The Expanse FLOWRUNNER Aspiration System is indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems.

Device Description

The Expanse FLOWRUNNER Aspiration System is a peripheral thrombectomy system consisting of several components:

FLOWRUNNER Aspiration Catheter
FLOWRUNNER Aspiration Sheath
Vacuum Fitting
High Flow Stopcock Connector
Y-Connector with Hemostatic Valve
Hand Actuator Clip

The FLOWRUNNER Aspiration System is designed for the minimally invasive removal of thrombus from the peripheral vasculature using aspiration. The system has demonstrated compatibility with standard vascular implants, including stents and filters. It is a single use, over-the-wire, catheter-based system with the ability to infuse fluid. The FLOWRUNNER Aspiration System consists of one aspiration catheter, one aspiration sheath, one vacuum fitting, one high flow stopcock connector, one Y-connector with hemostatic valve, and a hand actuator clip.

The FLOWRUNNER Aspiration System is introduced to the site of the primary occlusion. The Aspiration Catheter is advanced through the Aspiration Sheath and targets aspiration directly to the thrombus. The Aspiration Catheter is then retracted back into the Aspiration Sheath. This process of extension and retraction of the Aspiration Catheter is then repeated to fully aspirate the clot. Suction is applied directly to the Aspiration Catheter from an external vacuum source to aspirate thrombus from an occluded vessel (maximum pressure -27.6 in Hg and minimum pressure of -8.0 in Hg).

Sterile saline flows through the Aspiration Sheath and into the Aspiration Catheter when connected proximally. No saline is injected into the patient during aspiration. The Aspiration Catheter and Sheath are visible under fluoroscopy. The hand actuator is an optional, proximal clip attached to the Aspiration Catheter to assist the user.

The FLOWRUNNER Aspiration System comes in 12F, 14F compatible diameters and 60cm, 80cm, 100cm and 120cm lengths.

AI/ML Overview

The provided FDA 510(k) clearance letter and summary for the FLOWRUNNER Aspiration System are for a medical device (an embolectomy catheter), not an AI/ML powered device. As such, the document does not contain information typically found in submissions for AI/ML devices regarding acceptance criteria, study design for AI performance, ground truth, or expert involvement in classification.

The information provided focuses on the FLOWRUNNER Aspiration System's equivalence to a predicate device (ICE Aspiration System) for its intended use in removing emboli and thrombi from peripheral vessels. The "performance data" section refers to bench testing, which is standard for hardware medical devices, not AI/ML performance metrics.

Therefore, I cannot extract the requested information about acceptance criteria, study details, human reader improvement with AI, standalone performance, ground truth establishment, or training set size. This document does not describe a study involving AI/ML.

Here's a summary of what information can be extracted from the document, related to its non-AI performance claims:

1. A table of acceptance criteria and the reported device performance:

The document summarizes the performance testing generically as "Bench testing was performed to support a determination of substantial equivalence to the predicate." It lists the types of bench tests conducted but does not provide specific acceptance criteria values or detailed reported performance results against those criteria.

Acceptance Criteria (Implied)	Reported Device Performance
In-Stent and IVC Filter compatibility	"demonstrated compatibility with standard vascular implants, including stents and filters"
Thrombus Capture	Performed (specific results not detailed)
Conformance to intended use requirements	"designed and tested to assure conformance to the requirements for its intended use"
Reliability (general)	"Performance testing demonstrated that the FLOWRUNNER Aspiration System reliably raises no new questions of safety and effectiveness."

2. Sample size used for the test set and the data provenance:

Not applicable, as this refers to bench testing on physical components, not a clinical test set with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications:

Not applicable. Ground truth for clinical data is irrelevant to bench testing of a hardware device.

4. Adjudication method for the test set:

Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This device is not AI-powered, so no such study was conducted or is relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

No. This device is not an algorithm. Bench testing evaluates the physical device's performance.

7. The type of ground truth used:

Not applicable in the context of AI/ML. For the bench testing, the "ground truth" would be engineering specifications and validated test methods to assess the physical device's capabilities (e.g., ability to capture thrombus in a model, compatibility with stents).

8. The sample size for the training set:

Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established:

Not applicable. This is not an AI/ML device.

Summary

FDA 510(k) Clearance Letter - FLOWRUNNER Aspiration System

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

July 14, 2025

Expanse Medical Inc.
Shiva Ardakani
Sr. VP QA/RA/CA
7060 Koll Center Parkway
Suite 300
Pleasanton, California 94566

Re: K251488
Trade/Device Name: FLOWRUNNER Aspiration System
Regulation Number: 21 CFR 870.5150
Regulation Name: Embolectomy Catheter
Regulatory Class: Class II
Product Code: QEZ, KRA
Dated: June 18, 2025
Received: June 18, 2025

Dear Shiva Ardakani:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

Page 2

K251488 - Shiva Ardakani Page 2

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Page 3

K251488 - Shiva Ardakani Page 3

Sincerely,

GREGORY W. O'CONNELL -S
Digitally signed by GREGORY W. O'CONNELL -S
Date: 2025.07.14 14:24:05 -04'00'

Gregory O'Connell
Assistant Director
DHT2C: Division of Coronary and Peripheral Intervention Devices
OHT2: Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known): K251488

Device Name: FLOWRUNNER Aspiration System

Indications for Use (Describe):
The Expanse FLOWRUNNER Aspiration System is indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

Page 5

Expanse Medical, Inc. FLOWRUNNER Aspiration System 510(k) Notification
Page -1

510(k) Summary (K251488)

[As required by 21 CFR 807.92(c)]

1. Submitter's Name / Contact Person

Submitter: Expanse Medical, Inc.
7060 Koll Center Parkway, Suite 300
Pleasanton, CA 94566

Contact Person: Shiva Ardakani
Sr. VP QA/RA/CA
Phone: 925-931-1300 Ext. 209

Date Prepared: May 12, 2025

2. General Information

Trade Name: FLOWRUNNER Aspiration System
Regulation Number: 21 CFR 870.5150
Common/Usual Name: Aspiration Catheter
Classification Name: Embolectomy Catheter
Regulatory Class: Class II
Product Code: QEZ and KRA
Predicate Device: ICE Aspiration System (K234073)

3. Intended Use

The Expanse FLOWRUNNER Aspiration System is indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems.

4. Device Description

The Expanse FLOWRUNNER Aspiration System is a peripheral thrombectomy system consisting of several components:

FLOWRUNNER Aspiration Catheter
FLOWRUNNER Aspiration Sheath
Vacuum Fitting
High Flow Stopcock Connector
Y-Connector with Hemostatic Valve
Hand Actuator Clip

Page 6

Expanse Medical, Inc. FLOWRUNNER Aspiration System 510(k) Notification
Page -2

fitting, one high flow stopcock connector, one Y-connector with hemostatic valve, and a hand actuator clip.

The FLOWRUNNER Aspiration System comes in 12F, 14F compatible diameters and 60cm, 80cm, 100cm and 120cm lengths.

5. Performance Data

Bench testing was performed to support a determination of substantial equivalence to the predicate. Results from this testing provide assurance that the subject device FLOWRUNNER has been designed and tested to assure conformance to the requirements for its intended use.

5.1 Summary of Non-Clinical Data

As required under Section 12, Part (a)(i)(3A) of the Safe Medical Device, Act of 1990, a summary of any information regarding substantial equivalence of the device FLOWRUNNER Aspiration system is in the table of comparison. In this section, list of all testing has been outlined and summary of all the testing will be presented in the relevant section of this submission.

• Design Verification (Bench-Top Testing)

In-Stent and IVC Filter testing
Thrombus Capture Testing

6. Predicate Comparison

ICE Aspiration System K234073 is the predicate device. The FLOWRUNNER Aspiration System is substantial equivalence to the ICE Aspiration System K234073. Testing FLOWRUNNER Aspiration System demonstrated compatibility with standard vascular implants, including stents and filters and does not raise any new or different questions of safety and effectiveness.

Page 7

Expanse Medical, Inc. FLOWRUNNER Aspiration System 510(k) Notification
Page -3

7. Substantial Equivalence Comparison and Conclusion

For substantial equivalence to the FLOWRUNNER Aspiration System a valid, predicate device ICE Aspiration System was identified. The predicate device ICE has the same intended use. Any differences in technological characteristics did not raise new questions related to safety and effectiveness. The predicate device ICE Aspiration System was 510(k) cleared since 2023, and has been actively marketed throughout that period.

A summary of the considerations is provided in substantial equivalence section of this submission.

The FLOWRUNNER Aspiration System is deemed substantially equivalent to the predicate device ICE Aspiration System in intended use, design, materials, packaging, fundamental scientific technology, manufacturing, important performance specifications, and sterilization. Performance testing demonstrated that the FLOWRUNNER Aspiration System reliably raises no new questions of safety and effectiveness. Finally, the subject device FLOWRUNNER is offered in sizes comparable to the predicate device ICE Aspiration System intended for use within the peripheral vasculature. Therefore, the FLOWRUNNER Aspiration System is considered substantially equivalent to the predicate device ICE Aspiration System.

Device Characteristic	PredicateExpanse Medical, Inc.ICE Aspiration System	SubjectExpanse Medical, Inc.FLOWRUNNER Aspiration System
510(k) Number	K234073	K251488
Classification	Class II, QEW and KRA	Class II, QEZ and KRA
Intended Use	Embolectomy and Thrombectomy in Peripheral vasculature.	Embolectomy and Thrombectomy in Peripheral vasculature.
Indication for Use	The Expanse ICE Aspiration System is indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems.	The Expanse FLOWRUNNER Aspiration System is indicated for the removal of fresh, soft, emboli and thrombi from vessels of the peripheral arterial and venous systems.
Materials	Biocompatible, commonly utilized for interventional device	Same
Packaging Configuration	Individually packaged	Same
Sterilization	EO	Same
Biocompatibility	Biocompatible	Same
Shelf Life	2 years	Same

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).