The intended use of the Arrow VPS Stylet PLUS and VPS Console (together the VPS System) is to quickly and accurately guide market available central catheters to the desired location, which is the lower third of the superior vena cava (SVC) or at the cavo-atrial junction.

The CG+ Arrow PICC Catheters powered by Arrow VPS Stylet PLUS permit venous access to the central circulation through a peripheral vein, with the guidance of the VPS system.

The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters. The Stylet provides stiffess for use in placement of the cather , intravascular capability for ECG delection and intravascular ultrasound for catheter guiding and positioning. The VPS Style, when used with the VPS Console, provides real-time catherer in location information by using the patient's physiological (cardiae electrical activity and blood flow) 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 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 Bullseve is not obtained, standard hospital practice should be followed to confirm catheter tip location.

Limiting but not contraincied situations for this technique are in patients where allerations of cardias the presentation of the P-waye as in atrial flutter, severe tachycardia and pacemaker-driven rhythm, and in central venous catheterization procedures performed through femoral or saphenous vein access which change the Pwave. 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 Pressure Intectable PICC with Chlorag+ard Aniithombogenic Technology is indicated for short-lerm or long-term peripheral access to the central venous therapy, blood sampling, infusion, pressure injection of contrast media and allows for central venous pressure of pressure of pressure injection equipment used with the pressure injectable PICC catheter may not exceed 300 psi.

Chlorag+ard Technology treatment on the external surface of the entire fluid patiway of the catheler has been shown to be effective in reducing microbial colonization and thrombus accumulation on catheler surfaces. Antimicrobial and antitlersmoogenic effectiveness were evaluated using in viro and in vive test methods and no correlation between these test methods and clinical outcome has currently been asseriained. It is not intented of existing infections or vein thrombosis.

The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters. The Stylet provides stiffess for use in placement of the catheter, intravascular capability for ECG detection and intravascular ultrasound for catherer guiding and positioning. The VPS Style, when used with the VPS Console, provides real-time catheter ip location information by using the patient's physiological (cardial activity and blood flow) 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 allemative 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 patientions of cardiac rhythm change the presentation of the P-wave as in atrial flutter, severe tachyeardia and pacemaker-driven rhythm, and in central venous catheterization procedures performed through femoral or saphenous vein access which change the Pwave. 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 Vascular Positioning System (VPS) Stylet PLUS (hereafter referred to as Arrow VPS Stylet PLUS) is designed for use with a VPS Console to guide market available central catheters to the desired location, which is the lower third of the superior vena cava (SVC) or at the cavoatrial junction. The CG+ Arrow PICC powered by Arrow VPS Stylet PLUS provides the user with an Arrow VPS Stylet PLUS aiready loaded into a central catheter. (The Arrow VPS Stylet Plus and the Arrow VPS Stylet Plus included in the CG+ Arrow PICC powered by Arrow VPS Stylet Plus are exactly the same stylet.)

The subject device, the Arrow VPS Stylet PLUS has the following characteristics:

6 ft overall length .
< 0.021" outer diameter over working length of polyimide with polytetrafluoroethylene . (PTFE) heat shrink
Intravascular electrocardiogram (ivECG) signal sensing stainless steel wire with exposed . portion at the distal end
Doppler transducer connected to coaxial cable at the distal end .
Coaxial cable and ivECG wire attached to connector at the proximal end to be plugged in . to VPS Console or extension cable (that in turn connects to the VPS Console)
Tuohy-Borst adapter ●
Marking accessory .

The Arrow VPS Stylet PLUS is the stylet portion of a vascular positioning system designed to be used with the VPS Console and a market-available catheter. The Arrow VPS Stylet PLUS is a polyimide tube with a fluoropolymer (PTFE) heat shrink. The tubing contains a Doppler sensor on a coaxial cable and an intravascular electrocardiogram (ivECC) 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 CG+ Arrow PICC Powered by Arrow VPS Stylet PLUS is the Arrow VPS Stylet PLUS preloaded into a 4.5 Fr 1-Lumen, 5.5 Fr 2-Lumen, and 6 Fr 3-Lumen, 40-55 cm pressure injectable antimicrobial and antithrombogenic Peripherally Inserted Central Catheter (PICC).

The CG+ Arrow PICC 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 external catheter body and the internal fluid path of the device are treated with Chlorag+ard, a Chlorhexidine-based coating technology.

AI/ML Overview

This document describes a 510(k) submission for the Arrow VPS Stylet PLUS and CG+ Arrow PICC powered by Arrow VPS Stylet PLUS. It is a submission for substantial equivalence to previously cleared devices, meaning the focus of the study is to demonstrate that the new device performs as well as the predicate device(s), rather than establishing new clinical effectiveness. Therefore, the information provided below is extracted based on the nature of this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission seeking substantial equivalence for a medical device that has minor changes from existing predicate devices, the "acceptance criteria" are typically defined by demonstrating that the modified device performs comparably to the predicate device and meets established engineering and biocompatibility standards. Clinical performance is generally not evaluated with new efficacy endpoints unless the changes introduce new risks or intended uses. In this case, the acceptance criteria are largely implied by the PASS results in the nonclinical testing, indicating the device meets the set standards for each test.

Acceptance Criteria (Implied by Test)	Reported Device Performance
Mechanical strength (Tensile, Torque, Tip Flexibility, Flexing, Fracture)	PASS
Corrosion resistance	PASS
Component compatibility & grip strength (Marking accessory, Tuohy-Borst Adapter)	PASS
Leak integrity (Tuohy-Borst)	PASS
Physical characteristics met	PASS
X-ray Detectability	PASS
Electrical Performance (Hi-Pot, Continuity, Doppler Bandwidth, Capacitance, Sensitivity, Sensitivity Stability)	PASS
Biocompatibility (Cytotoxicity, Irritation, Sensitization, Acute Systemic Toxicity, Hemocompatibility)	PASS
Electrical Safety and Electromagnetic Compatibility	PASS
Catheter Compatibility (Simulated Use Insertion/Removal, Force to Remove stylet)	PASS
Substantial Equivalence to Predicate Device	Achieved

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

Since this is a 510(k) submission for substantial equivalence based on nonclinical testing, there is no "test set" of clinical data in the typical sense (i.e., a set of patient data used to evaluate clinical accuracy or performance metrics against a ground truth). The testing conducted was primarily bench testing and laboratory testing on the device itself.

Sample Size: The document does not specify exact sample sizes for each nonclinical test (e.g., how many stylets were tested for tensile strength). These are typically determined by engineering and quality control standards.
Data Provenance: The data is generated from laboratory and bench testing performed on the Arrow VPS Stylet PLUS and the CG+ Arrow PICC powered by Arrow VPS Stylet PLUS. The origin of the data is the manufacturer's internal testing. It is not patient or country-specific. The testing was performed after preconditioning with Et.O sterilization, ISTA simulated environmental conditions, and one year of accelerated aging.

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

This section is not applicable to this submission. "Ground truth" in the context of expert consensus is typically relevant for studies evaluating diagnostic accuracy or clinical outcomes where human experts interpret data. This 510(k) submission focuses on demonstrating the device's technical specifications and safety through nonclinical testing, not on clinical interpretation or an AI algorithm's performance against human experts.

4. Adjudication Method for the Test Set

This section is not applicable as there was no clinical test set requiring adjudication by experts. The "adjudication" in this context would be the successful completion of each nonclinical test according to predefined engineering and safety standards, as indicated by the PASS results.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed to evaluate the impact of an AI system on human reader performance, which is not the focus of this 510(k) submission for mechanical and electrical device changes.

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

The device described (Arrow VPS Stylet PLUS) is a physical medical instrument used to guide catheters and provides real-time information to a "VPS Console." While the VPS Console likely contains algorithms to process the ivECG and Doppler signals, this submission focuses on the stylet itself. Therefore, a "standalone algorithm performance" study in the context of AI models is not relevant or described in this document. The electrical performance tests (Hi-Pot, Continuity, Doppler Bandwidth, Capacitance, Sensitivity, Sensitivity stability) assess the functionality of the device's signal-sensing components, which are essential for the console's operation.

7. The Type of Ground Truth Used

The "ground truth" for the nonclinical testing performed can be defined as:

Engineering Specifications and Standards: Each test (e.g., tensile strength, electrical performance, biocompatibility) has predefined, objective acceptance criteria (e.g., a minimum tensile strength, a specific range for electrical resistance, absence of cytotoxic effects) based on international standards (e.g., ISO, ASTM, IEC) and the manufacturer's own design specifications.
Predicate Device Performance: A key aspect of "substantial equivalence" in a 510(k) is demonstrating that the new device performs "as well as" the predicate device(s). Therefore, the performance characteristics of the legally marketed predicate devices serve as an implicit "ground truth" or benchmark for comparison in the nonclinical testing.

8. The Sample Size for the Training Set

This section is not applicable. This submission describes a physical medical device and its nonclinical testing to demonstrate substantial equivalence, not the development or training of an AI algorithm. Therefore, there is no "training set."

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

This section is not applicable as there is no training set for an AI algorithm.

Summary

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K141618 6 510(K) SUMMARY

JUL 0882014

Submitter Information

Name:	Arrow International, Inc (subsidiary of Teleflex Inc.)
Address:	2400 Bernville RoadReading, PA 19605-9607 USA
Contact Person:	Elizabeth DuncanSr. Regulatory Affairs Specialist
Telephone Number:	(610) 378-0131 Extension 603220
Fax Number:	(610) 478-3179.
Email:	elizabeth.duncan@teleflex.com
Date Prepared:	June 16, 2014

Device Name

Device Trade Name: Arrow VPS Stylet PLUS and CG+ Arrow PICC powered by Arrow VPS Stylet PLUS

Common Name, Stylet: Catheter, Ultrasound, Intravascular

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

Predicate Devices

K 103255: Vascular Positioning System (VPS) Stylet ●
K122545: 4.5 French CG+ Arrow PICC powered by Arrow VPS Stylet .
K 123759: 5.5 French CG+ Arrow PICC powered by Arrow VPS Stylet ●
K130876: 6 French CG+ Arrow PICC powered by Arrow VPS Stylet ●

Device Description

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The subject device, the Arrow VPS Stylet PLUS has the following characteristics:

6 ft overall length .
< 0.021" outer diameter over working length of polyimide with polytetrafluoroethylene . (PTFE) heat shrink
Intravascular electrocardiogram (ivECG) signal sensing stainless steel wire with exposed . portion at the distal end
Doppler transducer connected to coaxial cable at the distal end .
Coaxial cable and ivECG wire attached to connector at the proximal end to be plugged in . to VPS Console or extension cable (that in turn connects to the VPS Console)
Tuohy-Borst adapter ●
Marking accessory .

Intended Use

The CG+ Arrow PIC Catheters powered by Arrow VPS Stylet PLUS permit venous access to the central circulation through a peripheral vein, with the guidance of the VPS system.

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Technological Characteristics and Substantial Equivalence

Characteristic	Predicate Device	Subject Device
Design	6 foot long stylet which contains aDoppler sensor and an intravascularelectrocardiogram (ivECG) signalsensing wire at the distal tip	SAME: 6 foot long stylet whichcontains a Doppler sensor and anintravascular electrocardiogram (ivECG)signal sensing wire at the distal tip
Signal Conductor	Two conductor stylet wires (ECGwire and coaxial cable)	SAME: Two conductor stylet wires(ECG wire and coaxial cable)
ECG Conductor pathway	Exposed conductive surface at distalend of ECG wire	SAME: Exposed conductive surface atdistal end of ECG wire
Connector	Single, 7 prong custom	SAME: Single, 7 prong custom
Polyimide Tube OD and ID(nominal)	OD: 0.0180"ID: 0.0150"	OD: 0.0154"ID: 0.0134"
Coaxial cable OD (nominal)	OD: .0073"	OD: .0063"
Stylet Materials	Transducer wire sleeve (styletbody): Polyimide embedded withFluoropolymer (PTFE)	Transducer wire sleeve (stylet body):Polyimide with Fluoropolymer (PTFE)heat shrink
	Tuohy-Borst: Polycarbonate,Polypropylene, silicone.	Tuohy-Borst: Polycarbonate,Polypropylene, PTFE, TPE
	Coaxial cable: Encapsulated SilverPlated Copper Wire	Coaxial cable: SAME, EncapsulatedSilver Plated Copper Wire
	Epoxy: Silver-filled Epoxy	Epoxy: SAME, Silver-filled Epoxy
	Stylet jacket: Gray Santoprene, 60-68 shore A (durometer)	Stylet jacket: Black Santoprene, 55shore A (durometer)
Stylet Doppler TransducerOperating Frequency	11.667 MHz	SAME: 11.667 MHz
Stylet Doppler TransducerSize	0.5 mm	0.4 mm
Stylet Doppler TransducerShape	Cruciform	Hexagonal
Marking Accessory	Ink marker	Twist-locking collet
PIC Catheters	All characteristics: materials,diameter, lengths, manufacturingprocesses, conditions and aids	SAME: All characteristics
Chlorhexidine Technology	All characteristics: Identity,formulation, concentration (contentper surface area), manufacturingprocesses, conditions and aids,method of application to the deviceand mechanism by which the agent isreleased from the device	SAME: All characteristics
Stylet Shelf life	2 years	1 year
Sterilization: Allcharacteristics, including:method, assurance level	All characteristics, including:Method: Ethylene OxideAssurance Level: 10-6	SAME: All characteristics, including:Method: Ethylene OxideAssurance Level: 10-6
Packaging	Standalone kits: PETG tray sealedin a Tyvek header pouchPreloaded kits: PETG tray with aTyvek lidstock	SAME:Standalone kits: PETG tray sealed ina Tyvek header pouchPreloaded kits: PETG tray with aTyvek lidstock

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The Arrow VPS Stylet PLUS and CG+ Arrow PICC powered by Arrow VPS Stylet PLUS is substantially equivalent to the predicate VPS Stylet (K103255) and the CG+ Arrow PICC powered by Arrow VPS Stylet (K122545, K123759, K130876) in terms of intended use, indications for use, patient population, contraindications, operating principle, functional performance, safety, efficacy, sterilization, fundamental scientific technology, material and design. Any differences between the subject device and the predicates do not render the device not-substantially equivalent (NSE), affect safety or effectiveness, or raise different questions of safety and effectiveness as proven through passing verification results.

There are no changes to the catheter or Chlorag+ard Technology portion of the predicate Arrow CG+ PICC catheters preloaded with the VPS Stylet (K122545, K123759, K130876). There are no changes being made to the VPS Consoles (K103260 and K123813), as part of this submission.

Nonclinical Testing

The following testing was performed on the Arrow VPS Stylet PLUS and the CG+ Arrow PICC powered by Arrow VPS Stylet PLUS after being preconditioned with Et.O sterilization. ISTA simulated environmental conditions and one year accelerated aging:

Test Device	Test	Results
Stylet	Tensile	PASS
	Torque strength	PASS
	Tip Flexibility	PASS
	Flexing BS EN ISO 11070	PASS
	Fracture BS EN ISO 11070	PASS
	Corrosion BS EN ISO 11070	PASS
	Component Compatibility: Marking accessory grip strength	PASS
	Component Compatibility: Tuohy-Borst Adapter grip strength	PASS
	Tuohy-Borst Leak	PASS
	Physical characteristics	PASS
	X-ray Detectability ASTM F640-07	PASS
	Electrical Performance: Hi-Pot, Continuity, DopplerBandwidth, Capicitance, Sensitivity, Sensitivity stability	PASS
Combined device	Biocompatibility: Cytotoxicity, Irritation, Sensitization, AcuteSystemic Toxicity and Hemocompatibility per ISO 10993-1	PASS
Combined device	Electrical Safety and Electromagnetic Compatibility Testing(IEC 60601-1-2, IEC 60601-2-37)	PASS
	Catheter Compatibility Simulated Use Insertion/ Removal	PASS
	Catheter Compatibility Force to Remove stylet from catheter	PASS

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Conclusions

The subject device is substantially equivalent to the predicate device in terms of intended use, indications for use, patient population, contraindications, operating principle, functional performance, safety, efficacy, fundamental scientific technology, design and material. The results of the risk assessment and resultant testing performed have demonstrated that the design and material modifications do not raise new issues of safety or effectiveness and therefore the subject device is considered substantially equivalent to the cited predicate device, performs as well as and is as safe and effective as the predicate devices.

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Public Health Service

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

July 8, 2014

Arrow International, Inc. (subsidiary Of Teleflex Inc.) Elizabeth Duncan Senor Regulatory Affairs Specialist 2400 Bernville Road Reading, PA 19605-907 USA

Re: K141618

Trade/Device Name: Arrow VPS stylet PLUS and CG+ Arrow PICC powered by ArrowVPS Stylet PLUS Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: II Product Code: OBJ Dated: June 16, 2014 Received: June 17, 2014

Dear Ms. Duncan:

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 10 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. Duncan

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 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/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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mary S. Runner -S

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

K141618 510(k) Number (if known):

Device Name: Arrow VPS Stylet PLUS

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Digitally signed by Richard C. Chapman -5 Date: 2014.07.08 09:36:33 -04'00'

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Indications for Use

K141618 510(k) Number (if known): _

Device Name: CG+ Arrow PICC powered by Arrow VPS Stylet PLUS

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

· Concurrence of CDRH, Office of Device Evaluation (ODE)

Digitally signed by Richard C. Chapman -S Date: 2014.07.08 09:36:54 -04'00'

Page 29 of 67

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).