MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE AND INTEGRAL HEMOSTASIS VALVE/SIDE PORT

K011761 · Arrow Intl., Inc. · DYB · Oct 31, 2001 · Cardiovascular

Device Facts

• Record ID: K011761
• Device Name: MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE AND INTEGRAL HEMOSTASIS VALVE/SIDE PORT
• Applicant: Arrow Intl., Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Oct 31, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The MAC™ Two-Lumen Central Venous Access Device with ARROWg+ard Blue® permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The ARROWg+ard® technology is intended to help provide protection against catheter-related infections. Clinical data have not been collected that demonstrate the use of the ARROWg+ard® antimicrobial surface in decreasing catheter-related infections for this device. It is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.

Device Story

Device is a two-lumen central venous access kit featuring an antimicrobial surface treatment (ARROWg+ard Blue). It facilitates venous access and catheter introduction into central circulation (jugular, subclavian, or femoral veins). Used by clinicians in clinical settings. Device components are provided in a sterile, high-impact polystyrene tray. The antimicrobial surface is intended to provide protection against catheter-related infections, though clinical data demonstrating this efficacy for this specific device are not available. The device is not for long-term use or treatment of existing infections.

Clinical Evidence

Bench testing only. No clinical data collected to demonstrate the efficacy of the ARROWg+ard antimicrobial surface in decreasing catheter-related infections for this device. Performance testing included tensile, leak, elongation, flow rate, priming volume, flex, burst, in vitro zone of inhibition, in vitro safety elution profile, hemolysis, fatigue life, stability, and biocompatibility tests.

Technological Characteristics

Two-lumen central venous access catheter with ARROWg+ard Blue antimicrobial surface treatment. Components housed in high-impact polystyrene (HIPS) tray with Tyvek lidstock. Sterilized. Mechanical performance characteristics include tensile strength, burst pressure, and flow rate specifications.

Indications for Use

Indicated for patients requiring central venous access via jugular, subclavian, or femoral veins for short-term use. Not indicated for treatment of existing infections or long-term use.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• Arrow 14 Fr & 12 Fr Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip® ARROWg*ard Blue® Antimicrobial Catheter for High Volume Infusions (K993933)
• Arrow Two-Lumen Central Venous Access Kit with Hemostasis Valve/Side Port (K002507)
• Arrow SUPER ARROWFLEX™ Percutaneous Sheath Introducer Kit with ARROWg ard Blue® and Arrow Raulerson Syringe (K940079)

Submission Summary (Full Text)

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# OCT 31 2001

### SECTION 2. 510(k) SUMMARY

KO11761

P.O. Box 12888 Reading, PA 19612

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Arrow International 2400 Bernville Road Reading, PA 19605

Research/Engineering 2400 Barnville Rood Reading, PA 19605

[phone] FAX: [phone]

Contact person:

Submitter:

Thomas D. Nickel Vice President, Regulatory Affairs and Quality Assurance Phone: [phone] [phone] Fax: E-mail: [e-mail]

Date summary prepared:

| Device trade name: | MAC™Two-Lumen Central Venous Access Kit with<br>ARROWg ard Blue® and Hemostasis Valve/Side Port |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------|
| Device common name: | Two-Lumen Central Venous Access device |
| Device classification name: | DBY, Class II at 21 CFR 870.1340, Introducer Catheter<br>FOZ, Class II at 21 CFR 880.5200, Intravascular Catheter |

# Legally marketed devices to which the device is substantially equivalent:

- 1. K993933: Arrow 14 Fr & 12 Fr Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip® ARROWg*ard Blue® Antimicrobial Catheter for High Volume Infusions
- 2. K002507: Arrow Two-Lumen Central Venous Access Kit with Hemostasis Valve/Side Port
- 3. K940079: Arrow SUPER ARROWFLEX™ Percutaneous Sheath Introducer Kit with ARROWg ard Blue® and Arrow Raulerson Syringe

Description of device:

The proposed device is a modification to Arrow's Two-Lumen Central Venous Access Kit with Integral Hemostasis Valve/Side Port, with the addition of ARROWg" ard Blue antimicrobial surface treatment. The proposed device was Arked to help provide protection against device-related infections. It is not intended to help provise a treatment for existing infections, nor is it indicated for long-term use.

The catheterization kit components are configured in a high-impact polystyrene (HIPS) tray, sealed with a Tyvek® lidstock, and sterilized.

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#### Intended use of the device:

The MAC™ Two-Lumen Central Venous Access Device with ARROWg+ard Blue® permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The ARROWg+ard® technology is intended to help provide protection against catheter-related infections. Clinical data have not been collected that demonstrate the use of the ARROWg+ard® antimicrobial surface in decreasing catheter-related infections for this device. It is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use..

#### Technological characteristics:

The proposed device has the same technological characteristics as the predicate devices.

#### Performance tests:

The following performance tests are included in the submission:

- 1. Tensile
- 2. Leak
- 3. Elongation
- 4. Flow Rate with Catheter
- 5. Flow Rate without Catheter
- 6. Priming Volume
- 7. Flex
- 8. Burst
- 9. In vitro efficacy zone of inhibition
- 10. In vitro safety elution profile
- 11. Hemolysis
- 12. Fatique life testing
- 13. Stability tests
- 14. Biocompatibility tests

#### Conclusions:

The results of the laboratory tests demonstrate that the device is as safe and effective as the legally marketed predicate devices.

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# OCT 3 1 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Thomas D. Nickel Vice President, Regulatory Affairs & Quality Assurance Arrow International, Incorporated 2400 Bernville Road Reading, Pennsylvania 19605

Re: K011761

Trade/Device Name: MAC™ Two-Lumen Central Venous Access Kit with ARROWg+ ard, Blue® Access Device and Integral Hemostasis Valve Regulation Number: 870.1340 and 880.5200 Regulation Name: Introducer Catheter and Catheter, Intravascular short-term Regulatory Class: II Product Code: DYB and FOZ Dated: September 17, 2001 Received: September 18, 2001

Dear Mr. Nickel:

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 (PMA). 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, listing 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 Register.

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

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## Page 2 - Mr. Nickel

of the Act or any Federal statutes and regulations administered by other Federal agencies. or the For of all the Act's requirements, including, but not limited to: registration 1 ou must compry with are are and manufacturing (21 CFR Part 801); good manufacturing practice and insting (21 es result 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 This letter will and in your your 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely vours.

L. Alatorre A

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

#### Enclosure

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## INDICATIONS

510(k) Number (if known): K011761

Device Name: MAC™Two-Lumen Central Venous Access Kit with ARROWgʻard Blue® Antimicrobial Surface and Integral Hemostasis Valve/Side Port.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Petrus Crescenti

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________