CG+ ARROW PICC POWERED BY ARROW VPS STYLET

{0}------------------------------------------------ # APR 2 6 2013 #### 06 510(K) SUMMARY ## Submitter Information | Name: | Arrow International, Inc (subsidiary of Teleflex Inc.) | |-------------------|--------------------------------------------------------| | Address: | 2400 Bernville Road | | | Reading, PA 19605-9607 USA | | Contact Person: | Elizabeth Duncan | | | Sr. Regulatory Affairs Specialist | | Telephone Number: | (610) 378-0131 Extension 603220 | | Fax Number: | (610) 478-3179 | | Email: | elizabeth.duncan@teleflex.com | | Date Prepared: | March 27, 2013 | #### Device Name Device Trade Name: CG+ Arrow PICC powered by Arrow VPS Stylet Common Name, Catheter: Peripherally Inserted Central Catheter (PICC) Classification Name, Catheter: Percutaneous, implanted, long-term intravascular catheter per 21 · CFR: 880.5970 #### Predicate Devices - K123759: CG+ Arrow PICC powered by Arrow VPS Stylet . #### Device Description The CG+ Arrow PICC powered by Arrow VPS Stylet has the following characteristics: - 6 Fr, 3-Lumen, 40-55 cm pressure injectable, antimicrobial and antithrombogenic . catheter preloaded with VPS Stylet The CG+ Arrow PICC is pre-loaded with the Arrow VPS Stylet and will be provided in sterile kit configurations. The Arrow CG+ PICC is a short-term or long-term, single use catheter designed to provide access to the central venous system. It consists of a non-tapered, radiopaque polyurethane extruded catheter body with a softer, contoured Blue Flex Tip. The catheter can be used for the injection of contrast media. The maximum recommended infusion rate is 6 mL/sec. The external catheter body and the internal fluid path of the device are treated with Chlorhexidine based coating technology. Studies have shown the technology to possess both antimicrobial and antithrombogenic properties. {1}------------------------------------------------ The Arrow VPS Stylet is a polyimide tube containing a Doppler sensor on a coax cable and an · intravascular electrocardiogram (ivECG) signal sensing stainless steel wire. The Doppler sensor and the exposed portion of the ivECG are located at the distal end of the stylet and are used to detect and transmit physiological information to the VPS Console for analysis. The proximal end contains a connector to the VPS Console or to an extension cable that in turn connects to the VPS Console. The stylet was designed to be inserted and removed from any catheter with a luminal diameter of at least 0.021 inch. The number of lumens has increased from 2 to 3 and as a result the subject device is French size has increased from 5.5 to 6 French. In order to identify the third lumen, an additional colorant and ink were used. Additionally, the internal lumen configuration of the predicate (K123759) has changed from a "Round-Crescent" to a "Round-Split-Crescent". The "Round-Split-Crescent" internal lumen design modification resulted in an increased flowrate in the distal lumen from a maximum of 5 ml/sec. (The proximal and medial lumen are not pressure injectable on the subject device.) The increased surface area on the subject device's 6 French 3-L catheter design resulted in a 3.8 mg increase in the maximum allowable chlorhexidine content as compared to the predicate device (the content per surface area remains unchanged). #### Intended Use A PICC permits venous access to the central circulation through a peripheral vein. The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market available central catheters to the desired location which is the lower third of the SVC or at the cavo-atrial junction. #### Technological Characteristics and Substantial Equivalence The subject CG+ Arrow PICC powered by Arrow VPS Stylet is substantially equivalent to the predicate CG+ Arrow PICC powered by Arrow VPS Stylet (K123759) 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 Arrow VPS Stylet from the predicate device. The design of the predicate CG+ Arrow PICC has been modified to create the subject device. The number of lumens has increased from 2 to 3 and as a result the subject device's French size has increased from 5.5 to 6 French. In order to identify the third lumen, an additional colorant and ink were used. Additionally, the internal lumen configuration of the predicate (K123759) has changed from a "Round-Crescent" to a "Round-Split-Crescent". The "Round-Split-Crescent" internal lumen design modification resulted in an increased flowrate in the distal lumen from a maximum of 5 ml/sec. (The proximal and medial lumen are not pressure injectable on the subject device.) The increased surface area on the subject device's 6 French 3-L catheter design resulted in a 3.8 mg increase in the maximum allowable chlorhexidine content as compared to the predicate device (the content per surface area remains unchanged). Biocompatibility (toxicity, etc.) testing on the final finished device verified that the increase in maximum allowable chlorhexidine content of 3.8 mg/catheter did not present any new safety or efficacy concerns. The chlorhexidine's content per {2}------------------------------------------------ surface area remains the same: therefore, efficacy and analytical release profile of the chlorhexidine were shown to be unaffected. Efficacy testing verified efficacy is unaffected. The antimicrobial/antithrombogenic chlorhexidine coating's identity, formulation, concentration (content per surface area), manufacturing processes, conditions and aids, method of application to the device and mechanism by which the agent is released from the device is the same as the predicate CG+ Arrow PICC powered by Arrow VPS (K123759). No changes were made to the VPS Stylet. ## Nonclinical Testing The following testing was performed on the 6 French CG+ Arrow PICC powered by Arrow VPS Stylet: Chlorhexidine coating testing: chlorhexidine content testing, chlorhexidine coating efficacy, chlorhexidine release rate (elution), mechanical hemolvsis, 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 test and force to remove stylet from catheter. After devices completed the simulated use insertion/removal test, the following tests were done to verify there was no damage to the catheter: catheter air and liquid leakage. Stylet electrical testing was also done post simulated use insertion/removal testing to verify stylet function. ### 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 device. {3}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 26, 2013 Ms. Elizabeth Duncan Senior Regulatory Affairs Specialist Arrow International, Incorporated -2400 Bernville Road READING PA 19605-9607 Re: K130876 Trade/Device Name: CG+ Arrow PICC 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 Dated: March 27, 2013 Received: March 29, 2013 Dear Ms. Duncan: 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. {4}------------------------------------------------ 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 (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 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of 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/ResourcesforYou/Industry/default.htm. Sincerely vours, Image /page/4/Picture/8 description: The image contains a logo or emblem with stylized text and geometric shapes. The text appears to read "For" at the top left, with additional words or letters below that are difficult to decipher due to the artistic style. There is a circular element in the center, and a triangular shape on the right, both filled with lines or patterns. Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ Indications for Use K130876 510(k) Number (if known): Device Name: CG+ Arrow PICC powered by Arrow VPS Styles Indications for Use: The Pressure Injectable PICC with Chierobial and Antitrombogenic Technology is indicated for short-erm or long-erm 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 injection equipment used with the pressure injectable PCC cathere may not exceed 300 psi. Chlorageard Technology treament on the cather of the cather fluid pathway of the cather ins been shown to be effective in reducing microbial colonization on cather surfaces. Antimicrobial and antitrombial and antithrombogenic effectiveness were evaluated using in viro test methods and no correlation between these est methods and clinical outcome has currently been ascerained. It is not intended to be used for the treatment of existing intections or vein thrombosis. The VPS Stylet and Console are indicated for guidening for central venous cathers. The Stylet provides stiffiess for use in placement of the catherer, intravascular conding and intravascular ultrasond for cathere guiding and positioning. The VPS Stylet, when used with the VPS Console, provides real-time cather in lormation by using the patient's physiological (cardias electrical activity and blood flow) information. When the VPS System guidance indicator shows a Blue Dullseye, 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 contraction of in adult patients when a steady Blue Bullsey. If a stedy Blue Bullseye is not oblained, standard hospital practice should be followed to confirm catheter tip location. Limiting but not contraindicated situations for this technique of earlier there allerations of cardiac the presentation of the Pwave as in attial fibrillation, arial flutter, severe achyandian driven rhythm, and in central venous catherization procedures performed through femoral or saphenous vein access which change the presents, who are easily identifiable prior to central venous catherer insertion, the use of an additional method is required to confirm catherer tip location. Prescription Use ਮ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Image /page/5/Picture/14 description: The image shows the FDA logo. The letters "FDA" are stylized with multiple outlines, giving them a three-dimensional appearance. The logo is rendered in black and white, with the letters standing out against the background. Richard C. Chapman 2013.04.25 11:23:34 -04'00' (Division Sign-Off) vision of Anesthesiology, General Hospital tection Control. Dental Devices K 130876 510(k) Number: _