JETi™Hydrodynamic Thrombectomy System

{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 is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 19, 2023 Abbott Medical Namratha Manthani Associate Director, Regulatory Affairs 3200 Lakeside Drive Santa Clara, California 95054 Re: K232458 Trade/Device Name: JETi™ Hydrodynamic Thrombectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEZ, KDQ, FOX Dated: August 11, 2023 Received: August 15, 2023 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 (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 available 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. 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 W. Digitally signed by Gregory W. O'connell -S O'connell -S Date: 2023.12.19 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K232458 Device Name JETiTM Hydrodynamic Thrombectomy System Indications for Use (Describe) The JETi Hydrodynamic Thrombectomy System is intended to remove/aspirate fluid and thrombus from the peripheral vasculature and to sub-selectively infuse/deliver diagnostics with or without vessel occlusion. Type of Use (Select one or both, as applicable) | <span style="font-size: 10pt;"> <span style="font-family: Symbol;">×</span> Prescription Use (Part 21 CFR 801 Subpart D)</span> | |---------------------------------------------------------------------------------------------------------------------------------| | <span style="font-size: 10pt;"> <span>□</span> Over-The-Counter Use (21 CFR 801 Subpart C)</span> | ## 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}------------------------------------------------ Image /page/3/Picture/0 description: The image contains the logo for Abbott Laboratories. The logo features a stylized letter "a" in blue, positioned above the company name "Abbott" in black, bold font. The "a" is designed with rounded corners and an open space in the middle, giving it a modern and recognizable appearance. The overall design is clean and professional, reflecting the company's corporate identity. ## 510(k) SUMMARY | 510(k) Summary<br>Per 21 CFR §807.92 | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K232458 | | Date Prepared | December 18, 2023 | | Submitter Name<br>& Address | Abbott Medical<br>3200 Lakeside Drive<br>Santa Clara, CA 95054 | | Contact Person | Maidy Cordova Audon<br>408-219-8350 | | Alternative<br>Contact Person | Namratha Manthani<br>408-220-5786 | | Proprietary/Trade<br>Name | JETiTM Hydrodynamic Thrombectomy System | | Common/Usual<br>Name | Embolectomy/Thrombectomy Catheter | | Classification<br>Name | Embolectomy Catheter (21 CFR 870.5150) | | Primary Procode | QEZ | | Secondary<br>Procodes | KDQ, FOX | | Predicate Device | Predicate Device: JETi All In One (AIO) Peripheral Thrombectomy System, K213565,<br>Reference Device: JETi All In One (AIO) Peripheral Thrombectomy System, K201988 | | Device<br>Description | The JETiTM Hydrodynamic Thrombectomy System is a hydro-mechanical aspiration system intended for the<br>removal of intravascular thrombus. The system is comprised of the JETiTM Catheter, JETiTM Pump Set, JETiTM<br>Saline Drive Unit (SDU), JETiTM Accessory Cart, JETiTM Suction Tubing, and JETiTM Non-sterile Canister Set.<br>The JETi Hydrodynamic Thrombectomy System is designed to continuously aspirate thrombotic material into<br>the JETi Catheter, where a high-pressure stream of saline within the catheter tip macerates the thrombus as it is | | aspirated. | | | The JETi Catheter has two (2) lumens. The primary lumen (largest) is a conduit for thrombus aspiration. A secondary lumen, placed within the primary lumen, delivers saline through an orifice to break up and dilute the aspirated thrombus and facilitates rapid movement of the aspirate towards the vacuum. One (1) radiopaque (RO) marker band is located stiff proximal section which transitions to a more flexible distal section with a round, soft tip. A filter is incorporated into the catheter connector to ensure that no debris or foreign material is injected into the patient vasculature. The JETi Catheter is available in two sizes: 6 French size (6F) and 8 French size (8F). The JETi Pump Set is intended to deliver a high pressure sterile saline stream to the JETi Catheter. The pressure for the saline stream is created through the cassette's piston assembly, which snaps into the SDU. | | | The JETi Saline Drive Unit (SDU) is a non-sterile reusable, (multiple patient, multiple use) device that incorporates the saline pumping components and the vacuum pump within a single enclosure. The fork drive of the SDU is designed to run the JETi Pump Set piston assembly to deliver a stream of saline to the JETi Catheter when activated by the handheld switch if the vacuum is present. In conjunction with the JETi Pump Set, the SDU can sub selectively infuse / deliver diagnostics or therapeutic fluids when utilizing the optional HYPER PULSET™ Fluid Delivery feature. The JETi Suction Tubing is a sterile single use device that incorporates the pressure monitoring sensor and valve into a single enclosure, that is in-line with the aspiration lumen, for the handheld switch. When the handheld switch is activated, within the aspiration lumen, the diluted thrombus and saline is then drawn back through the primary lumen of the JETi Catheter and deposited into the vacuum source (JETi Non-sterile Canister Set) via the JETi Suction Tubing. When the handheld switch is de-activated, a valve closes, stopping the flow of thrombus, and a relief valve inside the SDU briefly opens and closes to reduce foaming at the vacuum source (JETi Non-sterile Canister Set). The SDU contains a microprocessor-controller circuit board and firmware that monitors various functions of the motor and vacuum to ensure that the device is functioning as expected. A Liquid Crystal Display (LCD) screen on the front panel of the SDU indicates to the user the status of the system. Several safety features are incorporated into the firmware to ensure proper functionality. The SDU is supported by a mobile, height adjustable cart with an integrated IV pole. Energy is provided by a 24-volt external power supply, which is connected to the main supply. The external power supply is provided with the SDU and is part of the system | | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for Abbott. The logo consists of a stylized, rounded, sans-serif letter "A" in a bright blue color. Below the symbol is the word "Abbott" in a bold, sans-serif font, rendered in black. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Abbott, a healthcare company. The logo consists of a stylized letter 'A' in blue, positioned above the word "Abbott" in black, bold font. The 'A' is designed with rounded edges and an open top, giving it a modern and recognizable appearance. The overall design is clean and professional, reflecting the company's corporate identity. | Indications for<br>Use/Intended Use | The JETiTM Hydrodynamic Thrombectomy System is intended to remove / aspirate fluid and break-up soft emboli<br>and thrombus from the peripheral vasculature and to sub-selectively infuse / deliver diagnostics or therapeutics<br>with or without vessel occlusion. | | | | |-----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Comparison to<br>Predicate Device | The JETi TM Hydrodynamic Thrombectomy System is substantially equivalent to the predicate JETi AIO<br>Peripheral Thrombectomy System (K213565) in terms of indications for use, operational characteristics,<br>fundamental design and technological characteristics. | | | | | | Characteristic | Predicate Device<br>JETI AIO Peripheral<br>Thrombectomy System<br>(K213565) | Reference Device<br>JETI AIO<br>Peripheral<br>Thrombectomy<br>System (K201988) | Subject Device<br>JETi Hydrodynamic<br>Thrombectomy System | | | Indications for<br>Use Statement | The JETi AIO Peripheral<br>Thrombectomy System is<br>intended to:<br>remove/aspirate fluid<br>and break-up soft emboli<br>and thrombus from the<br>peripheral vasculature,<br>and subselectively<br>infuse/deliver<br>diagnostics or<br>therapeutics with or<br>without vessel occlusion. | Same as Predicate<br>Device (K213565) | The JETi Hydrodynamic<br>Thrombectomy System is<br>intended to:<br>remove/aspirate fluid and<br>break-up soft emboli and<br>thrombus from the peripheral<br>vasculature, and subselectively infuse/deliver<br>diagnostics or therapeutics<br>with or without vessel<br>occlusion. Minor change to the product<br>name, otherwise same as<br>indications as the Predicate<br>Device (K213565) | | | Contraindications | | | | | Contraindications | Contraindicated for use in<br>vessels smaller than 4 mm<br>(0.16") and Coronary,<br>pulmonary, and<br>neurovasculature. | Same as Predicate Device (K213565) | Same as Predicate Device (K213565) | | | Mode of<br>Operation | Simultaneous saline delivery<br>with aspiration<br><br>Infuse/deliver diagnostics or<br>therapeutics | Same as Predicate<br>Device (K213565) | Same as Predicate Device<br>(K213565) | | | Catheter | | | | | | Catheter<br>Working Length<br>(cm) | 100 cm (8 Fr)<br>120 cm (6 Fr) | 100 cm (8 Fr) | Same as Predicate Device<br>(K213565) | | | Catheter<br>Connections<br>(saline and<br>aspiration) and<br>location | Multi-port Luer adapter | Same as Predicate<br>Device (K213565) | Same as Predicate Device<br>(K213565) | | | Pump Set | | | | | | Saline Input<br>Tube Length<br>(feet) | 6 | Same as Predicate<br>Device (K213565) | Same as Predicate Device<br>(K213565) | | | Saline Drive Unit (SDU)…