(28 days)
The FlowSaver Blood Return System is used with Inari Medical catheters and sheaths for autologous blood transfusion.
The FlowSaver Blood Return System accessory allows for autologous injection of aspirated blood from Inari Medical catheters and sheaths during embolectomy procedures by dual layer 40 µm/200 µm filtration to minimize intraprocedural blood loss.
The provided text describes the 510(k) summary for the Inari Medical FlowSaver Blood Return System. This document is a premarket notification for a medical device and therefore does not contain information about an AI/ML device that requires traditional acceptance criteria and performance studies for diagnostic accuracy.
The FlowSaver Blood Return System is an autotransfusion apparatus. The submission is for an expansion of indications for an already cleared predicate device (K221483), allowing its use with Inari Medical catheters and sheaths for autologous blood transfusion and with a 30 cc large bore syringe.
Therefore, many of the requested details such as acceptance criteria for diagnostic performance, sample size for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for an AI/ML system are not applicable to this type of device and submission.
Instead, the submission focuses on demonstrating that the modified device remains substantially equivalent to its predicate through non-clinical testing.
Here's the information that can be extracted or stated as not applicable based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document does not specify quantitative acceptance criteria in a typical "table" format for diagnostic performance. Instead, it states that "Mechanical hemolysis testing was performed to demonstrate substantial equivalence to the predicate." It also lists various leveraged non-clinical tests without specific, quantitative acceptance criteria numbers in this summary. The implicit acceptance criterion is that the device performs comparably to the predicate and meets safety/performance standards for its intended use.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
Not applicable for diagnostic accuracy as this is not an AI/ML diagnostic device. The document mentions "Design verification testing was not required to support substantial equivalence for the expanded indications" and lists leveraged tests from previous submissions (K210176 and K221483). These are likely engineering and performance tests on physical devices rather than data from patient studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable, as this is not an AI/ML diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as this is not an AI/ML diagnostic device requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable, as this is not an AI/ML device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is a physical medical device (autotransfusion apparatus), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable, as this is not an AI/ML diagnostic device requiring ground truth for diagnostic accuracy. The "ground truth" for this device would be established engineering and performance specifications and biological compatibility (e.g., hemolysis levels).
8. The sample size for the training set:
Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established:
Not applicable, as this is not an AI/ML device.
Summary of Device Performance (Based on provided text, not in typical AI/ML format):
The device is deemed to meet acceptance criteria through a demonstration of substantial equivalence to an already cleared predicate device (K221483). This is supported by:
- Identical intended use, principles of operation, fundamental scientific technology, and technological characteristics compared to the predicate device.
- Non-clinical testing leveraging previous submissions (K210176 and K221483):
- Visual Inspection
- Dimensional Inspection
- Engagement & Disengagement Force Testing
- Flow Rate Testing
- Media Integrity testing
- Leakage Testing
- Vacuum Testing
- Clot Burden Filtration Validation
- Simulated Use and Tensile Testing
- Simulated Use and Torque Testing
- Burst Testing
- Particulate Matter Determination
- Filtration Efficiency
- Specific mechanical hemolysis testing performed for the current submission to demonstrate substantial equivalence to the predicate.
- Sterilization validation in accordance with ISO 11135:2014/Amd 1:2018 and AAMI TIR 28:2016 to achieve a sterility assurance level (SAL) of 10-6.
The conclusion states that "The verification testing results demonstrate that the proposed FlowSaver Blood Return System is substantially equivalent to the predicate device." This implies the device performed acceptably across all these tests, meeting the safety and performance standards equivalent to the predicate.
§ 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).