Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein Access Set, Traveler16 16ga Needle Portal Vein Access set

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below that. December 22, 2020 Argon Medical Devices, Inc. Amy Clendening-Wheeler Regulatory Affairs Manager 1445 Flat Creek Road Athens, Texas 75751 Re: K201489 Trade/Device Name: Traveler Portal Vein Access Set Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: November 20, 2020 Received: November 23, 2020 Dear Amy Clendening-Wheeler: 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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Finn Donaldson Assistant Director (Acting) DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K201489 Device Name Traveler™ Portal Vein Access Set Indications for Use (Describe) The Traveler™ Portal Vein Access Set is intended for transjugular liver access in diagnostic and interventional procedures. 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. 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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}------------------------------------------------ ## December 18, 2020 Date Prepared: Company: Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, Texas 75751 USA Facility Registration number: 1625425 Amy Clendening-Wheeler Contact: Regulatory Affairs Manager Phone: 469-731-1413 469-731-1480 Fax: Email: amy.wheeler@argonmedical.com Device Trade Name: Traveler™ Portal Vein Access Set Catheter Introducer Device Common Name: Device Classification: Introducer, Catheter Product code, DYB 21 CFR 870.1340 Class II Review Panel: Cardiovascular Devices Predicate Device(s): Primary: K171820 Transjugular Liver Access Sets / Cook Incorporated Reference: K152913 GORE TIPS Set / Creganna Medical Description of the The Traveler™ Portal Vein Access Set contains a 10F wall-reinforced Device: Introducer Sheath with radiopaque tip, a 10F Dilator, a 5F MPA catheter, a puncturing tool that comes in the following variations: 0.038" Stylet with a 5Fr Stylet Catheter (separated with a removable spacer clip), a 21ga Needle/5Fr Catheter or 16ga Needle/7Fr Catheter (both are separated with a removable spacer clip) and a bending tool. The 14ga stiffening cannula with cannula sheath and the 16ga needle have a curved end, with a directional handle that indicates the direction of the curve. The 10F Introducer Sheath hemostatic valve is designed to allow entry of a 13F (4.3mm/0.171") access sleeve but taper down to a 10F inner diameter. ## 510(k) Summary {4}------------------------------------------------ | | These components are used to create a pathway through the liver<br>parenchyma through which an endoprosthetic can be delivered. The<br>Portal Vein Access Set is used to gain access to the hepatic vein and<br>guide a sharp puncture tool toward the parenchyma. The puncture<br>tool is used to make a pathway from the hepatic vein to the portal<br>vein, and then the pathway is dilated to provide access for the 10F<br>Introducer Sheath. The shunt is inserted through the sheath and<br>deployed through the pathway. Then, all of the Portal Vein Access<br>Set components are removed. The Portal Vein Access Set is typically<br>in use in procedures up to 4 hours. | |--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indication for Use: | The Traveler™ Portal Vein Access Set is intended for transjugular liver<br>access in diagnostic and interventional procedures. | | Technological<br>Characteristics: | A comparison of the technological characteristics of the subject<br>device and the predicate devices shows the Traveler™ Portal Vein<br>Access Set to be substantially equivalent to the current marketed<br>predicate devices.<br>Equivalence is based upon the product performance, design and<br>intended use. The Traveler™ Portal Vein Access Set and the predicate<br>devices have similar materials of construction, dimensional<br>specifications, designs and sterilization process. | | Performance Tests<br>(Non-Clinical): | No performance standards have been established under section 514,<br>performance standards, of the Food, Drug and Cosmetic Act for<br>these devices. A series of testing was conducted in accordance with<br>protocols based on requirements outlined in guidances and industry<br>standards and the below were shown to meet the acceptance criteria<br>that were determined to demonstrate substantial equivalence.<br>The following tests were performed under the specified testing<br>parameters to support the Traveler™ Portal Vein Access Set<br>substantial equivalence.<br>Performance Testing, including:<br>• Dimensional & Functional Fit<br>• Surface Inspection | | Substantial<br>Equivalence: | Based on the Indication for Use, design, and safety and performance<br>testing, the Traveler TM Portal Vein Access Set meets the requirements<br>for its intended use and is substantially equivalent to the predicate<br>devices. | {5}------------------------------------------------ - Component Compatibility ● - Tensile Strength - Torque Strength Test ● - Liquid Leakage - Air Leakage ● - Burst Pressure - Flow Rate - Corrosion Resistance - Simulative Use ● - Radiopacity ● - Echogenicity ● - Luer Connector Functional Testing ● - Resistance to Fracture Testing ● ### Biocompatibility Testing, including: - Cytotoxicity (ISO 10993-5) - · Sensitization (ISO 10993-10) - · Intracutaneous Irritation (ISO 10993-10) - · Acute Systemic Toxicity (ISO 10993-11) - Material Mediated Pyrogen (ISO 10993-11) ● - · Hemocompatibility (ISO10993-4) - o ASTM Hemolysis Direct and Indirect Contact - o Complement Activation, SC5b-9 - O In Vivo Thrombogenicity - Platelet and Leucocyte Counts O - O Partial Thromboplastin Time (PTT) ### Substantial Equivalence Table | | SUBJECT DEVICE | PRIMARY<br>PREDICATE DEVICE | REFERENCE<br>PREDICATE DEVICE | |------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Traveler™ Portal Vein<br>Access Set | Transjugular Liver<br>Access Sets | GORE® TIPS Set | | Manufacturer | Argon Medical Devices, Inc. | Cook Incorporated | Creganna Medical | | 510(k) | TBD | K171820 | K152913 | | Class | II | SAME | SAME | | Classification Name | Catheter Introducer | SAME | SAME | | Regulation | 21 CFR 870.1340 | SAME | SAME | | Product Code | DYB | SAME | SAME | | | | | | | Clinical Comparison | | | | | Principle of Operation | Access to the jugular vein using<br>standard access techniques.<br>The Introducer sheath and<br>dilator are inserted over the<br>guidewire, advanced, and<br>positioned in the hepatic vein<br>and the dilator is removed. The<br>puncturing tool and guide<br>catheter is inserted into<br>the introducer sheath and the<br>puncturing tool is used<br>to puncture the hepatic vein,<br>liver parenchyma and access<br>the portal vein. | SAME | SAME | | Indication for Use | The Portal Vein Access Set is<br>intended for transjugular liver<br>access during diagnostic and<br>interventional procedures. | Intended for transjugular<br>liver<br>access in diagnostic and<br>interventional procedures. | Intended to be used together<br>for percutaneous<br>transjugular liver access<br>during diagnostic and<br>interventional procedures in<br>patients undergoing a<br>Transjugular<br>Intrahepatic Portosystemic<br>Shunt (TIPS) procedure. | | Contraindication | None Known | Unknown | Unknown | | Single Use | YES | SAME | SAME | | Supplied Sterile | YES | SAME | SAME | | Sterilization | EtO | SAME | SAME | | Technical and Biological Comparison | | | | | Introducer Sheath<br>Introducer Sheath, working length (cm)<br>Sheath, composition | Sheath hemostatic valve is designed to allow entry of a 13F (4.3mm/0.171") access sleeve but taper down to a 10F inner diameter. | some of these sets are a Check-Flo Introducer Set, selective catheters, and wire guides. | | | | 10F<br>42<br>Pebax or PTFE Inner Layer<br>Stainelss Steel Coil<br>Pebax Outer Layer | 9F or 10F<br>38.5, 40<br>PTFE liner<br>Stainless Steel Coil<br>Nylon Jacket | 10F<br>40<br>PTFE Liner<br>Stainless Steel Coil<br>Pebax 6333 Jacket<br>Pt/IR markerband<br>Grilamid hub<br>Hemostatis seal | | Dilator Length (cm) | 49 | 40, 51 | 47 | | Dilator end hold size (in) | 0.040 | 0.035, 0.038 | 0.035 | | Guidewire Compatibility (in) | 0.035, 0.038 | SAME | ≤ 0.035 | | Dilator, composition | HDPE with barium sulfate | Polyethylene | HDPE Extrusion | | Stiffening Cannula | 14ga | SAME | Not Available | | Puncturing Tool Assembly | 16ga Stainless Steel Needle<br>- 57 cm in length<br>7F Peek Catheter<br>- 51cm in length<br>OR<br>0.038" Stainless Steel<br>Stylet<br>- 69 cm in length<br>5F Peek Catheter<br>- 66 cm in length<br>OR<br>21ga Needle<br>- 72 cm in length<br>5F Peek Catheter<br>- 67 cm in length | 16ga Stainless Steel Needle<br>- 50.5 cm in length<br>9F or 10F Teflon Catheter<br>- 45.5 cm in length<br>OR<br>0.038" Stainless Steel<br>Needle<br>Stylet<br>- 62.5 cm in length<br>5.2F Teflon Catheter<br>- 62 cm in length<br>14ga Stainless Steel<br>Stiffening Access Cannula<br>- 54.5 cm in length<br>10F Teflon Catheter<br>- 51.8 cm in length | 16ga Stainless Steel Needle<br>- 56 cm in length<br>10F MDPE catheter<br>- 49 cm in length | | Puncturing Tool, composition | 304 Stainless Steel | SAME | SAME | | Puncturing Tool Catheter, composition | PEEK | Teflon/nylon | MDPE Extrusion<br>HDPE Hub | | Bending Tool | New | Not Available | Not Available | | Bending Tool, composition | 302 Stainless Steel | Not Available | Not Available | | Performance Testing | • Radiopacity | • Radiopacity | • Radiopacity | | | • Echogenicity | • Corrosion Resistance | • Echogenicity | | | • Corrosion Resistance | • Tensile Strength | • Corrosion Resistance | | | • Dimensional & Functional Fit<br>• Tensile Strength<br>• Torque Strength Test<br>• Liquid Leakage<br>• Air Leakage<br>• Burst Pressure<br>• Flow Rate<br>• Simulative Use - performance<br>testing including<br>dimensional, surface and<br>compatibility of components<br>• Luer Functional Testing<br>• Shipping Test<br>• Resistance to Fracture<br>testing | • Torque Strength Test<br>• Liquid leakage<br>• Air Leakage<br>• Burst Pressure<br>• Flexibility & Fracture<br>• Simulative Use –<br>performance testing<br>including dimensional,<br>surface and compatibility<br>of components | • Tensile Strength<br>• Torque Strength Test<br>• Liquid leakage<br>• Air Leakage<br>• Burst Pressure<br>• Flexibility & Fracture<br>• Simulative Use –<br>performance testing<br>including dimensional,<br>surface and compatibility of<br>components | | Biological Comparison | • Cytotoxicity (ISO 10993-5)<br>• Sensitization (ISO 10993-10)<br>• Intracutaneous Irritation (ISO<br>10993-10)<br>• Acute Systemic Toxicity (ISO<br>10993-11)<br>• Material Mediated Pyrogen<br>(ISO 10993-11)<br>• Hemocompatibility<br>(ISO10993-4)<br>o ASTM Hemolysis – Direct<br>and Indirect Contact<br>o Complement Activation,<br>SC5b-9<br>o In Vivo Thrombogenicity<br>o Platelet and Leucocyte<br>Counts<br>o Partial Thromboplastin<br>Time (PTT) | • Cytotoxicity (ISO 10993-5)<br>• Sensitization (ISO 10993-<br>10)<br>• Intracutaneous<br>Reactivity/Irritation (ISO<br>10993-10)<br>• Acute Systemic Toxicity<br>(ISO 10993-11)<br>• Material Mediated<br>Pyrogenicity<br>• Hemocompatibility<br>(ISO10993-4)<br>- Hemolysis<br>Direct/Indirect<br>- Complement Activation<br>(ISO Direct Contact)<br>In Vivo Thrombogenicity | • Cytotoxicity (ISO 10993-5)<br>• Sensitization (ISO 10993-10)<br>• Intracutaneous<br>Reactivity/Irritation (ISO<br>10993-10)<br>• Acute Systemic Toxicity (ISO<br>10993-11)<br>• Material Mediated<br>Pyrogenicity<br>• Hemocompatibility<br>(ISO10993-4)<br>- Hemolysis Direct/Indirect<br>- Complement Activation<br>(ISO Direct Contact)<br>- In Vivo Thrombogenicity | | Packaging<br>Configuration | PETG Tray in a Tyvek/poly<br>pouch | Individually pouches<br>components | Tyvek/Polyethylene-polyester<br>Film | | Intended Shelf Life | 3 years | 3 years | 1 year | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ ### Conclusion: The results of all testing demonstrate that the Traveler™ Portal Vein Access Set are substantially equivalent to the predicate device.