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 All In One (AIO) Peripheral Thrombectomy System consists of one aspiration 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 Accessory Device is supplied. In use, thrombus enters the distal catheter tip via the suction force provided by the JETi AIO SDU internal vacuum 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 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.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the JETi AIO Peripheral Thrombectomy System. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials. Therefore, the document does not contain the detailed information typically found in studies designed to prove a device meets specific acceptance criteria based on patient outcomes or detailed performance metrics.

Specifically, the document 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 means there isn't a study that directly proves the device meets acceptance criteria related to efficacy or clinical performance in a rigorous, quantitative manner as one might expect for a novel device or a device requiring a PMA.

The Summary of Non-Clinical Performance Data section only vaguely mentions: "All data met the acceptance criteria and fell within pre-determined product specifications and external standard requirements." However, it does not specify what those "acceptance criteria" were, nor does it present the "reported device performance" against those criteria.

Therefore, I cannot provide the requested information from the given text regarding the acceptance criteria and a study proving the device meets those criteria, as such a study with detailed reporting is explicitly stated as not having been conducted for this 510(k) submission.

To directly answer your request based on the provided text, I must state that the information is not available. The document focuses on demonstrating substantial equivalence to a predicate device, and the "studies" mentioned are largely bench testing and design validation, which are not detailed enough to fulfill your specific requirements about clinical performance or acceptance criteria as you've outlined them.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

November 17, 2020

Walk Vascular, LLC Paul Gasser Medical Device RA/QA Consultant 17171 Daimler Street Irvine, California 92614

Re: K201998

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: October 9, 2020 Received: October 13, 2020

Dear Paul 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

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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 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,

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

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Indications for Use

510(k) Number (if known) K201998

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)
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[X] Prescription Use (Part 21 CFR 801 Subpart D)
[] Over-The-Counter Use (21 CFR 801 Subpart C)

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Traditional 510(k) Summary

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:	July 10, 2020
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 88 Peripheral Thrombectomy System(510(k) K183403)

Device Description:

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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 the following table.

Design Features	Predicate JETi 88 PeripheralThrombectomy System	Subject JETi AIO 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	Handheld controller
Method to stop flow	Pinch valve	Handheld controller
Pinch valve control	Mode button	N/A
Aspiration method	Vacuum pump	Same, but internal to unit
Location	Mounted on cart outside sterile field	Same
Vacuum sensor connector	Standard RJ45	Same
Accessory Stand
Height adjustable	No	Yes
Sterile Accessory Kit	Present	Replaced with suction tubing
Non-Sterile Accessory Device	Present	Modified to accommodate internal pump

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

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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 validation SDU life cycle Software validation 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.

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. Shelf life testing was conducted for the SDU.

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 AIO 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).