JETi 88 Peripheral Thrombectomy System

K183403 · Walk Vascular, LLC · QEZ · Apr 17, 2019 · Cardiovascular

Device Facts

• Record ID: K183403
• Device Name: JETi 88 Peripheral Thrombectomy System
• Applicant: Walk Vascular, LLC
• Product Code: QEZ · Cardiovascular
• Decision Date: Apr 17, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The JETi 88 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

JETi 88 Peripheral Thrombectomy System removes/aspirates fluid and breaks up soft emboli/thrombus in peripheral vasculature; also enables subselective infusion of diagnostics/therapeutics. System comprises aspiration catheter, JETi 88 Pump Set, JETi 88 Peripheral Saline Drive Unit (SDU), and accessory cart. Catheter features multi-lumen design; delivers saline stream via displacement pump at distal tip to macerate thrombus while simultaneously aspirating material through primary lumen. Saline/thrombus mixture deposited into vacuum pump receptacle; no saline injected into patient. SDU uses microprocessor-controlled circuit/firmware to monitor motor/vacuum functions; user interface includes LED status indicators and foot pedal control for saline delivery and vacuum pinch valve. Operated by clinicians in clinical setting. Output allows physician to clear peripheral vascular obstructions, potentially improving blood flow and patient outcomes.

Clinical Evidence

No clinical data generated. Substantial equivalence established via bench testing only. Testing included pull, leak, pressure, flow, kink, embolic analysis, saline stream containment, and IEC 60601-1 electrical safety testing. Biocompatibility, sterilization, and shelf-life data were adopted from the predicate device.

Technological Characteristics

Multi-lumen aspiration catheter; hydro-mechanical thrombus disruption via saline stream; vacuum-based aspiration. System includes SDU with microprocessor-controlled circuit/firmware, piston pump, and vacuum pump. Connectivity: RJ45 vacuum sensor connector. Power: 24V external supply. Compliance: IEC 60601-1 (4th ed). Form factor: Cart-mounted SDU with adjustable arm.

Indications for Use

Indicated for removal/aspiration of fluid and break-up of soft emboli and thrombus from peripheral vasculature, and subselective infusion/delivery of diagnostics or therapeutics with or without vessel occlusion.

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

• ClearLumen II Peripheral Thrombectomy System (K172000)

Submission Summary (Full Text)

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April 17, 2019

Walk Vascular, LLC % Paul Gasser Medical Device RA/QA Consultant 13612 Rushmore Lane Santa Ana, California 92705

Re: K183403

Trade/Device Name: JETi 88 Peripheral Thrombectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEZ Dated: March 18, 2019 Received: March 19, 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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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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: | December 5, 2018 |
| Device Trade Name: | JETi 88 Peripheral Thrombectomy System |
| Common Name: | Embolectomy/Thrombectomy Catheter |
| Classification Name: | Embolectomy Catheter (21 CFR 870.5150) |
| Product Code: | QEZ, Aspiration Thrombectomy Catheter |
| Predicate Device: | ClearLumen II Peripheral Thrombectomy System<br>(510(k) K172000) |

# Device Description:

The JETi 88 Peripheral Thrombectomy System consists of one aspiration catheter, which is connected to the JETi 88 Pump Set, one JETi 88 Peripheral Saline Drive Unit (SDU), and an Accessory Cart. 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 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 vacuum pump receptacle. No saline is injected into the patient during normal operation. The peripheral SDU, an adjustable mounting arm, a mounting bracket for vacuum canisters, an IV pole and a vacuum pump are contained on an accessory cart.

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.

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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 vacuum.

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. Vacuum is achieved with a vacuum pump, turned on/off with the pinch valve on the side of the SDU, which is also controlled by the foot pedal. The vacuum sensor is connected to the vacuum 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 vacuum 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 88 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 intended use and have similar technological characteristics.

Key differences between the subject and predicate devices are reflected in the following table.

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| Design Features | Predicate ClearLumen II Peripheral Thrombectomy System | Subject JETi 88 Peripheral Thrombectomy System |
|-------------------------------------|----------------------------------------------------------------------------------|-------------------------------------------------------------|
| Catheter | | |
| Catheter working length (cm) | 115 | 100 |
| Catheter connections and location | Two port "Y" connector with Luer connections on the proximal end of the catheter | Multi-port Luer adapter on the proximal end of the catheter |
| Pump Set | | |
| Saline input tube length (feet) | 4 | 6 |
| Saline Drive Unit | | |
| IEC 60601-1-2 edition complied with | 3rd | 4th |
| On/off control | Stopcock activated (vacuum sensing) | Foot pedal |
| Method to stop flow | Stop cock | Pinch valve |
| Pinch valve control | None | Mode button |
| Aspiration method | Single use, rechargeable 60 mL syringe (e.g., VacLock) | Vacuum pump |
| Location | Pole mounted outside sterile field | Mounted on cart outside sterile field |
| Vacuum sensor connector | Merit Medical custom plug | Standard RJ45 |
| Accessory Cart | Not present | Present |
| Sterile Accessory Kit | Not present | Present |
| Non-Sterile Accessory Device | Not present | Present |

The JETi 88 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:

- Pull test of welded and glued joints Leak testing Pressure testing Flow testing Kink testing Embolic analysis Saline stream containment 60601-1 Product and electrical safety testing
# Biocompatibility Testing:

Biocompatibility testing was not conducted, as the test results from the ClearLumen II Thrombectomy System were adopted for the JETi 88 Peripheral Thrombectomy System.

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# Sterilization Testing:

Sterilization testing was not conducted, as the test results from the ClearLumen II Thrombectomy System were adopted for the JETi 88 Peripheral Thrombectomy System.

### Transportation and Shelf Life Testing:

Transportation and shelf life testing was not conducted, as the test results from the ClearLumen II Thrombectomy System were adopted for the JETi 88 Peripheral Thrombectomy System.

The data from the in vitro testing above supports the substantial equivalence of the subject device to the predicate and reference 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 88 Peripheral Thrombectomy System is substantially equivalent to the predicate device.