CG+ ARROW JACC POWERED BY ARROW VPS STYLET

{0}------------------------------------------------ #### 510(K) SUMMARY 06 ## Submitter Information | Name: | Arrow International, Inc (subsidiary of Teleflex Inc.) | |-------------------|--------------------------------------------------------| | Address: | 2400 Bernville Road<br>Reading, PA 19605-9607 USA | | Contact Person: | Julie Lawson<br>Regulatory Affairs Specialist | | Telephone Number: | (610) 378-0131 Extension 603256 | | Fax Number: | (610) 478-3179 | | Email: | julie.lawson@teleflex.com | | Date Prepared: | July 10, 2013 | SEP 26 2013 ### Device Name Device Trade Name: CG+ Arrow JACC powered by Arrow VPS Stylet Common Name, Catheter: Central Venous Catheter 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 . - K121501: Arrow® Pressure Injectable Jugular Axillo-subclavian Central Catheter™ (JACC™) with Chlorag ard® Antimicrobial and Antithrombogenic Technology ### Device Description The CG+ Arrow JACC powered by Arrow VPS Stylet has the following characteristics: - . 4.5 French, 1-Lumen, 15-35 cm pressure injectable, antimicrobial and antithrombogenic catheter preloaded with VPS Stylet - . 5.5 French, 2-Lumen, 15-35 cm pressure injectable, antimicrobial and antithrombogenic catheter preloaded with VPS Stylet - . 6 French, 3-Lumen, 15-35 cm pressure injectable, antimicrobial and antithrombogenic catheter preloaded with VPS Stylet The CG+ Arrow JACC powered by Arrow VPS Stylet is a CG+ Arrow JACC pre-loaded with the Arrow VPS Stylet and will be provided in sterile kit configurations. The CG+ Arrow JACC devices will also be provided in sterile kit configurations without the Arrow VPS Stylet preloaded in the catheter. {1}------------------------------------------------ The CG+ Arrow JACC 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 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 coating technology. 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 is designed to be compatible with any catheter with an inner luminal diameter of at least 0.021 inch. ### Intended Use The CG+ Arrow JACC powered by Arrow VPS Stylet permits venous access to the central circulation through a central vein. The VPS Stylet, used with the VPS Console, quickly and accurately guides the 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 subject CG+ Arrow JACC powered by Arrow VPS Stylet is substantially equivalent to the Vascular Positioning System (VPS) Stylet (K103255) and the Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Chlorag ard Antimicrobial and Antithrombogenic Technology (K121501) in terms of indications for use, manufacturing process, conditions and aids, functional performance, safety, efficacy, fundamental scientific technology and materials of construction. There is no change to the previously cleared Arrow VPS Stylet device associated with this modification. The design of the predicate Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Chlorae ard Antimicrobial and Antithrombogenic Technology has been modified to create the subject device. The following table reflects a comparison of the subject and predicate device characteristics. {2}------------------------------------------------ # K132133 Page 3 of 5 | Subject and Predicate Device Comparison | | | | |-----------------------------------------|--|--|--| | | | | | | | Subject and Predicate Device Comparison | | | |-------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------| | Characteristic | Predicate: Pressure Injectable JACC with<br>Chlorag+ard Antimicrobial and<br>Antithrombogenic Technology (K121501) | Subject:<br>CG+ Arrow JACC powered by Arrow VPS Stylet<br>(Catheter Portion - CG+ Arrow JACC) | | | Catheter Length | 20-30 cm | 15-35 cm | | | Catheter OD | 4.5 and 5.5 Fr | 4.5, 5.5, and 6 Fr | | | Number of<br>Lumens | 1 and 2 Lumen | 1,2, and 3 Lumen | | | Internal Lumen<br>Configuration | 1 Lumen - Round<br>2 Lumen - Double D | 1 Lumen - Round - SAME<br>2 Lumen - Round-Crescent<br>3 Lumen- Round-Split-Crescent | | | Pressure<br>Injection<br>Capabilities | 1 Lumen:<br>Distal:5 mL/sec. Pressure Injectable<br>2 Lumen:<br>Distal: 5 mL/sec. Pressure Injectable<br>Proximal: 5 mL/sec, Pressure Injectable | l Lumen:<br>Distal:5 mL/sec. Pressure Injectable - SAME<br>2 Lumen:<br>Distal: 5 mL/sec, Pressure Injectable - SAME<br>Proximal: 4 mL/sec, Pressure Injectable<br>3 Lumen:<br>Distal: 6 ml/sec, Pressure Injectable<br>Proximal: No Pressure Injection<br>Medial: No Pressure Injection<br>Note: Lumens that are not indicated for Pressure Injection<br>have "No CT" printed on the extension line hubs. | | | Catheter body<br>material | Radiopaque polyurethane (Blue 95A/55D<br>Tecothane with 30% Bismuth Oxychloride) | SAME | | | Catheter<br>Juncture Hub<br>Material | Blue Tecoflex 85A | SAME | | | Catheter Tip<br>Design and<br>material | Blue Flex Tip/Blue 85A Tecothane with 30%<br>Bismuth Oxychloride | SAME | | | Extension Line<br>Material | Clear Pellathane 90 Shore A | SAME | | | Extension Line<br>Hub Material | Distal - Pink Isolplast >100 polyurethane<br>Proximal - White Isoplast >100 Polyurethane | Distal - SAME<br>Proximal - SAME<br>Medial - Blue Isoplast >100 Polyurethane<br>Note: This new material is used on the medial lumen<br>extension line hub of the 6 Fr. catheter. | | | Printing Ink | 2405 Black Ink | 2405 Black Ink and White Ink<br>Note: The white ink is used to print "No CT" on the<br>medial lumen extension line hub of the 6 Fr. catheter. | | | Sterilization | 1 EtO | SAME | | | Performance<br>Specifications | Antimicrobial Efficacy<br>Effective in reducing microbial colonization<br>Antithrombogenic Efficacy | SAME | | | Characteristic | Predicate: Pressure Injectable JACC with<br>Chlorag+ard Antimicrobial and<br>Antithrombogenic Technology (K121501) | Subject:<br>CG+ Arrow JACC powered by Arrow VPS Stylet<br>(Catheter Portion - CG+ Arrow JACC) | | | Content Per<br>Surface Area | Internal: min 15 µg/cm²<br>External: min 324 µg/cm² | SAME | | | Chlorhexidine-<br>based Coating -<br>Content Per<br>1 cm piece of<br>catheter | 4.5 Fr. - All lengths<br>Internal Content: 4 - 20 µg/cm<br>External Content: 100-240 µg/cm<br>5.5 Fr. - All lengths<br>Internal Content: 8 - 30 µg/cm<br>External Content: 120-280 µg/cm<br>Extension Lines<br>Internal Content: 5 - 35 µg/cm | 4.5 and 5.5 Fr. are the SAME<br><br>6 Fr. - All lengths<br>Internal Content: 13-36 µg/cm<br>External Content: 205-309 µg/cm<br><br>Extension Lines - SAME | | | Total Maximum<br>Content of<br>Chlorhexidine | Maximum of 22.2 mg/catheter | SAME | | | Formulations<br>for Internal and<br>External<br>Antimicrobial<br>Coating | Substance | Internal Coating Concentration<br>(wt %) | External Coating Concentration<br>(wt %) | | | Chlorhexidine<br>Diacetate (CHA) | 1.5 | 2.0 | | | Chlorhexidine<br>Freebase (CHX) | 1.5 | None | | | Tetrahydrofuran<br>(THF) | None | 87.1 | | | Clear 95A<br>Tecothane<br>polyether-<br>polyurethane | None | 6.3 | | | Methyl Ethyl<br>Ketone (MEK) | 63.4 | None | | | Methanol | 14.5 | 4.6 | | | Acetone | 19.1 | None | | Predicate:<br>Vascular Positioning System (VPS System) Stylet<br>(K103255) | | Subject:<br>CG+ Arrow JACC powered by Arrow VPS Stylet<br>(VPS Stylet Portion - Arrow VPS Stylet) | | | Stylet Diameter<br>and catheter<br>compatibility | 0.019", compatible with catheters with an ID ≥<br>0.021". | SAME | | | Stylet Length | 6 Ft | SAME | | | Stylet Design | 6 foot long polymeric tube which contains a<br>Doppler sensor at the distal tip and Stainless Steel<br>intravascular electrocardiogram (ivECG) signal<br>sensing wire | SAME | | | Signal<br>Conductor | Two conductor stylet wires | SAME | | | Sterilization | EtO | SAME | | {3}------------------------------------------------ # K132133 Page 4 of 5 {4}------------------------------------------------ # K132133 Page 5 of 5 # Nonclinical Testing The following verification testing was performed and applies to the CG+ Arrow JACC powered by Arrow VPS Stylet: Chlorhexidine coating testing: chlorhexidine content testing, chlorhexidine coating efficacy, chiorhexidine release rate (elution), mechanical hemolysis, 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, luer hub testing, collapse resistance and central venous pressure monitoring. Combined device performance testing: stylet tensile, simulated use insertion/removal, force to remove stylet from catheter, and post-insertion/removal 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 formulation, concentration (content per surface area), method of application and mechanism of release and are manufactured using the same processes, conditions and aids. The results of the risk assessment and resultant testing performed have demonstrated that the proposed design and specification changes do not raise new issues of safety or effectiveness and therefore the subject device is considered substantially equivalent to the cited predicate devices. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo features a stylized eagle with three stripes forming its wing, representing the department's mission to protect the health of all Americans. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 26, 2013 Arrow International (Subsidiary of Teleflex Inc.) Ms. Julie Lawson Regulatory Affairs Specialist 2400 Bernville Road Reading, PA 19605 Re: K132133 Trade/Device Name: CG+ Arrow JACC powered by Arrow VPS Stylet Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OBJ LJS Dated: August 27, 2013 Received: August 29, 2013 Dear Ms. Julie 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. 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 {6}------------------------------------------------ Page 2 - Ms. Julie Lawson 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of 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, Owen-P.Faris -S for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ K132133 Page 1 of 1 Indications for Use 510(k) Number (if known): Device Name: CG+ Arrow JACC powered by Arrow VPS Stylet Indications for Use: The Arrow® Pessure Injectable Jugalarian Central Catherer™ with Chlorag+ard Antimicrobial and Antithrombagenc Technology is indicated for short-tern access to the central venous system for intrasenous therapy. blood sampling, infusion, pressure injection of contrast media and allows for contrasion The maximum pressure of pressure injector quipment used with the Arrow Pressure Injectable 1900 psi. The marimum pressure injection 110ve rate for the specific lumen heing used for pressure injection is printed on the extension line hub. Chionageurd Technology treatment on the cathere of the cathere body as well as the entire fibid pathway of the catherer has been shown to be citective in reducing microbial colonization on cathers. Antimierobial cities were evaluated using in ritre and in rive and in rive and in rive and in rive and in rive methods and no correlation between these esting methods and clinical outcome has currently been assertained. It is not intended to be used for the treatment of existing infections. The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheress for use in placement of the cather. intravascular espability for ECG devection and intravascular ultrasound for eatherer guiding and passioning. The VPS Stylet, when used with the VPS Console, provides real-time catherer information by using the patient's physiological (curdize clectrical activity and blow) 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 sherative method to Internation venus cather up placement confirmation in add patients when a steady Blue Bullseye is obtained, NOTE: IT's steady Blue Bullained, standard haspital proctive should be followed to confirm catherer tip location. Limiting but not contraindiented situations for this receivers where alterations of cardiae thythm change the presentation of the fwave as in atial fibrillation, arrial flutter severe achycardia and pacental venous catherization procedures performed through femoral or suphenous vein access which of the P-vave. 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. Prescription Use x (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ANDAOR Concurrence of CDRH, Office of Device Evaluation (ODE) Digitally signed by Owen P. Faris -S Date: 2013.09.26 14:49:51 -04'00'