(181 days)
The FlowSaver Blood Return System is used with Triever Catheters for autologous blood transfusion.
The FlowSaver Blood Return System accessory allows for autologous injection of aspirated blood from the FlowTriever Retrieval/Aspiration System embolectomy procedure. The sterile (EO), single use FlowSaver Blood Return System is comprised of 2 components: • FlowSaver Blood Filter • 60 cc Luer Lock Syringe The FlowSaver Blood Filter has a sideport with a female quick connector for connection to the 60 cc Large Bore Vacuum Syringe (provided with Triever Catheter). Another standard Luer lock 60 cc syringe (provided) is attached to the needleless valve integrated into the FlowSaver's cap. The aspirant from a Triever Catheter embolectomy procedure is injected into the FlowSaver Blood Filter. Blood passes through the FlowSaver's dual layer 40 μ/200 μ polyester screen filter, filling the 60 cc syringe pre-connected to the female Luer Lock that is integrated into the cap of the filter housing. The 60 cc syringe is disconnected and its contents are injected through a suitable transfusion filter (minimum requirement 40 micron filter) prior to immediately reinjecting collected blood through an access sheath or catheter. FlowSaver's threaded cap with filter may be detached allowing rinsing with saline to remove thrombus and permit re-use if another Triever aspiration is performed. The FlowSaver may be used for up to five filtrations.
The provided text is a 510(k) summary for the Inari Medical FlowSaver Blood Return System. This document focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance, rather than presenting a performance study against specific acceptance criteria for an AI/device's diagnostic or predictive capabilities. Therefore, I cannot extract the information required to answer your prompt about acceptance criteria and a study proving a device meets these criteria, especially concerning AI performance, MRMC studies, or specific ground truth methodologies.
The document details:
- Device Description: The FlowSaver Blood Return System accessory is used with Triever Catheters for autologous blood transfusion. It consists of a FlowSaver Blood Filter and a 60 cc Luer Lock Syringe. It filters aspirated blood through dual-layer 40 µ/200 µ polyester screens.
- Intended Use: Autologous blood transfusion.
- Comparison to Predicate: The FlowSaver is compared to the CellTrans Postoperative Autotransfusion Set (K024097) and deemed substantially equivalent due to similar intended use and technological characteristics (filtration through 40-micron filters, vacuum aspiration, polyester screens).
- Non-Clinical Testing: A list of verification and validation tests performed to demonstrate compliance with product requirements, including:
- Visual and Dimensional Inspection
- Engagement & Disengagement Force Testing
- Flow Rate Testing
- Media Integrity testing
- Leakage Testing
- Vacuum Testing
- Clot Burden Filtration Validation
- Preconditioning/Simulated Use and Tensile/Torque Testing
- Burst Testing
- Hematocrit Testing
- Mechanical Hemolysis Testing
- Filtration Efficiency
- Particulate Matter Determination
- Biocompatibility Testing: Conducted according to ISO 10993-1 guidelines, passing various tests such as Elution, Sensitization, Intracutaneous Injection, Systemic Injection, Pyrogen, Hemolysis, UPTT, Complement Activation, and Platelet/Leukocyte Count.
- Clinical Testing: "Clinical testing was not required for the determination of substantial equivalence."
In summary, there is no information in this document about:
- A table of acceptance criteria for diagnostic/predictive performance.
- Reported device performance against specific metrics (e.g., sensitivity, specificity, AUC).
- Sample size for test sets, data provenance related to AI.
- Number of experts, their qualifications, or adjudication methods for ground truth in an AI context.
- MRMC studies or effect sizes of human reader improvement with AI.
- Standalone algorithm performance.
- Type of ground truth used for AI (as this is not an AI device).
- Training set sample size or how its ground truth was established for an AI model.
This document is a regulatory submission for a medical device that performs a mechanical function (blood filtration for autotransfusion), not an AI/ML-driven diagnostic or treatment support system. Therefore, the questions related to AI performance, ground truth, and reader studies are not applicable to the content provided.
§ 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).