testing of the repeated clamping of the extensions of the catheter that simulates use over the life of the device must be conducted, and retested for leakage.
(G) Mechanical hemolysis testing must be conducted for new or altered device designs that affect the blood flow pattern.
(H) Chemical tolerance of the device to repeated exposure to commonly used disinfection agents must be established.
(iii) Performance data must demonstrate the sterility of the device.
(iv) Performance data must support the shelf life of the device for continued sterility, package integrity, and functionality over the requested shelf life that must include tensile, repeated clamping, and leakage testing.
(v) Labeling of implanted blood access devices for hemodialysis must include the following:
(A) Labeling must provide arterial and venous pressure versus flow rates, either in tabular or graphical format. The fluid and its viscosity used during testing must be stated.
(B) Labeling must specify the forward and reverse recirculation rates.
(C) Labeling must provide the arterial and venous priming volumes.
(D) Labeling must specify an expiration date.
(E) Labeling must identify any disinfecting agents that cannot be used to clean any components of the device.
(F) Any contraindicated disinfecting agents due to material incompatibility must be identified by printing a warning on the catheter. Alternatively, contraindicated disinfecting agents must be identified by a label affixed to the patient's medical record and with written instructions provided directly to the patient.
(G) Labeling must include a patient implant card.
(H) The labeling must contain comprehensive instructions for the following:
(
1 ) Preparation and insertion of the device, including recommended site of insertion, method of insertion, and a reference on the proper location for tip placement;(
2 ) Proper care and maintenance of the device and device exit site;(
3 ) Removal of the device;(
4 ) Anticoagulation;(
5 ) Management of obstruction and thrombus formation; and(
6 ) Qualifications for clinical providers performing the insertion, maintenance, and removal of the devices.(vi) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices that include subcutaneous ports must include the following:
(A) Labeling must include the recommended type of needle for access as well as detailed instructions for care and maintenance of the port, subcutaneous pocket, and skin overlying the port.
(B) Performance testing must include results on repeated use of the ports that simulates use over the intended life of the device.
(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.
(vii) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices with coatings or additives must include the following:
(A) A description and material characterization of the coating or additive material, the purpose of the coating or additive, duration of effectiveness, and how and where the coating is applied.
(B) An identification in the labeling of any coatings or additives and a summary of the results of performance testing for any coating or material with special characteristics, such as decreased thrombus formation or antimicrobial properties.
(C) A Warning Statement in the labeling for potential allergic reactions including anaphylaxis if the coating or additive contains known allergens.
(D) Performance data must demonstrate efficacy of the coating or additive and the duration of effectiveness.
(viii) The following must be included for A-V shunt cannulae (with vessel tips):
(A) The device must comply with Special Controls in paragraphs (b)(1)(i) through (v) of this section with the exception of paragraphs (b)(1)(ii)(B), (b)(1)(ii)(C), (b)(1)(v)(B), and (b)(1)(v)(C), which do not apply.
(B) Labeling must include Warning Statements to address the potential for vascular access steal syndrome, arterial stenosis, arterial thrombosis, and hemorrhage including exsanguination given that the device accesses the arterial circulation.
(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.
(2) Class II (performance standards) for the nonimplanted blood access device.
(3) Class II (performance standards) for accessories for both the implanted and the nonimplanted blood access devices not listed in paragraph (b)(4) of this section.
(4) Class I for the cannula clamp, disconnect forceps, crimp plier, tube plier, crimp ring, and joint ring, accessories for both the implanted and nonimplanted blood access device. The devices subject to this paragraph (b)(4) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

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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)
[Wholly owned Subsidiary of C. R. Bard, Inc.] |
|----------------------------------|----------------------------------------------------------------------------------|
| Address: | 5425 W. Amelia Earhart Drive
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
21 CFR 876.5540(b)(1) - Class III
Implanted Blood Access Device
Classification Panel:Gastroenterology and Renal

5.3 Predicate Device Information

| Device Name: | HemoSplit® Long-Term Hemodialysis Catheter
HemoStar™ Long-Term Hemodialysis Catheter |
|-----------------------|------------------------------------------------------------------------------------------------------------------|
| Trade Name: | HemoSplit®, HemoStar™ |
| Common/Usual Name: | Long-Term Hemodialysis Catheter |
| Classification Name: | 78 MSD – Catheter, Hemodialysis, Implanted
21 CFR 876.5540(b)(1) – Class III
Implanted Blood Access Device |
| Classification Panel: | Gastroenterology and Renal |

Predicate Device Name (Catheter Design)510(k)Clearance Date
HemoSplit® Long-Term Hemodialysis CatheterK0300206/16/2003
HemoStar™ Long-Term Hemodialysis CatheterK0517488/12/2005

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®
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
21 CFR 876.5540 - Class II
Blood Access Device |
| Classification Panel: | Gastroenterology and Renal |

Predicate Device Name(Coating)510(k)Clearance Date
14 Fr Two-Lumen Hemodialysis Catheterization Kit with
Blue FlexTip® ARROWg+ard Blue® Catheter for High
Volume InfusionsK9939339/14/2000

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