JETi AIO Peripheral Thrombectomy System

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February 1, 2022 Walk Vascular, LLC Namratha Manthani Senior Manager, Regulatory Affairs 17171 Daimler Street Irvine, California 92618 Re: K213565 Trade/Device Name: JETi AIO Peripheral Thrombectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEZ Dated: November 8, 2021 Received: November 9, 2021 ## Dear Namratha Manthani: 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, Gregory O'Connell Assistant Director 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) K213565 #### Device Name JETi AIO Peripheral Thrombectomy System #### Indications for Use (Describe) The JETi AIO Peripheral Thrombectomy System is intended to: - remove/aspirate fluid and break-up soft emboli and thrombus from the peripheral vasculature, and - subselectively infuse/deliver diagnostics or therapeutics with or without vessel occlusion. 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}------------------------------------------------ # Traditional 510(k) Summary | Submitter: | Walk Vascular, LLC<br>17171 Daimler Street<br>Irvine, CA 92614<br>USA | |------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact: | Namratha Manthani<br>Senior Manager, Regulatory Affairs<br>Walk Vascular, LLC<br>Telephone: 408-220-5786<br>Fax: Not applicable<br>Email: namratha.manthani@abbott.com | | Date Summary Prepared: | February 1, 2022 | | Device Trade Name: | JETI AIO Peripheral Thrombectomy System | | Common Name: | Embolectomy/Thrombectomy Catheter | | Classification Name: | Embolectomy Catheter (21 CFR 870.5150) | | Product Code: | QEZ | | Predicate Device: | JETI AIO Peripheral Thrombectomy System<br>(510(k) K201998) | ## Device Description: The JETi All In One (AIO) Peripheral Thrombectomy System consists of one catheter, which is connected to the JETi Pump Set and JETi AIO Suction Tubing, one JETi AIO Peripheral Saline Drive Unit (SDU), and an Accessory Cart. A Non-Sterile Kit and Sterile Kit are supplied for user convenience. In use, thrombus enters the distal catheter tip via the suction force provided by the JETi AIO SDU internal vacuum pump. Infusion is achieved by activating the Hyper Pulse® rocker switch. When in Hyper Pulse® mode, activating the handheld switch activates the SDU motor to infuse/deliver diagnostic or therapeutics to the targeted site. The peripheral SDU and pump set deliver a stream of sterile saline through the secondary lumen to break up and dilute the thrombus within the catheter. The diluted thrombus and saline are drawn back through the primary lumen and deposited into the disposable collection canister. No high pressure saline is injected into the patient during normal operation. The peripheral SDU, a height adjustable cart, a height adjustable canister mount, an IV pole, basket, and cart handle are contained on an accessory cart. {4}------------------------------------------------ # Indications for Use: The JETi AIO Peripheral Thrombectomy System is intended to: - remove/aspirate fluid and break-up soft emboli and thrombus from the peripheral vasculature, and - subselectively infuse/deliver diagnostics or therapeutics with or without vessel occlusion. #### Statement of Equivalence: The subject device and the predicate share the same intended use and have similar technological characteristics. Key differences between the subject and predicate devices are reflected in Table 1. | Design Features | Predicate JETi AIO Peripheral<br>Thrombectomy System (K201998) | Subject JETi AIO Peripheral<br>Thrombectomy System | |----------------------------------------|----------------------------------------------------------------|-------------------------------------------------------------------| | Catheter | | | | Size | 8 Fr | 8 Fr and 6 Fr | | Working length (cm) | 100 | Identical for 8 Fr<br>120 for 6 Fr | | Connections and location | Multi-port Luer adapter on the<br>proximal end of the catheter | Identical | | Pump Set | | | | Saline input tube length<br>(feet) | 6 | Identical | | Saline Drive Unit | | | | IEC 60601-1-2 edition<br>complied with | 4th | Identical | | On/off control | Handheld controller | Identical | | Method to stop flow | Handheld controller | Identical | | Aspiration method | Vacuum pump | Identical | | Location | Mounted on cart outside sterile field | Identical | | Vacuum sensor connector | Standard RJ45 | Identical | | Hyper Pulse® | Present, achieved through<br>manual clamping | Added Hyper Pulse rocker switch to<br>achieve this mode | | Accessory Stand | Present | Increased canister ring size | | Suction Tubing | Present | Identical | | Sterile Kit | Not present | Contains catheter, pump set, suction<br>tubing, valve bypass tool | | Non-Sterile Kit | Canister with in-line filter and<br>suction tubing | Canister with built-in filter and suction<br>tubing | ## Table 1 - Predicate and Subject Device Comparison The JETi AIO Peripheral Thrombectomy System is substantially equivalent to the predicate device. {5}------------------------------------------------ #### Summary of Non-Clinical Performance Data: Device evaluation consisted of testing performed pursuant to Walk Vascular's risk analysis. All data met the acceptance criteria and fell within pre-determined product specifications and external standard requirements. The following testing was performed to support the determination of substantial equivalence: Catheter design verification and validation Simulated use Torque testing Fluid flow rate and pressure System leak testing Infusion testing Kink testing Bond tensile strength Clot removal System design verification and validation Software validation IEC 60601-1 Product and electrical safety #### Biocompatibility Testing: Biocompatibility testing was not conducted, as the catheter and pump set materials are identical to the predicate device. #### Sterilization Testing: Sterilization testing was not conducted, as the catheter and pump set designs are comparable to the predicate device. The 6 Fr catheter was adopted into the existing sterilization cycle per AAMI TIR28:2016. #### Transportation and Shelf Life Testing: Transportation and shelf life testing was not conducted on the catheter and pump set, as the catheter and pump set are comparable to the predicate device. Transportation and shelf life testing was not conducted for the SDU, as the addition of the Hyper Pulse® was determined to not impact transportation and shelf life. The data from the testing above supports the substantial equivalence of the subject device to the predicate device. ## Summary of Pre-Clinical and Clinical Data: No pre-clinical or clinical data were generated to establish substantial equivalence. Bench data are considered adequate to support a determination of substantial equivalence. #### Summary: Based on the intended use and performance information provided in this premarket notification, the JETi AIO Peripheral Thrombectomy System is substantially equivalent to the predicate device.