(20 days)
No
The description focuses on the mechanical and electronic components for manual aspiration and sensing, with no mention of AI or ML algorithms for data processing or decision-making.
Yes
The device is indicated for "non-surgical removal of emboli and thrombi from blood vessels," which directly addresses and treats a medical condition.
No
Explanation: The Aventus Thrombectomy System is described as a device for "non-surgical removal of emboli and thrombi from blood vessels" and for "injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel." Its primary function is therapeutic (removal of clots and fluid management), not to diagnose a condition. While it has "Sensing electronics" and performs "Verification and Validation of Sensing," the purpose of this sensing is related to navigation and function of the thrombectomy procedure, not for diagnostic analysis of a patient's condition.
No
The device description clearly outlines multiple hardware components including a catheter, syringe, clot canister, and associated materials like stainless steel and polymeric jackets. While it mentions "Sensing electronics" and "Software Testing," the core functionality and components are physical.
Based on the provided information, the Aventus Thrombectomy System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Aventus Thrombectomy System Function: The Aventus Thrombectomy System is a medical device used within the body (in the peripheral vasculature) to physically remove blood clots and infuse/aspirate fluids. It does not analyze samples taken from the body.
The description clearly indicates it's a catheter-based system for a surgical/interventional procedure, not a laboratory test or analysis of biological samples.
N/A
Intended Use / 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.
Product codes
OEW, KRA
Device Description
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 Thrombectomy Catheter .
- Clot Management System consisting of:
- . Aspiration Syringe
- . Clot Canister
The System is compatible with standard introducer sheaths (24F or 16F). 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing:
Biocompatibility Testing: Biocompatibility testing was leveraged from the predicate device which was successfully completed in accordance 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 in accordance with ISO 14937:2009 - Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process 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 the predicate device per current test guidelines: USP Bacterial Endotoxin Test and AAMI ST72 Bacterial endotoxins- test methodologies, routine monitoring and alternatives to batch testing and confirmed 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 successfully demonstrated 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 the System's properties for the labeled six-month shelf-life.
Software Testing: Software documentation and testing was updated from the predicate device 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 leveraged from the predicate device to ensure the subject device complies 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 requirements were 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 accordance with FDA Guidance: General Considerations for Animal Studies for Cardiovascular Devices (July 2010) and FDA Guidance: General Considerations for Animal Studies Intended to Evaluate Medical devices (March 2023) provided for the predicate device, was leveraged for the subject device and demonstrated that the System was able to be used safely in a chronic large animal GLP study and met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Aventus Thrombectomy System (K250202)
Reference Device(s)
Flowtriever - Triever 16 (K213402)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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March 25, 2025
Inquis Medical Zachary Woodson VP of Regulatory Affairs & Quality Assurance 1530 O'Brien Drive Suite A Menlo Park, California 94025
Re: K250668
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: March 5, 2025 Received: March 5, 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.
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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).
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.
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-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 medical devices and radiation-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-regulatory
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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).
Sincerely,
Digitally signed by GREGORY W. GREGORY W. O'CONNELL -S 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
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.
· 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/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: 24 March 2025
ll. 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 (K250202) |
|---|---|
| Reference Device: | Flowtriever - Triever 16 (K213402) |
IV. DEVICE DESCRIPTION
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 Thrombectomy Catheter .
- Clot Management System consisting of:
- . Aspiration Syringe
- . Clot Canister
The System is compatible with standard introducer sheaths (24F or 16F). 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.
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Image /page/5/Picture/0 description: The image shows the logo for Inquis Medical. The word "INQUIS" is in a dark blue sans-serif font, with a lime green circle in the middle of the "Q". Below that, the word "MEDICAL" is in a lighter blue sans-serif font.
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 K250202. 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-2100 Aventus Thrombectomy catheter), is modified from the predicate device (with Model IM-2200 Aventus Thrombectomy catheter) as follows:
-
- Reduction of the catheter diameter.
-
- Update of the device software to refine the algorithm and account for the reduction in diameter.
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
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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 leaf-like shape incorporated into the "Q". Below this, in a smaller font, is the word "MEDICAL". The overall design is clean and modern.
| Performance Testing | Data provided |
|---|---|
| Biocompatibility | |
| Testing | Biocompatibility testing was leveraged from the predicate device which was successfully completed in |
| accordance 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 in |
| accordance with ISO 14937:2009 - Sterilization of health care products — General requirements for | |
| characterization of a sterilizing agent and the development, validation and routine control of a sterilization | |
| process 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 the
predicate device per current test guidelines: USP Bacterial Endotoxin Test and AAMI ST72
Bacterial endotoxins- test methodologies, routine monitoring and alternatives to batch testing and
confirmed 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 successfully
demonstrated 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 the
System's properties for the labeled six-month shelf-life. |
| Software Testing | Software documentation and testing was updated from the predicate device 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 leveraged from the predicate device to ensure the subject device
complies 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 requirements
were 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 accordance
with FDA Guidance: General Considerations for Animal Studies for Cardiovascular Devices (July
2010) and FDA Guidance: General Considerations for Animal Studies Intended to Evaluate Medical
devices (March 2023) provided for the predicate device, was leveraged for the subject device and
demonstrated that the System was able to be used safely in a chronic large animal GLP study and met |
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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 circle 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 and reference devices.