The Arrow Pressure Injectable JACC with Chlorag+ard Antithrombogenic Technology 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 of pressure injector equipment used with the 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 pathyav of the catheter has been shown to be effective in reducing microbial colonization on catheter surfaces. Antimicrobial effectiveness were 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 treating infections.

The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters. The Stylet provides stiffness for use in placement of the catheter, intravascular capability for ECG detection and recording and intravascular ultrasound for catheter guiding and positioning. The VPS Stylet, when used with the VPS Console, provides real-time catheter tip location information by using the patient's physiological (cardiac electrical activity and blood flow) information. When the Vascular Positioning System guidance indicator shows a Blue Bullseye, the catheter tip is in the desired location.

The VPS System is indicated for use as an alternative method to fluoroscopy or chest x-ray for central venous catheter tip placement confirmation in adult patients when a steady Blue Bullseye is obtained. NOTE: If a steady Blue Bullseye is not obtained, standard hospital practice should be followed to confirm catheter tip location.

Limiting but not contraindicated situations for this technique are in palients where alterations of cardiac rhythm change the presentation of the P-wave as in atrial flutter, severe tachycardia and pacemaker-driven rhythm, and in central venous catheterization procedures performed through femoral vein access which change the presentation of the P-wave. In such patients, who are easily identifiable prior to central venous catheter insertion, the use of an additional method is required to confirm catheter tip location.

Device Description

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

. 4.5 French, 1-Lumen, 15-35 cm pressure injectable, antimicrobial and antithrombogenic catheter with or without preloaded VPS stylet
5.5 French, 2-Lumen, 15-35 cm pressure injectable, antimicrobial and antithrombogenic . catheter with or without preloaded VPS Stylet
6 French, 3-Lumen, 15-35 cm pressure injectable, antimicrobial and antithrombogenic ● catheter with or without preloaded VPS Stylet

The subject device is a CG+ Arrow JACC with or without pre-loaded Arrow VPS Stylet and will be provided in sterile kit configurations. The modifications subject to this submission are additions to the recommended procedural technique to clarify that the catheter devices can be trimmed or cut to the appropriate length based on the specific patient's anatomy.

The CG+ Arrow JACC is a short-term or long-term, single use catheter designed to provide 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 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 modifications subject to this premarket notification related to the geometric or material design of the devices modified in this submission, nor are there any modifications to the Chlorag+ard technology that is incorporated in the modified device's physical design.

AI/ML Overview

The provided text is a 510(k) summary for Arrow International, Inc.'s CG+ Arrow JACC devices. It aims to demonstrate substantial equivalence to a predicate device, focusing on a modification to the recommended procedural technique (catheter trimming instructions).

Here's an analysis of the acceptance criteria and supporting study information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define "acceptance criteria" for performance metrics in the way one might expect for a formal clinical trial or algorithm validation. Instead, the focus is on demonstrating substantial equivalence to a predicate device after a modification to a procedural technique. The "performance" being evaluated is essentially the continued safety and functional equivalence of the modified device.

Characteristic	Acceptance Criteria (Implied from "SAME" or "Effective")	Reported Device Performance (Subject Device)
Catheter Trimming Compatibility	Catheter remains functional and safe after trimming.	Verified by internal method.
Antimicrobial Efficacy	Effective in reducing microbial colonization (same as predicate).	Effective in reducing microbial colonization. (Evaluated through in vitro and in vivo test methods, but no correlation between these testing methods and clinical outcome has currently been ascertained.)
Antithrombogenic Efficacy	Effective in reducing thrombus accumulation (same as predicate).	Effective in reducing thrombus accumulation.
Physical/Material Characteristics (Catheter Length, OD, Lumens, Material, Hubs, Ink, Sterilization)	Identical to predicate device.	Same as predicate device.
VPS Stylet Characteristics (Diameter, Length, Design, Signal Conductor, Sterilization)	Identical to predicate device.	Same as predicate device.
Finished Good Design Validation	The modified design meets specified validation requirements (details not provided).	Completed.

Important Note: The document explicitly states that "no correlation between these testing methods and clinical outcome has currently been ascertained" for the antimicrobial efficacy. This means while the device has shown antimicrobial activity in lab/animal settings, there isn't clinical evidence in this document proving it translates to reduced infections in humans.

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide specific sample sizes for test sets in a traditional sense. The "testing" mentioned is primarily design verification testing and risk analysis related to the modification (catheter trimming). There is no mention of a patient-based test set with specific sample sizes.

Data Provenance: The testing mentioned ("internal method", "in vitro and in vivo test methods") points to internal laboratory or animal studies, likely conducted by the manufacturer (Arrow International, Inc./Teleflex Inc.). There is no mention of country of origin for data or whether it's retrospective or prospective clinical data.

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

This information is not provided. Given the nature of the submission (510(k) for a procedural modification to an existing device), the "ground truth" for the verification testing would be based on engineering specifications, material science, and established safety standards rather than expert clinical consensus on a patient test set.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. There is no mention of a test set that would require expert adjudication in the context of this submission. The "adjudication" would be performed by the manufacturer's internal quality and regulatory teams, and subsequently by the FDA reviewers, applying regulatory standards to the provided test results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If so, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or mentioned. This submission is for a medical device (catheter) with guidance (VPS Stylet), not an AI-powered diagnostic imaging system that would typically involve human "readers" and AI assistance.

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

No, a standalone (algorithm only) performance study was not done. The "VPS Stylet" is a guidance system used by a human operator during a medical procedure, not a standalone AI algorithm.

7. The Type of Ground Truth Used

For the aspects evaluated:

Catheter Trimming Compatibility & Functional Performance: The "ground truth" would be engineering specifications, established mechanical/material properties, and successful demonstration of absence of adverse effects from trimming through design verification testing.
Antimicrobial & Antithrombogenic Efficacy: The "ground truth" was established through in vitro and in vivo test methods.

8. The Sample Size for the Training Set

This information is not applicable/not provided. There is no mention of an "AI algorithm" or a "training set" in this 510(k) submission.

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

This information is not applicable/not provided as there is no "training set" mentioned.

Summary

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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with a flowing design beneath them.

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

January 28, 2016

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

Re: K153423 Trade/Device Names: CG+ Arrow JACC CG+ Arrow JACC Powered By Arrow VPS Stylet Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS, OBJ Dated: January 4, 2016 Received: January 6, 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.

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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours, Tina Kiang S

for Erin I. Keith, M.S. 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) K153423

Device Name

CG+ Arrow JACC
CG+ Arrow JACC powered by Arrow VPS Stylet

Indications for Use (Describe)

The Arrow Pressure Injectable JACC with Chlorageard Antithrombogenic Technology 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 of pressure injector equipment used with the 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.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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7 510(K) SUMMARY: K153423

Submitter Information

Name:	Arrow International, Inc (subsidiary of Teleflex Inc.)
Address:	2400 Bernville RoadReading, PA 19605-9607 USA
Contact Person:	Julie LawsonRegulatory Affairs Specialist
Telephone Number:	(610) 378-0131 Extension 603256
Fax Number:	(610) 478-3179
Email:	julie.lawson@teleflex.com
Date Prepared:	November 24, 2015

Device Name

Device Trade Name:

CG+ Arrow JACC .
CG+ Arrow JACC powered by Arrow VPS Stylet ● Common Name, Catheter: Central Venous Catheter Common Name, Stylet: Catheter, Ultrasound, Intravascular Classification Regulation: 21 CFR: 880.5970 Classification Name: Percutaneous, implanted, long-term intravascular catheter Product Code: LJS, OBJ

Predicate Devices

K132133: CG+ Arrow JACC powered by Arrow VPS Stylet .

Device Description

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

. 4.5 French, 1-Lumen, 15-35 cm pressure injectable, antimicrobial and antithrombogenic catheter with or without preloaded VPS stylet
5.5 French, 2-Lumen, 15-35 cm pressure injectable, antimicrobial and antithrombogenic . catheter with or without preloaded VPS Stylet
6 French, 3-Lumen, 15-35 cm pressure injectable, antimicrobial and antithrombogenic ● catheter with or without preloaded VPS Stylet

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Indications for Use

The Arrow Pressure Injectable JACC with Chlorag+ard Antimicrobial and Antithrombogenic Technology 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 of 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 were 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 VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters. The Stylet provides stiffness for use in placement of the catheter, intravascular capability for ECG detection and recording and intravascular ultrasound for catheter guiding and positioning. The VPS Stylet, when used with the VPS Console, provides real-time catheter tip location information by using the patient's physiological (cardiac electrical activity and blood flow) information. When the VPS System guidance indicator shows a Blue Bullseye, the catheter tip is in the desired location.

Limiting but not contraindicated situations for this technique are in patients where alterations of cardiac rhythm change the presentation of the P-wave as in atrial fibrillation, atrial flutter, severe tachycardia and pacemaker-driven rhythm, and in central venous catheterization procedures performed through femoral or saphenous vein access which change the presentation of the P-

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wave. In such patients, who are easily identifiable prior to central venous catheter insertion, the use of an additional method is required to confirm catheter tip location.

The above Indication for Use is identical to the predicate.

Technological Characteristics and Substantial Equivalence

The subject CG+ Arrow JACC is substantially equivalent to the CG+ Arrow JACC powered by VPS (K132133) in terms of indications for use, manufacturing process, conditions and aids, functional performance, fundamental scientific technology and materials of construction. There is no change to the geometric design of the subject devices which is associated with the procedural clarifications subject to this submission. The procedure clarifications consist of the addition of catheter trimming instructions and other minor clarifications to make the instructions easier to read by eliminating redundancy and standard protocols as well as improving the flow of the written procedure, thus clarifying the recommended procedural steps. The following table reflects a comparison of the subject and predicate device characteristics.

Characteristic	Predicate:CG+ Arrow JACC powered by VPS Stylet(K132133)	Subject:CG+ Arrow JACC
Catheter Length	15-35 cm	SAME
Catheter OD	4.5, 5.5, and 6 Fr	SAME
Number ofLumens	1,2, and 3 Lumen	SAME
Internal LumenConfiguration	1 Lumen - Round2 Lumen – Double D2 Lumen - Round-Crescent3 Lumen- Round-Split-Crescent	SAME
PressureInjectionCapabilities	1 Lumen:Distal: 5 mL/sec. Pressure Injectable2 Lumen - Double D:Distal: 5 mL/sec, Pressure InjectableProximal: 5 mL/sec, Pressure Injectable2 Lumen - Round-Crescent:Distal: 5 mL/sec, Pressure InjectableProximal: 4 mL/sec, Pressure Injectable3 Lumen:Distal: 6 mL/sec, Pressure InjectableProximal: No Pressure InjectionMedial: No Pressure InjectionNote: Lumens that are not indicated for PressureInjection have "No CT" printed on the extensionline hubs.	SAME
Catheter bodymaterial	Radiopaque polyurethane	SAME

Subject and Predicate Device Comparison

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Characteristic	Predicate:CG+ Arrow JACC powered by VPS Stylet(K132133)	Subject:CG+ Arrow JACC
Catheter Juncture Hub Material	Blue polyurethane	SAME
Catheter Tip Design and material	Radiopaque, soft blue polyurethane	SAME
Extension Line Material	Clear polyurethane	SAME
Extension Line Hub Material	Distal - Pink polyurethaneProximal - White PolyurethaneMedial - Blue PolyurethaneNote: This new material is used on the medial lumen extension line hub of the 6 Fr. catheter.	SAME
Printing Ink	2405 Black Ink and White InkNote: The white ink is used to print "No CT" on the medial lumen extension line hub of the 6 Fr. catheter.	SAME
Sterilization	Provided Sterile. Sterilized by Ethylene Oxide.	SAME
Performance Specifications	Antimicrobial EfficacyEffective in reducing microbial colonizationAntithrombogenic EfficacyEffective in reducing thrombus accumulation	SAME

Characteristic	Predicate:CG+ Arrow JACC powered by VPS Stylet(K132133)	Subject:CG+ Arrow JACC powered by Arrow VPS Stylet
Stylet Diameterand cathetercompatibility	0.019", compatible with catheters with an ID ≥0.021".	SAME
Stylet Length	6 Ft	SAME
Stylet Design	6 foot long polymeric tube which contains aDoppler sensor at the distal tip and intravascularelectrocardiogram (ivECG) signal sensing wire	SAME
SignalConductor	Two conductor stylet wires	SAME
Sterilization	EtO	SAME

Nonclinical Testing

Risk analysis activities were conducted to assess the impact of the modification made to the subject device. Appropriate control mechanisms were defined to mitigate the identified risks. Design verification testing was conducted to mitigate identified risks and is summarized in the submission to support the substantial equivalence of the modified device. The following testing is summarized in the submission:

Catheter trimming compatibility verification test according to internal method ●
Finished Good Design Validation .

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Conclusions

The predicate and the subject devices have the same indications for use, intended use, materials, chlorhexidine formulation, concentration (content per surface area), method of application and mechanism of release and are manufactured using the same processes, conditions and aids. The results of the verification testing performed have supported the substantial equivalence of the modified devices to the predicate devices.

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.”