CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC

{0}------------------------------------------------ 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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with a flowing design beneath them. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 28, 2016 Arrow International, Inc. (subsidiary of Teleflex, Inc.) Ms. Julie Lawson Regulatory Affairs Specialist 2400 Bernville Road Reading, Pennsylvania 19605 Re: K153423 Trade/Device Names: CG+ Arrow JACC CG+ Arrow JACC Powered By Arrow VPS Stylet Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS, OBJ Dated: January 4, 2016 Received: January 6, 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. {1}------------------------------------------------ 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 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. Sincerely yours, Tina Kiang S for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K153423 #### Device Name - CG+ Arrow JACC - CG+ Arrow JACC powered by Arrow VPS Stylet #### Indications for Use (Describe) The Arrow Pressure Injectable JACC with Chlorageard Antithrombogenic Technology 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 of pressure injector equipment used with the 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 pathyav of the catheter has been shown to be effective in reducing microbial colonization on catheter surfaces. Antimicrobial effectiveness were 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 treating infections. The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters. The Stylet provides stiffness for use in placement of the catheter, intravascular capability for ECG detection and recording and intravascular ultrasound for catheter guiding and positioning. The VPS Stylet, when used with the VPS Console, provides real-time catheter tip location information by using the patient's physiological (cardiac electrical activity and blood flow) information. When the Vascular Positioning System guidance indicator shows a Blue Bullseye, the catheter tip is in the desired location. The VPS System is indicated for use as an alternative method to fluoroscopy or chest x-ray for central venous catheter tip placement confirmation in adult patients when a steady Blue Bullseye is obtained. NOTE: If a steady Blue Bullseye is not obtained, standard hospital practice should be followed to confirm catheter tip location. Limiting but not contraindicated situations for this technique are in palients where alterations of cardiac rhythm change the presentation of the P-wave as in atrial flutter, severe tachycardia and pacemaker-driven rhythm, and in central venous catheterization procedures performed through femoral vein access which change the presentation of the P-wave. In such patients, who are easily identifiable prior to central venous catheter insertion, the use of an additional method is required to confirm catheter tip location. 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 7 510(K) SUMMARY: K153423 # 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: | November 24, 2015 | # Device Name Device Trade Name: - CG+ Arrow JACC . CG+ Arrow JACC powered by Arrow VPS Stylet ● Common Name, Catheter: Central Venous Catheter Common Name, Stylet: Catheter, Ultrasound, Intravascular Classification Regulation: 21 CFR: 880.5970 Classification Name: Percutaneous, implanted, long-term intravascular catheter Product Code: LJS, OBJ # Predicate Devices - K132133: CG+ Arrow JACC powered by Arrow VPS Stylet . # Device Description The Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Chlorag ard Antimicrobial and Antithrombogenic Technology has the following characteristics: - . 4.5 French, 1-Lumen, 15-35 cm pressure injectable, antimicrobial and antithrombogenic catheter with or without preloaded VPS stylet - 5.5 French, 2-Lumen, 15-35 cm pressure injectable, antimicrobial and antithrombogenic . catheter with or without preloaded VPS Stylet - 6 French, 3-Lumen, 15-35 cm pressure injectable, antimicrobial and antithrombogenic ● catheter with or without preloaded VPS Stylet The subject device is a CG+ Arrow JACC with or without pre-loaded Arrow VPS Stylet and will be provided in sterile kit configurations. The modifications subject to this submission are additions to the recommended procedural technique to clarify that the catheter devices can be trimmed or cut to the appropriate length based on the specific patient's anatomy. {4}------------------------------------------------ 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, Chlorag+ard technology. There are no modifications subject to this premarket notification related to the geometric or material design of the devices modified 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 JACC with Chlorag+ard Antimicrobial and Antithrombogenic Technology 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 of 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 were 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. The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters. The Stylet provides stiffness for use in placement of the catheter, intravascular capability for ECG detection and recording and intravascular ultrasound for catheter guiding and positioning. The VPS Stylet, when used with the VPS Console, provides real-time catheter tip location information by using the patient's physiological (cardiac electrical activity and blood flow) information. When the VPS System guidance indicator shows a Blue Bullseye, the catheter tip is in the desired location. The VPS System is indicated for use as an alternative method to fluoroscopy or chest x-ray for central venous catheter tip placement confirmation in adult patients when a steady Blue Bullseye is obtained. NOTE: If a steady Blue Bullseye is not obtained, standard hospital practice should be followed to confirm catheter tip location. Limiting but not contraindicated situations for this technique are in patients where alterations of cardiac rhythm change the presentation of the P-wave as in atrial fibrillation, 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- {5}------------------------------------------------ wave. In such patients, who are easily identifiable prior to central venous catheter insertion, the use of an additional method is required to confirm catheter tip location. The above Indication for Use is identical to the predicate. ### Technological Characteristics and Substantial Equivalence The subject CG+ Arrow JACC is substantially equivalent to the CG+ Arrow JACC powered by VPS (K132133) in terms of indications for use, manufacturing process, conditions and aids, functional performance, fundamental scientific technology and materials of construction. There is no change to the geometric design of the subject devices which is associated with the procedural clarifications subject to this submission. The procedure clarifications consist of the addition of catheter trimming instructions and other minor clarifications to make the instructions easier to read by eliminating redundancy and standard protocols as well as improving the flow of the written procedure, thus clarifying the recommended procedural steps. The following table reflects a comparison of the subject and predicate device characteristics. | Characteristic | Predicate:<br>CG+ Arrow JACC powered by VPS Stylet<br>(K132133) | Subject:<br>CG+ Arrow JACC | |---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------| | Catheter Length | 15-35 cm | SAME | | Catheter OD | 4.5, 5.5, and 6 Fr | SAME | | Number of<br>Lumens | 1,2, and 3 Lumen | SAME | | Internal Lumen<br>Configuration | 1 Lumen - Round<br>2 Lumen – Double D<br>2 Lumen - Round-Crescent<br>3 Lumen- Round-Split-Crescent | SAME | | Pressure<br>Injection<br>Capabilities | 1 Lumen:<br>Distal: 5 mL/sec. Pressure Injectable<br>2 Lumen - Double D:<br>Distal: 5 mL/sec, Pressure Injectable<br>Proximal: 5 mL/sec, Pressure Injectable<br>2 Lumen - Round-Crescent:<br>Distal: 5 mL/sec, Pressure Injectable<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<br>Injection have "No CT" printed on the extension<br>line hubs. | SAME | | Catheter body<br>material | Radiopaque polyurethane | SAME | ### Subject and Predicate Device Comparison {6}------------------------------------------------ | Characteristic | Predicate:<br>CG+ Arrow JACC powered by VPS Stylet<br>(K132133) | Subject:<br>CG+ Arrow JACC | |----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------| | Catheter Juncture Hub Material | Blue polyurethane | SAME | | Catheter Tip Design and material | Radiopaque, soft blue polyurethane | SAME | | Extension Line Material | Clear polyurethane | SAME | | Extension Line Hub Material | Distal - Pink polyurethane<br>Proximal - White Polyurethane<br>Medial - Blue Polyurethane<br>Note: This new material is used on the medial lumen extension line hub of the 6 Fr. catheter. | SAME | | Printing Ink | 2405 Black Ink and White Ink<br>Note: The white ink is used to print "No CT" on the medial lumen extension line hub of the 6 Fr. catheter. | SAME | | Sterilization | Provided Sterile. Sterilized by Ethylene Oxide. | SAME | | Performance Specifications | Antimicrobial Efficacy<br>Effective in reducing microbial colonization<br>Antithrombogenic Efficacy<br>Effective in reducing thrombus accumulation | SAME | | Characteristic | Predicate:<br>CG+ Arrow JACC powered by VPS Stylet<br>(K132133) | Subject:<br>CG+ Arrow JACC powered by 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 intravascular<br>electrocardiogram (ivECG) signal sensing wire | SAME | | Signal<br>Conductor | Two conductor stylet wires | SAME | | Sterilization | EtO | SAME | # Nonclinical Testing Risk analysis activities were conducted to assess the impact of the modification 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: - Catheter trimming compatibility verification test according to internal method ● - Finished Good Design Validation . {7}------------------------------------------------ ### 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 verification testing performed have supported the substantial equivalence of the modified devices to the predicate devices.