(126 days)
No
The description mentions a microprocessor-controller circuit board and firmware for monitoring functions and safety features, but there is no indication of AI or ML being used for decision-making, image analysis, or other complex tasks. The system appears to be based on mechanical and electronic control of the saline stream and vacuum.
Yes
The device is described as "intended to remove/aspirate fluid and thrombus from the peripheral vasculature", which is a therapeutic intervention. It also mentions the ability to "sub-selectively infuse/deliver diagnostics with or without vessel occlusion" and "deliver therapeutic fluids", clearly indicating therapeutic capabilities.
No
Explanation: The "Intended Use / Indications for Use" states that the device is intended "to sub-selectively infuse/deliver diagnostics with or without vessel occlusion." This indicates that the device delivers diagnostics, not that it is a diagnostic device itself. The primary function described is thrombectomy (removal/aspiration of fluid and thrombus).
No
The device description clearly outlines multiple hardware components including a catheter, pump set, saline drive unit (SDU), accessory cart, suction tubing, and canister set. While the SDU contains a microprocessor and firmware, the system is fundamentally a hardware-based device with integrated software for control and monitoring.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "remove/aspirate fluid and thrombus from the peripheral vasculature and to sub-selectively infuse/deliver diagnostics with or without vessel occlusion." This describes a therapeutic and interventional procedure performed in vivo (within the body), not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The description details a system for physically removing thrombus from blood vessels using a catheter, saline stream, and vacuum. This is a mechanical process, not a diagnostic test.
- Lack of Diagnostic Function: While the system can be used to "infuse/deliver diagnostics," the device itself is not performing the diagnostic test. It is a delivery mechanism for a separate diagnostic agent.
- No Mention of In Vitro Testing: The description and performance studies focus on the mechanical and electrical performance of the device, not on its ability to analyze biological samples or provide diagnostic information.
Therefore, the JETiTM Hydrodynamic Thrombectomy System is a medical device used for therapeutic intervention, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
QEZ, KDQ, FOX
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No clinical testing is provided in this pre-market notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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)
| × Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
| 510(k) Summary
| Per 21 CFR §807.92 | |
|---|---|
| 510(k) Number | K232458 |
| Date Prepared | December 18, 2023 |
| Submitter Name | |
| & Address | Abbott Medical |
| 3200 Lakeside Drive | |
| Santa Clara, CA 95054 | |
| Contact Person | Maidy Cordova Audon |
| 408-219-8350 | |
| Alternative | |
| Contact Person | Namratha Manthani |
| 408-220-5786 | |
| Proprietary/Trade | |
| Name | JETiTM Hydrodynamic Thrombectomy System |
| Common/Usual | |
| Name | Embolectomy/Thrombectomy Catheter |
| Classification | |
| Name | Embolectomy Catheter (21 CFR 870.5150) |
| Primary Procode | QEZ |
| Secondary | |
| Procodes | 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 | |
| Device | |
| Description | 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 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 for
Use/Intended Use | The JETiTM Hydrodynamic Thrombectomy System is intended to remove / aspirate fluid and break-up soft emboli
and thrombus from the peripheral vasculature and to sub-selectively infuse / deliver diagnostics or therapeutics
with or without vessel occlusion. | | | |
|-----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to
Predicate Device | The JETi TM Hydrodynamic Thrombectomy System is substantially equivalent to the predicate JETi AIO
Peripheral Thrombectomy System (K213565) in terms of indications for use, operational characteristics,
fundamental design and technological characteristics. | | | |
| | Characteristic | Predicate Device
JETI AIO Peripheral
Thrombectomy System
(K213565) | Reference Device
JETI AIO
Peripheral
Thrombectomy
System (K201988) | Subject Device
JETi Hydrodynamic
Thrombectomy System |
| | Indications for
Use Statement | 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. | Same as Predicate
Device (K213565) | The JETi Hydrodynamic
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. Minor change to the product
name, otherwise same as
indications as the Predicate
Device (K213565) |
| | Contraindications | | | |
| Contraindications | Contraindicated for use in
vessels smaller than 4 mm
(0.16") and Coronary,
pulmonary, and
neurovasculature. | Same as Predicate Device (K213565) | Same as Predicate Device (K213565) | |
| Mode of
Operation | Simultaneous saline delivery
with aspiration
Infuse/deliver diagnostics or
therapeutics | Same as Predicate
Device (K213565) | Same as Predicate Device
(K213565) | |
| Catheter | | | | |
| Catheter
Working Length
(cm) | 100 cm (8 Fr)
120 cm (6 Fr) | 100 cm (8 Fr) | Same as Predicate Device
(K213565) | |
| Catheter
Connections
(saline and
aspiration) and
location | Multi-port Luer adapter | Same as Predicate
Device (K213565) | Same as Predicate Device
(K213565) | |
| Pump Set | | | | |
| Saline Input
Tube Length
(feet) | 6 | Same as Predicate
Device (K213565) | Same as Predicate Device
(K213565) | |
| Saline Drive Unit (SDU) | | | | |
| On/Off Control | Hand-held controller | Same as Predicate
Device (K213565) | Same as Predicate Device
(K213565) | |
| Method to Stop
Flow | Hand-held controller | Same as Predicate
Device (K213565) | Same as Predicate Device
(K213565) | |
| Aspiration
Method | Vacuum pump | Same as Predicate
Device (K213565) | Same as Predicate Device
(K213565) | |
| Location | Mounted on cart outside
sterile field | Same as Predicate
Device (K213565) | Same as Predicate Device
(K213565) | |
| Vacuum Sensor
Connector | Standard RJ45 | Same as Predicate
Device (K213565) | Same as Predicate Device
(K213565) | |
| Hyper Pulse
Mode | Rocker switch on SDU to
shut off the vacuum pump
and enter Hyper Pulse mode | No rocker switch for
Hyper Pulse mode.
Hyper Pulse mode
achieved by manual
method | Same as Reference Device
cleared under K201988.
Minor modification. | |
| Accessory Cart | | | | |
| Saline Bag
Mounting | Integrated IV pole | Same as Predicate
Device (K213565) | Same as Predicate Device
(K213565) | |
| Product code/
Classification
Regulation | QEZ/
21 CFR 870.5150 | Same as Predicate
Device (K213565) | FOX/
21 CFR 880.6990 | |
| | | | Update to the product code and
classification to align with the
intended use/function. | |
| Suction Tubing | | | | |
| Accessory device
required for
procedure | • 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 | | | | |
| Accessory
devices | Canister with built-in filter
and suction tubing | Canister, inline filter
and suction
tubing | Same as Predicate Device
(K213565) | |
| Product code/
Classification
Regulation | QEZ/
21 CFR 870.5150 | Same as Predicate
Device (K213565) | KDQ/
21 CFR 880.6740
Update to the product code and
classification to align with the
intended 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 Thrombectomy
System per ASTM D4332, ASTM 4169 and per Abbott's internal procedures. All the data met the acceptance
criteria and fell within pre-determined product specifications.
Human factors evaluation was performed for IFU changes and 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.
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, and
medical (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 on | |
| Clinical Testing | No clinical testing is provided in this pre-market notification. |
| Statement of | |
| Equivalence | 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. |