(59 days)
Aventus Thrombectomy System (K232730)
No
The description focuses on mechanical and electronic components for aspiration and navigation, with no mention of AI/ML algorithms for data processing, decision-making, or image analysis. The "Sensing electronics" and "Sensing Indicator" suggest basic sensor data processing, not AI/ML.
Yes
The device is intended for the "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," which are therapeutic actions aimed at treating medical conditions.
No.
The Aventus Thrombectomy System is described as a "catheter-based manual aspiration system designed for minimally invasive removal of emboli and thrombi" and for "injection, infusion, and/or aspiration of contrast media and other fluids." These functions are therapeutic (removing clots, infusing/aspirating fluids) rather than diagnostic (identifying or characterizing a disease or condition). Although it includes "Sensing electronics" and a "Sensing Indicator" for navigation, its primary intended use is interventional rather than diagnostic.
No
The device description explicitly lists hardware components such as catheters, syringes, and canisters. While it mentions "Sensing electronics" and "Software documentation," the core function and components are physical medical devices.
Based on the provided information, the Aventus Thrombectomy System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is the "non-surgical removal of emboli and thrombi from blood vessels" and "Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel." This describes a therapeutic and interventional procedure performed directly on the patient's body, not a test performed on samples taken from the body.
- Device Description: The device 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." This further reinforces its role in a direct medical intervention.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (like blood, urine, tissue, etc.) to provide information about a patient's health status, diagnose a condition, or monitor treatment.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. The Aventus Thrombectomy System is a therapeutic device used to physically remove blockages from blood vessels.
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
QEW, 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 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.
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)
- Biocompatibility Testing: Leveraged from the predicate device (ISO 10993-1:2018 and FDA Guidance). Tested for Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Hemocompatibility (Hemolysis, Complement Activation, Thrombogenicity). Demonstrated materials do not pose a risk of negative interaction with patients.
- Sterilization: Leveraged from the predicate device (ISO 14937:2009). Demonstrated an SAL of 10-6. Bacterial endotoxins test (BET) or Limulus amebocyte lysate (LAL) testing conducted per USP and AAMI ST72, confirmed System meets pyrogen limit specifications.
- Distribution, Packaging and Shelf-Life Testing: Distribution testing completed on subject device, demonstrating integrity of sterile barrier and preservation of System's properties. Accelerated Aging simulating six-month shelf life leveraged from predicate, showing integrity of sterile barrier and preservation of properties for labeled six-month shelf-life.
- Software Testing: Software documentation, including successful software verification and validation testing, provided as recommended by FDA Guidance: "Content of Premarket Submissions for Device Software Functions", issued June 14, 2023.
- Electrical Safety / EMC Testing: Conducted on the Aventus Thrombectomy System. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6 and IEC 62366-1.
- Performance Testing - Bench: Design verification testing performed, demonstrating physical and functional requirements were met. Specifically, 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 testing leveraged from the predicate based on no change in the shaft constructions or materials.
- Performance Testing - Non-Clinical: GLP animal study 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 all pre-defined study endpoints.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Aventus Thrombectomy System (K232730)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Indigo Aspiration System - Lightning Aspiration Tubing (K193244)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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)
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
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
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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 |
|---|---|
| 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 subject 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 testing was successfully completed on the subject device;
final packaging and device performance were successfully tested
demonstrating integrity of the sterile barrier and preservation of the
System's properties.
Accelerated Aging simulating six-month shelf life was leveraged from
the predicate and final packaging and device performance were
successfully tested demonstrating integrity of the sterile barrier and
preservation of the System's properties for the labeled six-month shelf-
life. |
| Software Testing | Software documentation, including successful software verification and
validation 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 Aventus
Thrombectomy System. The subject device complies with the
requirements of IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6 and IEC
62366-1. |
| Performance Testing -
Bench | Design verification testing was performed demonstrated that the physical
and 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: 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 all pre-defined study endpoints. |
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Image /page/6/Picture/1 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 also in a dark blue sans-serif font.
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.