(28 days)
No
The summary describes a mechanical filtration system for autologous blood transfusion and does not mention any AI or ML components or functionalities.
No
The device is used for autologous blood transfusion during embolectomy procedures to minimize blood loss, acting as an accessory for blood management rather than directly treating a medical condition itself.
No
The device is used for autologous blood transfusion and filtration during embolectomy procedures, not for diagnosing a condition or disease.
No
The device description and performance studies clearly indicate this is a physical medical device involving filtration and mechanical testing, not software.
Based on the provided information, the FlowSaver Blood Return System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "autologous blood transfusion" during embolectomy procedures. This involves processing blood within the patient's body (or immediately outside for reinfusion), not for analyzing a sample in vitro to diagnose a condition.
- Device Description: The description focuses on filtering blood to minimize loss during a procedure. This is a therapeutic/procedural function, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing blood components, detecting biomarkers, or providing diagnostic information.
IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening. The FlowSaver's function is to process and return blood to the patient during a procedure.
N/A
Intended Use / Indications for Use
The FlowSaver Blood Return System is used with Inari Medical catheters and sheaths for autologous blood transfusion.
Product codes (comma separated list FDA assigned to the subject device)
CAC
Device Description
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.
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
Prescription Use (Part 21 CFR 801 Subpart D)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
Design verification testing was not required to support substantial equivalence for the expanded indications and the testing performed in K210176 and K221483 remains applicable to support the use of the FlowSaver with Inari Medical catheters and sheaths for autologous blood transfusion. Mechanical hemolysis testing was performed 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Inari Medical, FlowSaver Blood Return System (K221483)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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) |
|---|
| ------------------------------------------------- |
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 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 | Inari Medical, FlowSaver Blood Return System (K221483) |
| Description | 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. | |
| Indications for Use | The FlowSaver Blood Return System is used with Inari Medical catheters and |
| sheaths for autologous blood transfusion. | |
| Device Modifications | The purpose of this submission is to expand the indications of the FlowSaver Blood |
| Return System to be used with Inari Medical catheters and sheaths for autologous | |
| blood transfusion, and for use with the 30 cc large bore syringe. | |
| Comparison of | |
| Technological | |
| Characteristics with | |
| the Predicate Device | There is no change to the intended use, technological characteristics, principles of |
| operation, or fundamental scientific technology between the proposed FlowSaver | |
| Blood Return System and the predicate device. | |
| Summary of | |
| substantial equivalence | The proposed FlowSaver Blood Return System and the predicate device have the |
| same intended use, principles of operation, fundamental scientific technology, and | |
| technological characteristics. | |
| Non-Clinical Testing | |
| Design verification testing was not required to support substantial equivalence for | |
| the expanded indications and the testing performed in K210176 and K221483 | |
| remains applicable to support the use of the FlowSaver with Inari Medical catheters | |
| and sheaths for autologous blood transfusion. Mechanical hemolysis testing was | |
| performed 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 a | |
| sterility assurance level (SAL) of 10-6 using a validated sterilization process in | |
| accordance with the principles of ISO 11135:2014/Amd 1:2018 and AAMI TIR | |
| 28:2016. | |
| Conclusion | |
| The proposed FlowSaver Blood Return System indication expansion 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. |
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