The Arrow® Pressure Injectable Jugular Axillo-subclavian Central Catheter with Chlorag+ard® Antimicrobial and Antithrombogenic Technology (CG+ Arrow JACC) is indicated for short-term (<30 days) or long-term (>30 days) access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media and allows for central venous pressure monitoring. The maximum pressure injector equipment used with the Arrow Pressure Injectable JACC may not exceed 300 psi (2068.4 kPa). The maximum pressure injection flow rate for the specific lumen being used for pressure injection is printed on the extension line hub.

Chlorag+ard Technology treatment on the external surface of the catheter body as well as the entire fluid pathway of the catheter has been shown to be effective in reducing microbial colonization on catheter surfaces. Antimicrobial effectiveness was evaluated using in vitro and in vivo test methods and no correlation between these testing methods and clinical outcome has currently been ascertained. It is not intended to be used for the treatment of existing infections.

Device Description

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

4.5 French, 1-Lumen, 35 cm pressure injectable, antimicrobial and antithrombogenic catheter
5.5 French, 2-Lumen, 35 cm pressure injectable, antimicrobial and antithrombogenic catheter ●
6 French. 3-Lumen. 35 cm pressure injectable, antimicrobial and antithrombogenic catheter ●

The CG+ Arrow JACC is a short-term or long-term, single use catheter designed to provide access to the central venous system. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The CG+ Arrow JACC consists of a non-tapered, radiopaque polyurethane extruded catheter body, a juncture hub, extension lines for each lumen and printed extension line hubs. The extension lines each contain a clamp. The catheter can be used for the injection of contrast media. The maximum recommended infusion rate is 5 mL/sec for the 1-lumen and 2-lumen catheters and 6 mL/sec for the 3-lumen catheter. The external catheter body and the internal fluid path of the device are treated with chlorhexidine-based, Chlorag-ard technology. There are no modifications subject to this premarket notification related to the material design of the devices included in this submission, nor are there any modifications to the Chlorag+ard technology that is incorporated in the modified device's physical design.

The subject device is a CG+ Arrow JACC without a Blue FlexTip that will be provided in sterile kit configurations. A catheter-compatible tunneling device will be offered as an optional kit component. In addition to the catheter tip modification, the printed text on the catheter body and the extension lines has also been modifications, as well as the addition of the tunneling device as an optional kit component, require additions to the recommended procedural technique; procedure steps related to the tunneler and updated graphic representation of the catheter have been included in the instructions for use. All other portions of the catheter design and instructions for use remain unchanged.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the ARROW Pressure-Injectable Jugular Axillo-Subclavian Central Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology (CG+ Arrow JACC). This document outlines the device's characteristics, its comparison to a predicate device, and the nonclinical testing performed to support its substantial equivalence.

Based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a set of quantified numerical targets in the way typically seen for performance evaluation studies (e.g., sensitivity, specificity thresholds). Instead, for this 510(k) submission, the primary acceptance criteria revolve around demonstrating substantial equivalence to a predicate device and confirming that the modifications made do not negatively impact safety or effectiveness. The device performance is reported as "SAME" for most characteristics, indicating that the performance remains consistent with the predicate.

Here's a table summarizing the relevant performance aspects based on the provided text, and the implicit 'acceptance criteria' are that these aspects are substantially equivalent or confirmed to be safe/functional after modifications.

Performance Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance
Catheter Length	Maintain previous range or justify new range.	35 cm only (changed from 15-35 cm)
Catheter OD	Substantially equivalent to predicate.	SAME (4.5, 5.5, and 6 Fr)
Number of Lumens	Substantially equivalent to predicate.	SAME (1, 2, and 3 Lumen)
Internal Lumen Configuration	Functional equivalence to predicate.	One configuration removed (2 Lumen - Round-Crescent), others are SAME. Justification implicit that removed configuration is not necessary for equivalence.
Pressure Injection Capabilities	Maintain flow rates and pressure limits.	SAME. Max pressure injector equipment not to exceed 300 psi (2068.4 kPa). Flow rates match predicate.
Catheter body material	Substantially equivalent to predicate.	SAME (Radiopaque polyurethane)
Catheter Juncture Hub Material	Substantially equivalent to predicate.	SAME (Blue polyurethane)
Catheter Tip Design and material	Safe and functionally equivalent to predicate (especially when trimmed).	Non Blue FlexTip; blunt tip (integral with and same material as the catheter body and equivalent to a trimmed predicate CG+ Arrow JACC). This is a modification.
Catheter trimmable?	Maintain existing functionality.	SAME (Yes)
Extension Line Material	Substantially equivalent to predicate.	SAME (Clear polyurethane)
Extension Line Hub Material	Substantially equivalent to predicate.	SAME (Distal - Pink polyurethane, Proximal - White Polyurethane, Medial - Blue Polyurethane)
Printing Ink	Substantially equivalent to predicate.	SAME (2405 Black Ink and White Ink)
Sterilization	Substantially equivalent to predicate regarding sterility and method.	SAME (Provided Sterile. Sterilized by Ethylene Oxide.)
Antimicrobial Efficacy	Effective in reducing microbial colonization on catheter surfaces (as demonstrated by in vitro and in vivo methods).	Effective in reducing microbial colonization on catheter surfaces. (Antimicrobial effectiveness was evaluated using in vitro and in vivo test methods, but no correlation between these testing methods and clinical outcome has currently been ascertained.)
Antithrombogenic Efficacy	Effective in reducing thrombus accumulation on catheter surfaces.	Effective in reducing thrombus accumulation on catheter surfaces.
Tunneler Compatibility	Safe and functionally compatible when used as an accessory.	Can accommodate a tunneler accessory which is specifically designed for use with the catheter to facilitate the tunneled insertion technique. This is an addition. --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Biocompatibility (Tunneler Device)	No cytotoxicity, corrosion resistance, appropriate tip penetration, no extraneous matter.	Testing performed for Cytotoxicity (L929 MEM Elution O), Corrosion Resistance, Tip Penetration, and Extraneous Matter. Results are summarized as supporting substantial equivalence.
Tunneler device/Catheter Compatibility	Tunneler detaches from catheter without damage to catheter.	Testing performed for Tunneler detachment force from catheter and Catheter not damaged by tunnel disconnection. Results are summarized as supporting substantial equivalence.
Catheter Priming Volume	Accurate data for labeling purposes.	Determined for labeling purposes only.

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

The document does not explicitly state "sample sizes" in terms of number of patients or specific items for the nonclinical testing. It only states that "Design verification testing was conducted to mitigate identified risks and is summarized in the submission to support the substantial equivalence of the modified device."

Test Set Sample Size: Not explicitly stated. The nature of biocompatibility and mechanical testing usually involves a certain number of units or replicates, but these specifics are missing.
Data Provenance: The testing appears to be prospective as it was conducted specifically for this 510(k) submission to demonstrate the safety and effectiveness of the modified device. The country of origin for the data is implied to be where the manufacturer (Arrow International, Inc., subsidiary of Teleflex Inc.) performed their R&D and testing, which is in the USA (Reading, PA). However, this is not formally stated.

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

This type of information (experts, ground truth for a test set) is typically relevant for studies evaluating diagnostic accuracy, where human interpretation is compared against a gold standard. The provided document describes a device modification for a physical medical device (catheter) and the testing outlined is nonclinical (benchtop/in vitro) to demonstrate substantial equivalence in performance and safety characteristics. Therefore, the concept of "experts establishing ground truth" in the clinical imaging sense is not applicable here. The "ground truth" for these tests would be the established scientific methods and engineering specifications for biocompatibility, mechanical properties, etc.

4. Adjudication Method for the Test Set

As the testing is nonclinical and focuses on physical and biological properties rather than human interpretation, a formal "adjudication method" as seen in clinical reader studies (e.g., 2+1, 3+1) is not applicable. The results of the nonclinical tests are compared against predefined engineering specifications or performance of the predicate device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of a diagnostic algorithm or digital health tool on human reader performance. The device in question is a physical central venous catheter, not a diagnostic imaging or AI tool.

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

Not Applicable. This question relates to AI or algorithm performance. The device is a physical catheter, so there is no "algorithm" or standalone software performance to evaluate in this context.

7. The Type of Ground Truth Used

For the nonclinical tests, the "ground truth" would be:

Biocompatibility: Established ISO standards for biocompatibility (e.g., cytotoxicity, material characterization).
Mechanical Performance (e.g., tip penetration, detachment force): Engineering specifications, validated test methods, and comparison data from the predicate device.
Antimicrobial/Antithrombogenic Efficacy: Results from in vitro and in vivo laboratory test methods designed to assess these properties. The document notes that a correlation between these test methods and clinical outcomes has not been ascertained, indicating the ground truth here is the demonstration of efficacy in a controlled lab setting, not necessarily clinical outcome.

8. The Sample Size for the Training Set

Not Applicable. The device is a physical catheter; there is no "training set" in the context of machine learning or AI models.

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

Not Applicable. As there is no training set, this question is not relevant.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

September 6, 2016

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

Re: K161765

Trade/Device Name: ARROW Pressure-Injectable Jugular Axillo-Subclavian Central Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology (CG+ Arrow JACC) Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: August 5, 2016 Received: August 8, 2016

Dear Ms. Lawson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical 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" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerelv.

Tina Kiang
-s

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

Enclosure

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Indications for Use

510(k) Number (if known) K161765

Device Name

ARROW Pressure-Injectable Jugular Axillo-Subclavian Central Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology (CG+ Arrow JACC)

Indications for Use (Describe)

Chlorag+ard Technology treatment on the external surface of the catheter body as well as the entire fluid pathway of the catheter has been shown to be effective in reducing microbial colonization on catheter surfaces. Antimicrobial effectiveness was evaluated using in vivo test methods and no correlation between these testing methods and clinical outcome has currently been ascertained. It is not intended to be used for the treatment of existing infections.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY: K161765

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:	June 24, 2016

Device Name

Device Trade Name: ARROW Pressure-Injectable Jugular Axillo-Subclavian Central Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology (CG+ Arrow JACC) Common Name: Central Venous Catheter Classification Regulation: 21 CFR: 880.5970 Classification Name: Percutaneous, implanted, long-term intravascular catheter Product Code: LJS

Predicate Device

K153423: CG+ Arrow JACC / CG+ Arrow JACC powered by Arrow VPS Stylet

Device Description

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

4.5 French, 1-Lumen, 35 cm pressure injectable, antimicrobial and antithrombogenic catheter
5.5 French, 2-Lumen, 35 cm pressure injectable, antimicrobial and antithrombogenic catheter ●
6 French. 3-Lumen. 35 cm pressure injectable, antimicrobial and antithrombogenic catheter ●

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modifications subject to this premarket notification related to the material design of the devices included in this submission, nor are there any modifications to the Chlorag+ard technology that is incorporated in the modified device's physical design.

Indications for Use

The Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter with Chlorag'arde Antimicrobial and Antithrombogenic Technology (CG+ Arrow JACC) is indicated for shortterm (<30 days) or long-term (>30 days) access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media and allows for central venous pressure monitoring. The maximum pressure injector equipment used with the Arrow Pressure Injectable JACC may not exceed 300 psi (2068.4 kPa). The maximum pressure injection flow rate for the specific lumen being used for pressure injection is printed on the extension line hub.

The above Indication for Use is identical to the catheter portion of the predicate Indications for Use. The predicate CG+ Arrow JACC / CG+ Arrow JACC powered by Arrow VPS Stylet (K153423) includes a 2-part indications for use statement; the first portion covers the CG+ Arrow JACC and the second portion covers the CG+ Arrow JACC preloaded with the Arrow VPS Stylet. The subject of this submission is the CG+ Arrow JACC portion of the device only. The VPS-preloaded portion of the indications for use is not impacted by the changes described for the proposed CG+ Arrow JACC. Therefore, only the catheter portion of the indications for use statement for the proposed CG+ Arrow JACC is applicable.

Technological Characteristics and Substantial Equivalence

The subject CG+ Arrow JACC is substantially equivalent to the predicate CG+ Arrow JACC / CG+ Arrow JACC powered by VPS (K153423) in terms of indications for use (catheter portion), manufacturing processes, conditions and aids, functional performance, fundamental scientific technology and materials of construction. There is no change to the geometric design of the subject devices with the exception of the catheter tip: the predicate device is constructed with a

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Blue FlexTip distal tip design and the catheter is trimmable; the proposed device omits the Blue FlexTip distal tip, yielding the same catheter distal tip design as the predicate device when trimmed. The instructions for use are being modified to add detail pertaining to the use of a tunneler; catheter trimming instructions were previously included in the instructions for use and continue to apply to the subject device. The following table reflects a comparison of the subject and predicate device characteristics.

Characteristic	Predicate:CG+ Arrow JACC / CG+ Arrow JACC poweredby VPS Stylet (K153423)	Subject:CG+ Arrow JACC
Catheter Length	15-35 cm	35 cm only
Catheter OD	4.5, 5.5, and 6 Fr	SAME
Number ofLumens	1,2, and 3 Lumen	SAME
Internal LumenConfiguration	1 Lumen - Round2 Lumen - Double D2 Lumen - Round-Crescent3 Lumen- Round-Split-Crescent	1 Lumen - Round2 Lumen - Double D3 Lumen- Round-Split-Crescent
PressureInjectionCapabilities	1 Lumen:Distal:5 mL/sec. Pressure Injectable	1 Lumen:Distal:5 mL/sec. Pressure Injectable
	2 Lumen - Double D:Distal: 5 mL/sec, Pressure InjectableProximal: 5 mL/sec, Pressure Injectable	2 Lumen - Double D:Distal: 5 mL/sec, Pressure InjectableProximal: 5 mL/sec, Pressure Injectable
	2 Lumen - Round-Crescent:Distal: 5 mL/sec, Pressure InjectableProximal: 4 mL/sec, Pressure Injectable
	3 Lumen:Distal: 6 ml/sec, Pressure InjectableProximal: No Pressure InjectionMedial: No Pressure Injection	3 Lumen:Distal: 6 ml/sec, Pressure InjectableProximal: No Pressure InjectionMedial: No Pressure Injection
	Note: Lumens that are not indicated for PressureInjection have "No CT" printed on the extensionline hubs.	Note: Lumens that are not indicated for Pressure Injectionhave "No CT" printed on the extension line hubs.
Catheter bodymaterial	Radiopaque polyurethane	SAME
CatheterJuncture HubMaterial	Blue polyurethane	SAME
Catheter TipDesign andmaterial	Radiopaque, soft blue polyurethane "BlueFlexTip"	Non Blue FlexTip; blunt tip (integral with and samematerial as the catheter body and equivalent to a trimmedpredicate CG+ Arrow JACC)
Cathetertrimmable?	Yes	Yes
Extension LineMaterial	Clear polyurethane	SAME
Characteristic	Predicate:CG+ Arrow JACC / CG+ Arrow JACC poweredby VPS Stylet (K153423)	Subject:CG+ Arrow JACC
Extension LineHub Material	Distal - Pink polyurethaneProximal - White PolyurethaneMedial - Blue Polyurethane	SAME
Printing Ink	2405 Black Ink and White Ink	SAME
Sterilization	Provided Sterile. Sterilized by Ethylene Oxide.	SAME
PerformanceSpecifications;Cathetertreatmentsolutionefficacy	Antimicrobial EfficacyEffective in reducing microbial colonization oncatheter surfacesAntithrombogenic EfficacyEffective in reducing thrombus accumulation oncatheter surfaces	SAME
TunnelerCompatibility	N/A	Can accommodate a tunneler accessory which isspecifically designed for use with the catheter to facilitatethe tunneled insertion technique.
Indications forUse	The Arrow® Pressure Injectable JACC withChlorag+ard® Antimicrobial andAntithrombogenic Technology is indicated forshort-term (<30 days) or long-term (>30 days)access to the central venous system for intravenoustherapy, blood sampling, infusion, pressureinjection of contrast media and allows for centralvenous pressure monitoring. The maximumpressure of pressure injector equipment used withthe Pressure Injectable JACC may not exceed 300psi (2068.4 kPa). The maximum pressure injectionflow rate for the specific lumen being used forpressure injection is printed on the extension linehub.Chlorag+ard Technology treatment on the externalsurface of the catheter body as well as the entirefluid pathway of the catheter has been shown to beeffective in reducing microbial colonization oncatheter surfaces. Antimicrobial effectiveness wasevaluated using in vitro and in vivo test methodsand no correlation between these testing methodsand clinical outcome has currently beenascertained. It is not intended to be used for thetreatment of existing infections.The VPS Stylet and Console are indicated forguidance and tip positioning for central venouscatheters. The Stylet provides stiffness for use inplacement of the catheter, intravascular capabilityfor ECG detection and recording and intravascularultrasound for catheter guiding and positioning.The VPS Stylet, when used with the VPS Console,provides real-time catheter tip location informationby using the patient's physiological (cardiacelectrical activity and blood flow) information.When the VPS System guidance indicator shows aBlue Bullseye, the catheter tip is in the desiredlocation.The VPS System is indicated for use as analternative method to fluoroscopy or chest x-rayfor central venous catheter tip placementconfirmation in adult patients when a steady Blue	The Arrow® Pressure Injectable JACC withChlorag+ard® Antimicrobial and AntithrombogenicTechnology is indicated for short-term (<30 days) or long-term (>30 days) access to the central venous system forintravenous therapy, blood sampling, infusion, pressureinjection of contrast media and allows for central venouspressure monitoring. The maximum pressure of pressureinjector equipment used with the Pressure InjectableJACC may not exceed 300 psi (2068.4 kPa). Themaximum pressure injection flow rate for the specificlumen being used for pressure injection is printed on theextension line hub.Chlorag+ard Technology treatment on the external surfaceof the catheter body as well as the entire fluid pathway ofthe catheter has been shown to be effective in reducingmicrobial colonization on catheter surfaces.Antimicrobial effectiveness was evaluated using in vitroand in vivo test methods and no correlation between thesetesting methods and clinical outcome has currently beenascertained. It is not intended to be used for the treatmentof existing infections.
Characteristic	Predicate:CG+ Arrow JACC / CG+ Arrow JACC poweredby VPS Stylet (K153423)	Subject:CG+ Arrow JACC
	Bullseye is not obtained, standard hospital practiceshould be followed to confirm catheter tip location.Limiting but not contraindicated situations for thistechnique are in patients where alterations ofcardiac rhythm change the presentation of the P-wave as in atrial fibrillation, atrial flutter, severetachycardia and pacemaker-driven rhythm, and incentral venous catheterization proceduresperformed through femoral or saphenous veinaccess which change the presentation of thePwave.
	In such patients, who are easily identifiable priorto central venous catheter insertion, the use of anadditional method is required to confirm cathetertip location.

Subject and Predicate Device Comparison

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Nonclinical Testing

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

Tunneler Device Testing
- Biocompatibility Cytotoxicity L929 MEM Elution O
- o Corrosion Resistance
- o Tip Penetration
- O Extraneous Matter
Tunneler device/Catheter Compatibility ●
- Tunneler detachment force from catheter O
- Catheter not damaged by tunnel disconnection O
Catheter Priming Volume (for labeling purposes only) .

Conclusions

The predicate and the subject devices have indications for use (catheter portion), intended use, materials (with the exception of the elimination of the material used to form the Blue FlexTip), chlorhexidine formulation, concentration (content per treated surface area), method of application and mechanism of release and are manufactured using the same processes with the exception of the Blue FlexTip formation process, conditions and aids. The results of the verification testing performed support the substantial equivalence of the modified devices to the predicate devices.

Regulation Number and Section

§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.

(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”