(91 days)
The Aventus Clot Management System is indicated for use with the Aventus Thrombectomy System for autologous blood transfusion.
The Aventus Clot Management System accessory allows for autologous injection of aspirated blood from the Aventus Thrombectomy System embolectomy procedure. The sterile, single-use Aventus Clot Management System is comprised of the following two components:
- Aspiration Syringe
- . Clot Canister
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 Clot Canister connects to the Aspiration Syringe via quick disconnect connector at the inlet port on the side of the Canister. The aspirant from the Aventus Thrombectomy System procedure is injected into the Clot Canister. The blood passes through the Clot Canister dual layer nominal 40u/200u polyester screen filter, filling a syringe pre-connected to the female luer lock that is positioned below the filter assembly. The clinician can then return the filtered blood back to the patient via a standard sterile syringe with a required suitable blood transfusion filter (not provided).
The Clot Canister also has a flush port with a standard 3-way stopcock positioned above the filter assembly where an additional syringe can be attached to inject saline or air to assist in clot visualization without removing the lid.
The provided text describes a 510(k) premarket notification for the Aventus Clot Management System. The document focuses on regulatory approval and substantial equivalence to a predicate device, rather than detailed performance study results with specific acceptance criteria and performance metrics for an AI/ML component.
Therefore, I cannot provide the information requested in the format of acceptance criteria and reported device performance, sample sizes for test and training sets, expert qualifications, or details about MRMC studies. The device is a physical medical device (Autotransfusion apparatus), not an AI/ML-driven device, so many of the requested technical details are not applicable or present in this regulatory document.
However, I can extract the general performance testing categories that were conducted.
The document indicates that Inquis Medical performed comprehensive non-clinical bench testing to demonstrate that the device met all required specifications and performs as intended.
Here's what information I can glean from the provided text regarding performance testing, even without specific acceptance criteria and numerical results:
General Performance Testing Categories
The following categories of performance data were provided in support of the substantial equivalence determination:
-
Biocompatibility Testing:
- Tests Conducted: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Hemocompatibility (Hemolysis, Complement Activation, Thrombogenicity).
- Guidance: Conducted in accordance with FDA Guidance Document for the Use of International Standard ISO 10993-1.
- Conclusion: Demonstrated that the materials do not pose a risk of negative interaction with patients.
-
Sterilization:
- Tests Conducted: Sterilization testing and Bacterial Endotoxins Test (BET)/Limulus amebocyte lysate (LAL) testing.
- Guidance/Standard: ISO 14937:2009 for sterilization, USP <85> and AAMI ST72 for BET.
- Conclusion: Demonstrated an SAL of 10^-6 and confirmed the system meets established pyrogen limit specifications.
-
Distribution, Packaging, and Shelf-Life Testing:
- Tests Conducted: Distribution testing and accelerated aging.
- Conclusion: Successfully tested demonstrating integrity of the sterile barrier and preservation of properties through the labeled shelf-life.
-
Performance Testing – Bench:
- Tests Conducted: Visual and Dimensional Inspection, Tensile Strength, Pressure/Leak Integrity, Clot Burden Removal Validation, Vacuum Test, Leak Test, Compatibility Testing, Simulated-Use Particulate Testing, Hematocrit Testing, Mechanical Hemolysis Testing, Filtration Efficiency.
- Conclusion: Design verification testing demonstrated that physical and functional requirements were met.
-
Performance Testing – Non-Clinical (Animal Study):
- Type of Study: GLP animal study (chronic large animal GLP study).
- Guidance: Complied with GLP regulation (21 CFR Part 58) and 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).
- Conclusion: Demonstrated that the device was able to be used safely to return aspirated blood and met all pre-defined study endpoints.
Note: The document does not contain specific quantitative acceptance criteria or numerical results for any of these tests, nor does it refer to an AI/ML component or associated studies like MRMC or standalone algorithm performance. The focus is on the substantial equivalence of the physical device to a predicate device.
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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, followed by the words "U.S. FOOD & DRUG" in large, bold, blue letters, and the word "ADMINISTRATION" in smaller, blue letters below.
May 14, 2024
Inquis Medical Mojgan Sadaat Official Correspondent 127 Independence Drive Menlo Park, California 94025
Re: K240426
Trade/Device Name: Aventus Clot Management System Regulation Number: 21 CFR 868.5830 Regulation Name: Autotransfusion apparatus Regulatory Class: Class II Product Code: CAC Dated: February 13, 2024 Received: April 22, 2024
Dear Mojgan Sadaat:
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 (OS) 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.
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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-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,
Eric E. Richardson -S 2024.05.14 11:31:38 -04'00'
for Nicole Gillette
Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
Aventus Clot Management System
Indications for Use (Describe)
The Aventus Clot Management System is indicated for use with the Aventus Thrombectomy System for autologous blood transfusion.
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. 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: April 22, 2024
II. DEVICE
| Name of Device: | Aventus Clot Management System |
|---|---|
| Common or Usual Name: | Autotransfusion Apparatus |
| Classification Name: | Autotransfusion Apparatus |
| Regulatory Class: | Class II |
| Product Code: | CAC |
| Regulation Number: | 21 CFR 868.5830 |
III. PREDICATE DEVICES
Predicate Device:
FlowSaver Blood Return System (K210176)
IV. DEVICE DESCRIPTION
The Aventus Clot Management System accessory allows for autologous injection of aspirated blood from the Aventus Thrombectomy System embolectomy procedure. The sterile, single-use Aventus Clot Management System is comprised of the following two components:
- Aspiration Syringe
- . Clot Canister
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 Clot Canister connects to the Aspiration Syringe via quick disconnect connector at the inlet port on the side of the Canister. The aspirant from the Aventus Thrombectomy System procedure is injected into the Clot Canister. The blood passes through the Clot Canister dual layer nominal 40u/200u polyester screen filter, filling a syringe pre-connected to the female luer lock that is positioned below the filter assembly. The clinician can then return the filtered blood back to the patient via a standard sterile syringe with a required suitable blood transfusion filter (not provided).
The Clot Canister also has a flush port with a standard 3-way stopcock positioned above the filter assembly where an additional syringe can be attached to inject saline or air to assist in clot visualization without removing the lid.
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Image /page/5/Picture/0 description: The image contains 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.
V. INDICATIONS FOR USE
The Aventus Clot Management System is indicated for use with the Aventus Thrombectomy System for autologous blood transfusion.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The subject device, Aventus Clot Management System, is substantially equivalent to the predicate device: FlowSaver Blood Return System cleared under K210176. The intended use of the subject device is the same as the predicate in that both devices are intended to be used to return blood to a patient after filtration. The collection method for both the subject device and predicate device is through vacuum aspiration.
The subject device and predicate device share the same technological characteristics in that both devices include an aspiration syringe that connects to the aspiration catheter and injects the blood/clot into the blood return device using positive pressure and a second syringe for removing the filtered blood via negative pressure. Both devices have a dual layer filtration for separating clot from aspirated blood. Both devices use a suitable blood transfusion filter (not provided). Both devices can be opened to remove clot and flushed between filtrations. Both devices utilize a dedicated "inlet" for aspirated blood and "outlet" to remove filtered blood.
The subject device includes a third port for flushing the filter assembly which improves the convenience of use but does not change the principle of operation or blood filtration.
VII. PERFORMANCE DATA
Inquis Medical performed comprehensive testing on the Clot Management System, including non-clinical bench testing to demonstrate that the device met all required specifications and performs as intended. The following performance data were provided in support of the substantial equivalence determination.
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Image /page/6/Picture/1 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.
| Performance Testing | Data provided |
|---|---|
| BiocompatibilityTesting | Biocompatibility testing was conducted in accordance FDA GuidanceDocument for the Use of International Standard ISO 10993-1, "Biologicalevaluation of medical devices - Part 1: Evaluation and testing within a riskmanagement process" (September 2023). 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 Clot ManagementSystem do not pose a risk of negative interaction with patients. |
| Sterilization | Sterilization testing successfully completed in accordance with ISO14937:2009 - Sterilization of health care products — General requirementsfor characterization of a sterilizing agent and the development, validationand routine control of a sterilization process for medical devices anddemonstrated an SAL of 10-6.Bacterial endotoxins test (BET), a.k.a. Limulus amebocyte lysate (LAL)testing was conducted on the subject device per current test guidelines:USP <85> Bacterial Endotoxin Test and AAMI ST72 Bacterialendotoxins- test methodologies, routine monitoring and alternatives tobatch testing and confirmed that the System meets established pyrogenlimit specifications. |
| Distribution,Packaging and Shelf-Life Testing | Distribution testing and accelerated aging were successfully completed onthe subject device; final packaging and device performance weresuccessfully tested demonstrating integrity of the sterile barrier andpreservation of the subject device's properties through the labeled shelf-life. |
| Performance Testing –Bench | Design verification testing was performed demonstrated that the physical andfunctional 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 Compatibility Testing Simulated-Use Particulate Testing Hematocrit Testing Mechanical Hemolysis Testing Filtration Efficiency |
| Performance Testing | Data provided |
| Performance Testing –Non-Clinical | The GLP animal study completed in compliance with GLP regulation (21 CFR Part 58) and in accordance with FDA Guidance: GeneralConsiderations for Animal Studies for Cardiovascular Devices (July 2010) and FDA Guidance: General Considerations for Animal Studies Intendedto Evaluate Medical devices (March 2023) for the subject device anddemonstrated that the device was able to be used safely to return aspiratedblood in a chronic large animal GLP study and met all pre-defined studyendpoints. |
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Image /page/7/Picture/1 description: The image contains the logo for Inquis Medical. The word "INQUIS" is in a dark blue color, with the "O" replaced by a yellow-green circle. Below that, the word "MEDICAL" is in a lighter blue color. The font is sans-serif and modern.
VIII. CONCLUSIONS
In conclusion, the intended use, indications for use, and technological characteristics of the Aventus Clot Management System are the same or equivalent to the predicate device. Performance testing has demonstrated that the Aventus Clot Management System is substantially equivalent to the predicate devices.
§ 868.5830 Autotransfusion apparatus.
(a)
Identification. An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.(b)
Classification. Class II (performance standards).