The Pressure Injectable PICC with Chlorag+ard Antithrombogeaic 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 catherer has been shown to be effective in reducing microbial colonization and thrombus accumulation on cather 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 ascenained. 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 catheres. The Stylet provides stiffess 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 Coasole, 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 catherer 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 cardias 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 catherer tip location.

Device Description

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

5.5 Fr, 2-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 CG+ 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 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. To accommodate the VPS stylet, the internal lumen configuration of the predicate Arrow Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology (K112896) has changed from a "Double-D" design to a "Round-Crescent". As a result of the internal lumen design change, the flow rate of the proximal lumen has changed from a maximum rate of 5 ml/sec to 4 ml/sec. The distal lumen flow rate remains the same as the predicate PICC (K112896).

AI/ML Overview

Here's an analysis of the provided text to extract the requested information about acceptance criteria and a study:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to existing devices rather than presenting a comprehensive clinical study to establish new performance metrics. Therefore, some of the requested information (like specific acceptance criteria for a novel performance claim, MRMC studies, or detailed ground truth establishment for a large training set) may not be explicitly present or fully detailed as it would be in a clinical trial report.

Acceptance Criteria and Study Details for K123759

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance (Summary from text)
PICC Catheter Performance
Maximum Pressure Injection Rate (Proximal Lumen)	Not explicitly stated as a separate acceptance criterion, but the change from predicate is acknowledged.	Reduced from 5 mL/sec (predicate) to 4 mL/sec (subject device).
Maximum Pressure Injection Rate (Distal Lumen)	Must be equivalent to predicate.	Remains 5 mL/sec (same as predicate K112896).
Tensile Strength (Catheter)	Not explicitly quantified, but implied to be acceptable for safe use.	Testing performed; results led to conclusion of no new safety/effectiveness issues.
Catheter Body Kink Resistance	Not explicitly quantified, but implied to be acceptable for safe use.	Testing performed; results led to conclusion of no new safety/effectiveness issues.
Flow Rate (Catheter)	Not explicitly quantified beyond pressure injection, but implied to be acceptable for intended use.	Testing performed; results led to conclusion of no new safety/effectiveness issues.
Static Burst Pressure (Catheter)	Not explicitly quantified, but implied to be acceptable for safe use.	Testing performed; results led to conclusion of no new safety/effectiveness issues.
Air and Liquid Leakage (Catheter)	Must prevent air/liquid leakage.	Testing performed; results led to conclusion of no new safety/effectiveness issues.
Flex Cycling (Catheter)	Must withstand repeated flexing.	Testing performed; results led to conclusion of no new safety/effectiveness issues.
Catheter Whip Stability	Must be stable during use.	Testing performed; results led to conclusion of no new safety/effectiveness issues.
Catheter Tip Compression Stiffness	Must meet stiffness requirements.	Testing performed; results led to conclusion of no new safety/effectiveness issues.
Collapse Resistance (Catheter)	Must resist collapse.	Testing performed; results led to conclusion of no new safety/effectiveness issues.
CVP Monitoring Capability	Must allow for CVP monitoring.	Testing performed; results led to conclusion of no new safety/effectiveness issues.
Chlorhexidine Solution Performance
Chlorhexidine Content	Must meet specifications (formulation, total content, content per surface area).	Specifications remain unchanged from predicate. Testing performed; results led to conclusion of no new safety/effectiveness issues.
Chlorhexidine Solution Efficacy	Must demonstrate antimicrobial/antithrombogenic properties.	Testing performed; results led to conclusion of no new safety/effectiveness issues.
Chlorhexidine Release Rate (Elution)	Must meet specifications.	Testing performed; results led to conclusion of no new safety/effectiveness issues.
Solvent Residual	Must be within acceptable limits.	Testing performed; results led to conclusion of no new safety/effectiveness issues.
Chemical Degradation	Must be within acceptable limits.	Testing performed; results led to conclusion of no new safety/effectiveness issues.
Combined Device Performance (PICC + VPS Stylet)
Stylet Tensile Strength	Not explicitly quantified, but implied for safe use.	Testing performed; results led to conclusion of no new safety/effectiveness issues.
Simulated Use Insertion/Removal	Must allow for successful insertion and removal without damage.	Testing performed to evaluate; subsequent tests (leakage, electrical) verified no damage.
Force to Remove Stylet from Catheter	Must allow for appropriate removal force.	Testing performed; results led to conclusion of no new safety/effectiveness issues.
Stylet Electrical Testing (after simulated use)	Must maintain electrical integrity.	Testing performed; results led to conclusion of no new safety/effectiveness issues.
Catheter Air and Liquid Leakage (after simulated use)	Must prevent air/liquid leakage.	Testing performed; results led to conclusion of no new safety/effectiveness issues.
VPS System (Stylet and Console for tip positioning)
Guidance for Catheter Tip Location (Blue Bullseye)	When a steady Blue Bullseye is obtained, the catheter tip is in the desired location (lower third of SVC or cavo-atrial junction).	The VPS System (stylet and console) provides real-time catheter tip location information using cardiac electrical activity and blood flow. The Blue Bullseye indicates the desired location.

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

Sample Size: Not explicitly stated for each test beyond "testing was performed." The document focuses on demonstrating substantial equivalence to pre-existing, cleared devices (K103255 and K112896). It refers to the testing as "Nonclinical Testing," which typically involves bench testing, material characterization, and simulated use rather than studies on patient data.
Data Provenance: The studies mentioned are "Nonclinical Testing" and were likely conducted in a laboratory setting by the manufacturer, Arrow International, Incorporated (Subsidiary of Teleflex, Incorporated). No mention of data from specific countries or whether it was retrospective or prospective clinical data is made, as it appears to be primarily bench/engineering testing.

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

Not Applicable / Not Stated: This type of information is typically relevant for studies involving human interpretation (e.g., imaging studies) where human experts determine ground truth. The presented tests are non-clinical, mechanical, and performance evaluations. The "ground truth" would be objective measurements against defined engineering specifications or the performance of the predicate device.

4. Adjudication Method for the Test Set

Not Applicable / Not Stated: Adjudication methods like "2+1" or "3+1" are used in clinical trials, especially for endpoints requiring human assessment of data. For the non-clinical testing described, results are typically determined by direct measurement, observation, or adherence to test protocols without expert adjudication in the clinical sense.

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: The document describes a medical device (PICC catheter and a stylet for guidance), not an AI system for diagnostic or interpretive purposes. Therefore, an MRMC study or AI assistance effect size is not applicable.

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

No: The device itself is a physical medical instrument (catheter and stylet), not an algorithm. The VPS Stylet uses physiological information for guidance, but it's part of a human-in-the-loop system (the clinician uses the guidance). There's no AI algorithm operating standalone in the context of this device's submission.

7. The Type of Ground Truth Used

For the non-clinical testing, the "ground truth" was established based on:
- Engineering Specifications: Adherence to predefined mechanical, material, and performance standards.
- Predicate Device Performance: Demonstrating that the modified device performs equivalently or within acceptable limits compared to the predicate devices (K103255 and K112896).
- Validated Test Methods: Using established methods to measure parameters like tensile strength, flow rates, leakage, chemical composition, and release rates.

8. The Sample Size for the Training Set

Not Applicable / Not Stated: This device does not involve a "training set" in the context of machine learning or AI. The testing performed is to validate the physical device's characteristics and performance.

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

Not Applicable / Not Stated: As there is no training set for an algorithm, this question is not relevant to the described device.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is facing to the right. The logo is simple and clean, and it is easily recognizable.

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

September 12, 2016

Arrow International, Incorporated (Subsidiary of Teleflex, Incorporated) Elizabeth Duncan Senior Regulatory Affairs Specialist 2400 Bernville Road Reading, Pennsylvania 19605

Re: K123759

Trade/Device Name: CG+ Arrow PICC Powdered 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: December 6, 2012 Received: December 7, 2012

Dear Ms. Elizabeth Duncan:

This letter corrects our substantially equivalent letter of January 3, 2013.

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 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 (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/ResourcesforYou/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/ResourcesforYou/Industry/default.htm.

Sincerely,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital. Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known): _K |23759

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

Indications for Use:

Prescription Use ਮ (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 Date: 2013.01.04 14:46:32 -05'00'

.. . . . . .

(Division Sign-Off) (Division Sign-Off)
Division of Anesthestology, General Hospital
Division of Anesthestology, General Devices Division of Antonol, Dental Devices

KR37 59 510(k) Number,

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Image /page/3/Picture/0 description: The image shows handwritten text that reads "K123759 page 1 of". The text is written in black ink on a white background. The handwriting is somewhat messy, but the text is still legible. The phrase "page 1 of" suggests that this is part of a larger document.

JAN 3 2013

б 510(K) SUMMARY

Submitter Information

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
K 1 12896: 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:

5.5 Fr, 2-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.

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K123754
page 2 of 3

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 Usc

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 iunction.

Technological Characteristics and Substantial Equivalence

The CG+ Arrow PICC powered by Arrow VPS Stylct is substantially equivalent to the Vascular Positioning System (VPS System) Stylet (K103255) in terms of indications for use, design, manufacturing process, conditions and aids, functional performance, safety, efficacy and materials of construction. The CG+ Arrow PICC powered by Arrow VPS Stylet is substantially equivalent to the Pressure Injectable Peripherally Inserted Central Catheter (PICC) with Chlorag+ard Antimicrobial and Antithrombogenic Technology (K112896) in terms of indications for use, manufacturing process, conditions and aids, safety, efficacy and materials of construction. To accommodate the VPS stylet, the internal lumen configuration of the predicate Arrow Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology (KII2896) has changed from a "Double-D" design to a "Round-Crescent". The antimicrobial / antithrombogenic chlorhexidine solution remains unchanged. As a result of the internal lumen design change, the maximum pressure injection flow rate of the proximal lumen has been reduced from a 5 ml/sec. The maximum pressure injectable flow rate of the distal lumen flow rate remains the same as the predicate PICC (K112896) at 5 ml/sec.

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K123759
page 3 of 3

No changes were made to the chlorhexidine solution as a result of this change. The solution's specifications (formulation), total content, content per surface area, manufacturing processes, conditions and aids as well as the process by which the catheter is treated remain unchanged from the predicate PICC (K112896).

No changes were made to the proposed Stylet.

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 indications for use.

Nonclinical Testing

The following testing was performed on the CG+ Arrow PICC powered by Arrow VPS Stylet:

Chlorhexidine solution testing: chlorhexidine content testing, chlorhexidine solution efficacy, chlorhexidine release rate (elution), 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, collapse resistance and CVP monitoring.

Combined device performance testing: stylet tensile, simulated use insertion/removal test and force to remove stylet from catheter. After devices completed the simulated use insertion/removal test, the following tests were done to verify there was no damage to the catheter: 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 specifications and content and are manufactured using the same processes. conditions and aids. The results of the testing performed have demonstrated that combining the two previously cleared devices and changing the internal lumen configuration of the catheter to accommodate the VPS stylet do not raise new issues of safety or effectiveness and therefore the combination and design change is considered substantially equivalent to the cited 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.”