(128 days)
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No
The provided text describes a blood collection and reinfusion system for surgical use in specific environments. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the device description, intended use, or performance study sections.
Yes
The device is indicated for the reinfusion of collected whole blood, which is a therapeutic intervention aimed at restoring blood volume and preventing complications from blood loss during surgery.
No
The device is indicated for the collection and reinfusion of whole blood shed during surgical procedures, which is a therapeutic rather than a diagnostic function.
No
The 510(k) summary describes a "HEMAFUSE™ System" for collecting and reinfusing shed blood during surgery. This clearly indicates a physical device with hardware components for blood handling, not a software-only medical device.
Based on the provided information, the HEMAFUSE™ System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the collection and reinfusion of whole blood shed during surgery. This is a process performed on the patient's blood within the surgical field, not a test performed on a sample of blood outside the body to diagnose or monitor a condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a biological sample (like blood, urine, tissue) to provide information about a patient's health status.
- Using reagents or assays to detect specific substances or markers.
- Providing diagnostic, monitoring, or screening information.
The HEMAFUSE™ System is a device used for blood salvage and reinfusion during surgery, which falls under the category of surgical or therapeutic devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The HEMAFUSE™ System is indicated for the collection of whole blood shed during a surgical procedure in which blood can be collected from the surgical field during periods of significant hemorrhage for purpose of reinfusion. It should only be used when performing surgery in remote military and austere military environments, when other sources of blood or autotransfusion are unavailable or thought inadequate for the need. Each Hemafuse System unit is indicated for a period of use no greater than 5 minutes.
Product codes
CAC
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
remote military and austere military environments
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 29, 2021
SISU Global Health % Adrienne Harris Product Development Manager in2being LLC 131 E Michigan Ave Suite E Saline, Michigan 48176
Re: K210862
Trade/Device Name: Hemafuse System Regulation Number: 21 CFR 868.5830 Regulation Name: Autotransfusion Apparatus Regulatory Class: Class II Product Code: CAC Dated: June 25, 2021 Received: June 29, 2021
Dear Adrienne Harris:
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
1
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 (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 Gillette Assistant Director (Acting) 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
2
Indications for Use
510(k) Number (if known) K210862
Device Name Hemafuse System
Indications for Use (Describe)
The HEMAFUSE™ System is indicated for the collection of whole blood shed during a surgical procedure in which blood can be collected from the surgical field during periods of significant hemorrhage for purpose of reinfusion. It should only be used when performing surgery in remote military and austere military environments, when other sources of blood or autotransfusion are unavailable or thought inadequate for the need. Each Hemafuse System unit is indicated for a period of use no greater than 5 minutes.
| 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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