(55 days)
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.
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:
- Aspiration Catheter
- 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 Aspiration Catheter includes an atraumatic radiopaque Distal Tip with angled aspiration orifice for directional aspiration and navigation without a dilator, a dedicated navigation catheter lumen with integrated Navigation Catheter, a dedicated infusion lumen for injection of fluids, and a Handle designed to navigate within the vasculature. The Aspiration Catheter shaft incorporates a metallic reinforcement made of stainless steel, an inner liner and polymeric jacket material with 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 text describes a 510(k) premarket notification for the Aventus Thrombectomy System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study proving the device meets those criteria in a clinical or AI performance context.
The document does not contain information related to AI/software performance, human reader studies, or explicit acceptance criteria for such an AI system. It primarily details the physical and functional characteristics of a medical device (a thrombectomy catheter) and its non-clinical performance testing (biocompatibility, sterilization, bench testing, and animal studies).
Therefore, I cannot provide the requested information, which pertains to the performance validation of an AI/software device. The provided text describes the regulatory filing for a physical medical device, not an AI or software product.
Based on the provided text, the device is a physical medical device (Aventus Thrombectomy System), not an AI/software product. Therefore, the requested information (AI acceptance criteria, human reader studies, ground truth establishment for AI, etc.) is not present in the document.
The document details the following performance data, which are typical for physical medical devices seeking 510(k) clearance:
- Biocompatibility Testing: Successful completion per ISO 10993-1:2018 (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Hemocompatibility). This demonstrated no risk of negative interaction with patients.
- Sterilization Testing: Successful completion per ISO 14937:2009, with a demonstrated SAL of 10^-6. Bacterial endotoxins test (BET) also confirmed meeting pyrogen limit specifications.
- Distribution, Packaging and Shelf-Life Testing: Successful completion of distribution testing and accelerated aging simulating a six-month shelf-life, demonstrating integrity of the sterile barrier and preservation of properties.
- Performance Testing - Bench: Design verification testing demonstrated physical and functional requirements were met. Specific tests included: Visual and Dimensional Inspection, Tensile Strength, Pressure/Leak Integrity, Clot Burden Removal Validation, Vacuum Test, Leak Test, Pouch Seal Visual Inspection and Bubble Test, Pouch Seal Strength, Compatibility Testing, Torque Transmission Testing, Kink Testing, Kink and Torque to Failure, Simulated-Use.
- Performance Testing – Non-Clinical (GLP Animal Study): A GLP animal study demonstrated the system could be used safely in a chronic large animal study and met all pre-defined study endpoints.
The document does not describe any acceptance criteria or studies related to AI/software performance, such as sensitivity, specificity, human reader performance, or ground truth derived from expert consensus/pathology. Thus, I cannot populate the table or answer the specific questions about AI/software validation.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 1, 2023
Inquis Medical Moigan Saadat, President 1755 East Bayshore Road, Suite 26 Redwood City, California 94063
Re: K232730
Trade/Device Name: Aventus Thrombectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEW, KRA Dated: September 6, 2023 Received: September 7, 2023
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 (OS) 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,
Gregory W. Digitally signed by O'connell -S 10:39:32 -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
510(k) Number (if known) K232730
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) |
|---|
| ------------------------------------------------- |
X 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 contains the logo for Inquis Medical. The word "INQUIS" is in large, bold, dark blue font, with a green circle in the middle of the "Q". Below that, the word "MEDICAL" is in a smaller, lighter blue font. The logo is simple and modern.
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: September 6, 2023
II. DEVICE
Name of Device: Common or Usual Name: Classification Name: Regulatory Class: Product Code: Regulation Number:
Aventus Thrombectomy System Aspiration Thrombectomy Catheter Embolectomy Catheter Class II QEW, KRA 21 CFR 878.5150
III. PREDICATE/REFERENCE DEVICE
| Predicate Device: | Malibu Aspiration Catheter (K223929) |
|---|---|
| Reference Device: | AngioDynamics: AlphaVac Multipurpose Mechanical Aspiration(MMA) F1885 System (K213388) |
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:
- Aspiration Catheter •
- . 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 Aspiration Catheter includes an atraumatic radiopaque Distal Tip with angled aspiration orifice for directional aspiration and navigation without a dilator, a dedicated navigation catheter lumen with integrated Navigation Catheter, a dedicated infusion lumen for injection of fluids, and
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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.
a Handle designed to navigate within the vasculature. The Aspiration Catheter shaft incorporates a metallic reinforcement made of stainless steel, an inner liner and polymeric jacket material with 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: Malibu Aspiration Catheter cleared under K223929. 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 injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The subject and predicate device share similar technological characteristics in that both devices are large bore aspiration catheters which utilize a 60-cc manual syringe as the aspiration source. Both devices utilize a dedicated infusion port for injection and infusion of contrast media and other fluids into or from the blood vessel. Both devices utilize similar construction such as metallic (stainless steel) reinforcement and a polvmeric jacket with variable stiffness for the shaft, radiopaque markings at the distal tip for fluoroscopic visualization, and use of flow-control valves to direct the flow of fluids.
The subject device differs from the predicate device in that it incorporates additional features that increase the convenience of use and does not include any coating or surface materials like the predicate device.
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 inside the "Q". Below that, the word "MEDICAL" is in a thinner, sans-serif font. The overall design is clean and modern.
| Performance Testing | Data provided |
|---|---|
| BiocompatibilityTesting | Biocompatibility testing was successfully completed in accordance withISO 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, ComplementActivation, 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 successfully completed in accordance with ISO14937:2009 - Sterilization of health care products – Generalrequirements for characterization of a sterilizing agent and thedevelopment, validation and routine control of a sterilization process formedical devices and demonstrated an SAL of 10-6. |
| Bacterial endotoxins test (BET), a.k.a. Limulus amebocyte lysate | |
| (LAL) testing was conducted per current test guidelines: USP <85> | |
| 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 limitspecifications. | |
| Distribution,Packaging and Shelf-Life Testing | Distribution testing and Accelerated Aging simulating six-month shelflife was successfully completed. |
| 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. | |
| 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 Tensile Strength Pressure/ Leak Integrity Clot Burden Removal Validation Vacuum Test Leak Test Pouch Seal Visual Inspection and Bubble Test Pouch Seal Strength Compatibility Testing Torque Transmission Testing Kink Testing Kink and Torque to Failure Simulated-Use |
| Performance Testing | Data provided |
| Performance Testing –Non-Clinical | A GLP animal study was completed in compliance with GLPregulation (21 CFR Part 58) and in accordance with FDA Guidance:General Considerations for Animal Studies for CardiovascularDevices (July 2010) and FDA Guidance: General Considerations forAnimal Studies Intended to Evaluate Medical devices (March 2023),demonstrated 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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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 yellow circle in the "Q". Below that, the word "MEDICAL" is in a lighter blue 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 device. 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).