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.

AI/ML Overview

The provided document describes the ClearLumen II Peripheral Thrombectomy System (K163051). The acceptance criteria and the study proving the device meets these criteria are related to non-clinical performance and a pre-clinical study.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All data met the acceptance criteria and fell within pre-determined product specifications and external standard requirements." However, it does not explicitly list specific numerical or qualitative acceptance criteria for each test or the exact performance metrics achieved. Instead, it lists the types of tests performed.

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical integrity and strength of welded/glued joints (Pull test)	Met acceptance criteria, fell within pre-determined product specifications.
Resistance to fluid leakage (Leak)	Met acceptance criteria, fell within pre-determined product specifications.
Pressure and flow characteristics (Pressure Flow)	Met acceptance criteria, fell within pre-determined product specifications.
Resistance to kinking (Kink resistance)	Met acceptance criteria, fell within pre-determined product specifications.
Rotational force transmission and durability (Torque strength)	Met acceptance criteria, fell within pre-determined product specifications.
Compatibility with guidewires (Guidewire compatibility)	Met acceptance criteria, fell within pre-determined product specifications.
Ease and success of navigation through tortuous pathways (Deliverability in tortuous model)	Met acceptance criteria, fell within pre-determined product specifications.
Efficacy in removing simulated clots (Performance - simulated clot removal)	Met acceptance criteria, fell within pre-determined product specifications.
Biocompatibility in accordance with ISO 10993-1	Met acceptance criteria, acceptable for patient contact.
Adequacy of sterilization cycle in accordance with AAMI TIR 28	Met acceptance criteria, adequately sterilized.
Ability to withstand shipping and distribution (Transportation and Shelf Life Testing - ISTA 2A)	Met acceptance criteria.
Maintenance of device integrity and function over time (Shelf Life Testing)	Met acceptance criteria.
Safety of peripheral catheter in peripheral arteries (Pre-clinical study - histological evaluation)	Established safety.

2. Sample Size Used for the Test Set and Data Provenance

Non-Clinical (Design Verification, Biocompatibility, Sterilization, Transportation, Shelf Life): The document does not specify the sample sizes (e.g., number of catheters, pump sets, etc.) used for these in vitro tests. The provenance is internal company testing ("Walk Vascular's risk analysis"). These are laboratory/bench studies, not patient data.
Pre-Clinical Study: The document states "A pre-clinical study was conducted to evaluate the safety of the peripheral catheter." It does not specify the sample size (e.g., number of animals) or the provenance (e.g., specific animal model, institution). This study is prospective in nature as it evaluates the device in an animal model before human use.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Non-Clinical Tests: No explicit mention of external experts or their qualifications for establishing ground truth for these engineering or material science tests. These typically rely on defined industry standards, internal specifications, and trained technicians/engineers.
Pre-Clinical Study: Ground truth was established through "Histological evaluation." While this implies expertise in pathology, the document does not specify the number of experts or their qualifications (e.g., board-certified pathologists with X years of experience).

4. Adjudication Method for the Test Set

Not applicable for the described non-clinical and pre-clinical studies. These types of studies typically involve direct measurement against defined criteria or single expert evaluation (e.g., a pathologist for histology), rather than an expert consensus/adjudication process commonly used in clinical image interpretation studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was done. The document explicitly states: "No clinical data were generated to establish substantial equivalence." This means there was no study involving human readers (e.g., physicians interpreting images) to assess the effectiveness of the device, with or without AI assistance. The device is a thrombectomy system, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance Study

Not applicable. The ClearLumen II Peripheral Thrombectomy System is a medical device for mechanical clot removal, not a diagnostic algorithm or AI system. Therefore, there is no "algorithm only" performance to evaluate.

7. Type of Ground Truth Used

Non-Clinical (Design Verification): Ground truth was based on pre-determined product specifications and external standard requirements (e.g., for strength, flow, kink resistance). For "Performance (simulated clot removal)," the ground truth would be the extent of clot removal in a simulated environment, measured against a benchmark or expected outcome.
Biocompatibility: Ground truth was established against ISO 10993-1 standards.
Sterilization: Ground truth was established against AAMI TIR 28.
Transportation and Shelf Life: Ground truth was based on ISTA 2A standards and the device maintaining its specified qualities over time.
Pre-Clinical Study: "Histological evaluation" was used as the ground truth to assess the safety and tissue response in peripheral arteries. This represents a form of pathology ground truth.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set. The "training set" concept is relevant for machine learning models, not for mechanical medical devices.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set was used.

Summary

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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.

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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

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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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Traditional 510(k) Summary

Submitter:	Walk Vascular, LLC17171 Daimler StreetIrvine, CA 92614
Contact:	Brad CulbertVP, EngineeringWalk Vascular LLCTelephone: 949-752-9642Fax: 949-752-9658Email: 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:

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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.

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 IICatheter	Subject ClearLumen IIPeripheral Catheter
Intended use	Coronary and peripheral	Peripheral
Catheter overall length(cm)	135	115
Minimum guide catheterID (inches)	0.070	0.113
Number of lumens	Tri-lumen	Dual-lumen
Proximal design	Saline lumen is bonded to thestraight-away main port of theY-site adaptor	Saline lumen is bonded to theside-branch port of the Y-siteadaptor
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.

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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:

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.

Regulation Number and Section

§ 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).