The Aventus Thrombectomy System is a catheter-based manual aspiration system designed for minimally invasive removal of emboli and thrombi from the peripheral vasculature and/or infusing fluids into the peripheral vasculature. The System is comprised of the following major components:

Aventus Aspiration Catheter II .
. Clot Management System consisting of:
- . Aspiration Syringe
- . Clot Canister

The System is compatible with a standard 24-French (24F) introducer sheath, 4-French (4F) Support Catheters and is to be used with 0.035" guidewires. The System is provided sterile and is intended for single use only.

The Aventus Aspiration Catheter II includes an atraumatic radiopaque Distal Tip with embedded sensors, and an angled aspiration orifice for directional aspiration and navigation without a dilator. A dedicated navigation catheter lumen for use with an off-the-shelf 4F Navigation Catheter, and dedicated infusion lumen for injection of fluids is also included in the shaft. The Catheter Handle assists the clinician in navigating within the vasculature and also includes a Sensing Indicator and houses the Sensing electronics. The Aspiration Catheter shaft incorporates a metallic reinforcement layer made of stainless steel, an inner liner and polymeric outer jacket having variable stiffness.

The System is provided with a 60-cc dual action manual syringe which allows for directional flow control and directs aspirated blood and clot into the Clot Canister.

AI/ML Overview

This document is a 510(k) summary for the Inquis Medical Aventus Thrombectomy System (IM-2001/IM-0002). It describes the device, its intended use, and the performance data provided to demonstrate substantial equivalence to a predicate device.

Based on the provided text, the device in question is a medical device (Aventus Thrombectomy System), not an AI/software device. Therefore, the questions regarding acceptance criteria for AI/software, MRMC studies, standalone performance, ground truth for training/test sets, and sample sizes for training/test sets related to AI/software are not applicable.

The performance data section (VII. PERFORMANCE DATA) describes various tests conducted to support the substantial equivalence claim. Here's a breakdown of the relevant information provided:

A table of acceptance criteria and the reported device performance: This document does not present a formal table of "acceptance criteria" for the device's performance in the way one might expect for a software or AI model's accuracy. Instead, it lists various performance tests and states that the device "successfully met" or "complied with requirements" or "demonstrated that the physical and functional requirements were met."

Performance Testing	Reported Device Performance and "Acceptance"
Biocompatibility Testing	"...do not pose a risk of negative interaction with patients." (Leveraged from predicate)
Sterilization	"demonstrated an SAL of 10-6." and "meets established pyrogen limit specifications." (Leveraged from predicate)
Distribution, Packaging & Shelf-Life	"successfully tested demonstrating integrity of the sterile barrier and preservation of the System's properties." (Accelerated aging for 6-month shelf life leveraged from predicate)
Software Testing	"successful software verification and validation testing, was provided as recommended by FDA Guidance..."
Electrical Safety / EMC Testing	"complies with the requirements of IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6 and IEC 62366-1."
Performance Testing - Bench	"demonstrated that the physical and functional requirements were met." This includes: Visual and Dimensional Inspection, Tensile Strength, Pressure/Leak Integrity, Clot Burden Removal Validation, Vacuum Test, Leak Test, Compatibility Testing, Torque Transmission Testing, Kink Testing, Simulated-Use Verification and Validation of Sensing. (Kink and Torque to Failure leveraged from predicate).
Performance Testing - Non-Clinical	"demonstrated that the System was able to be used safely in a chronic large animal GLP study and met all pre-defined study endpoints." (Leveraged from predicate)

Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document does not specify exact sample sizes for each bench test (e.g., number of catheters tested for tensile strength).
- For the non-clinical (animal) study, it mentions "a chronic large animal GLP study." It does not specify the number of animals or data provenance (country of origin), nor whether it was retrospective or prospective, though GLP (Good Laboratory Practice) studies are typically prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This is not applicable as the document describes performance testing of a physical medical device, not a diagnostic AI system requiring expert-established ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for the type of device and testing described.
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:
- Not applicable as this is not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device includes "disposable powered electronics and embedded software" for sensing (as stated in Section IV and VII), and "Software documentation, including successful software verification and validation testing, was provided." However, the description refers to V&V for the software functions of the device, not a standalone AI diagnostic algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the physical and functional performance tests (bench testing), the "ground truth" would be established engineering specifications and physical measurements, rather than clinical consensus or pathology.
- For the non-clinical animal study, the "ground truth" would be observed safety and performance metrics in the animal model, as defined by the study protocol and endpoints.
The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set in the typical sense. The software mentioned is "embedded software" likely controlling device functions, not a learning algorithm trained on data.
How the ground truth for the training set was established:
- Not applicable.

Summary

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March 15, 2024

Inquis Medical Mojgan Saadat President 127 Independence Drive Menlo Park, California 94025

Re: K240117

Trade/Device Name: Aventus Thrombectomy System (IM-2001/IM-0002) Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEW, KRA Dated: January 8, 2024 Received: January 16, 2024

Dear Mojgan Saadat:

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" (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).

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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 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-reportingcombination-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.

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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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).

Sincerely,

Digitally signed by Gregory W. Gregory W. O'connell -S Date: 2024.03.15 14:45:43 O'connell -S -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

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Indications for Use

Submission Number (if known)

K240117

Device Name

Aventus Thrombectomy System (IM-2001/IM-0002)

Indications for Use (Describe)

The Aventus Thrombectomy System is indicated for:

· The non-surgical removal of emboli and thrombi from blood vessels.

· Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.

The Aventus Thrombectomy System is intended for use in 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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Image /page/3/Picture/0 description: The image shows the logo for Inquis Medical. The word "INQUIS" is in a dark blue sans-serif font, with the "Q" stylized to include a green circle. Below the first word is the word "MEDICAL" in a smaller, light blue sans-serif font.

510(k) Summary

I. SUBMITTER

Inquis Medical 127 Independence Drive Menlo Park, CA 94025 408-209-8326

Contact Person: Mojgan Saadat, President Inquis Medical

Date Prepared: January 5, 2024

II. DEVICE

Name of Device:	Aventus Thrombectomy System (IM-2001/IM-0002)
Common or Usual Name:	Aspiration Thrombectomy Catheter
Classification Name:	Embolectomy Catheter
Regulatory Class:	Class II
Product Code:	QEW, KRA
Regulation Number:	21 CFR 878.5150

III. PREDICATE DEVICE/REFERENCE DEVICE

Predicate Device:	Aventus Thrombectomy System (K232730)
Reference Device:	Indigo Aspiration System - Lightning Aspiration Tubing(K193244)

IV. DEVICE DESCRIPTION

Aventus Aspiration Catheter II .
. Clot Management System consisting of:
- . Aspiration Syringe
- . Clot Canister

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Image /page/4/Picture/0 description: The image shows the logo for Inquis Medical. The word "INQUIS" is in a dark blue sans-serif font, with a green circle in the middle of the "Q". Below that, the word "MEDICAL" is in a smaller, lighter blue sans-serif font.

Catheter, and dedicated infusion lumen for injection of fluids is also included in the shaft. The Catheter Handle assists the clinician in navigating within the vasculature and also includes a Sensing Indicator and houses the Sensing electronics. The Aspiration Catheter shaft incorporates a metallic reinforcement layer made of stainless steel, an inner liner and polymeric outer jacket having variable stiffness.

The System is provided with a 60-cc dual action manual syringe which allows for directional flow control and directs aspirated blood and clot into the Clot Canister.

V. INDICATIONS FOR USE

The Aventus Thrombectomy System is indicated for:

. The non-surgical removal of emboli and thrombi from blood vessels.
Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.

The Aventus Thrombectomy System is intended for use in the peripheral vasculature.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The subject device, Aventus Thrombectomy System, is substantially equivalent to the predicate device: Aventus Thrombectomy System cleared under K232730. The intended use of the subject device is the same as the predicate, namely removal of thrombi or emboli from the peripheral vasculature system. Additionally, the intended use of injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel is identical to the predicate.

The subject and predicate device share similar technological characteristics in that both devices are single patient use, large bore aspiration catheters which utilize a 60-cc manual syringe as the aspiration source. Both devices utilize a dedicated infusion port/lumen for injection and infusion of contrast media and other fluids into or from the blood vessel. Both devices utilize the shaft made with metallic (stainless steel) reinforced polymeric jacketed shaft with variable stiffness, radiopaque markings at the distal tip for fluoroscopic visualization, and use of stopcocks to direct the flow of fluids. Neither the subject nor predicate device includes any coating or surface materials.

The subject device shares similar technological characteristics as the reference device in that it incorporates disposable powered electronics and embedded software.

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

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Image /page/5/Picture/1 description: The image contains the logo for Inquis Medical. The word "INQUIS" is in a bold, sans-serif font, with a green circle in the "Q". Below that, the word "MEDICAL" is in a thinner, sans-serif font.

Performance Testing	Data provided
BiocompatibilityTesting	Biocompatibility testing was leveraged from the predicate device whichwas successfully completed in accordance with ISO 10993-1:2018 andthe FDA Guidance re: Use of ISO-10993. Testing included:Cytotoxicity Sensitization Intracutaneous Reactivity Acute Systemic Toxicity Material Mediated Pyrogenicity Hemocompatibility (Hemolysis, ComplementActivation, Thrombogenicity) This testing demonstrated the materials of the Aventus ThrombectomySystem do not pose a risk of negative interaction with patients.
Sterilization	Sterilization testing was leveraged from the predicate device which wassuccessfully completed in accordance with ISO 14937:2009 -Sterilization of health care products — General requirements forcharacterization of a sterilizing agent and the development, validationand routine control of a sterilization process for medical devices anddemonstrated an SAL of 10-6.Bacterial endotoxins test (BET), a.k.a. Limulus amebocyte lysate(LAL) testing was conducted on the subject device per current testguidelines: USP <85> Bacterial Endotoxin Test and AAMI ST72Bacterial endotoxins- test methodologies, routine monitoring andalternatives to batch testing and confirmed that the System meetsestablished pyrogen limit specifications.
Distribution,Packaging and Shelf-Life Testing	Distribution testing was successfully completed on the subject device;final packaging and device performance were successfully testeddemonstrating integrity of the sterile barrier and preservation of theSystem's properties.Accelerated Aging simulating six-month shelf life was leveraged fromthe predicate and final packaging and device performance weresuccessfully tested demonstrating integrity of the sterile barrier andpreservation of the System's properties for the labeled six-month shelf-life.
Software Testing	Software documentation, including successful software verification andvalidation testing, was provided as recommended by FDA Guidance:Content of Premarket Submissions for Device Software Functions ,issued June 14, 2023.
Electrical Safety /EMC Testing	Electrical Safety and EMC testing were conducted on the AventusThrombectomy System. The subject device complies with therequirements of IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6 and IEC62366-1.
Performance Testing -Bench	Design verification testing was performed demonstrated that the physicaland functional requirements were met.Specifically, the following was tested:Visual and Dimensional Inspection
Performance Testing	Data provided
	Tensile Strength Pressure/ Leak Integrity Clot Burden Removal Validation Vacuum Test Leak Test Compatibility Testing Torque Transmission Testing Kink Testing Simulated-Use Verification and Validation of Sensing Kink and Torque to Failure testing was leveraged from the predicate based on no change in the shaft constructions or materials.
Performance Testing -Non-Clinical	The GLP animal study completed in compliance with GLP regulation(21 CFR Part 58) and in accordance with FDA Guidance: GeneralConsiderations for Animal Studies for Cardiovascular Devices (July2010) and FDA Guidance: General Considerations for Animal StudiesIntended to Evaluate Medical devices (March 2023) provided for thepredicate device, was leveraged for the subject device anddemonstrated that the System was able to be used safely in a chroniclarge animal GLP study and met all pre-defined study endpoints.

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CONCLUSIONS VIII.

In conclusion, the intended use, indications for use, and technological characteristics of the Aventus Thrombectomy System are similar or equivalent to the predicate device. Performance testing has demonstrated that the Aventus 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).