(84 days)
Not Found
No
The device description and performance studies focus on mechanical and fluid dynamics for thrombus removal and infusion, with no mention of AI or ML algorithms for analysis, decision-making, or control. Software validation is mentioned, but this is standard for medical devices and does not necessarily imply AI/ML.
Yes
The device is intended to remove and aspirate fluid, break up soft emboli and thrombus from the peripheral vasculature, and subselectively infuse/deliver diagnostics or therapeutics, indicating a direct therapeutic function.
No
The device is a thrombectomy system for removing fluid, emboli, and thrombus. While it can "subselectively infuse/deliver diagnostics," its primary purpose as described is therapeutic/interventional, not diagnostic. The term "diagnostics" here refers to substances delivered, not a diagnostic capability of the device itself.
No
The device description clearly outlines multiple hardware components including a catheter, pump set, suction tubing, saline drive unit, and accessory cart. While software validation is mentioned, it is part of a larger system that includes significant hardware.
Based on the provided information, the JETi AIO Peripheral Thrombectomy System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to remove/aspirate fluid and break up thrombus from the peripheral vasculature, and to infuse/deliver diagnostics or therapeutics. This is a therapeutic and interventional procedure performed directly on the patient's body.
- Device Description: The device description details a system that physically interacts with the patient's blood vessels to remove material and deliver substances. It involves a catheter, pump, and suction mechanism.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, tissue, etc.) outside of the body to provide diagnostic information. IVDs are designed for testing samples in a laboratory or point-of-care setting.
The device is clearly intended for direct clinical intervention within the patient's circulatory system, which falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
QEZ
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.
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)
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
No pre-clinical or clinical data were generated to establish substantial equivalence. Bench data are considered adequate to support a determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
JETI AIO Peripheral Thrombectomy System (510(k) K201998)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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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. 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.
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
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)
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)
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3
Traditional 510(k) Summary
| Submitter: | Walk Vascular, LLC
17171 Daimler Street
Irvine, CA 92614
USA |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Namratha Manthani
Senior Manager, Regulatory Affairs
Walk Vascular, LLC
Telephone: 408-220-5786
Fax: Not applicable
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
(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
Thrombectomy System (K201998) | Subject JETi AIO Peripheral
Thrombectomy System |
|----------------------------------------|----------------------------------------------------------------|-------------------------------------------------------------------|
| Catheter | | |
| Size | 8 Fr | 8 Fr and 6 Fr |
| Working length (cm) | 100 | Identical for 8 Fr
120 for 6 Fr |
| Connections and location | Multi-port Luer adapter on the
proximal end of the catheter | Identical |
| Pump Set | | |
| Saline input tube length
(feet) | 6 | Identical |
| Saline Drive Unit | | |
| IEC 60601-1-2 edition
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
manual clamping | Added Hyper Pulse rocker switch to
achieve this mode |
| Accessory Stand | Present | Increased canister ring size |
| Suction Tubing | Present | Identical |
| Sterile Kit | Not present | Contains catheter, pump set, suction
tubing, valve bypass tool |
| Non-Sterile Kit | Canister with in-line filter and
suction tubing | Canister with built-in filter and suction
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.