(94 days)
None
No
The description mentions a microprocessor and firmware for monitoring functions, but there is no indication of AI or ML being used for decision-making, pattern recognition, or learning. The functions described are standard control and monitoring processes.
Yes
The device is intended to remove / aspirate fluid and break-up soft emboli and thrombus from the peripheral vasculature, which directly treats a medical condition. It can also infuse/deliver therapeutics.
No
The device is intended to remove/aspirate fluid and break-up soft emboli and thrombus from the peripheral vasculature, and subselectively infuse/deliver diagnostics or therapeutics. While it can deliver diagnostics, its primary function as described in the "Device Description" is mechanical thrombectomy and fluid infusion, not the analysis or interpretation of health data for diagnostic purposes.
No
The device description clearly outlines multiple hardware components including a catheter, pump set, SDU, peristaltic pump, and accessory stand. While the SDU contains software, the device is not solely software.
Based on the provided information, the JETi 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 soft emboli and thrombus from the peripheral vasculature, and subselectively infuse/deliver diagnostics or therapeutics with or without vessel occlusion." This describes a therapeutic and interventional procedure performed directly on the patient's body (in vivo).
- Device Description: The description details a system that physically interacts with the patient's vasculature to remove blockages and potentially deliver substances. It involves a catheter inserted into the body, a pump system to create suction and deliver saline, and associated components for controlling the process.
- Mechanism of Action: The device works by physically disrupting and aspirating thrombus from within the blood vessels. This is a mechanical action performed within the patient's body.
- Lack of In Vitro Testing: While there is mention of "in vitro testing" for design verification, this refers to testing the device's functionality and performance outside of a living organism, not testing biological samples from a patient to diagnose a condition.
- No Mention of Analyzing Biological Samples: The description does not mention the device being used to analyze blood, tissue, or other biological samples outside of the body for diagnostic purposes.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The JETi Peripheral Thrombectomy System operates in vivo (within the body) to treat a condition directly.
N/A
Intended Use / Indications for Use
The JETi 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
QEZ
Device Description
The JETi Peripheral Thrombectomy System consists of one aspiration catheter, which is connected to the JETi Pump Set, one JETi Peripheral Saline Drive Unit (SDU), one Peristaltic Pump, and an Accessory Stand. A Sterile Accessory Kit and Non-Sterile Accessory Device are supplied. In use, thrombus enters the distal catheter tip via the suction force provided by the peristaltic pump. 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 peristaltic pump receptacle. No saline is injected into the patient during normal operation. The peripheral SDU, peristaltic pump, an adjustable mounting arm, an accessory basket, and an IV pole are contained on an accessory stand.
The peripheral catheter is a multi-lumen device that allows for simultaneous hydro-mechanical thrombus disruption and thrombus aspiration. It is designed to simultaneously deliver a stream of saline via a displacement pump within the distal tip of the catheter, while aspirating thrombotic material macerated by the saline stream.
The peripheral catheter has the ability to infuse fluid through the aspiration lumen and saline lumen.
For infusion through the aspiration lumen, an appropriate sized syringe filled with fluid is infused to the treatment area by passing through the side arm of the rotating hemostasis valve (RHV) that is attached to the catheter.
For infusion through the saline lumen, a clamp is used on the suction tubing to cut off aspirate flow.
The proximal end of the pump set consists of a spike and an in-line drip chamber that is used to pierce the saline bag and connect the pump set to the saline source. The cassette contains a piston pump and is mounted onto the peripheral SDU. The cassette is powered by the motor contained in the peripheral SDU. The distal end of the pump set has a connector, which mounts to the proximal end of the multi-port Luer adapter of the peripheral catheter and delivers the saline to the peripheral catheter.
The peripheral SDU is a reusable device. The fork drive of the peripheral SDU is designed to run the piston pump contained in the pump set to deliver the stream of saline to the peripheral catheter, when activated by the foot pedal. Aspiration is achieved with a peristaltic pump that is connected to the SDU and is also turned on/off with the foot pedal. The pressure sensor is connected to the suction tubing, which is connected to the multi-port connector of the peripheral catheter. The peripheral SDU contains a microprocessor controlled circuit and firmware that monitors various functions of the motor and pressure to assure that the device is functioning as expected. Various colored LED lights on the front panel indicate to the user what the current status is of the SDU. Energy is provided by a 24 volt external power supply, which is connected to mains power.
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 in vitro 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:
Design Verification Testing:
SDU/peristaltic pump software and functional performance
SDU/peristaltic pump/accessory stand validation
Peristaltic pump life cycle
Aspiration source comparison
Clot removal
Software validation
60601-1 Product and electrical safety
The data from the in vitro testing above supports the substantial equivalence of the subject device to the predicate device.
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)
Reference Device(s)
Not Found
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 contains 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 9, 2019
Walk Vascular, LLC % Mr. Paul Gasser Medical Device RA/QA Consultant 13612 Rushmore Lane Santa Ana, California 92705
Re: K192439
Trade/Device Name: JETi Peripheral Thrombectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ Dated: November 19, 2019 Received: November 21, 2019
Dear Mr. Gasser:
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 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
1
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 medical devices and radiation-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,
For
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) K192439
Device Name JETi Peripheral Thrombectomy System
Indications for Use (Describe) The JETi 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) Summarv
| Submitter: | Walk Vascular, LLC
17171 Daimler Street
Irvine, CA 92614
USA |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Brad Culbert
VP, Engineering
Walk Vascular LLC
Telephone: 949-752-9642
Fax: 949-752-9658
Email: bsculbert@yahoo.com |
| Date Summary Prepared: | September 6, 2019 |
| Device Trade Name: | JETi Peripheral Thrombectomy System |
| Common Name: | Embolectomy/Thrombectomy Catheter |
| Classification Name: | Embolectomy Catheter (21 CFR 870.5150) |
| Product Code: | QEZ |
| Predicate Device: | JETi 88 Peripheral Thrombectomy System
(510(k) K183403) |
Device Description:
The JETi Peripheral Thrombectomy System consists of one aspiration catheter, which is connected to the JETi Pump Set, one JETi Peripheral Saline Drive Unit (SDU), one Peristaltic Pump, and an Accessory Stand. A Sterile Accessory Kit and Non-Sterile Accessory Device are supplied. In use, thrombus enters the distal catheter tip via the suction force provided by the peristaltic pump. 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 peristaltic pump receptacle. No saline is injected into the patient during normal operation. The peripheral SDU, peristaltic pump, an adjustable mounting arm, an accessory basket, and an IV pole are contained on an accessory stand.
The peripheral catheter is a multi-lumen device that allows for simultaneous hydro-mechanical thrombus disruption and thrombus aspiration. It is designed to simultaneously deliver a stream of saline via a displacement pump within the distal tip of the catheter, while aspirating thrombotic material macerated by the saline stream.
4
The peripheral catheter has the ability to infuse fluid through the aspiration lumen and saline lumen.
For infusion through the aspiration lumen, an appropriate sized syringe filled with fluid is infused to the treatment area by passing through the side arm of the rotating hemostasis valve (RHV) that is attached to the catheter.
For infusion through the saline lumen, a clamp is used on the suction tubing to cut off aspirate flow.
The proximal end of the pump set consists of a spike and an in-line drip chamber that is used to pierce the saline bag and connect the pump set to the saline source. The cassette contains a piston pump and is mounted onto the peripheral SDU. The cassette is powered by the motor contained in the peripheral SDU. The distal end of the pump set has a connector, which mounts to the proximal end of the multi-port Luer adapter of the peripheral catheter and delivers the saline to the peripheral catheter.
The peripheral SDU is a reusable device. The fork drive of the peripheral SDU is designed to run the piston pump contained in the pump set to deliver the stream of saline to the peripheral catheter, when activated by the foot pedal. Aspiration is achieved with a peristaltic pump that is connected to the SDU and is also turned on/off with the foot pedal. The pressure sensor is connected to the suction tubing, which is connected to the multi-port connector of the peripheral catheter. The peripheral SDU contains a microprocessor controlled circuit and firmware that monitors various functions of the motor and pressure to assure that the device is functioning as expected. Various colored LED lights on the front panel indicate to the user what the current status is of the SDU. Energy is provided by a 24 volt external power supply, which is connected to mains power.
Indications for Use:
The JETi 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 the following table.
5
| Design Features | Predicate JETi 88 Peripheral
Thrombectomy System | Subject JETi Peripheral
Thrombectomy System |
|----------------------------------------|----------------------------------------------------------------|----------------------------------------------------|
| Catheter | | |
| Catheter working length
(cm) | 100 | Same |
| Catheter connections and
location | Multi-port Luer adapter on the
proximal end of the catheter | Same |
| Pump Set | | |
| Saline input tube length
(feet) | 6 | Same |
| Saline Drive Unit | | |
| IEC 60601-1-2 edition
complied with | 4th | Same |
| On/off control | Foot pedal | Same |
| Method to stop flow | Pinch valve | Peristaltic pump |
| Pinch valve control | Mode button | N/A |
| Location | Mounted on cart outside sterile field | Same |
| Vacuum sensor connector | Standard RJ45 | Same |
| Aspiration | | |
| Aspiration Method | Vacuum pump | Peristaltic pump |
| Aspiration Flow Rate | 650 mL/min | 450 mL/min |
| Pressure – Free Flow | - 23.6 inHg | - 12.9 inHg |
| Pressure - Engaged in
Clot |