(112 days)
Not Found
No
The description mentions a microprocessor and firmware for monitoring functions, but there is no indication of AI or ML being used for decision-making, analysis, or learning. The device operates based on mechanical and vacuum principles controlled by a simple circuit.
Yes
The device is intended to remove and aspirate fluid and thrombus from the peripheral vasculature, which is a direct treatment for a medical condition.
No
The device is intended to remove/aspirate fluid and thrombus from the peripheral vasculature, which is a therapeutic function, not a diagnostic one. It describes a system for physical removal of material, not for identifying or characterizing health conditions.
No
The device description clearly outlines hardware components including a catheter, pump set, saline drive unit (SDU), syringe, vacuum sensor, and external power supply. The SDU contains a microprocessor and firmware, but it is part of a larger hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "remove/aspirate fluid and thrombus from the peripheral vasculature." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a mechanical system designed to physically disrupt and remove blood clots from blood vessels. It involves a catheter, pump, and saline delivery system.
- Lack of In Vitro Activity: The device does not perform tests on samples taken from the body (like blood, urine, or tissue) outside of the body. It operates directly within the patient's circulatory system.
IVD devices are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The ClearLumen II Peripheral Thrombectomy System is intended to remove/aspirate fluid and thrombus from the peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
DXE
Device Description
The ClearLumen II Peripheral Thrombectomy System 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 high pressure saline via a displacement pump to the distal tip of the catheter, while aspirating thrombotic material macerated by the saline stream.
The ClearLumen II Peripheral Thrombectomy System consists of one aspiration catheter, which connects to the ClearLumen II Pump Set and the ClearLumen Peripheral Saline Drive Unit (SDU). In use, thrombus enters the distal catheter tip via the suction force provided by a 60 ml VacLok syringe, which is connected to the vacuum sensor. 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 is drawn back through the primary lumen and deposited into the syringe. No saline is injected into the patient during normal operation.
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, which is centered in the pump set, 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 Y-connector of the peripheral catheter and delivers the saline to the peripheral catheter.
The peripheral SDU is a reusable, IV pole mounted 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 vacuum sensor. Vacuum is achieved by a vacuum syringe (not provided), which is connected to the vacuum sensor. The vacuum sensor is connected to the aspiration lumen on the Y-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 the current status of the SDU. Energy is provided by a 24 volt external power supply, which is connected to mains power.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature, peripheral arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Design Verification Testing included: Pull test of welded and glued joints, Leak, Pressure, Flow, Kink resistance, Torque strength, Guidewire compatibility, Deliverability in torturous model, Performance (simulated clot removal).
Biocompatibility testing was conducted on the peripheral catheter and pump set combination, in accordance with ISO 10993-1.
Sterilization Testing: A sterilization adoption assessment was conducted in accordance with AAMI TIR 28.
Transportation and Shelf Life Testing: Shipping and distribution testing was conducted in accordance with ISTA 2A. Shelf life testing was performed.
A pre-clinical study was conducted to evaluate the safety of the peripheral catheter. Histological evaluation established the safety of the peripheral catheter when used in peripheral arteries.
No clinical data were generated to establish substantial equivalence. Bench data and pre-clinical data are considered adequate to support a determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Walk Vascular ClearLumen II Thrombectomy System (K161786)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 21, 2017
Walk Vascular, LLC % Mr. Paul Gasser Medical Device RA/QA Consultant 13612 Rushmore Lane Santa Ana, CA 92705
Re: K163051
Trade/Device Name: ClearLumen II Peripheral Thrombectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: January 10, 2017 Received: January 11, 2017
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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
M.A. Willemsen
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K163051
Device Name
ClearLumen II Peripheral Thrombectomy System
Indications for Use (Describe)
The ClearLumen II Peripheral Thrombectomy System is intended to remove/aspirate fluid and thrombus from the peripheral vasculature.
| 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) |
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3
Traditional 510(k) Summary
| Submitter: | Walk Vascular, LLC
17171 Daimler Street
Irvine, CA 92614 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Brad Culbert
VP, Engineering
Walk Vascular LLC
Telephone: 949-752-9642
Fax: 949-752-9658
Email: bsculbert@yahoo.com |
| Date Summary Prepared: | October 28, 2016 |
| Device Trade Name: | ClearLumen II Peripheral Thrombectomy System |
| Common Name: | Embolectomy/Thrombectomy Catheter |
| Classification Name: | Embolectomy Catheter (21 CFR 870.5150) |
| Product Code: | DXE |
| Predicate Device: | Walk Vascular ClearLumen II Thrombectomy System (K161786) |
Device Description:
The ClearLumen II Peripheral Thrombectomy System 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 high pressure saline via a displacement pump to the distal tip of the catheter, while aspirating thrombotic material macerated by the saline stream.
The ClearLumen II Peripheral Thrombectomy System consists of one aspiration catheter, which connects to the ClearLumen II Pump Set and the ClearLumen Peripheral Saline Drive Unit (SDU). In use, thrombus enters the distal catheter tip via the suction force provided by a 60 ml VacLok syringe, which is connected to the vacuum sensor. 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 is drawn back through the primary lumen and deposited into the syringe. No saline is injected into the patient during normal operation.
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, which is centered in the pump set, 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
4
set has a connector, which mounts to the proximal end of the Y-connector of the peripheral catheter and delivers the saline to the peripheral catheter.
The peripheral SDU is a reusable, IV pole mounted 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 vacuum sensor. Vacuum is achieved by a vacuum syringe (not provided), which is connected to the vacuum sensor. The vacuum sensor is connected to the aspiration lumen on the Y-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 the current status of the SDU. Energy is provided by a 24 volt external power supply, which is connected to mains power.
Indications for Use:
The ClearLumen II Peripheral Thrombectomy System is intended to remove/aspirate fluid and break-up soft emboli and thrombus from the peripheral vasculature.
Statement of Equivalence:
The subject device and the predicate share a similar intended use and technological characteristics.
| Design Features | Predicate ClearLumen II
Catheter | Subject ClearLumen II
Peripheral Catheter |
|---------------------------------------|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Intended use | Coronary and peripheral | Peripheral |
| Catheter overall length
(cm) | 135 | 115 |
| Minimum guide catheter
ID (inches) | 0.070 | 0.113 |
| Number of lumens | Tri-lumen | Dual-lumen |
| Proximal design | Saline lumen is bonded to the
straight-away main port of the
Y-site adaptor | Saline lumen is bonded to the
side-branch port of the Y-site
adaptor |
| Tip design | Beveled | Blunt, soft |
| Guidewire | Rapid exchange | Over the wire |
| SDU to be used with | Coronary SDU | Peripheral SDU |
Key differences between the two are reflected in the table below.
The ClearLumen II Peripheral Thrombectomy System is substantially equivalent to the predicate device with regard to its similar intended use, design, function, materials and sterilization method.
5
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:
Design Verification Testing:
- Pull test of welded and glued joints Leak Pressure Flow Kink resistance Torque strength Guidewire compatibility Deliverability in torturous model Performance (simulated clot removal)
Biocompatibility Testing:
Biocompatibility testing was conducted on the peripheral catheter and pump set combination, as the two devices are used concurrently during the surgical procedure. Biocompatibility testing was conducted in accordance with ISO 10993-1.
Sterilization Testing:
A sterilization adoption assessment was conducted in accordance with AAMI TIR 28 in order to support the ability of the current sterilization cycle to adequately sterilize the subject device.
Transportation and Shelf Life Testing:
Shipping and distribution testing was conducted in accordance with ISTA 2A.
Shelf life testing was performed.
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:
A pre-clinical study was conducted to evaluate the safety of the peripheral catheter. Histological evaluation established the safety of the peripheral catheter when used in peripheral arteries.
No clinical data were generated to establish substantial equivalence. Bench data and pre-clinical data are considered adequate to support a determination of substantial equivalence.
Summary:
Based on the intended use, in vitro performance and biocompatibility information provided in this premarket notification, the ClearLumen II Peripheral Thrombectomy System is substantially equivalent to the predicate device.