JETi AIO Peripheral Thrombectomy System

K201998 · Walk Vascular, LLC · QEZ · Nov 17, 2020 · Cardiovascular

Device Facts

• Record ID: K201998
• Device Name: JETi AIO Peripheral Thrombectomy System
• Applicant: Walk Vascular, LLC
• Product Code: QEZ · Cardiovascular
• Decision Date: Nov 17, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

System removes/aspirates fluid and soft emboli/thrombus from peripheral vasculature; also enables subselective infusion of diagnostics/therapeutics. Operates via aspiration catheter connected to Saline Drive Unit (SDU) and pump set. SDU internal vacuum pump creates suction at distal catheter tip; secondary lumen delivers sterile saline to break up/dilute thrombus; diluted thrombus/saline drawn through primary lumen into disposable collection canister. Used in clinical settings by physicians. Handheld controller manages flow; height-adjustable cart supports SDU and canister. No high-pressure saline injected into patient. Benefits include effective thrombus removal and targeted delivery of therapeutic agents.

Clinical Evidence

No clinical data generated. Substantial equivalence supported by bench testing only, including design validation, SDU life cycle testing, software validation, and electrical safety testing (IEC 60601-1).

Technological Characteristics

System includes aspiration catheter, pump set, suction tubing, and Saline Drive Unit (SDU). SDU features internal vacuum pump and handheld controller. Materials identical to predicate. Electrical safety compliant with IEC 60601-1. Connectivity includes standard RJ45 for vacuum sensor. System mounted on height-adjustable accessory cart.

Indications for Use

Indicated for removal/aspiration of fluid and soft emboli/thrombus from peripheral vasculature and subselective infusion/delivery of diagnostics or therapeutics in patients requiring peripheral vascular intervention.

Regulatory Classification

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.

Predicate Devices

• JETi 88 Peripheral Thrombectomy System (K183403)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) |
|-------------------------------------------------|
|-------------------------------------------------|

| <span> \[X] Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|---------------------------------------------------------------------|
| <span> \[] Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# Traditional 510(k) Summary

| Submitter: | Walk Vascular, LLC<br>17171 Daimler Street<br>Irvine, CA 92614<br>USA |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Brad Culbert<br>VP, Engineering<br>Walk Vascular LLC<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| 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<br>(510(k) K183403) |

# 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.

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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 Peripheral<br>Thrombectomy System | Subject JETi AIO Peripheral<br>Thrombectomy System |
|----------------------------------------|----------------------------------------------------------------|----------------------------------------------------|
| <b>Catheter</b> | | |
| Catheter working length<br>(cm) | 100 | Same |
| Catheter connections and<br>location | Multi-port Luer adapter on the<br>proximal end of the catheter | Same |
| <b>Pump Set</b> | | |
| Saline input tube length<br>(feet) | 6 | Same |
| <b>Saline Drive Unit</b> | | |
| IEC 60601-1-2 edition<br>complied 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 |
| <b>Accessory Stand</b> | | |
| Height adjustable | No | Yes |
| <b>Sterile Accessory Kit</b> | Present | Replaced with suction tubing |
| <b>Non-Sterile Accessory Device</b> | 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.