(126 days)
The JETiTM 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.
The JETiTM Hydrodynamic Thrombectomy System is a hydro-mechanical aspiration system intended for the removal of intravascular thrombus. The system is comprised of the JETiTM Catheter, JETiTM Pump Set, JETiTM Saline Drive Unit (SDU), JETiTM Accessory Cart, JETiTM Suction Tubing, and JETiTM Non-sterile Canister Set. The JETi Hydrodynamic Thrombectomy System is designed to continuously aspirate thrombotic material into 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 PULSETM 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
The provided text is a 510(k) summary for the JETi™ Hydrodynamic Thrombectomy System, which is a medical device for removing thrombus from peripheral vasculature. This document focuses on demonstrating substantial equivalence to a predicate device, rather than reporting on a study that proves the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy. Therefore, information regarding acceptance criteria for clinical performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, or multi-reader multi-case studies are not available in this document.
The document primarily details the device's technical specifications and compares them to predicate devices to establish substantial equivalence for regulatory clearance. It also mentions non-clinical testing for areas like packaging, human factors, and electromagnetic compatibility (EMC).
Here's a breakdown of the information that is available based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a formal table of clinical acceptance criteria and device performance as would be seen in a study evaluating diagnostic accuracy or clinical outcomes. Instead, it focuses on non-clinical testing and substantial equivalence to a predicate device.
| Test Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Non-Clinical Testing | ||
| Packaging Validation | Per ASTM D4332, ASTM 4169, and Abbott's internal procedures; all data meet pre-determined product specifications. | All data met the acceptance criteria and fell within pre-determined product specifications. |
| Human Factors Evaluation | IFU conveys appropriate information clearly and concisely to support safe and effective use. | The evaluation demonstrated that the IFU conveys the appropriate information in a clear and concise manner, i.e., facilitates understanding of the device usage to support safe and effective use of the device. |
| EMC Testing (IEC 60601-1-2) | Conformance with emission limits (CISPR 11 Class A), specific ESD, radiated RF immunity, proximity field immunity, power frequency magnetic fields, conducted disturbances, electrical fast transient/burst, surge immunity, current harmonics, voltage fluctuation and flicker test. | The device met the acceptance criteria for all listed EMC tests. |
2. Sample size used for the test set and the data provenance:
- Not Applicable / Not Provided for clinical performance. The document explicitly states "No clinical testing is provided in this pre-market notification."
- For non-clinical testing:
- Packaging Validation: The sample size is not specified, but the data provenance would be internal Abbott testing.
- Human Factors Evaluation: The sample size (number of users) is not specified, but the data provenance would be from the human factors study conducted by Abbott.
- EMC Testing: The sample size is not specified (typically one or a few devices tested), and the data provenance would be from laboratory testing conforming to IEC standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable / Not Provided. This information is relevant for clinical studies involving expert interpretation for ground truth, which were not part of this submission.
4. Adjudication method for the test set:
- Not Applicable / Not Provided. This information is relevant for clinical studies that involve multiple readers and potentially discrepancies in their assessments for ground truth, which were not part of this submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. The document explicitly states "No clinical testing is provided in this pre-market notification." This device is a physical thrombectomy system, not an AI-assisted diagnostic or treatment planning tool for which MRMC studies would typically be conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm, so "standalone" performance in the context of an algorithm is not relevant.
7. The type of ground truth used:
- Not Applicable / Not Provided for clinical performance. For the non-clinical tests mentioned:
- Packaging Validation: Ground truth is based on established ASTM standards and internal product specifications.
- Human Factors Evaluation: Ground truth relates to adherence to human factors principles and user understanding, evaluated through methods like usability testing.
- EMC Testing: Ground truth is defined by the limits and methodologies specified in the IEC 60601-1-2 standard.
8. The sample size for the training set:
- Not Applicable / Not Provided. This device is not an AI/ML algorithm that would typically use a "training set."
9. How the ground truth for the training set was established:
- Not Applicable / Not Provided. As this is not an AI/ML algorithm requiring a training set, the concept of establishing ground truth for a training set does not apply.
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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).
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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
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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)
| × Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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) SummaryPer 21 CFR §807.92 | |
|---|---|
| 510(k) Number | K232458 |
| Date Prepared | December 18, 2023 |
| Submitter Name& Address | Abbott Medical3200 Lakeside DriveSanta Clara, CA 95054 |
| Contact Person | Maidy Cordova Audon408-219-8350 |
| AlternativeContact Person | Namratha Manthani408-220-5786 |
| Proprietary/TradeName | JETiTM Hydrodynamic Thrombectomy System |
| Common/UsualName | Embolectomy/Thrombectomy Catheter |
| ClassificationName | Embolectomy Catheter (21 CFR 870.5150) |
| Primary Procode | QEZ |
| SecondaryProcodes | KDQ, FOX |
| Predicate Device | Predicate Device: JETi All In One (AIO) Peripheral Thrombectomy System, K213565,Reference Device: JETi All In One (AIO) Peripheral Thrombectomy System, K201988 |
| DeviceDescription | The JETiTM Hydrodynamic Thrombectomy System is a hydro-mechanical aspiration system intended for theremoval of intravascular thrombus. The system is comprised of the JETiTM Catheter, JETiTM Pump Set, JETiTMSaline Drive Unit (SDU), JETiTM Accessory Cart, JETiTM Suction Tubing, and JETiTM Non-sterile Canister Set.The JETi Hydrodynamic Thrombectomy System is designed to continuously aspirate thrombotic material intothe 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 |
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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.
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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 forUse/Intended Use | The JETiTM Hydrodynamic Thrombectomy System is intended to remove / aspirate fluid and break-up soft emboliand thrombus from the peripheral vasculature and to sub-selectively infuse / deliver diagnostics or therapeuticswith or without vessel occlusion. | |||
|---|---|---|---|---|
| Comparison toPredicate Device | The JETi TM Hydrodynamic Thrombectomy System is substantially equivalent to the predicate JETi AIOPeripheral Thrombectomy System (K213565) in terms of indications for use, operational characteristics,fundamental design and technological characteristics. | |||
| Characteristic | Predicate DeviceJETI AIO PeripheralThrombectomy System(K213565) | Reference DeviceJETI AIOPeripheralThrombectomySystem (K201988) | Subject DeviceJETi HydrodynamicThrombectomy System | |
| Indications forUse Statement | The JETi AIO PeripheralThrombectomy System isintended to:remove/aspirate fluidand break-up soft emboliand thrombus from theperipheral vasculature,and subselectivelyinfuse/deliverdiagnostics ortherapeutics with orwithout vessel occlusion. | Same as PredicateDevice (K213565) | The JETi HydrodynamicThrombectomy System isintended to:remove/aspirate fluid andbreak-up soft emboli andthrombus from the peripheralvasculature, and subselectively infuse/deliverdiagnostics or therapeuticswith or without vesselocclusion. Minor change to the productname, otherwise same asindications as the PredicateDevice (K213565) | |
| Contraindications | ||||
| Contraindications | Contraindicated for use invessels smaller than 4 mm(0.16") and Coronary,pulmonary, andneurovasculature. | Same as Predicate Device (K213565) | Same as Predicate Device (K213565) | |
| Mode ofOperation | Simultaneous saline deliverywith aspirationInfuse/deliver diagnostics ortherapeutics | Same as PredicateDevice (K213565) | Same as Predicate Device(K213565) | |
| Catheter | ||||
| CatheterWorking Length(cm) | 100 cm (8 Fr)120 cm (6 Fr) | 100 cm (8 Fr) | Same as Predicate Device(K213565) | |
| CatheterConnections(saline andaspiration) andlocation | Multi-port Luer adapter | Same as PredicateDevice (K213565) | Same as Predicate Device(K213565) | |
| Pump Set | ||||
| Saline InputTube Length(feet) | 6 | Same as PredicateDevice (K213565) | Same as Predicate Device(K213565) | |
| Saline Drive Unit (SDU) | ||||
| On/Off Control | Hand-held controller | Same as PredicateDevice (K213565) | Same as Predicate Device(K213565) | |
| Method to StopFlow | Hand-held controller | Same as PredicateDevice (K213565) | Same as Predicate Device(K213565) | |
| AspirationMethod | Vacuum pump | Same as PredicateDevice (K213565) | Same as Predicate Device(K213565) | |
| Location | Mounted on cart outsidesterile field | Same as PredicateDevice (K213565) | Same as Predicate Device(K213565) | |
| Vacuum SensorConnector | Standard RJ45 | Same as PredicateDevice (K213565) | Same as Predicate Device(K213565) | |
| Hyper PulseMode | Rocker switch on SDU toshut off the vacuum pumpand enter Hyper Pulse mode | No rocker switch forHyper Pulse mode.Hyper Pulse modeachieved by manualmethod | Same as Reference Devicecleared under K201988.Minor modification. | |
| Accessory Cart | ||||
| Saline BagMounting | Integrated IV pole | Same as PredicateDevice (K213565) | Same as Predicate Device(K213565) | |
| Product code/ClassificationRegulation | QEZ/21 CFR 870.5150 | Same as PredicateDevice (K213565) | FOX/21 CFR 880.6990 | |
| Update to the product code andclassification to align with theintended use/function. | ||||
| Suction Tubing | ||||
| Accessory devicerequired forprocedure | • 3D-printed parts• Injection-molded Polypropylene Syringe• 3D-printed Acrylonitrile (ABS) Handle• Polyvinyl Chloride (PVC) Tubing containing DEHP | Same as Predicate Device (K213565) | • Molded parts• Injection-molded Polycarbonate Syringe• Injection-molded Polycarbonate Handle• DEHP-free Polyvinyl Chloride (PVC) Tubing | |
| Non-sterile Canister Set | ||||
| Accessorydevices | Canister with built-in filterand suction tubing | Canister, inline filterand suctiontubing | Same as Predicate Device(K213565) | |
| Product code/ClassificationRegulation | QEZ/21 CFR 870.5150 | Same as PredicateDevice (K213565) | KDQ/21 CFR 880.6740Update to the product code andclassification to align with theintended use/function. | |
| Sterile Kit | ||||
| Sterile Kit | Present | Same as Predicate Device (K213565) | Same as Predicate Device except optional accessory, Valve Bypass tool, is not included. | |
| Contains:- Catheter- Pump set- Sterile suction tubing- Valve bypass tool | ||||
| Summary on Non-Clinical Testing | Packaging validation including functional testing was performed on the JETi Hydrodynamic ThrombectomySystem per ASTM D4332, ASTM 4169 and per Abbott's internal procedures. All the data met the acceptancecriteria and fell within pre-determined product specifications.Human factors evaluation was performed for IFU changes and the evaluation demonstrated that the IFU conveysthe appropriate information in a clear and concise manner, i.e., facilitates understanding of the device usage to supportsafe and effective use of the device.The following EMC testing per IEC 60601-1-2 was performed and the device met the acceptance criteria:- Evidence of conformance with the emission limits (both radiated and conducted) of CISPR 11 Class A- Air Electrostatic Discharge (ESD) tested at ±2, ±4, ±8, and ±15 kV and Contact Electrostatic Discharge(ESD) tested at ±8 kV- Radiated RF immunity testing data at 3 V/m- Proximity field immunity testing data (Table 9) of 60601-1-2- Power frequency magnetic fields testing data at 30 A/m- Conducted disturbances induced by RF fields testing data for 3 Vrms outside industrial, scientific, andmedical (ISM) and 6 Vrms in ISM bands- Electrical fast transient/burst immunity testing data- Surge immunity testing data in mains mode |
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| Current Harmonics test Voltage Fluctuation and Flicker test | |
|---|---|
| Summary onClinical Testing | No clinical testing is provided in this pre-market notification. |
| Statement ofEquivalence | The JETiTM Hydrodynamic Thrombectomy System is substantially equivalent to the predicate device, JETi AIO Peripheral Thrombectomy System (K213565) and reference device, JETi AIO Peripheral Thrombectomy System (K201988) in terms of indications for use, operational characteristics, fundamental design, and technological characteristics. |
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).