K Number

Device Name

ARROW JUGULAR AXILLO-SUBCLAVIAN CENTRAL CATHETER (JACC)

Manufacturer

ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.)

Date Cleared

2012-11-29

(192 days)

Product Code

LJS

Regulation Number

880.5970

Intended Use

The Arrow® Pressure Injectable Jugular Axillo-subclavian Central Catheter™ with Chlorag ard® Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term 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 of pressure injector equipment used with the Arrow Pressure Injectable JACC™ may not exceed 300 psi. 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.

Device Description

The Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter with Chlorag ard Antimicrobial and Antithrombogenic Technology is a single use catheter designed to provide short-term or long-term access to the central venous system. It consists of a non-tapered, radiopaque polyurethane extruded catheter body with a softer, contoured Blue Flex Tip. The catheter is available in 4.5 Fr. Single lumen and 5.5 Fr. Double lumen configurations with usable lengths of 20, 25, and 30 cm. The catheters can be used for the injection of contrast media. The maximum recommended infusion rate is 5 mL/sec. The external catheter body and the entire internal fluid path of the device are treated with Chlorhexidine based solution technology. Studies have shown the technology to possess both antimicrobial and antithrombogenic properties. The catheters will be packaged sterile in kits that will include components to facilitate insertion.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K112896, K071538

Reference Devices

K112896, K071538

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a physical medical device (a catheter) with antimicrobial and antithrombogenic coatings. There is no mention of software, algorithms, data processing, or any other components typically associated with AI/ML. The performance studies focus on physical and biological properties of the catheter.

Therapeutic

Explanation: The device is indicated for access to the central venous system for various purposes, including intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and central venous pressure monitoring. While it facilitates the delivery of therapies, it does not itself directly treat a disease or condition. The "Chloragard Antimicrobial and Antithrombogenic Technology" is described as effective in reducing microbial colonization and possessing antithrombogenic properties, but the "Intended Use / Indications for Use" explicitly states: "It is not intended to be used for the treatment of existing infections." Therefore, its primary function is assistive access rather than direct therapeutic intervention.

Diagnostic

Explanation: The device is a central venous catheter used for therapy, sampling, infusion, contrast media injection, and pressure monitoring. It does not perform a diagnostic function by analyzing data or providing a diagnosis.

SaMD (Software as a Medical Device)

The device description clearly outlines a physical catheter made of polyurethane with a Blue Flex Tip and treated with Chlorag ard technology. It also mentions being packaged in kits with components for insertion, all of which are hardware components.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly describes a device for accessing the central venous system for therapeutic purposes (intravenous therapy, blood sampling, infusion, pressure injection of contrast media, CVP monitoring). It is used in vivo (within the body) for direct patient care.
Device Description: The description details a catheter designed for insertion into the central venous system.
Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information for the diagnosis, prevention, or treatment of a disease or condition. While it allows for blood sampling, the device itself is not performing a diagnostic test on the blood sample. The diagnostic testing would be performed separately on the collected sample.

IVD devices are typically used to analyze samples like blood, urine, or tissue in a laboratory setting to provide diagnostic information. This device is a therapeutic and access device used directly on the patient.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

LJS

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

central venous system

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 performed on the ArrowEVOLUTION™ Pressure Injectable PICC with Chlorag ard Antimicrobial and Antithrombogenic Technology (K112896) supports the safety and efficacy of the subject device because the subject device is the same as the predicate device in shorter lengths. The following performance testing has been completed for the predicate device and applies directly to the subject device:

0 air leakage
collapse resistance o
liquid leakage o
radio detectability O
clamp closure efficacy 0
0 flow restriction after clamping of extension line
internal and external CHA content 0
tensile testing, catheter kinking 0
ink adhesion testing O
column strength ಂ
tip stiffness 0
biocompatibility 0
o in vitro antimicrobial efficacy up to 30 days using predicate device as compared to uncoated control
in vivo infection study up to 30 days using predicate device as compared o to uncoated control

The following additional bench testing has been performed to specifically support the subject device, as these tests are specifically related to catheter length:

priming volume o
gravity flow rate o
pressure injection 0
static burst O
mechanical hemolysis 0
whip testing O

Key results: The results of the testing performed have demonstrated that the devices are safe, effective, and perform as intended.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K112896, K071538

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.

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

Summary

K121501

510(k) SUMMARY

NOV 2 9 2012

SUMMARY OF SAFETY AND EFFECTIVENESS FOR ARROW PRESSURE INJECTABLE JUGULAR AXILLO-SUBCLAVIAN CENTRAL CATHETER WITH CHLORAG*ARD ANTIMICROBIAL AND ANTITHROMBOGENIC TECHNOLOGY

1. Submitter Information

Name:	Arrow International, Inc. (subsidiary of Teleflex Inc.)
Address:	2400 Bernville Road
Reading, PA 19605-9607
Telephone Number:	(610) 378-0131
Contact Person:	Julie Lawson
Regulatory Affairs Specialist
Telephone Number:	(610) 378-0131 Extension 603256
Fax Number:	(610) 478-3179
Email:	julie.lawson@teleflex.com

November 29, 2012

2. Device Name

Date Prepared:

| Device Trade Name: | Arrow® Pressure Injectable Jugular Axillo-subclavian
Central Catheter™ (JACC™) with Chlorag+ard®
Antimicrobial and Antithrombogenic Technology |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Central Venous Catheter |
| Classification Name: | Percutaneous, implanted, long-term intravascular catheter |

3. Predicate Devices

ArrowEvolution™ Pressure Injectable PICC with Chlorag ard Predicate 1: Antimicrobial and Antithrombogenic Technology (K112896) Predicate 2: Arrow Pressure Injectable CVC (K071538)

4. Device Description

The catheters will be packaged sterile in kits that will include components to facilitate insertion.

5. Indications for Use

The Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Chlorag ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term 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 of pressure injector equipment used with the Arrow Pressure Injectable JACC may not exceed 300 psi. 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 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.

6. Technological Characteristics and Substantial Equivalence

The Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter with Chlorag ard Antimicrobial and Antithrombogenic Technology is substantially equivalent to the ArrowEVOLUTION™ Pressure Injectable PICC with Chlorag ard Antimicrobial and Antithrombogenic Technology (K112896) in terms of overall design, manufacturing process, functional performance, and materials of construction. The indications for use, for the subject catheter, are the same as the predicate device (K112896) with the exception of the word peripheral that describes the external insertion site.

The antimicrobial agent for the subject device is the same Chlorhexidine based solution used for the ArrowEVOLUTION™ Pressure Injectable PICC with Chlorag ard Antimicrobial and Antithrombogenic Technology (K112896). The process of application of the antimicrobial agent is also the same as that of the predicate device.

The Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter with Chlorag ard Antimicrobial and Antithrombogenic Technology is substantially equivalent to the Arrow Pressure Injectable CVC (K071538) in terms of the intended use which describes a central venous access insertion point that is not peripheral.

7. Nonclinical Testing

0 air leakage
collapse resistance o
liquid leakage o
radio detectability O
clamp closure efficacy 0
0 flow restriction after clamping of extension line
internal and external CHA content 0
tensile testing, catheter kinking 0
ink adhesion testing O
column strength ಂ
tip stiffness 0
biocompatibility 0
o in vitro antimicrobial efficacy up to 30 days using predicate device as compared to uncoated control
in vivo infection study up to 30 days using predicate device as compared o to uncoated control

in vitro and in vivo antithrombogenic effectiveness testing performed to o assess platelet adhesion, patency and thrombus accumulation comparing the predicate device, the uncoated predicate PICC and the Zeus devices for up to 30 days
The following additional bench testing has been performed to specifically support the subject device, as these tests are specifically related to catheter length:
priming volume o
gravity flow rate o
pressure injection 0
static burst O
mechanical hemolysis 0
whip testing O

8. Conclusions

The Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter with Chlorag ard Antimicrobial and Antithrombogenic Technology is the same device as the ArrowEVOLUTION Pressure Injectable PICC with Chlorag ard Antimicrobial and Antithrombogenic Technology (KII2896) with the exception of usable catheter length, insertion location and extension line printed text. The results of the testing performed have demonstrated that the devices are safe, effective, and perform as intended. The subject device and both predicate devices are intended to have the final tip position in the same location regardless of the insertion site.

In conclusion, the AM/AT JACC is substantially equivalent to the AM/AT PICC (K112896) and the PI CVC (K071538).

Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract caduceus or a representation of human services, featuring three intertwined shapes.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

November 29, 2012

Ms. Julie Lawson

Regulatory Affairs Specialist

Arrow International, Incorporated (Subsidiary of Teleflex, Incorporated)

2400 Bernville Road

Reading, Pennsylvania 19605

Re: K121501

Trade/Device Name: Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter™ (JACCTM) with Chlorag ard® Antimicrobial and Antithrombogenic Technology

Regulation Number: 21 CFR 880.5970

Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: November 20, 2012 Received: November 21, 2012

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.

Page 2 - Ms. Lawson

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 (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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041. or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Chatham Co. N.C.

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and

Radiological Health

Enclosure

Indications for Use

510(k) Number (if known): K12150)

Device Name: Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Chlorag ard Antimicrobial and Antithrombogenic Technology

Indications for Use:

Prescription Use X .: Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

んだ……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… Digitally signed by Richard C. Chapman Date: 2012.11/30 10:02:14 -05'00'

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: