The Arrow® Pessure Injectable Jugalarian Central Catherer™ with Chlorag+ard Antimicrobial and Antithrombagenc Technology is indicated for short-tern access to the central venous system for intrasenous therapy. blood sampling, infusion, pressure injection of contrast media and allows for contrasion The maximum pressure of pressure injector quipment used with the Arrow Pressure Injectable 1900 psi. The marimum pressure injection 110ve rate for the specific lumen heing used for pressure injection is printed on the extension line hub.

Chionageurd Technology treatment on the cathere of the cathere body as well as the entire fibid pathway of the catherer has been shown to be citective in reducing microbial colonization on cathers. Antimierobial cities were evaluated using in ritre and in rive and in rive and in rive and in rive and in rive methods and no correlation between these esting methods and clinical outcome has currently been assertained. 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 catheress for use in placement of the cather. intravascular espability for ECG devection and intravascular ultrasound for eatherer guiding and passioning. The VPS Stylet, when used with the VPS Console, provides real-time catherer information by using the patient's physiological (curdize clectrical activity and blow) information. When the VPS System guidance indicator shows a Blue Bullseye, the catheter tip is in the desired location.

The VPS System is indicated for use as an sherative method to Internation venus cather up placement confirmation in add patients when a steady Blue Bullseye is obtained, NOTE: IT's steady Blue Bullained, standard haspital proctive should be followed to confirm catherer tip location.

Limiting but not contraindiented situations for this receivers where alterations of cardiae thythm change the presentation of the fwave as in atial fibrillation, arrial flutter severe achycardia and pacental venous catherization procedures performed through femoral or suphenous vein access which of the P-vave. In such patients, who are easily identifiable prior to central venous catheter insertion. the use of an additional method is required to confirm catherer tip location.

Device Description

The CG+ Arrow JACC powered by Arrow VPS Stylet has the following characteristics:

. 4.5 French, 1-Lumen, 15-35 cm pressure injectable, antimicrobial and antithrombogenic catheter preloaded with VPS Stylet
. 5.5 French, 2-Lumen, 15-35 cm pressure injectable, antimicrobial and antithrombogenic catheter preloaded with VPS Stylet
. 6 French, 3-Lumen, 15-35 cm pressure injectable, antimicrobial and antithrombogenic catheter preloaded with VPS Stylet

The CG+ Arrow JACC powered by Arrow VPS Stylet is a CG+ Arrow JACC pre-loaded with the Arrow VPS Stylet and will be provided in sterile kit configurations. The CG+ Arrow JACC devices will also be provided in sterile kit configurations without the Arrow VPS Stylet preloaded in the catheter.

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 coating technology.

The Arrow VPS Stylet is a polyimide tube containing a Doppler sensor on a coax cable and an intravascular electrocardiogram (ivECG) signal sensing stainless steel wire. The Doppler sensor and the exposed portion of the ivECG are located at the distal end of the stylet and are used to detect and transmit physiological information to the VPS Console for analysis. The proximal end contains a connector to the VPS Console or to an extension cable that in turn connects to the VPS Console. The stylet is designed to be compatible with any catheter with an inner luminal diameter of at least 0.021 inch.

AI/ML Overview

The provided text is a 510(k) summary for the "CG+ Arrow JACC powered by Arrow VPS Stylet." This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a standalone study with defined metrics for the device itself.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, particularly for AI/algorithm performance, cannot be fully extracted from this document in the way it would for a software device with performance claims. The document is primarily a comparison against existing hardware devices.

However, I can provide the information available that most closely aligns with your request, focusing on the verification testing performed.

Summary of Device and its Purpose:

The "CG+ Arrow JACC powered by Arrow VPS Stylet" combines a Central Venous Catheter (CG+ Arrow JACC) with a Vascular Positioning System (VPS) Stylet. The VPS Stylet, used with a console, guides the catheter to the desired location (lower third of the SVC or cavo-atrial junction) using Doppler and intravascular electrocardiogram (ivECG) signals.

1. Table of Acceptance Criteria and Reported Device Performance

As this document is a 510(k) for substantial equivalence of a hardware device (catheter and stylet), it does not present acceptance criteria in the typical format of a standalone performance study for an AI/algorithm, with metrics like AUC, sensitivity, or specificity. Instead, it describes verification testing performed to ensure the device meets engineering and safety specifications, demonstrating equivalence to predicate devices.

The "acceptance criteria" can be inferred from the need for the device to perform "the same" or comparably to its predicates in various tests. The "reported device performance" is a statement that these tests were performed and the device passed, leading to the conclusion of substantial equivalence.

Acceptance Criterion (Inferred from testing)	Reported Device Performance
Chlorhexidine Coating Testing:
- Chlorhexidine content (Internal, External, Total Maximum)	- "SAME" as predicate devices for 4.5 and 5.5 Fr catheters. New 6 Fr catheter: Internal Content: 13-36 µg/cm; External Content: 205-309 µg/cm. Total Max Content: "SAME" (Maximum of 22.2 mg/catheter). - Testing performed for content.
- Chlorhexidine coating efficacy (Antimicrobial, Antithrombogenic)	- "SAME" as predicate device ("Effective in reducing microbial colonization," "Antithrombogenic Efficacy"). - Testing performed for efficacy.
- Chlorhexidine release rate (elution)	- Testing performed.
- Mechanical Hemolysis	- Testing performed.
- Solvent Residual	- Testing performed.
- Chemical Degradation	- Testing performed.
Catheter Performance Testing:
- Tensile strength	- Testing performed.
- Catheter body kink resistance	- Testing performed.
- Flow rate (Max infusion rate, Pressure injection capabilities)	- Max infusion rate: 1-Lumen: 5 mL/sec; 2-Lumen: 5 mL/sec; 3-Lumen: 6 mL/sec. - Pressure Injection: 1-Lumen Distal: 5 mL/sec (SAME); 2-Lumen Distal: 5 mL/sec (SAME), Proximal: 4 mL/sec; 3-Lumen Distal: 6 mL/sec, Proximal/Medial: No Pressure Injection. Testing performed.
- Static burst pressure	- Testing performed.
- Air and liquid leakage	- Testing performed.
- Flex cycling	- Testing performed.
- Catheter whip	- Testing performed.
- Catheter tip compression stiffness	- Testing performed.
- Luer hub testing	- Testing performed.
- Collapse resistance	- Testing performed.
- Central venous pressure monitoring	- Testing performed.
Combined Device Performance Testing (Catheter + VPS Stylet):
- Stylet tensile strength	- Testing performed.
- Simulated use insertion/removal (Force to remove stylet from catheter)	- Testing performed.
- Post-insertion/removal catheter air and liquid leakage	- Testing performed.
- Stylet electrical testing	- Testing performed.
Overall (from "Conclusions" section):	The results of the risk assessment and resultant testing performed have demonstrated that the proposed design and specification changes do not raise new issues of safety or effectiveness and therefore the subject device is considered substantially equivalent to the cited predicate devices. This implies all tests were passed to demonstrate no new safety/effectiveness concerns.

No information is provided for the following points as they are generally related to AI/algorithm performance studies, which this document does not contain:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

The document only states that "Antimicrobial efficacies were evaluated using in vitro and in vivo methods" for the Chlorag+ard technology on the catheter, but does not provide details on sample sizes, ground truth, or expert involvement for these specific tests. The VPS Stylet's function is described as providing "real-time catheter information by using the patient's physiological (cardiac electrical activity and blood) information," leading to a "Blue Bullseye" indicator, but no performance metrics for this guidance system itself are provided beyond acknowledging its indication and an alternative method for tip placement confirmation.

Summary

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510(K) SUMMARY 06

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:	July 10, 2013

SEP 26 2013

Device Name

Device Trade Name: CG+ Arrow JACC powered by Arrow VPS Stylet Common Name, Catheter: Central Venous Catheter Common Name, Stylet: Catheter, Ultrasound, Intravascular

Classification Name, Catheter: Percutaneous, implanted, long-term intravascular catheter per 21 CFR: 880.5970

Classification Name, Stylet: Diagnostic Intravascular Catheter per 21 CFR 870.1200

Predicate Devices

K103255: Vascular Positioning System (VPS System) Stylet .
K121501: Arrow® Pressure Injectable Jugular Axillo-subclavian Central Catheter™ (JACC™) with Chlorag ard® Antimicrobial and Antithrombogenic Technology

Device Description

The CG+ Arrow JACC powered by Arrow VPS Stylet has the following characteristics:

. 4.5 French, 1-Lumen, 15-35 cm pressure injectable, antimicrobial and antithrombogenic catheter preloaded with VPS Stylet
. 5.5 French, 2-Lumen, 15-35 cm pressure injectable, antimicrobial and antithrombogenic catheter preloaded with VPS Stylet
. 6 French, 3-Lumen, 15-35 cm pressure injectable, antimicrobial and antithrombogenic catheter preloaded with VPS Stylet

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Intended Use

The CG+ Arrow JACC powered by Arrow VPS Stylet permits venous access to the central circulation through a central vein. The VPS Stylet, used with the VPS Console, quickly and accurately guides the central catheters to the desired location which is the lower third of the SVC or at the cavo-atrial junction.

Technological Characteristics and Substantial Equivalence

The subject CG+ Arrow JACC powered by Arrow VPS Stylet is substantially equivalent to the Vascular Positioning System (VPS) Stylet (K103255) and the Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Chlorag ard Antimicrobial and Antithrombogenic Technology (K121501) in terms of indications for use, manufacturing process, conditions and aids, functional performance, safety, efficacy, fundamental scientific technology and materials of construction. There is no change to the previously cleared Arrow VPS Stylet device associated with this modification. The design of the predicate Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Chlorae ard Antimicrobial and Antithrombogenic Technology has been modified to create the subject device. The following table reflects a comparison of the subject and predicate device characteristics.

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K132133 Page 3 of 5

Subject and Predicate Device Comparison

	Subject and Predicate Device Comparison
Characteristic	Predicate: Pressure Injectable JACC withChlorag+ard Antimicrobial andAntithrombogenic Technology (K121501)	Subject:CG+ Arrow JACC powered by Arrow VPS Stylet(Catheter Portion - CG+ Arrow JACC)
Catheter Length	20-30 cm	15-35 cm
Catheter OD	4.5 and 5.5 Fr	4.5, 5.5, and 6 Fr
Number ofLumens	1 and 2 Lumen	1,2, and 3 Lumen
Internal LumenConfiguration	1 Lumen - Round2 Lumen - Double D	1 Lumen - Round - SAME2 Lumen - Round-Crescent3 Lumen- Round-Split-Crescent
PressureInjectionCapabilities	1 Lumen:Distal:5 mL/sec. Pressure Injectable2 Lumen:Distal: 5 mL/sec. Pressure InjectableProximal: 5 mL/sec, Pressure Injectable	l Lumen:Distal:5 mL/sec. Pressure Injectable - SAME2 Lumen:Distal: 5 mL/sec, Pressure Injectable - SAMEProximal: 4 mL/sec, Pressure Injectable3 Lumen:Distal: 6 ml/sec, Pressure InjectableProximal: No Pressure InjectionMedial: No Pressure InjectionNote: Lumens that are not indicated for Pressure Injectionhave "No CT" printed on the extension line hubs.
Catheter bodymaterial	Radiopaque polyurethane (Blue 95A/55DTecothane with 30% Bismuth Oxychloride)	SAME
CatheterJuncture HubMaterial	Blue Tecoflex 85A	SAME
Catheter TipDesign andmaterial	Blue Flex Tip/Blue 85A Tecothane with 30%Bismuth Oxychloride	SAME
Extension LineMaterial	Clear Pellathane 90 Shore A	SAME
Extension LineHub Material	Distal - Pink Isolplast >100 polyurethaneProximal - White Isoplast >100 Polyurethane	Distal - SAMEProximal - SAMEMedial - Blue Isoplast >100 PolyurethaneNote: This new material is used on the medial lumenextension line hub of the 6 Fr. catheter.
Printing Ink	2405 Black Ink	2405 Black Ink and White InkNote: The white ink is used to print "No CT" on themedial lumen extension line hub of the 6 Fr. catheter.
Sterilization	1 EtO	SAME
PerformanceSpecifications	Antimicrobial EfficacyEffective in reducing microbial colonizationAntithrombogenic Efficacy	SAME
Characteristic	Predicate: Pressure Injectable JACC withChlorag+ard Antimicrobial andAntithrombogenic Technology (K121501)	Subject:CG+ Arrow JACC powered by Arrow VPS Stylet(Catheter Portion - CG+ Arrow JACC)
Content PerSurface Area	Internal: min 15 µg/cm²External: min 324 µg/cm²	SAME
Chlorhexidine-based Coating -Content Per1 cm piece ofcatheter	4.5 Fr. - All lengthsInternal Content: 4 - 20 µg/cmExternal Content: 100-240 µg/cm5.5 Fr. - All lengthsInternal Content: 8 - 30 µg/cmExternal Content: 120-280 µg/cmExtension LinesInternal Content: 5 - 35 µg/cm	4.5 and 5.5 Fr. are the SAME6 Fr. - All lengthsInternal Content: 13-36 µg/cmExternal Content: 205-309 µg/cmExtension Lines - SAME
Total MaximumContent ofChlorhexidine	Maximum of 22.2 mg/catheter	SAME
Formulationsfor Internal andExternalAntimicrobialCoating	Substance	Internal Coating Concentration(wt %)	External Coating Concentration(wt %)
	ChlorhexidineDiacetate (CHA)	1.5	2.0
	ChlorhexidineFreebase (CHX)	1.5	None
	Tetrahydrofuran(THF)	None	87.1
	Clear 95ATecothanepolyether-polyurethane	None	6.3
	Methyl EthylKetone (MEK)	63.4	None
	Methanol	14.5	4.6
	Acetone	19.1	None
Predicate:Vascular Positioning System (VPS System) Stylet(K103255)		Subject:CG+ Arrow JACC powered by Arrow VPS Stylet(VPS Stylet Portion - 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 Stainless Steelintravascular electrocardiogram (ivECG) signalsensing wire	SAME
SignalConductor	Two conductor stylet wires	SAME
Sterilization	EtO	SAME

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K132133 Page 4 of 5

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K132133 Page 5 of 5

Nonclinical Testing

The following verification testing was performed and applies to the CG+ Arrow JACC powered by Arrow VPS Stylet:

Chlorhexidine coating testing: chlorhexidine content testing, chlorhexidine coating efficacy, chiorhexidine release rate (elution), mechanical hemolysis, solvent residual and chemical degradation.

Catheter performance testing: tensile, catheter body kink, flow rate, static burst pressure, air and liquid leakage, flex cycling, catheter whip, catheter tip compression stiffness, luer hub testing, collapse resistance and central venous pressure monitoring.

Combined device performance testing: stylet tensile, simulated use insertion/removal, force to remove stylet from catheter, and post-insertion/removal catheter air and liquid leakage and stylet electrical testing.

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 risk assessment and resultant testing performed have demonstrated that the proposed design and specification changes do not raise new issues of safety or effectiveness and therefore the subject device is considered substantially equivalent to the cited predicate devices.

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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo features a stylized eagle with three stripes forming its wing, representing the department's mission to protect the health of all Americans. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement.

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

September 26, 2013

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

Re: K132133

Trade/Device Name: CG+ Arrow JACC powered by Arrow VPS Stylet Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OBJ LJS Dated: August 27, 2013 Received: August 29, 2013

Dear Ms. Julie 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.

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

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Page 2 - Ms. Julie Lawson

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Owen-P.Faris -S

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K132133 Page 1 of 1

Indications for Use

510(k) Number (if known):

Device Name: CG+ Arrow JACC powered by Arrow VPS Stylet

Indications for Use:

Prescription Use x (Part 21 CFR 801 Subpart D)

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

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

ANDAOR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Digitally signed by
Owen P. Faris -S
Date: 2013.09.26
14:49:51 -04'00'

Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).