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.

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.

AI/ML Overview

The provided text describes the JETi Peripheral Thrombectomy System and its 510(k) premarket notification (K192439) to the FDA. The document primarily focuses on demonstrating substantial equivalence to a predicate device (JETi 88 Peripheral Thrombectomy System, K183403) through non-clinical performance data.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All data met the acceptance criteria and fell within pre-determined product specifications and external standard requirements." However, it does not explicitly list the quantitative acceptance criteria for each test. It only lists the tests performed and mentions that the results were compliant.

The table below presents the functional specifications of the device that can be inferred from the comparison table between the predicate and subject device, along with the implied "acceptance criteria" (i.e., that the new device met these specifications, often matching the predicate or a new measured value).

Design Feature (Performance Aspect)	Predicate JETi 88 Peripheral Thrombectomy System (Implied Acceptance Criteria)	Subject JETi Peripheral Thrombectomy System (Reported Performance)
Aspiration Flow Rate	650 mL/min (Predicate Value)	450 mL/min
Pressure – Free Flow	-23.6 inHg (Predicate Value)	-12.9 inHg
Pressure - Engaged in Clot	< -27 inHg (Predicate Value)	< -27 inHg (Same as predicate)
Catheter Working Length	100 cm (Predicate Value)	100 cm (Same as predicate)
Saline Input Tube Length	6 feet (Predicate Value)	6 feet (Same as predicate)
IEC 60601-1-2 Edition	4th (Predicate Value)	4th (Same as predicate)
On/off Control	Foot pedal (Predicate Value)	Foot pedal (Same as predicate)
Method to Stop Flow	Pinch valve (Predicate Value)	Peristaltic pump (Change from predicate)
Pinch Valve Control	Mode button (Predicate Value)	N/A (Change from predicate due to different method)
Location (SDU)	Mounted on cart outside sterile field (Predicate Value)	Mounted on cart outside sterile field (Same as predicate)
Vacuum Sensor Connector	Standard RJ45 (Predicate Value)	Standard RJ45 (Same as predicate)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the sample sizes for any of the in vitro tests (e.g., clot removal, aspiration source comparison). It simply states that "in vitro testing" was performed.
Data Provenance: The data is non-clinical/in vitro testing, meaning it was generated in a lab setting, likely by the manufacturer (Walk Vascular, LLC). The country of origin is not explicitly stated, but the company is based in Irvine, CA, USA. The data is prospective in the sense that it was conducted for the purpose of this 510(k) submission, not collected from prior clinical use.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This device is a physical medical device (thrombectomy system), not an AI/software device that requires expert-established ground truth from images or other diagnostic data. The "acceptance criteria" here refers to engineering specifications and performance metrics tested in a lab, not diagnostic accuracy against expert consensus. Therefore, this information is not applicable to this submission.

4. Adjudication Method for the Test Set

Not applicable. As this is not a diagnostic AI system, there is no need for expert adjudication of results. Performance was evaluated against predetermined specifications.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No pre-clinical or clinical data were generated to establish substantial equivalence. Bench data are considered adequate to support a determination of substantial equivalence." This type of study would involve human readers (likely clinicians) evaluating cases, which was not performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical medical instrument, not a standalone algorithm/AI for diagnosis or treatment planning. Its function involves a human operator.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance studies would be the objective measurement of the device's physical and functional characteristics against defined engineering specifications and, in some cases, comparison to the performance of the predicate device (e.g., flow rates, pressure, software functionality, electrical safety, clot removal in an in vitro model). It is not expert consensus, pathology, or outcomes data in the typical sense of diagnostic devices. For "clot removal," it would likely involve quantified removal of a simulated clot in a controlled in vitro environment.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

{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)
---------------	-----------------------------------------------------------------------------------------	---------------	----------------------------------------------------------------------------------------

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}------------------------------------------------

Traditional 510(k) Summarv

Submitter:	Walk Vascular, LLC17171 Daimler StreetIrvine, CA 92614USA
Contact:	Brad CulbertVP, EngineeringWalk Vascular LLCTelephone: 949-752-9642Fax: 949-752-9658Email: 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:

{4}------------------------------------------------

The peripheral catheter has the ability to infuse fluid through the aspiration lumen and saline lumen.

For infusion through the saline lumen, a clamp is used on the suction tubing to cut off aspirate flow.

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 PeripheralThrombectomy System	Subject JETi PeripheralThrombectomy System
Catheter
Catheter working length(cm)	100	Same
Catheter connections andlocation	Multi-port Luer adapter on theproximal end of the catheter	Same
Pump Set
Saline input tube length(feet)	6	Same
Saline Drive Unit
IEC 60601-1-2 editioncomplied 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 inClot	< - 27 inHg	Same
Accessory Stand	Present	Re-designed to accommodate theperistaltic pump
Sterile Accessory Kit	Four components	Three components
Non-Sterile AccessoryDevice	Present	Tubing section added

The JETi Peripheral Thrombectomy System is substantially equivalent to the predicate device.

Summary of Non-Clinical Performance Data:

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

{6}------------------------------------------------

Biocompatibility Testing:

Biocompatibility testing was not conducted, as the catheter and pump set are identical to the predicate device.

Sterilization Testing:

Sterilization testing was not conducted, as the catheter and pump set are identical to the predicate device.

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 identical to the predicate device. Transportation /shelf life testing was not repeated for the SDU, sterile accessory kit, non-sterile disposable accessory device, and accessory stand, as the design differences between the predicate and subject devices are not considered sufficiently significant to justify repeating those studies. Shelf life testing was conducted for the peristaltic pump.

The data from the in vitro 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 in vitro performance information provided in this premarket notification, the JETi Peripheral Thrombectomy System is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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).