Hemafuse System

K210862 · Sisu Global Health · CAC · Jul 29, 2021 · Anesthesiology

Device Facts

• Record ID: K210862
• Device Name: Hemafuse System
• Applicant: Sisu Global Health
• Product Code: CAC · Anesthesiology
• Decision Date: Jul 29, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5830
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Hemafuse System is a manual autotransfusion device; collects shed whole blood from surgical field during significant hemorrhage; intended for reinfusion. Used in remote/austere military environments; operated by clinicians when standard blood sources/autotransfusion systems are unavailable. Device provides immediate blood salvage capability; reduces reliance on external blood supply in resource-limited settings. Each unit limited to 5-minute operational window.

Indications for Use

Indicated for collection of shed whole blood during surgery for reinfusion in patients experiencing significant hemorrhage. Restricted to use in remote or austere military environments where standard autotransfusion or blood sources are unavailable or inadequate. Limited to 5 minutes of use per unit.

Regulatory Classification

Identification

An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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) | |
|-------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="text-decoration: overline;"> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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