(33 days)
The Aventus Thrombectomy System is indicated for:
- The non-surgical removal of emboli and thrombi from blood vessels.
- Iniection, 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.
The Aventus Thrombectomy System is a catheter-based manual aspiration svstem 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 Thrombectomy Catheter
- Clot Management System consisting of:
- Aspiration Syringe
- Clot Canister
The System is compatible with a standard 24-French (24F) introducer sheath, 4F or 5F Navigation Catheters (based on Aventus Thrombectomy Catheter model) and is to be used with 0.035" guidewires. The System is provided sterile and is intended for single use only.
The Aventus Thrombectomy Catheter includes an atraumatic radiopaque Distal Tip with embedded sensors, and an angled aspiration orifice for directional aspiration and navigation without a dilator. The Catheter Handle assists the clinician in navigating within the vasculature and 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.
The provided document is a 510(k) summary for the Aventus Thrombectomy System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive details on a de novo clinical study with specific acceptance criteria and detailed performance of an AI algorithm.
Therefore, the requested information regarding acceptance criteria, specific device performance metrics in a clinical context (like sensitivity, specificity, accuracy), sample sizes for test sets, expert qualifications, and ground truth establishment, is not present in this document. The document primarily addresses engineering and safety performance data, often leveraged from the predicate device, to support the claim of substantial equivalence.
Here's an analysis based on the information available in the document:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria for clinical performance (e.g., sensitivity, specificity, or success rates for thrombus removal in a clinical setting) or reported device performance against such metrics. Instead, it lists various engineering and safety performance tests and states that the "physical and functional requirements were met" and that the device "demonstrated that the System was able to be used safely ... and met all pre-defined study endpoints" in an animal study.
| Performance Testing Type | Criteria (Implicit from "met," "demonstrated," "complies") | Reported Device Performance (Summary) |
|---|---|---|
| Biocompatibility | No risk of negative interaction with patients | Materials do not pose a risk of negative interaction with patients. |
| Sterilization | SAL of 10^-6, meets pyrogen limit specifications | Achieved SAL of 10^-6, confirmed to meet pyrogen limit specifications. |
| Distribution, Packaging, Shelf-Life | Integrity of sterile barrier, preservation of properties | Demonstrated integrity of sterile barrier and preservation for 6-month shelf-life. |
| Software Testing | Complies with FDA Guidance | Documentation leveraged from predicate, as recommended by guidance. |
| Electrical Safety / EMC | Complies with IEC 60601-1, -1-2, -1-6, IEC 62366-1 | Complies with relevant IEC standards; electrical leak testing repeated on subject device. |
| Bench Performance Testing | Physical and functional requirements met | Physical and functional requirements were met (e.g., tensile strength, leak integrity, clot removal validation, vacuum, kink, simulated use, sensing verification). |
| Non-Clinical (GLP Animal Testing) | Safe usage in chronic large animal study; met pre-defined study endpoints | System was able to be used safely and met all pre-defined study endpoints in GLP animal study. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for any clinical or human-use test set. The animal study mentions a "chronic large animal GLP study," but an N is not given.
- Data Provenance: Not specified for any clinical or human-use data. The animal study was conducted in compliance with GLP regulation (21 CFR Part 58), which implies a controlled, prospective study design, but the location is not mentioned.
3. 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 information is not available in the document. The submission focuses on substantial equivalence based on material, engineering, and safety testing, not on a clinical performance study requiring expert ground truth establishment for diagnostic or treatment effectiveness.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the document, as there is no described clinical test set requiring expert adjudication for ground truth.
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
There is no mention of an MRMC study or AI assistance in this document. The device is a physical thrombectomy system, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is not an AI algorithm. It's a medical device system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the safety and performance tests described:
- Biocompatibility: Ground truth is established by standardized testing protocols (ISO 10993-1:2018) and the observation of biological responses to the materials.
- Sterilization: Ground truth is established by demonstrating a Sterility Assurance Level (SAL) and meeting pyrogen limits.
- Bench Performance: Ground truth is against predefined engineering specifications and physical properties (e.g., tensile strength values, leak rates, clot removal efficiency in a model).
- Non-Clinical (GLP Animal Testing): Ground truth is established by pre-defined study endpoints focusing on safety and functional performance in an animal model, observed by veterinary and research staff.
Ultimately, the ground truth for this submission is that the device is substantially equivalent to its predicate based on the provided engineering, safety, and non-clinical data.
8. The sample size for the training set
This information is not applicable as the device is not an AI algorithm.
9. How the ground truth for the training set was established
This information is not applicable as the device is not an AI algorithm.
{0}------------------------------------------------
February 26, 2025
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue and "ADMINISTRATION" in a smaller font size.
Inquis Medical Zachary Woodson VP of Regulatory Affairs & Ouality Assurance 1530 O'Brien Drive Suite A Menlo Park, California 94025
Re: K250202
Trade/Device Name: Aventus Thrombectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: OEW. KRA Dated: January 23, 2025 Received: January 24, 2025
Dear Zachary Woodson:
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"
{1}------------------------------------------------
(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 OS 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.
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 Rue"). 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-advicecomprehensive-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-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).
{2}------------------------------------------------
Sincerely,
Digitally signed by Gregory W. Gregory W. O'connell -S O'connell -S Date: 2025.02.26
14:46:42 -05'00'
Gregory O'Connell Assistant Director DHT2C: Division of Coronary And Peripheral Interventional Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
Submission Number (if known)
Device Name
Aventus Thrombectomy System
Indications for Use (Describe)
The Aventus Thrombectomy System is indicated for:
· The non-surgical removal of emboli and thrombi from blood vessels.
· Iniection, 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)
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."
{4}------------------------------------------------
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 lighter blue sans-serif font.
510(k) Summary
1. SUBMITTER
Inquis Medical 1530 O'Brien Drive, Ste. A Menlo Park, CA 94025
Contact Person: Zachary Woodson, VP of Regulatory Affairs & Quality Assurance
Date Prepared: 10 February 2025
II. DEVICE
Name of Device: Common or Usual Name: Classification Name: Regulatory Class: Product Code: Requlation Number:
Aventus Thrombectomy System Aspiration Thrombectomy Catheter Embolectomy Catheter Class II QEW, KRA 21 CFR 870.5150
= PREDICATE DEVICES
| Predicate Device: | Aventus Thrombectomy System (K240117) |
|---|---|
| Reference Device: | Flowtriever - Triever 24 (K213402) |
IV. DEVICE DESCRIPTION
The Aventus Thrombectomy System is a catheter-based manual aspiration svstem 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 Thrombectomy Catheter .
- Clot Management System consisting of:
- . Aspiration Syringe
- . Clot Canister
The System is compatible with a standard 24-French (24F) introducer sheath, 4F or 5F Navigation Catheters (based on Aventus Thrombectomy Catheter model) and is to be used with 0.035" guidewires. The System is provided sterile and is intended for single use only.
The Aventus Thrombectomy Catheter includes an atraumatic radiopaque Distal Tip with embedded sensors, and an angled aspiration orifice for directional aspiration and navigation without a dilator. The Catheter Handle assists the clinician in navigating within the vasculature and includes a Sensing Indicator and houses the Sensing electronics.
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the logo for Inquis Medical. The word "INQUIS" is in a bold, dark blue font, with a yellow circle in the middle of the "Q". Below that, the word "MEDICAL" is in a thinner, light blue font. The logo is simple and modern.
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. ●
- . Iniection, 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 K240117. The intended use of the subject device is the same as the predicate, namely removal of thrombi or emboli from the peripheral vasculature system and infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The subject and predicate devices share the same 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 the subject and predicate device incorporate disposable powered electronics and embedded software. From a manufacturing standpoint, both devices utilize shafts made with metallic (stainless steel) reinforced polymeric jackets 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 (with model IM-2200 Aventus Thrombectomy catheter), is modified from the predicate device (with model IM-2001 Aventus Thrombectomy Catheter) as follows:
- Simplification of lumen construction from three to one, re-routing of applicable ports, 1. and addition of Navigation Port valve.
-
- Repositioning of electrical wires to within the catheter wall.
-
- Removal of distal infusion holes.
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the logo for Inquis Medical. The word "INQUIS" is in a bold, sans-serif font, with a green circle in the middle of the "Q". Below that, the word "MEDICAL" is in a smaller, thinner, sans-serif font. The overall design is clean and modern.
| Performance Testing | Data provided |
|---|---|
| BiocompatibilityTesting | Biocompatibility testing was leveraged from the predicate device which was successfully completed inaccordance with ISO 10993-1:2018 and the FDA Guidance re: Use of ISO-10993. Testing included:• Cytotoxicity• Sensitization• Intracutaneous Reactivity• Acute Systemic Toxicity• Material Mediated Pyrogenicity• Hemocompatibility (Hemolysis, Complement Activation, Thrombogenicity)This testing demonstrated the materials of the Aventus Thrombectomy System do not pose a risk of negative interaction with patients. |
| Sterilization | Sterilization testing was leveraged from the predicate device which was successfully completed inaccordance with ISO 14937:2009 - Sterilization of health care products - General requirements forcharacterization of a sterilizing agent and the development, validation and routine control of a sterilizationprocess for medical devices and demonstrated an SAL of 10-6.Bacterial endotoxins test (BET), a.k.a. Limulus amebocyte lysate (LAL) testing was conducted on thepredicate device per current test guidelines: USP <85> Bacterial Endotoxin Test and AAMI ST72Bacterial endotoxins- test methodologies, routine monitoring and alternatives to batch testing andconfirmed that the System meets established pyrogen limit specifications. |
| Distribution,Packaging and Shelf-Life Testing | Distribution and packaging testing was leveraged from the predicate device which successfullydemonstrated the integrity of the sterile barrier and preservation of the System's properties.Shelf-life testing was leveraged from the predicate device which has demonstrated preservation of theSystem's properties for the labeled six-month shelf-life. |
| Software Testing | Software documentation was leveraged from the predicate device as recommended by FDA Guidance:Content of Premarket Submissions for Device Software Functions, issued June 14, 2023. |
| Electrical Safety / EMCTesting | Electrical Safety and EMC testing were leveraged from the predicate device to ensure the subject devicecomplies with the requirements of IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6 and IEC 62366-1.Electrical Leak Testing per IEC 60601-1 was repeated on the subject device. |
| Performance Testing –Bench | Design verification testing was performed and demonstrated that the physical and functional requirementswere met.Specifically, the following was tested:• Visual & 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 |
| Performance Testing –Non-Clinical | GLP animal testing completed in compliance with GLP regulation (21 CFR Part 58) and in accordancewith FDA Guidance: General Considerations for Animal Studies for Cardiovascular Devices (July2010) and FDA Guidance: General Considerations for Animal Studies Intended to Evaluate Medicaldevices (March 2023) provided for the predicate device, was leveraged for the subject device anddemonstrated that the System was able to be used safely in a chronic large animal GLP study and metall pre-defined study endpoints. |
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the logo for Inquis Medical. The word "INQUIS" is in a bold, sans-serif font, with a green lemon shape in the middle of the "Q". Below that, the word "MEDICAL" is in a thinner, sans-serif font.
VIII. CONCLUSIONS
In conclusion, the intended use, indications for use, and technological characteristics of the Aventus Thrombectomy System are the same or equivalent to the predicate devices. Performance testing has demonstrated that the Aventus Thrombectomy System is substantially equivalent to the predicate device.
§ 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).