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.

AI/ML Overview

This is a 510(k) summary for a medical device (Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology), not an AI/ML medical device. Therefore, the information typically expected for AI/ML device studies (such as acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance for an algorithm) is not applicable or provided in this document.

The document describes the device, its intended use, and argues for its substantial equivalence to predicate devices (K112896 and K071538). The "study" mentioned refers to nonclinical (bench) testing performed to demonstrate that the device meets performance, safety, and efficacy requirements, largely by referencing tests performed on its predicate device, K112896, and some additional tests specific to the new device's length.

However, I can extract information related to the device's performance based on the nonclinical testing mentioned.

Here's a summary of the relevant sections, re-framing traditional "acceptance criteria" and "reported performance" based on the provided text, recognizing this is for a physical medical device and not an AI model.

Device: Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology

Type of Device: Percutaneous, implanted, long-term intravascular catheter (physical medical device)

1. Table of Acceptance Criteria and Reported Device Performance

As this is not an AI/ML device, the concept of "acceptance criteria" is typically met by demonstrating compliance with established performance standards for medical devices and showing substantial equivalence to a legally marketed predicate device. The document lists performance tests conducted or referenced from the predicate device.

Acceptance Criteria (Bench Tests Performed/Referenced)	Reported Device Performance (Implied Successful Outcome for Substantial Equivalence)
Referenced from Predicate Device (K112896):
0 air leakage	Device demonstrates no air leakage.
collapse resistance	Device is resistant to collapse.
liquid leakage	Device demonstrates no liquid leakage.
radio detectability	Device is radiodetectable.
clamp closure efficacy	Clamping mechanisms are effective.
0 flow restriction after clamping of extension line	No flow restriction occurs after extension line clamping.
internal and external CHA content	Chlorhexidine content is within specifications.
tensile testing, catheter kinking	Catheter meets tensile strength and kink resistance requirements.
ink adhesion testing	Ink on the device adheres appropriately.
column strength	Catheter possesses adequate column strength.
tip stiffness	Catheter tip stiffness is within specifications.
biocompatibility	Device is biocompatible.
in vitro antimicrobial efficacy up to 30 days	Effective in reducing microbial colonization in vitro (compared to uncoated control).
in vivo infection study up to 30 days	Effective in reducing microbial colonization in vivo (compared to uncoated control).
in vitro and in vivo antithrombogenic effectiveness testing (platelet adhesion, patency, thrombus accumulation up to 30 days)	Effective in reducing thrombosis and maintaining patency (compared to uncoated predicate PICC and Zeus devices).
Additional Tests for Subject Device (due to length changes):
priming volume	Priming volume is characterized and acceptable.
gravity flow rate	Gravity flow rate is characterized and acceptable.
pressure injection	Device withstands pressure injection conditions (up to 300 psi, up to 5 mL/sec).
static burst	Device withstands static burst pressure.
mechanical hemolysis	Device exhibits acceptable levels of mechanical hemolysis.
whip testing	Device withstands whip testing.

2. Sample Size for the Test Set and Data Provenance

Sample Size: The document does not specify exact sample sizes for each bench test. For physical device testing, sample size is typically determined by statistical methods for specific tests, but these details are not provided in this summary.
Data Provenance: The tests are "bench testing," meaning they were conducted in a laboratory setting. No country of origin for the data is mentioned, but typically such testing would be done by the manufacturer (Arrow International, Inc., based in Reading, PA, USA) or a qualified contract lab. The tests are prospective in the sense that they were designed and executed to support the submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. "Ground truth" in the context of expert consensus is relevant for AI/ML devices interpreting medical images or data. For physical device performance testing, the "ground truth" is established by direct measurement of physical properties against engineering specifications and regulatory standards. The "experts" would be the engineers and technicians conducting the bench tests.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1 or 3+1) are used for resolving disagreements among human readers/experts, typically in the context of diagnostic interpretation for AI/ML devices. For physical device testing, results are typically objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

Not applicable. MRMC studies are for evaluating diagnostic performance of AI/ML systems, often with human readers. This document describes a physical medical device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

Not applicable. There is no AI algorithm in this device.

7. The Type of Ground Truth Used

The "ground truth" for these physical device tests would be the established engineering specifications, regulatory standards, and comparative performance against predicate devices as measured by objective physical and chemical methods (e.g., pressure resistance, flow rates, antimicrobial activity measured in agar cultures or animal models, physical integrity tests).

8. The Sample Size for the Training Set

Not applicable. There is no AI algorithm to train. The "training" for a physical device involves designing and manufacturing processes to meet specifications, but not in the AI sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no AI algorithm to train in this context.

Summary

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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 RoadReading, PA 19605-9607
Telephone Number:	(610) 378-0131
Contact Person:	Julie LawsonRegulatory 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-subclavianCentral 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

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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.

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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

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

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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).

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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.

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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

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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:

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.”