CG+ Arrow JACC

K161765 · Arrow International, Inc. (Subsidiary of Teleflex · LJS · Sep 6, 2016 · General Hospital

Device Facts

• Record ID: K161765
• Device Name: CG+ Arrow JACC
• Applicant: Arrow International, Inc. (Subsidiary of Teleflex
• Product Code: LJS · General Hospital
• Decision Date: Sep 6, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5970
• Device Class: Class 2

Intended Use

The Arrow® Pressure Injectable Jugular Axillo-subclavian Central Catheter with Chlorag+ard® Antimicrobial and Antithrombogenic Technology (CG+ Arrow JACC) is indicated for short-term (<30 days) or long-term (>30 days) access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media and allows for central venous pressure monitoring. The maximum pressure injector equipment used with the Arrow Pressure Injectable JACC may not exceed 300 psi (2068.4 kPa). The maximum pressure injection flow rate for the specific lumen being used for pressure injection is printed on the extension line hub. Chlorag+ard Technology treatment on the external surface of the catheter body as well as the entire fluid pathway of the catheter has been shown to be effective in reducing microbial colonization on catheter surfaces. Antimicrobial effectiveness was evaluated using in vivo test methods and no correlation between these testing methods and clinical outcome has currently been ascertained. It is not intended to be used for the treatment of existing infections.

Device Story

The CG+ Arrow JACC is a radiopaque polyurethane central venous catheter treated with chlorhexidine-based Chlorag+ard technology to reduce microbial colonization and thrombus accumulation. It is available in 1, 2, or 3-lumen configurations. The device is inserted into the central venous system to provide access for intravenous therapy, blood sampling, infusion, and pressure injection of contrast media (up to 300 psi). It is used in clinical settings by healthcare professionals. The device is provided sterile and is compatible with an optional tunneling device for tunneled insertion techniques. The catheter body is non-tapered and features extension lines with clamps and hubs indicating pressure injection capabilities. By providing reliable venous access and antimicrobial protection, the device supports long-term therapy while mitigating risks of catheter-related infections.

Clinical Evidence

Bench testing only. No clinical data provided. Verification testing included biocompatibility (L929 MEM elution), corrosion resistance, tip penetration, extraneous matter, and tunneler/catheter compatibility (detachment force and structural integrity).

Technological Characteristics

Radiopaque polyurethane catheter body; chlorhexidine-based antimicrobial/antithrombogenic coating; 1, 2, or 3-lumen configurations; 4.5F to 6F diameters; 35cm length; pressure injectable up to 300 psi; ethylene oxide sterilization; compatible with optional tunneling accessory.

Indications for Use

Indicated for short-term (<30 days) or long-term (>30 days) central venous access for IV therapy, blood sampling, infusion, contrast media pressure injection, and CVP monitoring in patients requiring central venous access. Not for treatment of existing infections.

Regulatory Classification

Identification

A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.

Special Controls

*Classification.* Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”

Predicate Devices

• CG+ Arrow JACC / CG+ Arrow JACC powered by Arrow VPS Stylet (K153423)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/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 a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 6, 2016

Arrow International, Inc. (subsidiary of Teleflex Inc.) Ms. Julie Lawson Regulatory Affairs Specialist 2400 Bernville Road Reading, Pennsylvania 19605

Re: K161765

Trade/Device Name: ARROW Pressure-Injectable Jugular Axillo-Subclavian Central Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology (CG+ Arrow JACC) Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: August 5, 2016 Received: August 8, 2016

Dear Ms. Lawson:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

{1}------------------------------------------------

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 and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerelv.

Tina Kiang
-s

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K161765

#### Device Name

ARROW Pressure-Injectable Jugular Axillo-Subclavian Central Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology (CG+ Arrow JACC)

#### Indications for Use (Describe)

The Arrow® Pressure Injectable Jugular Axillo-subclavian Central Catheter with Chlorag+ard® Antimicrobial and Antithrombogenic Technology (CG+ Arrow JACC) is indicated for short-term (<30 days) or long-term (>30 days) access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media and allows for central venous pressure monitoring. The maximum pressure injector equipment used with the Arrow Pressure Injectable JACC may not exceed 300 psi (2068.4 kPa). The maximum pressure injection flow rate for the specific lumen being used for pressure injection is printed on the extension line hub.

Chlorag+ard Technology treatment on the external surface of the catheter body as well as the entire fluid pathway of the catheter has been shown to be effective in reducing microbial colonization on catheter surfaces. Antimicrobial effectiveness was evaluated using in vivo test methods and no correlation between these testing methods and clinical outcome has currently been ascertained. It is not intended to be used for the treatment of existing infections.

| Type of Use (Select one or both, as applicable) |
|----------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
| <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 510(K) SUMMARY: K161765

#### Submitter Information

| Name: | Arrow International, Inc (subsidiary of Teleflex Inc.) |
|-------------------|--------------------------------------------------------|
| Address: | 2400 Bernville Road<br>Reading, PA 19605-9607 USA |
| Contact Person: | Julie Lawson<br>Regulatory Affairs Specialist |
| Telephone Number: | [phone] Extension 603256 |
| Fax Number: | [phone] |
| Email: | [e-mail] |
| Date Prepared: | June 24, 2016 |

#### Device Name

Device Trade Name: ARROW Pressure-Injectable Jugular Axillo-Subclavian Central Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology (CG+ Arrow JACC) Common Name: Central Venous Catheter Classification Regulation: 21 CFR: 880.5970 Classification Name: Percutaneous, implanted, long-term intravascular catheter Product Code: LJS

### Predicate Device

K153423: CG+ Arrow JACC / CG+ Arrow JACC powered by Arrow VPS Stylet

### Device Description

The Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter with Chlorag arde Antimicrobial and Antithrombogenic Technology (CG+ Arrow JACC) has the following characteristics:

- 4.5 French, 1-Lumen, 35 cm pressure injectable, antimicrobial and antithrombogenic catheter
- 5.5 French, 2-Lumen, 35 cm pressure injectable, antimicrobial and antithrombogenic catheter ●
- 6 French. 3-Lumen. 35 cm pressure injectable, antimicrobial and antithrombogenic catheter ●

The CG+ Arrow JACC is a short-term or long-term, single use catheter designed to provide access to the central venous system. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The CG+ Arrow JACC consists of a non-tapered, radiopaque polyurethane extruded catheter body, a juncture hub, extension lines for each lumen and printed extension line hubs. The extension lines each contain a clamp. The catheter can be used for the injection of contrast media. The maximum recommended infusion rate is 5 mL/sec for the 1-lumen and 2-lumen catheters and 6 mL/sec for the 3-lumen catheter. The external catheter body and the internal fluid path of the device are treated with chlorhexidine-based, Chlorag-ard technology. There are no

{4}------------------------------------------------

modifications subject to this premarket notification related to the material design of the devices included in this submission, nor are there any modifications to the Chlorag+ard technology that is incorporated in the modified device's physical design.

The subject device is a CG+ Arrow JACC without a Blue FlexTip that will be provided in sterile kit configurations. A catheter-compatible tunneling device will be offered as an optional kit component. In addition to the catheter tip modification, the printed text on the catheter body and the extension lines has also been modifications, as well as the addition of the tunneling device as an optional kit component, require additions to the recommended procedural technique; procedure steps related to the tunneler and updated graphic representation of the catheter have been included in the instructions for use. All other portions of the catheter design and instructions for use remain unchanged.

## Indications for Use

The Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter with Chlorag'arde Antimicrobial and Antithrombogenic Technology (CG+ Arrow JACC) is indicated for shortterm (<30 days) or long-term (>30 days) access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media and allows for central venous pressure monitoring. The maximum pressure injector equipment used with the Arrow Pressure Injectable JACC may not exceed 300 psi (2068.4 kPa). The maximum pressure injection flow rate for the specific lumen being used for pressure injection is printed on the extension line hub.

Chlorag+ard Technology treatment on the external surface of the catheter body as well as the entire fluid pathway of the catheter has been shown to be effective in reducing microbial colonization on catheter surfaces. Antimicrobial effectiveness was evaluated using in vitro and in vivo test methods and no correlation between these testing methods and clinical outcome has currently been ascertained. It is not intended to be used for the treatment of existing infections.

The above Indication for Use is identical to the catheter portion of the predicate Indications for Use. The predicate CG+ Arrow JACC / CG+ Arrow JACC powered by Arrow VPS Stylet (K153423) includes a 2-part indications for use statement; the first portion covers the CG+ Arrow JACC and the second portion covers the CG+ Arrow JACC preloaded with the Arrow VPS Stylet. The subject of this submission is the CG+ Arrow JACC portion of the device only. The VPS-preloaded portion of the indications for use is not impacted by the changes described for the proposed CG+ Arrow JACC. Therefore, only the catheter portion of the indications for use statement for the proposed CG+ Arrow JACC is applicable.

### Technological Characteristics and Substantial Equivalence

The subject CG+ Arrow JACC is substantially equivalent to the predicate CG+ Arrow JACC / CG+ Arrow JACC powered by VPS (K153423) in terms of indications for use (catheter portion), manufacturing processes, conditions and aids, functional performance, fundamental scientific technology and materials of construction. There is no change to the geometric design of the subject devices with the exception of the catheter tip: the predicate device is constructed with a

{5}------------------------------------------------

Blue FlexTip distal tip design and the catheter is trimmable; the proposed device omits the Blue FlexTip distal tip, yielding the same catheter distal tip design as the predicate device when trimmed. The instructions for use are being modified to add detail pertaining to the use of a tunneler; catheter trimming instructions were previously included in the instructions for use and continue to apply to the subject device. The following table reflects a comparison of the subject and predicate device characteristics.

| Characteristic | Predicate:<br>CG+ Arrow JACC / CG+ Arrow JACC powered<br>by VPS Stylet (K153423) | Subject:<br>CG+ Arrow JACC |
|---------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Catheter Length | 15-35 cm | 35 cm only |
| Catheter OD | 4.5, 5.5, and 6 Fr | SAME |
| Number of<br>Lumens | 1,2, and 3 Lumen | SAME |
| Internal Lumen<br>Configuration | 1 Lumen - Round<br>2 Lumen - Double D<br>2 Lumen - Round-Crescent<br>3 Lumen- Round-Split-Crescent | 1 Lumen - Round<br>2 Lumen - Double D<br>3 Lumen- Round-Split-Crescent |
| Pressure<br>Injection<br>Capabilities | 1 Lumen:<br>Distal:5 mL/sec. Pressure Injectable | 1 Lumen:<br>Distal:5 mL/sec. Pressure Injectable |
| | 2 Lumen - Double D:<br>Distal: 5 mL/sec, Pressure Injectable<br>Proximal: 5 mL/sec, Pressure Injectable | 2 Lumen - Double D:<br>Distal: 5 mL/sec, Pressure Injectable<br>Proximal: 5 mL/sec, Pressure Injectable |
| | 2 Lumen - Round-Crescent:<br>Distal: 5 mL/sec, Pressure Injectable<br>Proximal: 4 mL/sec, Pressure Injectable | |
| | 3 Lumen:<br>Distal: 6 ml/sec, Pressure Injectable<br>Proximal: No Pressure Injection<br>Medial: No Pressure Injection | 3 Lumen:<br>Distal: 6 ml/sec, Pressure Injectable<br>Proximal: No Pressure Injection<br>Medial: No Pressure Injection |
| | Note: Lumens that are not indicated for Pressure<br>Injection have "No CT" printed on the extension<br>line hubs. | Note: Lumens that are not indicated for Pressure Injection<br>have "No CT" printed on the extension line hubs. |
| Catheter body<br>material | Radiopaque polyurethane | SAME |
| Catheter<br>Juncture Hub<br>Material | Blue polyurethane | SAME |
| Catheter Tip<br>Design and<br>material | Radiopaque, soft blue polyurethane "Blue<br>FlexTip" | Non Blue FlexTip; blunt tip (integral with and same<br>material as the catheter body and equivalent to a trimmed<br>predicate CG+ Arrow JACC) |
| Catheter<br>trimmable? | Yes | Yes |
| Extension Line<br>Material | Clear polyurethane | SAME |
| Characteristic | Predicate:<br>CG+ Arrow JACC / CG+ Arrow JACC powered<br>by VPS Stylet (K153423) | Subject:<br>CG+ Arrow JACC |
| Extension Line<br>Hub Material | Distal - Pink polyurethane<br><br>Proximal - White Polyurethane<br><br>Medial - Blue Polyurethane | SAME |
| Printing Ink | 2405 Black Ink and White Ink | SAME |
| Sterilization | Provided Sterile. Sterilized by Ethylene Oxide. | SAME |
| Performance<br>Specifications;<br>Catheter<br>treatment<br>solution<br>efficacy | Antimicrobial Efficacy<br>Effective in reducing microbial colonization on<br>catheter surfaces<br><br>Antithrombogenic Efficacy<br>Effective in reducing thrombus accumulation on<br>catheter surfaces…