AortaSTAT Occlusion Device

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July 9, 2021 RenalPro Medical, Inc. % Roberta Hines Regulatory Consultant Northwest Clinical Research Group, Inc. 19836 NE 125th Place Woodinville, Washington 98077 Re: K210602 Trade/Device Name: AortaSTAT Occlusion Device Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: MJN Dated: May 29, 2021 Received: June 3, 2021 Dear Roberta Hines: 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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Sincerely. # Rohini Retarekar -S Carmen Gacchina Johnson, PhD for Assistant Director DHT2B: Division of Circulatory Support. Structural and Vascular 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) K210602 Device Name AortaSTAT Occlusion Device Indications for Use (Describe) The AortaSTAT Occulsion Device is indicated for temporary vessel occlusion in the suprarenal and infrarenal aorta in applications for perioperative occlusion and emergency control of hemorrhage X 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}------------------------------------------------ ## TRADITIONAL 510(k) SUMMARY #### RenalPro Medical, Inc., AortaSTAT Occlusion Device Submitter: RenalPro Medical, Inc. 2370-B Walsh Avenue Santa Clara, CA 95051 Phone: (508) 397-6191 Contact Person: Jim Twitchell, Chief Operating Officer Date Prepared: July 9, 2021 Trade Name of Device: AortaSTAT Occlusion Device Common or Usual Name: Catheter, Intravascular Occluding, Temporary Classification Name: Vascular Clamp Regulatory Class: Class II Requlation Number: 21 CFR 870.4450 Product Code: MJN Predicate Device: QXMedical, LLC Occlusion Balloon Catheter (K183679) Reference Device: Roxwood Medical, Inc. CenterCross Catheter (K140910) #### Device Description: The RenalPro Medical AortaSTAT Occlusion device allows continued distal perfusion of the aorta while occluding the entrance into the target side branch arteries. The RenalPro Medical AortaSTAT Occlusion Device is comprised of a polymeric thin film membrane covering a self-expanding Nitinol scaffold connected to a stainless-steel central lumen, contained within a stainlesssteel braid-reinforced, Pebax outer shaft lined with PTFE for lubricity. The outer shaft and central lumen are attached to a deployment handle. The AortaSTAT Occlusion Device is provided sterile and non- pyrogenic and is for single patient use only. The AortaSTAT device is delivered to the targeted vasculature location under fluoroscopy using standard endovascular techniques over a commercially available 0.018″ Guidewire. Once the device is positioned, the covered scaffold is deployed by actuating the handle to slide the outer shaft back, allowing the scaffold to expand and providing radial occlusion of the target vessel. The AortaSTAT has a radiopaque marker near the distal ends of the nitinol scaffold, and another marker encapsulated at the distal end of the outer shaft to enable visualization under fluoroscopy. The AortaSTAT device is 8 Fr compatible in four diameters of occluding scaffolds: 19mm, 22mm, 25mm, and 28mm. The device has a 55 ± 5mm occlusive length and a 65cm working length. #### Intended Use / Indications for Use The AortaSTAT Occlusion Device is indicated for temporary vessel occlusion in the suprarenal and infrarenal aorta in applications for perioperative occlusion and emergency control of hemorrhage. {4}------------------------------------------------ The device is intended for one-time use. #### Summary of Technological Characteristics Like the predicated device, the AortaSTAT is intended for large vessel occlusion in perioperative and emergent hemorrhage cases. Other similarities to the predicate device are percutaneous access via an introducer sheath, the range of sizes including 19mm - 28mm expanded diameter, an overthe-wire catheter design, Ethylene Oxide sterilization by Platinum-Iridium markers, and some materials such as a Pebax catheter shaft. The Roxwood Medical CenterCross Catheter cleared under K140910, was identified specifically to support the temporarily expandable and retractable nitinol structure of the reference device has a Product Code DOY, Percutaneous Catheter. The device also has a handle and central lumen similar to the AortaSTAT device. However, the intended use of the reference device differs from the AortaSTAT as it is intended to be used in conjunction with steerable quidewires to access discrete regions of the coronary and peripheral vasculature. ### Performance Data The AortaSTAT Occlusion Device has undergone design verification testing through a series of physical and mechanical performance tests on the covered self-expanding scaffold. Testing was conducted according to applicable US and international standards and quidance documents, including ISO. ASTM, and USP standards, and to applicable internal test methods. FDA-recognized consensus standards were considered for testing. Testing included: visual inspection/physical dimensions, particulate analysis, scaffold radial force, contrast compatibility, radiopacity, simulated use, torque strength, flexibility and kink resistance, air leak / liquid leak, water entry pressure and burst, tensile strength, shelf life, package integrity, sterilization, pyrogenicity, bacterial endotoxin, corrosion resistance, and biocompatibility testing included cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, material-mediated pyrogenicity, and hemocompatibility. A series of GLP Animal Safety and Performance Studies were conducted to confirm safety and performance of the AortaSTAT in the swine model as compared to the predicate device. #### Conclusions Based on a comparison of the intended use/indications for use, technological characteristics, and the results from a series of non-clinical tests, the AortaSTAT device has demonstrated substantial equivalence to the predicate device.