(270 days)
No
The document describes a mechanical filtration system for blood return and does not mention any AI/ML components or capabilities.
No
The device is described as an accessory for autologous blood transfusion and blood loss minimization during an embolectomy procedure, which is a supportive function rather than a direct therapeutic intervention for a disease or condition.
No
The device description states its purpose is for "autologous injection of aspirated blood...by dual layer 40 µ/200 µ filtration to minimize intraprocedural blood loss," indicating a therapeutic function rather than a diagnostic one.
No
The device description clearly indicates a physical system with filtration components ("dual layer 40 µ/200 µ filtration") and mentions non-clinical testing related to physical properties like filtration efficiency, flow rate, leakage, and mechanical testing. This is not a software-only device.
Based on the provided information, the FlowSaver Blood Return System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "autologous blood transfusion" during an embolectomy procedure. This involves processing blood within the patient's body (or immediately outside for reinfusion), not for analyzing a sample in vitro (outside the body) to diagnose a condition.
- Device Description: The description focuses on filtration of aspirated blood for reinfusion, a mechanical process, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing blood components, detecting biomarkers, or providing information for diagnosis.
- Performance Studies: The performance studies focus on the mechanical and filtration aspects of the device, not on diagnostic accuracy or clinical outcomes related to diagnosis.
IVD devices are typically used to examine specimens (like blood, urine, tissue) in vitro to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The FlowSaver's function is to process blood for reinfusion, which is a therapeutic or procedural support function, not a diagnostic one.
N/A
Intended Use / Indications for Use
The FlowSaver Blood Return System is used with Triever Catheters for autologous blood transfusion.
Product codes
CAC
Device Description
The FlowSaver Blood Return System accessory allows for autologous injection of aspirated blood from the FlowTriever Retrieval/Aspiration System embolectomy procedure by dual layer 40 µ/200 µ filtration to minimize intraprocedural blood loss.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-Clinical Testing:
The following verification test demonstrated compliance with product requirements: Filtration Efficiency.
The following testing was leveraged from the predicate device (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, Hematocrit Testing, Mechanical Hemolysis Testing.
Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications.
Clinical Testing:
Post-market clinical data was used to demonstrate the safety and effectiveness of the FlowSaver Blood Return System's use without a secondary filtration procedure. Post-market clinical data from PEERLESS (NCT05111613), FLAME (NCT04795167), and FLASH (NCT03761173) studies demonstrated the FlowSaver's filtration efficiency and safety without use of the second filter in support of substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
FlowSaver Blood Return System (K210176)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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February 17, 2023
Inari Medical, Inc. Kaitlyn Weinkauf Sr. Regulatory Affairs Specialist 6001 Oak Canyon, Suite 100 Irvine, California 92618
Re: K221483
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: December 16, 2022 Received: December 20, 2022
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 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
1
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 (QS) 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.
Nicole M. Gillette -S
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)
K221483
Device Name FlowSaver Blood Return System
Indications for Use (Describe)
The FlowSaver Blood Return System is used with Triever Catheters for autologous blood transfusion.
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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510(K) SUMMARY
| Date prepared | February 16, 2023 |
|---|---|
| Name | Inari Medical, Inc. |
| 6001 Oak Canyon, Suite 100 | |
| Irvine, CA 92618 | |
| 949.600.8433 | |
| Contact person | Kaitlyn Weinkauf |
| Sr. 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 | FlowSaver Blood Return System (K210176) |
| Description | The FlowSaver Blood Return System accessory allows for autologous |
| injection of aspirated blood from the FlowTriever Retrieval/Aspiration | |
| System embolectomy procedure by dual layer 40 µ/200 µ filtration to | |
| minimize intraprocedural blood loss. | |
| Indications for Use | The FlowSaver Blood Return System is used with Triever Catheters for |
| autologous blood transfusion. | |
| Device modification | The purpose of this submission is a labeling change to remove the secondary |
| filtration procedure that is performed after the initial filtration with the | |
| FlowSaver Blood Return System. | |
| Comparison of | |
| Technological | |
| Characteristics with | |
| the Predicate Device | There is no change to the principles of operation, indications for use, |
| intended use, fundamental scientific technology, or technological | |
| characteristics between the proposed FlowSaver Blood Return System and | |
| the predicate device. |
4
| Summary of
substantial
| equivalence | The proposed FlowSaver Blood Return System accessory and the predicate device have the same indications for use, intended use, principles of operation, and fundamental scientific technology. |
|---|---|
| Non-Clinical Testing | |
| The following verification test demonstrated compliance with product requirements: | |
| • Filtration Efficiency | |
| The following testing was leveraged from the predicate device (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 | |
| • Hematocrit Testing | |
| • Mechanical Hemolysis Testing | |
| Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications. | |
| Clinical Testing | |
| Post-market clinical data was used to demonstrate the safety and effectiveness of the FlowSaver Blood Return System's use without a secondary filtration procedure. Post-market clinical data from PEERLESS (NCT05111613), FLAME (NCT04795167), and FLASH (NCT03761173) studies demonstrated the FlowSaver's filtration efficiency and safety without use of the second filter in support of substantial equivalence. | |
| Conclusion | |
| The proposed labeling change to the FlowSaver Blood Return System does not change its intended use nor does it change the principles of operation. The verification testing results demonstrate that the proposed FlowSaver Blood Return System is substantially equivalent to the predicate device. |