The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology

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September 26, 2018 Access Scientific, LLC Ms. Martina Nguyen Regulatory Affairs & Ouality Assurance Specialist 3910 Sorrento Valley Boulevard, Suite 200 San Diego, California 92121 Re: K181563 Trade/Device Name: The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY, DYB Dated: August 24, 2018 Received: August 27, 2018 Dear Ms. Nguyen: 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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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You must comply with all the Act's {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Image /page/1/Picture/6 description: The image shows the name "Finn E. Donaldson -S" in large, bold font. To the right of the name is a digital signature block. The signature block includes information such as the signer's name, organization, and date. DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=200097967 3, cn=Finn E. Donaldson -S Date: 2018.09.26 15:36:30 -04'00' for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K181563 Device Name ARTERIAL WAND™ Safety Introducer with Arterial Catheter made of ChronoFlex C® with BioGUARD™ Technology Indications for Use (Describe) The ARTERIAL WAND™ Safety Introducer with Arterial Catheter made of ChronoFlex C® with BioGUARD™ Technology is used to gain access to the vascular (e.g. arterial) system to sample blood, administer fluids, and monitor blood pressure intravascularly. Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) | <div> <input checked="true" type="checkbox"/> </div> | |----------------------------------------------|------------------------------------------------------| | Over-The-Counter Use (21 CFR 801 Subpart C) | <div> <input type="checkbox"/> </div> | #### 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}------------------------------------------------ # 510(K) SUMMARY The following 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. # 1. SUBMITTER INFORMATION | Company Name: | Access Scientific, LLC | |--------------------|-----------------------------------------------------------------------------------------------------| | Company Address: | 3910 Sorrento Valley Boulevard<br>Suite 200<br>San Diego, CA 92121 | | Company Phone: | (858) 259-8333 | | Company Facsimile: | (858) 259-5298 | | Contact Person: | Martina Nguyen<br>Regulatory Affairs & Quality Assurance Specialist<br>mnguyen@accessscientific.com | | Date: | September 25, 2018 | ## 2. PROPOSED DEVICE IDENTIFICATION | Trade Name: | The ARTERIAL WAND™ Safety Introducer with<br>Arterial Catheter made of ChronoFlex C® with<br>BioGUARD™ Technology | |----------------------------|-------------------------------------------------------------------------------------------------------------------| | Common Name: | Percutaneous Catheter | | Classification Name: | Catheter, Percutaneous | | Classification Regulation: | 21 CFR 870.1250 | | Device Class: | Class II | | Product Code(s): | DQY, DYB | | Advisory Panel: | Cardiovascular | {4}------------------------------------------------ #### 3. PREDICATE DEVICE IDENTIFICATION The ARTERIAL WAND™ Safety Introducer with Arterial Catheter made of ChronoFlex C® with BioGUARD™ Technology is substantially equivalent to the following predicate device: - K171146 Arrow Seldinger Arterial Catheterization Device ● #### 4. REFERENCE DEVICE IDENTIFICATION The ARTERIAL WAND™ Safety Introducer with Arterial Catheter made of ChronoFlex C® with BioGUARD™ Technology is substantially equivalent to the following reference devices: - K162322 The POWERWAND™ Safety Introducer with an Extended Dwell Catheter ● - K052564 - Leaderflex #### 5. DEVICE DESCRIPTION The ARTERIAL WAND™ Safety Introducer with Arterial Catheter made of ChronoFlex C® with BioGUARD™ Technology is an all-in-one preassembled device that combines the functionality of a catheter introducer system with an arterial catheter. The ARTERIAL WAND™ is used to gain access to the vascular (e.g. arterial) system to insert the arterial catheter. The arterial catheter may then be left in place for a period of <30 days, used to sample blood, administer fluids, and monitor blood pressure intravascularly. The ARTERIAL WAND™ catheter has been proven in vitro to be 100% as accurate as a steel cannula and in vivo to be more accurate in assessing mean arterial pressure than a competitive polyurethane catheter (Arrow 4020 Radial Artery Catheter, Arrow International, Inc.).1 1 Clinical correlation to in vivo animal testing and in vitro testing has not been ascertained. The ARTERIAL WAND™ Safety Introducer with Arterial Catheter made of ChronoFlex C® with BioGUARD™ Technology pre-assembled device includes the following components: - Introducer Needle - Guidewire - Dilator Hub ● - Catheter made of ChronoFlex C® with BioGUARD™ Technology ● The ARTERIAL WAND™ is sterile, single-use (<30 days) intravascular catheter. It is used to gain access to the vascular (e.g. arterial) system. {5}------------------------------------------------ #### 6. INDICATION FOR USE The ARTERIAL WAND™ Safety Introducer with Arterial Catheter made of ChronoFlex C® with BioGUARD™ Technology is used to gain access to the vascular (e.g. arterial) system to sample blood, administer fluids, and monitor blood pressure intravascularly. ## 7. TECHNOLOGICAL CHARACTERISTICS The ARTERIAL WAND™ Safety Introducer with Arterial Catheter made of ChronoFlex C® with BioGUARD™ Technology is substantially equivalent to the predicate device's technological characteristics in terms of overall performance. The difference between the proposed device and the predicate device is the catheter material. ChronoFlex C® with BioGUARD™ Technology and Polyether Block Amide respectively. The catheter material of the proposed device is equivalent to the reference device, the POWERWAND™ Safety Introducer with an Extended Dwell Catheter (hereafter POWERWAND™), also manufactured by Access Scientific and previously cleared for commercial distribution under 510(k) K162322. The performance data was leveraged from the reference device, the POWERWAND™, which is similar to the proposed device except for a different effective catheter length, and has substantially equivalent performance. The proposed device indications for use to gain access to the vascular system to sample blood and administer fluids share the same indications for use as the reference device, the POWERWAND™. In addition, the proposed device indications for use to gain access to the vascular system to monitor blood pressure intravascularly share the same indications for use as the reference device, the Leaderflex, manufactured by Vygon and previously cleared for commercial distribution under 510(k) K052564. Table 1 provides a comparison of the features between the ARTERIAL WAND™ Safety Introducer with Arterial Catheter made of ChronoFlex C® with BioGUARD™ Technology to the predicate device and the reference devices. {6}------------------------------------------------ | Table 1: Comparison Feature between the Proposed, Predicate, and Reference Devices | | | | | |------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Technological<br>Characteristics | Proposed Device | Predicate Device<br>(K171146) | Reference Device<br>(K162322) | Reference Device<br>(K052564) | | Trade name | The ARTERIAL<br>WAND™ Safety<br>Introducer with<br>Arterial Catheter<br>made of<br>ChronoFlex C®<br>with<br>BioGUARD™<br>Technology | Arrow Seldinger<br>Arterial<br>Catheterization<br>Device | The<br>POWERWAND™<br>Safety Introducer<br>with an Extended<br>Dwell Catheter | Vygon Leaderflex | | Classification<br>Name | Catheter,<br>percutaneous | Catheter,<br>percutaneous | Introducer,<br>Catheter | Catheter,<br>Intravascular,<br>Therapeutic,<br>Short-Term Less<br>Than 30 Days | | Classification<br>Regulation | 21 CFR 870.1250 | 21 CFR 870.1250 | 21 CFR 870.1340 | 21 CFR 880.5200 | | Product Code | DQY | DQY | DYB | FOZ | | Indications for<br>Use | The ARTERIAL<br>WAND™ Safety<br>Introducer with<br>Arterial Catheter<br>made of<br>ChronoFlex C®<br>with<br>BioGUARD™<br>Technology is<br>used to gain<br>access to the<br>vascular (e.g.<br>arterial) system to<br>sample blood,<br>administer fluids,<br>and monitor blood<br>pressure<br>intravascularly. | The Arrow<br>Seldinger Arterial<br>Catheterization<br>Device permits<br>access to the<br>peripherical arterial<br>circulation or to<br>other small vessels. | The<br>POWERWAND™<br>Safety Introducer<br>with an Extended<br>Dwell Catheter is<br>used to gain access<br>to the vascular<br>system to sample<br>blood and<br>administer fluids<br>intravenously. It<br>may be used for<br>power injection of<br>contrast media up<br>to a rate of 8 ml/sec<br>and at a maximum<br>of 325 psi fluid<br>pressure. | The primary<br>indications of the<br>Leaderflex<br>catheter is<br>pressure<br>monitoring in<br>peripheral arteries.<br>The device may<br>also be used for<br>venous access in<br>pediatric patients. | | Mechanism of<br>Action | "all-in-one"<br>preassembled<br>device that<br>combines the<br>functionality of a<br>catheter<br>introducer system<br>with an arterial<br>catheter | preassembled<br>device that<br>combines the<br>functionality of a<br>catheter introducer<br>system with an<br>arterial catheter | "all-in-one"<br>preassembled<br>device that<br>combines the<br>functionality of a<br>catheter introducer<br>system with an<br>extended dwell<br>catheter | Suitable for a<br>variety of venous<br>and arterial<br>applications in<br>adults and<br>children:<br>• Central venous<br>catheterization<br>• Arterial<br>catheterization | | Table 1: Comparison Feature between the Proposed, Predicate, and Reference Devices | | | | | | Technological<br>Characteristics | Proposed Device | Predicate Device<br>(K171146) | Reference Device<br>(K162322) | Reference Device<br>(K052564) | | | | | | • Peripheral<br>venous<br>catherization | | Principle of<br>Operation | Seldinger<br>Technique | Seldinger<br>Technique | Seldinger<br>Technique | Seldinger<br>Technique | | Catheter<br>Material | ChronoFlex C®<br>with<br>BioGUARD™<br>Technology | Polyether Block<br>Amide | ChronoFlex C®<br>with BioGUARD™<br>Technology | Polyurethane | | Components | • Introducer<br>Needle<br>• Guidewire<br>• Dilator Hub<br>• Catheter made<br>of ChronoFlex<br>C® with<br>BioGUARD™<br>Technology | • Introducer<br>Needle or<br>Catheter over<br>Needle assembly<br>• Spring wire<br>guide<br>• Catheter<br>assembly with<br>extension tube<br>segment with<br>side clamp, and<br>luer hub with<br>dust cap | • Introducer<br>Needle<br>• Guidewire<br>• Dilator Hub<br>• Catheter made of<br>ChronoFlex C®<br>with<br>BioGUARD™<br>Technology | • Catheter<br>• Guidewire<br>• Needle | | Introducer<br>Needle Gauge | 21 gauge | 18 gauge<br>20 gauge<br>22 gauge<br>24 gauge | 21 gauge<br>24 gauge | 21 gauge | | Catheter<br>Effective<br>Length | 5 cm | 2.5 – 23 cm | 6 cm | 4 – 20 cm | | Guidewire<br>Outer<br>Diameter | 0.46 mm | 18 gauge: 0.64 mm<br>20 gauge: 0.53 mm<br>22 gauge: 0.53 mm<br>24 gauge: 0.46 mm | 21 gauge: 0.46 mm<br>24 gauge: 0.30 mm | 0.7 mm | | Introducer<br>Method | Introducer needle | Introducer needle<br>and Introducer<br>catheter-over-<br>needle | Introducer Needle | Introducer Needle | | Sterilization<br>Method | Ethylene oxide<br>method | Ethylene oxide<br>method | Ethylene oxide<br>method | — | | Shelf-life | 2 years | 2 years | 2 years | — | | Packaging | PETG tray with<br>Tyvek® lid | PET/LDPE film<br>mated with<br>Tyvek® | PETG tray with<br>Tyvek® lid | — | {7}------------------------------------------------ # K181563 {8}------------------------------------------------ ### 8. SUMMARY OF TESTING Design verification testing was conducted to demonstrate that the performance characteristics of the ARTERIAL WAND™ Safety Introducer with Arterial Catheter made of ChronoFlex C® with BioGUARD™ Technology, is equivalent to the predicate device and satisfy the requirements of the product design specification for its intended use. Performance data was leveraged from the reference device, the POWERWAND™, because the fundamental scientific technology of the ARTERIAL WAND™ Safety Introducer with Arterial Catheter made of ChronoFlex C® with BioGUARD™ Technology is the same as the POWERWAND™ with the exception of the catheter effective length. Therefore, performance testing was only conducted on the modified component. Refer to Table 2 for a summary of the design verification tests performed. | Table 2: Design Verification Testing of the ARTERIAL WAND™ Safety | | |------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------| | Introducer with Arterial Catheter made of ChronoFlex C® with BioGUARD™ | | | Technology | | | Component | Testing | | Introducer Needle | Strength of union between needle hub and needle tube Resistance to breakage | | Catheter | Collapse pressure Column strength Flowrate Force at break Priming volume Burst pressure Freedom from leakage | | Device System | Axial Forces Fast-flashTM evaluation Insertability Needle-stick safety Intraluminal positioning visual indicators Particulate Matter content | #### 9. CONCLUSIONS The results from testing demonstrate that the ARTERIAL WAND™ Safety Introducer with Arterial Catheter made of ChronoFlex C® with BioGUARD™ Technology is substantially equivalent to the predicate device in design, function, and indications for use.