The Arrow Antimicrobial Pressure Injectable PICC is indicated for short-term or longterm 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 injector equipment used with the Arrow Antimicrobial Pressure Injectable PICC may not exceed 300 psi. Antimicrobial 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. Antimicrobial effectiveness was evaluated using in vitro methods, and no correlation between in vitro and clinical outcome has currently been ascertained. It is not intended to be used for the treatment of existing infections.

Device Description

The Arrow Antimicrobial Pressure Injectable 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 is available in 4.5 Fr. single lumen and 5.5 Fr. double lumen configurations with usable lengths of 40 - 55 cm. The catheters 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 antimicrobial technology.

The catheters will be packaged sterile in both nursing and radiology The canoters will be passfigurations will include components to facilitate insertion. .

AI/ML Overview

The Arrow Antimicrobial Pressure Injectable PICC underwent extensive nonclinical (bench, in vitro, and in vivo animal) testing to demonstrate its safety and effectiveness.

1. Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Performance
Air Leakage during aspiration	No air leakage in the form of an air bubble in the syringe connected to the PICC after the first 5 seconds when tested per BS EN ISO 10555-1:1997 Annex D. All catheters must pass to achieve a 5% LTPD with 95% confidence.	Pass
Collapse Resistance	Catheter shall not collapse during aspiration as evidenced by water being able to be pulled out of the catheter when vacuum is applied by a minimum of a 10 cc syringe. The extension line clamps, if present, shall be in the fully constrained position. All catheters must pass to achieve a 5% LTPD with 95% confidence.	Pass
Liquid Leakage under pressure	No liquid leakage in the form of a falling drop of water at 300-320 kPa (43.5 -46.4 psi) for 30 sec when tested per BS EN ISO 10555-1:1997 Annex C. All catheters must pass to achieve a 5% LTPD with 95% confidence.	Pass
Force at break - Tensile Testing and Catheter Elongation	95% confidence level that 95% of the population meets the specification.	Pass
Tensile attribute	Requirement per BS EN ISO 10555-1 and 10555-3: - Catheter Body Force at Break ≥ 10N - Blue Flex Tip to Catheter Body Force at Break ≥ 4N - Catheter Body to Juncture Hub Force at Break ≥ 10N - Extension Line to Juncture Hub Force at Break ≥ 15N - Extension Line to Luer Hub Force at Break ≥ 15N - Catheter Body Elongation > 100%	Pass
Radio-Detectability	The optical density contrast must be at least 0.1.	Pass
Catheter Body Kink	Does not kink at a radius greater than 0.5 inch when tested per BS EN 13868:2002 Annex A under simulated in vivo conditions. This requirement shall be met with 95% assurance.	Pass
Central Venous Pressure Monitoring	The average amplitude difference between input and output signals shall be less than or equal to 1 mmHg when tested using a 1 Hz sinusoidal input signal. This requirement shall be met with 95% assurance.	Pass
Column Strength and Tip Stiffness	For catheters having a tip of different construction to the catheter body, the tip shall be constructed in accordance with requirement 5.1.6 (identical to ISO 10555-3 Section 4.3) and shall be made of lower durometer material than that of the catheter body. Design of tip shall ensure that the average force required to deflect or compress the tip is no greater than the average force required to deflect or compress the catheter body.	Pass
Static Burst Pressure	The maximum internal static pressure during pressure injection shall not exceed the static burst pressure.	Pass
Rate Limited Injection Testing	Each pressure injectable lumen shall withstand at least 5 repeat injections without rupture or visually evident yielding of the catheter when injected at the maximum indicated flow rate using 125 mL of contrast media or equivalent (maximum viscosity of 11.8 ± 0.2 cP) at 37 ± 2 °C.	Pass
Pressure Limited Injection Testing	The average flow rate of each catheter lumen shall be at least 90% of the maximum indicated flow rate.	Pass
Ink Adhesion Testing	The catheter shall remain legible when examined without magnification with exposure to ChloroPrep and Iodine for 1 minute each, then application and removal of semi-permeable adhesive dressing and Biopatch after 7 days. The acceptance criteria for meeting this requirement will be a legible marking.	Pass
Step Stress Testing	The catheters shall pass the first 10 injections at the maximum flow rate without visually evident yielding or rupture.	Pass
Trim Tool	After trimming with the provided trimming tool and visualized under 2.5X magnification, the indwelling catheter shall terminate at the distal end with a square tip that: Has no points, Produces a clean, smooth surface. With a sample size of n=60, zero failures are required to show a 95% confidence level and LTPD=5%.	Pass
Luer Hub Slip	The hub shall meet the following Luer slip requirements with 95% confidence and a LTPD of 10% when tested per BS EN 20594-1:1994, ISO 594-1:1986 Clauses 5.1 through 5.5: Gauging, Liquid Leakage, Air Leakage, Separation force, Stress cracking.	Pass
Luer Hub Lock	The hub shall meet the following Luer lock requirements with 95% confidence and a LTPD of 10% when tested per BS EN 1707:1997 Clauses 5.2 through 5.8: Gauging, Liquid Leakage, Air Leakage, Separation force, Unscrewing torque, Ease of Assembly to Male Fitting, Resistance to Overriding Male to Female Luer Connection, Stress cracking.	Pass
Catheter Securement	The catheter shall include a feature that enables the catheter to be secured to the patient's skin. Demonstrate a 95% confidence level and LTPD=5% by having the suture holes for all catheters fit over the Securement posts with zero failures and the retainer wings from all catheters lock.	Pass
First Article Inspection	Distance markings: If provided, shall indicate distance from the distal end. From the first mark, distance between marks shall not exceed 5cm. (BS EN ISO 10555-3: 1997 Section 4.4 and JIS T 3218:2005, Section 5.7). Multilumen identification: Identification of each lumen shall be apparent to the user (BS EN ISO 10555-3:1997, Item 4.5 and JIS T 3218:2005, Item 5.8). French size: Shall be printed on the integral juncture hub or in a location that can be seen after insertion. Manufacturer/tradename: Shall be printed on the integral juncture hub or in a location that can be seen after insertion.	Pass
Clamp Closure Efficacy	The clamp closure capability shall be such that when the clamps are in the fully constrained position, there shall be no flow through the lumen being tested when tested in accordance with BS EN ISO 10555-3 Annex A or JIS T 3218 Annex C.	Pass
Flow restriction after clamping	The extension lines shall not be permanently deformed from the use of extension line clamps during the maximum expected clamp duration of the catheter to the point where a restriction in the extension line decreases the gravity flow through the catheter below the minimum gravity flow rate requirement (i.e. 90 mL/hr).	Pass
In vitro efficacy testing - external antimicrobial treatment	The antimicrobial agent release rate will be sufficiently slow to provide efficacy against gram (+), gram (-) and fungi for a minimum of 7 days. Efficacy will be based upon a minimum 4 log reduction of adherent biomass (microbial colonization) when compared to the initial inoculum concentration.	Pass
In vitro efficacy testing - internal antimicrobial treatment	The antimicrobial agent release rate will be sufficiently slow to provide efficacy against gram (+), gram (-) and fungi for a minimum of 7 days. Efficacy will be based upon a minimum 4 log reduction of adherent biomass (microbial colonization) when compared to the initial inoculum concentration.	Pass
In vivo animal infection study	The product shall exhibit efficacy against Staphylococcus aureus at minimum 7 days for in-vivo studies. Efficacy will be based upon a minimum 4 log reduction of adherent biomass (microbial colonization) when compared to the initial inoculum concentration.	Pass

2. Sample size and data provenance for the test set

The document does not explicitly state the exact sample sizes for each test in the provided "Summary of Verification Activities." However, it specifies confidence levels and LTPD (Lot Tolerance Percent Defective) for several tests, indicating sample-based testing.
For example:

Air Leakage, Collapse Resistance, Liquid Leakage: "All catheters must pass to achieve a 5% LTPD with 95% confidence."
Force at break: "There must be a 95% confidence level that 95% of the population meets the specification."
Catheter Body Kink, Central Venous Pressure Monitoring: "This requirement shall be met with 95% assurance."
Trim Tool: "With a sample size of n=60, zero failures are required to show a 95% confidence level and LTPD=5%."
Luer Hub Slip/Lock: "with 95% confidence and a LTPD of 10%".
Catheter Securement: "Demonstrate a 95% confidence level and LTPD=5%".

The data provenance is from nonclinical testing, including bench testing, in vitro testing, and in vivo animal infection studies. No specific country of origin is mentioned for the data, but the testing was performed by Arrow International, Inc. (a subsidiary of Teleflex Inc.) in the USA. These are laboratory studies, not clinical (human) studies.

3. Number of experts and qualifications for ground truth

Not applicable. This submission describes nonclinical "bench" and "in vitro/in vivo animal" testing. There is no mention of experts establishing ground truth for a test set in the context of human data or diagnoses. The "ground truth" for these tests comes from objective measurements and predefined engineering or biological criteria.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 typically refer to expert review processes for human data (e.g., medical imaging) to establish ground truth. The tests described are objective nonclinical measurements.

5. Multi-reader multi-case (MRMC) comparative effectiveness study

No MRMC study was done. This is a 510(k) summary for a medical device (PICC catheter), focusing on nonclinical safety and performance, not diagnostic effectiveness with human readers.

6. Standalone (algorithm only without human-in-the-loop performance)

This is a physical medical device, not an algorithm. Therefore, "standalone" performance in the context of AI algorithms is not applicable. The device's performance was evaluated inherently "standalone" in bench, in vitro, and in vivo animal tests against predefined criteria.

7. Type of ground truth used

The ground truth used for these nonclinical studies is based on:

Objective physical measurements: Electrical resistance, force at break, optical density, flow rates, pressure measurements, mechanical integrity assessments (e.g., kink resistance, leakage).
Standardized protocols and specifications: Adherence to ISO standards (ISO 10555-1, 10555-3), BS EN standards (BS EN 13868, BS EN 20594-1, BS EN 1707), JIS T standards (JIS T 3218), and FDA Guidance documents.
Biological efficacy criteria: For antimicrobial tests, a "minimum 4 log reduction of adherent biomass (microbial colonization)" compared to initial inoculum concentration. This is a predefined microbiological efficacy threshold.

8. Sample size for the training set

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

9. How the ground truth for the training set was established

Not applicable, as there is no training set for a physical medical device.

Summary

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KIDQ635

510(k) SUMMARY

SUMMARY OF SAFETY AND EFFECTIVENESS FOR ARROW ANTIMICROBIAL PRESSURE INJECTABLE PICC

AUG 27 2010

1. Submitter Information

Name:	Arrow International, Inc (subsidiary of Teleflex Inc.)
Address:	2400 Bernville Road
	Reading, PA 19605-9607
Telephone Number:	(610) 378-0131
Contact Person:	Tracy Maddock
	Regulatory Affairs Specialist
Telephone Number:	(610) 378-0131 Extension 3384
Fax Number:	(610) 374-5360
Email:	tracy.maddock@teleflexmedical.com
Date Prepared:	June 4, 2010

2. Device Name

Device Trade Name:	Arrow Antimicrobial Pressure Injectable PeripherallyInserted Central Catheter (PICC)
Common Name:	Peripherally Inserted Central Catheter
Classification Name:	Percutaneous, implanted, long-term intravascular catheter

3. Predicate Devices

Predicate 1:	Pressure Injectable PICC (K061289)
Predicate 2:	6 French Triple Lumen Pressure Injectable PICC (K080604)
Predicate 3:	ARROWg+ard Blue PLUS® Multi-Lumen CVC (K993691)

4. Device Description

The catheters will be packaged sterile in both nursing and radiology The canoters will be passfigurations will include components to facilitate insertion. .

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5. Indications for Use

The Arrow Antimicrobial Pressure Injectable PICC 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 injector equipment used with the Arrow Antimicrobial Pressure Injectable PICC may not exceed 300 psi. Antimicrobial 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. Antimicrobial effectiveness was evaluated using in vitro methods, and no correlation between in vitro and clinical outcome has currently been ascertained. It is not intended to be used for the treatment of existing infections.

6. Summary Comparing Technological Modifications

Modifications to existing Arrow products include:

Inclusion of 4.5 Fr. single lumen and 5.5 Fr double lumen catheters to ● those ARROW PICCs already marketed. The increase in OD of the catheters allow for the subject devices to achieve 5 mL/sec pressure injection and to accommodate external / internal treatment.
The catheter body material for the subject devices consist of a blending of . two durometers of polyurethane resin. A blue colorant was added to the catheter body resins to differentiate from non-antimicrobial PIC catheters.
A blue colorant was added to the juncture hub material of the subject . devices to further differentiate the antimicrobial catheters.
The catheter tip material of the subject devices includes a different . radiopacifier for enhanced radiopacity.
Antimicrobial treatment has been applied to the external catheter body ● surface and the entire fluid path of the device.
The antimicrobial treatment present on the external catheter body of the . subject devices consist of chlorhexidine only as opposed to chlorhexidine and silver sulfadiazine present on currently marketed Arrowgard Blue Plus central venous catheters.

7. Nonclinical Testing

Bench testing was performed on the Arrow Antimicrobial Pressure Injectable PICC in accordance with ISO 10555-1, 10555-3 and FDA Guidance on Premarket Notification [510(k)] Submission for Short- Term and Long- Term Intravascular Catheters. In vitro and in vivo testing was performed to assess the safety and efficacy of the proposed device. Testing included biocompatibility, in vitro antimicrobial efficacy, and in vivo animal infection study.

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8. Summary of Verification Activities

Test	Acceptance Criteria	Results
Air Leakageduringaspiration	There shall be no air leakage in the form of an air bubble in thesyringe connected to the PICC after the first 5 seconds whentested per BS EN ISO 10555-1:1997 Annex D.All catheters must pass to achieve a 5% LTPD with 95%confidence	Pass
CollapseResistance	The catheter shall not collapse during aspiration as evidenced bywater being able to be pulled out of the catheter when vacuum isapplied by a minimum of a 10 cc syringe. The extension lineclamps, if present, shall be in the fully constrained position.All catheters must pass to achieve a 5% LTPD with 95%confidence	Pass
LiquidLeakage underpressure	There shall be no liquid leakage in the form of a falling drop ofwater at 300-320 kPa (43.5 -46.4) for 30 sec when tested per BSEN ISO 10555-1:1997 Annex C.All catheters must pass to achieve a 5% LTPD with 95%confidence	Pass
Force at break-TensileTesting andCatheterElongation	There must be a 95% confidence level that 95% of the populationmeets the specification.	Pass
	Tensile attribute
	Requirement per BS EN ISO 10555-1 and 10555-3 Catheter Body Force at Break ≥ 10N Blue Flex Tip to Catheter Body Force at Break ≥ 4N Catheter Body to Juncture Hub Force at Break ≥ 10N Extension Line to Juncture Hub Force at Break ≥ 15N Extension Line to Luer Hub Force at Break ≥ 15N Catheter Body Elongation > 100%
	Radio-Detectability		The optical density contrast must be at least 0.1.	Pass
	Catheter BodyKink		Does not kink at a radius greater than 0.5 inch when tested per BSEN 13868:2002 Annex A under simulated in vivo conditions. Thisrequirement shall be met with 95% assurance.	Pass

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Test	Acceptance Criteria	Results
CentralVenousPressureMonitoring	The average amplitude difference between input and outputsignals shall be less than or equal to 1 mmHg when tested using a1 Hz sinusoidal input signal. This requirement shall be met with95% assurance.	Pass
ColumnStrength andTip Stiffness	For catheters having a tip of different construction to the catheterbody, the tip shall be constructed in accordance with therequirement 5.1.6 and shall be made of lower durometer materialthan that of the catheter body.Design of tip shall ensure that the average force required todeflect or compress the tip is no greater than the average forcerequired to deflect or compress the catheter body.NOTE: Requirement 5.1.6 referenced above is taken from aninternal Arrow requirements document. Requirement 5.1.6 isidentical to the requirement found in ISO 10555-3 Section 4.3.	Pass
Static BurstPressure	The maximum internal static pressure during pressure injectionshall not exceed the static burst pressure.	Pass
Static BurstPressure	The maximum internal static pressure during pressure injectionshall not exceed the static burst pressure.	Pass
Rate LimitedInjectionTesting	Each pressure injectable lumen shall withstand at least 5 repeatinjections without rupture or visually evident yielding of thecatheter when injected at the maximum indicated flow rate using125 mL of contrast media or equivalent (maximum viscosity of$11.8 \pm 0.2$ cP) at $37 \pm 2$ °C.	Pass
PressureLimitedInjectionTesting	The average flow rate of each catheter lumen shall be at least 90%of the maximum indicated flow rate.	Pass
Ink AdhesionTesting	The catheter shall remain legible when examined withoutmagnification with exposure to ChloroPrep and Iodine for 1minute each, then application and removal of semi-permeableadhesive dressing and Biopatch after 7 days. The acceptancecriteria for meeting this requirement will be a legible marking.	Pass
Step StressTesting	The catheters shall pass the first 10 injections at the maximumflow rate without visually evident yielding or rupture.	Pass
Trim Tool	After trimming with the provided trimming tool and visualizedunder 2.5X magnification, the indwelling catheter shall terminateat the distal end with a square tip that:Has no pointsProduces a clean, smooth surfaceWith a sample size of n=60, zero failures are required to show a	Pass
Test	Acceptance Criteria	Result
Luer Hub Slip	Luer Hub SlipThe hub shall meet the following Luer slip requirements with 95% confidence and a LTPD of 10% when tested per BS EN 20594-1:1994, ISO 594-1:1986 Clauses 5.1 through 5.5:Gauging: The plane of the maximum diameter at the opening of the female conical fitting shall lie between the two limit planes of the gauge. Rocking shall not be evident between the gauge and the fitting made of rigid material undergoing test.Liquid Leakage: No liquid leakage shall occur in the form of one or more falling drops of water.Air Leakage: There shall be no signs of continued formation of air bubbles.Separation force: The Luer hub shall remain attached to the reference fitting.Stress cracking: There shall be no evidence of stress cracking of the fitting.	Pass
Luer Hub Lock	Luer Hub LockThe hub shall meet the following Luer lock requirements with 95% confidence and a LTPD of 10% when tested per BS EN 1707:1997 Clauses 5.2 through 5.8:Gauging: When tested with the appropriate gauge, the conical part of the lock fitting shall have the plane of the maximum diameter at the opening of the female conical fitting shall lie between the two limit planes of the gauge. Rocking shall not be evident between the gauge and the fitting made of rigid material undergoing test.Liquid Leakage: No liquid leakage shall occur in the form of one or more falling drops of water.Air Leakage: There shall be no signs of continued formation of air bubbles.Separation force: The Luer hub shall remain attached to the reference fitting.Unscrewing torque: The Luer hub shall remain attached to the reference fitting.Ease of Assembly to Male Fitting: No resistance shall be observed until the taper of the fitting under test and the reference fitting fit together securely.Resistance to Overriding Male to Female Luer Connection: The reference fitting shall not override the threads or lugs of the fitting under test.Stress cracking: There shall be no evidence of stress cracking of the fitting	Pass
Catheter Securement	The catheter shall include a feature that enables the catheter to be secured to the patient's skin.Demonstrate a 95% confidence level and LTPD=5% by having the suture holes for all catheters fit over the Securement posts with zero failures and the retainer wings from all catheters lock	Pass
Test	Acceptance Criteria	Results
First ArticleInspection	If the catheter is provided with distance markings, the markingsystem shall indicate distance from the distal end. From the firstmark, the distance between marks shall not exceed 5cm. (BS EN ISO10555-3: 1997 Section 4.4 and JIS T 3218:2005, Section 5.7)For multilumen catheters, identification of each lumen shall beapparent to the user (BS EN ISO 10555-3:1997, Item 4.5 and JIS T3218:2005, Item 5.8)The French size of the catheter shall be printed on the integraljuncture hub or in a location that can be seen after the catheter hasbeen inserted.The tradename and/or name of the manufacturer of the catheter shallbe printed on the integral juncture hub or in a location that can beseen after the catheter has been inserted.	Pass
ClampClosureEfficacy	The clamp closure capability shall be such that when the clampsare in the fully constrained position, there shall be no flowthrough the lumen being tested when tested in accordance withBS EN ISO 10555-3 Annex A or JIS T 3218 Annex C.	Pass
Flowrestrictionafter clamping	The extension lines shall not be permanently deformed from theuse of extension line clamps during the maximum expected clampduration of the catheter to the point where a restriction in theextension line decreases the gravity flow through the catheterbelow the minimum gravity flow rate requirement (i.e. 90 mL/hr)	Pass
In vitroefficacy testing- externalantimicrobialtreatment	The antimicrobial agent release rate will be sufficiently slow toprovide efficacy against gram (+), gram (-) and fungi for aminimum of 7 days.Note: Efficacy will be based upon a minimum 4 log reduction ofadherent biomass (microbial colonization) when compared to theinitial inoculum concentration.	Pass
In vitroefficacy testing- internalantimicrobialtreatment	The antimicrobial agent release rate will be sufficiently slow toprovide efficacy against gram (+), gram (-) and fungi for aminimum of 7 days.Note: Efficacy will be based upon a minimum 4 log reduction ofadherent biomass (microbial colonization) when compared to theinitial inoculum concentration.	Pass
In vivo animalinfection study	The product shall exhibit efficacy against Staphylococcus aureusat minimum 7 days for in-vivo studies. Efficacy will be basedupon a minimum 4 log reduction of adherent biomass (microbialcolonization) when compared to the initial inoculumconcentration.	Pass

and the comments of the comments of the comments of

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and the comments of the comments of

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9. Conclusions

The Arrow Antimicrobial Pressure Injectable PICCs are substantially equivalent to the Arrow Pressure Injectable PICCs (K061289) and the Arrow 6 French Triple to the Pressure Injectable PICCs (K080604). The subject devices have the same intended use, principles of operation and technological characteristics as the predicates. The indications for use, for the proposed catheters, are the same as the

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Arrow PICC predicate device K080604 with the addition of the proposed catheter's effectiveness in reducing microbial colonization.

The antimicrobial agent for the proposed device is a similar Chlorhexidine-based solution used for the ARROWg ard Blue PLUS® Multi-Lumen CVC (K993691). The process of application of the antimicrobial agent is also similar to that of the predicate device.

The results of the testing performed have demonstrated that the Arrow Antimicrobial Pressure Injectable PICC devices are safe and perform as intended. The differences, between subject devices and predicate devices, do not raise any new issues of safety and effectiveness. Thus, the Arrow Antimicrobial Pressure Injectable PICCs are substantially equivalent to the predicate devices.

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Image /page/7/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized representation of a human figure, with three lines forming the body and head. The figure is facing to the right.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Ms. Tracy Maddock Regulatory Affairs Specialist Arrow International, Incorporated 2400 Bernville Road Reading, Pennsylvania 19605

AUG 2 7 2010

Re: K100635

Trade/Device Name: Arrow Antimicrobial Pressure Injectable Peripherally Inserted Central Catheter (PICC) Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: August 23, 2010 Received: August 24, 2010

Dear Ms. Maddock:

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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Page 2- Ms. Maddock

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 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 vours.

Sisa Tuone

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and

Radiological Health

Enclosure

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K100635

Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Arrow Antimicrobial Pressure Injectable Peripherally Inserted Central Catheter (PICC)

Indications for Use:

Prescription Use (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Anesthesiology, General HospitalPage _ of _
Infection Control, Dental Devices

510(k) Number: K100635

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.”