CLEARLUMEN THROMBECTOMY SYSTEM

K120508 · Walk Vascular, LLC · QEZ · Nov 7, 2012 · Cardiovascular

Device Facts

• Record ID: K120508
• Device Name: CLEARLUMEN THROMBECTOMY SYSTEM
• Applicant: Walk Vascular, LLC
• Product Code: QEZ · Cardiovascular
• Decision Date: Nov 7, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ClearLumen Thrombectomy System is intended to break-up, remove/aspirate soft emboli and thrombus from the peripheral vasculature.

Device Story

ClearLumen Thrombectomy System is a catheter-based device for peripheral vascular thrombus removal. System comprises a multi-lumen 6F or 7F catheter (135 cm length, rapid exchange), a battery-operated saline drive unit (SDU), and waste collection bottles. Operated by physicians in clinical settings, the device uses a 0.014″ guidewire for navigation. The SDU facilitates simultaneous infusion of saline to lyse thrombus and aspiration to remove debris through the catheter lumens. A toggle switch on the SDU controls pump activation. By mechanically breaking up and aspirating soft emboli/thrombus, the device restores blood flow in the peripheral vasculature, potentially improving patient outcomes in cases of vascular occlusion.

Clinical Evidence

Bench testing only. Design verification testing confirmed the device performs according to its intended use.

Technological Characteristics

Multi-lumen 6F/7F catheter (135 cm length, 7 cm rapid exchange); polycarbonate hub; atraumatic distal tip. Battery-operated saline drive unit (SDU) for infusion/aspiration. Compatible with 0.014″ guidewires. Mechanical pump-driven system.

Indications for Use

Indicated for the removal/aspiration of soft emboli and thrombus from the peripheral vasculature in patients requiring thrombectomy.

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

• Kerberos Rinspirator (K050130)
• Possis AngioJet (K972610)
• Medtronic Export AP Aspiration Catheter (K081573)
• eV3 X-Sizer Catheter System (K021096)

Submission Summary (Full Text)

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# 510(k) Summary (21 CFR § 807.92(c))

NOV 7 2012

| Submitter: | Walk Vascular, LLC<br>17171 Daimler Street<br>Irvine, CA 92614 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Angela B. Soito, Esq.<br>Regulatory Consultant to Walk Vascular LLC<br>Telephone: [phone]<br>Email: [e-mail] |
| Date Summary Prepared: | 04 October 2012 |
| Device Trade Name: | ClearLumen Thrombectomy System |
| Common Name: · | Embolectomy / Thrombectomy Catheter |
| Classification Name: | Embolectomy Catheter (21 CFR §870.5150) |
| Product Code: | DXE |
| Equivalent Devices: | Kerberos Rinspirator (K050130)<br>Possis AngioJet (K972610)<br>Medtronic Export AP Aspiration Catheter (K081573)<br>eV3 X-Sizer Catheter System (K021096) |

#### Device Description:

The ClearLumen Thrombectomy Device consists of a thrombectomy catheter, saline drive unit ("SDU") and waste collection bottles. The thrombectomy catheter is a multi-lumen 6F or 7F guide compatible, 135 cm in length and is used over the wire. The catheters have a 7 cm rapid exchange length. The device is intended for use with conventional 0.014″ guidewires. The proximal end of the catheter contains a polycarbonate hub that connects to the SDU and provides access to the infusion and aspiration lumens. The distal end of the catheter shaft is comprised of an atraumatic tip. The ClearLumen Catheter is connected to the battery operated SDU which allows for simultaneous lysing and aspiration of thrombus from the treatment site. The SDU contains a port for connection to a standard saline bag. The device uses a toggle switch to turn the pump on and off.

#### Intended Use:

The ClearLumen Thrombectomy System is intended to break-up, remove/aspirate soft emboli and thrombus from the peripheral vasculature.

#### Non-Clinical Performance Data:

Design verification testing confirmed that the ClearLumen device performs according to the stated intended use. Device evaluation consisted of functional testing performed pursuant to Walk Vascular's

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Walk Vascular LLC c/o Angela B. Soito, Esq. ABS Consulting Services, LLC 17171 Daimler St. Irvine, CA 92614 US

Re: K120508

> Trade/Device Name: ClearLumen Thrombectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: October 11, 2012 Received: October 15, 2012

Dear Ms. Soito:

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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

v
7 2012

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### Page 2 - Ms. Angela Soito

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, Misbranding by reference to premarket notification (21CFR 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.htmfor the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

M.g. Killeben

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

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## Indications for Use Statement

510(k) Number if Known: TBD K120508

Device Name: ClearLumen Thrombectomy Device

Indications for Use:

The ClearLumen Thrombectomy System is intended to break-up, remove/aspirate soft emboli and thrombus from the peripheral vasculature.

মি Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrent of CDRH, Office of Device Evaluation (ODE)

UM.S. Wilhelm

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K1120508