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.

AI/ML Overview

Here's an analysis of the provided text regarding the ClearLumen Thrombectomy System, focusing on the acceptance criteria and supporting studies.

Based on the provided 510(k) summary, the document does not contain the detailed information necessary to fully address all aspects of your request, particularly regarding specific acceptance criteria, study methodologies (sample sizes, ground truth establishment, expert qualifications), or comparative effectiveness studies. The summary focuses on establishing substantial equivalence to predicate devices through non-clinical performance data.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria:
The document states, "Design verification testing confirmed that the ClearLumen device performs according to the stated intended use." However, no specific quantitative or qualitative acceptance criteria are provided within this summary.

Reported Device Performance:
The summary broadly claims that "Design verification testing confirmed that the ClearLumen device performs according to the stated intended use." This is a general statement and no specific performance metrics or data points are reported for characteristics like thrombus removal efficiency, time taken, safety parameters, or comparability to predicate devices.

Acceptance Criteria	Reported Device Performance
Not specified in this document. (e.g., Thrombus removal efficiency > X%; Aspiration rate > Y mL/min; Catheter integrity maintained under Z pressure)	"Device performs according to the stated intended use." (No specific quantitative results provided)

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

The document mentions "Design verification testing" and "functional testing performed pursuant to Walk Vascular's [standard/protocol - cut off in the text]."

Sample Size for Test Set: Not specified.
Data Provenance (Country of Origin, Retrospective/Prospective): Not specified. This appears to be internal company testing, likely conducted within the US (where the company is based), but no explicit details are given. It is non-clinical testing, meaning it's not patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

For non-clinical performance data, the concept of "ground truth established by experts" as typically applied in clinical studies (e.g., radiologists interpreting images) is not applicable in this context. The testing would have involved engineering and laboratory personnel verifying device specifications and performance against pre-defined engineering requirements. There is no mention of external clinical experts reviewing this non-clinical data to establish ground truth.

4. Adjudication Method for the Test Set

Given that the testing is described as "Design verification testing" and "functional testing," an "adjudication method" in the sense of resolving discrepancies among human readers (like 2+1 or 3+1) is not applicable. This would involve standard engineering and quality control verification processes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The provided text explicitly states "Non-Clinical Performance Data" and describes these evaluations as "Design verification testing" and "functional testing." This indicates laboratory and bench testing, not clinical studies involving human readers or patient cases. Therefore, an MRMC study and effects of AI assistance are not relevant or discussed in this document.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

Not applicable. The ClearLumen Thrombectomy System is a physical medical device (catheter system), not an AI algorithm. Therefore, a "standalone" performance study for an algorithm is not relevant to this device.

7. The Type of Ground Truth Used

For the non-clinical "Design verification testing" and "functional testing," the "ground truth" would be engineering specifications, performance standards, and established laboratory measurement techniques. For example, if testing flow rate, the ground truth is the measured flow rate compared to a defined specification. If testing thrombus removal, it would be the objective measurement of removed material against a target. No specific type of ground truth (e.g., pathology, outcomes data) is mentioned from clinical data, as this is non-clinical testing.

8. The Sample Size for the Training Set

Not applicable. This device is a physical thrombectomy system, not an AI/machine learning model. Therefore, there is no "training set" in the context of data for an algorithm.

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

Not applicable. As above, there is no "training set" for this type of device.

Summary of Missing Information:

The provided 510(k) summary is very high-level regarding the performance studies. It serves to inform the FDA that design verification and functional testing were performed but does not delve into the detailed methodology, specific quantitative results, or the precise acceptance criteria used in those non-clinical tests. For a clinical device, especially one involving patient interaction, detailed clinical study data would be expected, which is not present in this non-clinical submission summary.

Summary

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510(k) Summary (21 CFR § 807.92(c))

NOV 7 2012

Submitter:	Walk Vascular, LLC17171 Daimler StreetIrvine, CA 92614
Contact:	Angela B. Soito, Esq.Regulatory Consultant to Walk Vascular LLCTelephone: 650.303.0525Email: soitoconsulting@gmail.com
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)Possis AngioJet (K972610)Medtronic Export AP Aspiration Catheter (K081573)eV3 X-Sizer Catheter System (K021096)

Device Description:

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 (800) 638 2041 or (301) 796-7100 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

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).