The Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term peripheral 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 injection equipment used with the pressure injectable PICC catheter may not exceed 300 psi.

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 and thrombus accumulation on catheter surfaces. Antimicrobial and antithrombogenic effectiveness were evaluated using in vitro and in vivo test methods and no correlation between these test methods and clinical outcome has currently been ascertained. It is not intended to be used for the treatment 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 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.

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 patients 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 or saphenous 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 CG+ Arrow PICC powered by Arrow VPS Stylet has the following characteristics:

4.5 Fr, 1-Lumen, 40-55 cm pressure injectable, antimicrobial and antithrombogenic . catheter preloaded with VPS Stylet
The CG+ Arrow PICC is pre-loaded with the Arrow VPS Stylet and will be provided in sterile kit configurations.

The Arrow Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology 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. The external catheter body and the 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 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 was designed to be inserted and removed from any catheter with a luminal diameter of at least 0.021 inch.

For user convenience, Arrow has created the CG+ Arrow PICC powered by Arrow VPS Stylet in which the Arrow Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is provided pre-loaded with the Arrow VPS Stylet.

AI/ML Overview

The provided 510(k) summary (K122545) describes a device, the "CG+ Arrow PICC powered by Arrow VPS Stylet," which is a combination of two previously cleared predicate devices: the Vascular Positioning System (VPS System) Stylet (K103255) and the Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology (K112896).

Crucially, this submission is for a combination device, not a new AI/software-as-a-medical-device (SaMD) product. The 510(k) summary explicitly states: "The subject device combines the predicate Arrow VPS Stylet and the Arrow Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology; there is no change to the previously cleared devices or their indications for use."

Therefore, the document does not report on a study proving the device meets new acceptance criteria for an AI or SaMD component. Instead, the nonclinical testing performed focused on ensuring that combining the two previously cleared devices did not introduce new safety or effectiveness issues.

Given this context, most of the requested information regarding acceptance criteria, device performance metrics, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for AI/SaMD are not applicable or not present in this document.

However, I can extract the relevant information based on the nature of this 510(k):

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a combination of pre-approved physical devices, the "acceptance criteria" and "reported device performance" are primarily related to the physical integrity and continued functionality of the combined product. There are no specific performance metrics like sensitivity, specificity, accuracy, or AUC typically associated with AI/SaMD.

Acceptance Criteria Category	Reported Device Performance (Summary)
Catheter Performance	Passed tests for air and liquid leakage.
Stylet Performance	Passed tests for tensile strength, electrical function, and removal.
Combined Device Performance	Passed simulated use insertion/removal test.
Substantial Equivalence	Demonstrated that combining the two previously cleared devices does not raise new issues of safety or effectiveness.

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

The document does not specify sample sizes for the "test set" in the context of typical AI/SaMD validation (e.g., number of images or patient cases). The testing described is nonclinical, involving engineering and bench testing.

Sample Size: Not specified in terms of distinct units or cases. The testing would have involved appropriate numbers of devices/components to satisfy engineering test standards for the mentioned performance categories.
Data Provenance: Not applicable as it's nonclinical, bench testing.

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

Not applicable. Ground truth for these nonclinical tests would be established by engineering specifications, physical measurements, and adherence to established test protocols. No human expert interpretation of data for ground truthing is described or required for this type of submission.

4. Adjudication Method for the Test Set

Not applicable. Adjudication is not typically part of standard nonclinical engineering bench testing.

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

No. An MRMC study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This submission does not involve such an AI component.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a physical catheter and stylet; it is not a standalone algorithm.

7. The Type of Ground Truth Used

For the nonclinical testing, the "ground truth" would be objective engineering measurements and compliance with predetermined physical and mechanical specifications. For example, for air and liquid leakage, the ground truth is "no leakage" beyond an acceptable threshold. For tensile strength, it's maintaining integrity under a specified load.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

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

Not applicable. No training set for an AI/ML algorithm is involved.

In summary, the K122545 submission is for a combined medical device, not an AI or SaMD product. The testing performed focused on ensuring the physical and functional integrity of the combined components, and therefore, the document does not contain the specific details relevant to AI/SaMD performance validation.

Summary

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K.122545

SEP 20 2012

510(K) SUMMARY 6

Submitter Information

Name:	Arrow International, Inc (subsidiary of Teleflex Inc.)
Address:	2400 Bernville Road Reading, PA 19605-9607 USA
Contact Person:	Elizabeth Duncan Sr. Regulatory Affairs Specialist
Telephone Number:	(610) 378-0131 Extension 603220
Fax Number:	(610) 478-3179
Email:	elizabeth.duncan@teleflex.com
Date Prepared:	August 20, 2012

Device Name

Device Trade Name: CG+ Arrow PICC powered by Arrow VPS Stylet Common Name, Catheter: Peripherally Inserted Central Catheter (PICC) 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
K112896: Pressure Injectable PICC with Chlorag+ard Antimicrobial and . Antithrombogenic Technology

Device Description

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

4.5 Fr, 1-Lumen, 40-55 cm pressure injectable, antimicrobial and antithrombogenic . catheter preloaded with VPS Stylet
The CG+ Arrow PICC is pre-loaded with the Arrow VPS Stylet and will be provided in sterile kit configurations.

Page 22 of 118

page 1 of 3

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K122545

contrast media. The maximum recommended infusion rate is 5 mL/sec. The external catheter body and the 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.

Intended Use

A PICC permits venous access to the central circulation through a peripheral vein.

The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market available 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 CG+ Arrow PICC powered by Arrow VPS Stylet is substantially equivalent to the Vascular Positioning System (VPS System) Stylet (K103255) and the Pressure Injectable Peripherally Inserted Central Catheter (PICC) with Chlorag+ard Antimicrobial and Antithrombogenic Technology (K112896) in terms of indications for use, design, manufacturing process, functional performance, and materials of construction. The subject device combines the predicate Arrow VPS Stylet and the Arrow Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology; there is no change to the previously cleared devices or their indications for use.

Nonclinical Testing

The following testing was performed on the CG+ Arrow PICC powered by Arrow VPS Stylet: catheter performance testing: air and liquid leakage, stylet performance testing: tensile, electrical function and removal testing and the combined device performance testing: simulated use insertion/removal test.

Page 23 of 118

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K122545

Conclusions

The predicate and the subject devices have the same indications for use, intended use, design, materials, and are manufactured using the same processes. The results of the testing performed have demonstrated that combining the two previously cleared devices does not raise new issues of safety or effectiveness and therefore the combination is considered substantially equivalent to the cited predicate devices.

Page 24 of 118

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. 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 eagle or bird-like symbol with three overlapping, curved lines forming its body and wings. The logo is black and white.

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

SEP 20 2012

Arrow International, Inc. c/o Ms. Elizabeth Duncan Sr. Regulatory Affairs Specialist 2400 Bernville Road Reading, PA 19605

Re: K122545

K122343
Trade/Device Name: CG+ Arrow PICC powered by Arrow VPS Stylet Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous Implanted Long-Term Intravascular Catheter Regulatory Class: Class II Product Code: LJS, OBJ Dated: August 20, 2012 Received: August 21, 2012

Dear Ms. Duncan:

We have reviewed your Section 510(k) premarket notification of intent to market the device in We have reviewed your Section 310(x) prematics is substantially equivalent (for the indications referenced above and nave uctchined the arrow as a society of the started in interstate for use stated in the encrosury manated position of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior in May 28, 1970, the chacinent care of the provisions of the Federal Food, Drug, devices that have been reclassified in accordance with a proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act. The and Cosmetic Act (Act) that to not require approval controls provisions of the Act. The Act. The Act. The You may, therefore, market the device, sucject to urements for annual registration, listing of
general controls provisions of the Act include requirements wishrending and general controls provisions of the Act mendo requirements misbranding and adulteration. Please note: CDRH does not evaluate information related to contract fiability adulteration. Please note: CDNT docs not evaluate international of truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it
and be If your device is classified (see above) mio energentions affecting your device can be
may be subject to additional controls. Existed on addition, EDA may may be subject to addinonal confrois: "Existing migral" - "Edecal Register found in the Code of Federal Rogarations, Frins Boys, In the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualice of a substitive with other requirements of the Act
that FDA has made a determination that your device and or and of excepcies. You mus that FDA has made a determilation in an your arrived by other Federal agencies. You must
or and Federal statutes and regulations administered by registration and listing or any Federal statures and regulations administered by Callery of Childred to: registration and listing (21

{4}------------------------------------------------

Page 2 – Ms. Elizabeth Duncan

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 (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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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Indications for Use

510(k) Number (if known): K122545

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

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)

Division Sign-Off
Division of Cardiovascular Devices
510(k) Number	K122545
Page	21 of 118

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.”