(113 days)
ClearLumen II Peripheral Thrombectomy System (510(k) K163051)
No
The description focuses on mechanical and fluid dynamics for thrombus removal and infusion, with a microprocessor controlling basic functions like motor and vacuum monitoring. There is no mention of AI or ML algorithms for analysis, decision-making, or image processing.
Yes
The device is intended to "remove/aspirate fluid and break-up soft emboli and thrombus from the peripheral vasculature," which directly treats a medical condition. It also has the ability to "subselectively infuse/deliver diagnostics or therapeutics," further supporting its therapeutic function.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended to "subselectively infuse/deliver diagnostics or therapeutics with or without vessel occlusion." This indicates a diagnostic capability.
No
The device description clearly outlines multiple hardware components including a catheter, pump set, saline drive unit (SDU), syringe, and power supply. While the SDU contains a microprocessor and firmware, the system is fundamentally a hardware-based medical device with integrated software for control and monitoring.
Based on the provided information, the ClearLumen II Peripheral Thrombectomy System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to remove/aspirate fluid and break-up soft emboli and thrombus from the peripheral vasculature, and to infuse/deliver diagnostics or therapeutics. This is a direct intervention on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a system designed for mechanical and hydro-mechanical removal of thrombus from within blood vessels. It involves a catheter inserted into the patient's vasculature.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) outside of the body to provide diagnostic information. The device's function is therapeutic and interventional.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The ClearLumen II system operates directly within the patient's circulatory system.
N/A
Intended Use / 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, and
- subselectively infuse/deliver diagnostics or therapeutics with or without vessel occlusion.
Product codes
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 ClearLumen II 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 non-vented Luer cap is placed between the rotating hemostasis valve (RHV) side arm and the pressure monitor tubing.
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
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. The following testing was performed to support the new indication for use:
Design Verification Testing:
- Saline flow rate through aspiration lumen
- 60% ionic contrast media flow rate through aspiration lumen
- Infusion pressure of aspiration lumen
- Saline lumen pressure
Biocompatibility Testing: Not conducted, as the subject device is identical to the reference device.
Sterilization Testing: Not conducted, as the subject device is identical to the reference device.
Transportation and Shelf Life Testing: Transportation testing was not conducted, as the subject device is identical to the reference device. Additional shelf life testing was conducted to support the new indication.
The data from the in vitro testing above supports the substantial equivalence of the subject device to the predicate and reference device.
No pre-clinical or clinical data were generated to establish substantial equivalence. Bench data and data are considered adequate to support a determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Medtronic Export AP Aspiration Catheter (510(k) K081573)
Reference Device(s)
ClearLumen II Peripheral Thrombectomy System (510(k) K163051)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below it.
October 24, 2017
Walk Vascular, LLC % Mr. Paul Gasser Medical Device RA/QA Consultant 13612 Rushmore Lane Santa Ana, CA 92705
Re: K172000
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: September 29, 2017 Received: October 3, 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 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.
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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) 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,
Kenneth J. Cavanaugh -S
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) K172000
Device Name
ClearLumen II Peripheral Thrombectomy System
Indications for Use (Describe)
The ClearLumen II 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) | |
|---|---|
| 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, 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: | June 30, 2017 |
| 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: | Medtronic Export AP Aspiration Catheter (510(k) K081573) |
| Reference Device: | ClearLumen II Peripheral Thrombectomy System
(510(k) K163051) |
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 ClearLumen II Peripheral catheter has the ability to infuse fluid through the aspiration lumen and saline lumen.
4
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 non-vented Luer cap is placed between the rotating hemostasis valve (RHV) side arm and the pressure monitor tubing.
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.
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, 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. The reference device design is identical to the subject device.
Key differences between the subject, predicate and reference devices are reflected in the table below.
| Design Features | Subject
ClearLumen II
Catheter | Reference
ClearLumen II
Catheter | Predicate Medtronic
Aspiration Catheter |
|-----------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Intended use | The ClearLumen
II Peripheral
Thrombectomy
System is
intended to: | The ClearLumen
II Peripheral
Thrombectomy
System is
intended to
remove/aspirate | The Medtronic Export
AP Aspiration Catheter
is indicated for:
- removal/aspiration of
embolic material |
5
| Design Features | Subject
ClearLumen II
Catheter | Reference
ClearLumen II
Catheter | Predicate Medtronic
Aspiration Catheter |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | - 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." | fluid and break
up soft emboli
and thrombus
from the
peripheral
vasculature | (thrombus/debris) from
vessels of the arterial
system, and - to subselectively
infuse/deliver
diagnostics or
therapeutic agents
with or without vessel
occlusion. |
| Catheter working length (cm) | 115 | Same | 140 |
| Catheter maximum OD
(inches) | 0.105 | Same | 0.068 |
| Wire lumen configuration | Over-the-wire:
Aspiration lumen
is used as
guidewire lumen | Same | Rapid exchange, a
dedicated guidewire
lumen external to the
aspiration lumen |
| Guide catheter and sheath
compatibility (Fr) | 8 | Same | 6 |
| Distal tip shape | Angled skive, 6 -
8 mm in length | Same | Angled skive, forward
facing |
| Guidewire compatibility | Up to 0.035" | Same | Up to 0.014" |
| Catheter connections and
location | Two port "Y"
connector with
Luer connections
on the proximal
end of the
catheter | Same | One port with Luer
connection on the
proximal end of the
catheter |
The ClearLumen II Peripheral Thrombectomy System is substantially equivalent to the predicate device with regard to its indication for use. The ClearLumen II Peripheral Thrombectomy System is being used as a reference device, and is identical in design to the subject 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 new indication for use:
Design Verification Testing:
- Saline flow rate through aspiration lumen
- 60% ionic contrast media flow rate through aspiration lumen
- Infusion pressure of aspiration lumen
- Saline lumen pressure
6
Biocompatibility Testing:
Biocompatibility testing was not conducted, as the subject device is identical to the reference device.
Sterilization Testing:
Sterilization testing was not conducted, as the subject device is identical to the reference device.
Transportation and Shelf Life Testing:
Transportation testing was not conducted, as the subject device is identical to the reference device. Additional shelf life testing was conducted to support the new indication.
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 and 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 ClearLumen II Peripheral Thrombectomy System is substantially equivalent to the predicate device.