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.

AI/ML Overview

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.

Summary

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July 14, 2023

Inari Medical, Inc. Kaitlyn Weinkauf Sr. Regulatory Affairs Specialist 6001 Oak Canvon. Suite 100 Irvine, California 92618

Re: K231782

Trade/Device Name: FlowSaver Blood Return System Regulation Number: 21 CFR 868.5830 Regulation Name: Autotransfusion Apparatus Regulatory Class: Class II Product Code: CAC Dated: June 16, 2023 Received: June 16, 2023

Dear Kaitlyn Weinkauf:

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 (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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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,

Kathleen M. Grunder -S

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

510(k) Number (if known) K231782

Device Name FlowSaver Blood Return System

Indications for Use (Describe)

The FlowSaver Blood Return System is used with Inari Medical catheters and sheaths for autologous blood transfusion.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

Date prepared	July 14, 2023
Name	Inari Medical, Inc.6001 Oak Canyon, Suite 100Irvine, CA 92618949.600.8433
Contact person	Kaitlyn WeinkaufSr. Regulatory Affairs Specialist
Trade Name	FlowSaver Blood Return System
Common name	Blood filter
Regulation name	Autotransfusion apparatus
Classification number	21 CFR 868.5830
Product code	CAC
Regulatory class	II
Predicate device	Inari Medical, FlowSaver Blood Return System (K221483)
Description	The FlowSaver Blood Return System accessory allows for autologous injection ofaspirated blood from Inari Medical catheters and sheaths during embolectomyprocedures by dual layer 40 µm/200 µm filtration to minimize intraprocedural bloodloss.
Indications for Use	The FlowSaver Blood Return System is used with Inari Medical catheters andsheaths for autologous blood transfusion.
Device Modifications	The purpose of this submission is to expand the indications of the FlowSaver BloodReturn System to be used with Inari Medical catheters and sheaths for autologousblood transfusion, and for use with the 30 cc large bore syringe.
Comparison ofTechnologicalCharacteristics withthe Predicate Device	There is no change to the intended use, technological characteristics, principles ofoperation, or fundamental scientific technology between the proposed FlowSaverBlood Return System and the predicate device.
Summary ofsubstantial equivalence	The proposed FlowSaver Blood Return System and the predicate device have thesame intended use, principles of operation, fundamental scientific technology, andtechnological characteristics.
	Non-Clinical Testing
	Design verification testing was not required to support substantial equivalence forthe expanded indications and the testing performed in K210176 and K221483remains applicable to support the use of the FlowSaver with Inari Medical cathetersand sheaths for autologous blood transfusion. Mechanical hemolysis testing wasperformed to demonstrate substantial equivalence to the predicate.
The following testing was leveraged from K210176:
•	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
The following testing was leveraged from K221483:
•	Filtration Efficiency
Clinical Testing
Clinical testing was not required to support substantial equivalence.
Sterilization
The subject device, including its accessories, is sterilized using EtO to achieve asterility assurance level (SAL) of 10-6 using a validated sterilization process inaccordance with the principles of ISO 11135:2014/Amd 1:2018 and AAMI TIR28:2016.
Conclusion
The proposed FlowSaver Blood Return System indication expansion does notchange its intended use, nor does it change the principles of operation. Theverification testing results demonstrate that the proposed FlowSaver Blood ReturnSystem is substantially equivalent to the predicate device.

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K231782

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