The Blood Product Questionnaire Module supports single and/or multi-site blood establishment collection facilities' creation of a donor history questionnaire, the collection of donor history, the determination of visit requirements, and the determination of donor eligibility through system logic or via analysis by trained facility staff members.
Device Story
Blood Product Questionnaire Module is SaMD for blood collection facilities; manages Donor History Questionnaire (DHQ) and donor eligibility. Donors use native iPad app to authenticate, answer health/lifestyle/travel questions, and confirm education materials. System checks for active deferrals and donation frequency rules. If eligible, donor completes DHQ; responses are either processed by system logic or reviewed by trained facility staff to determine donation eligibility. System also identifies required visit steps, such as specific tests or physical exams. Output is provided to other applications for further processing. Benefits include standardized donor screening and efficient eligibility determination.
Clinical Evidence
No clinical data. Evidence consists of software verification and validation testing, and human factors/usability testing conducted per FDA guidance.
Technological Characteristics
Web-based SaMD; utilizes industry-standard operating systems, browsers, and computing hardware. Supports English language and font/size adjustment. Logic-based eligibility determination.
Indications for Use
Indicated for use in single or multi-site blood establishment collection facilities to assist trained staff in documenting, querying, and accessing information to determine blood donor eligibility.
Regulatory Classification
Identification
Blood establishment computer software (BECS) is a device used in the manufacture of blood and blood components to assist in the prevention of disease in humans by identifying ineligible donors, by preventing the release of unsuitable blood and blood components for transfusion or for further manufacturing into products for human treatment or diagnosis, by performing compatibility testing between donor and recipient, or by performing positive identification of patients and blood components at the point of transfusion to prevent transfusion reactions. This generic type of device may include a BECS accessory, a device intended for use with BECS to augment the performance of the BECS or to expand or modify its indications for use.
Special Controls
*Classification.* Class II (special controls). The special controls for these devices are:(1) Software performance and functional requirements including detailed design specifications (
*e.g.,* algorithms or control characteristics, alarms, device limitations, and safety requirements).(2) Verification and validation testing and hazard analysis must be performed.
(3) Labeling must include:
(i) Software limitations;
(ii) Unresolved anomalies, annotated with an explanation of the impact on safety or effectiveness;
(iii) Revision history; and
(iv) Hardware and peripheral specifications.
(4) Traceability matrix must be performed.
(5) Performance testing to ensure the safety and effectiveness of the system must be performed, including when adding new functional requirements (
*e.g.,* electrical safety, electromagnetic compatibility, or wireless coexistence).
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# 510(k) Summary
# Contact Details
Applicant Name: Buoy Software, LLC
Applicant Address: 55 Post Road West 2nd Floor
Westport CT 06880 United States
Applicant Contact Telephone: 513-314-4653
Applicant Contact Email: (b) (6) @buoysoftware.com
# Device Name
Device Trade Name: Blood Product Questionnaire Module
Common Name: Blood establishment computer software and accessories
Classification Name: Blood Establishment Computer Software And Accessories
Regulation Number: 864.9165
Product Code: MMH
# Legally Marketed Predicate Device(s)
Predicate #: BK210607
Predicate Trade Name: SoftDonor Version 4.5.5
Product Code: MMH
# Device Description Summary
The Blood Product Questionnaire Module is a Software as a Medical Device (SaMD) intended to support single and/or multi-site blood establishment collection facilities to create and/or manage a Donor History Questionnaire (DHQ), collect and/or review donor history information, determine visit requirements, and determine donor eligibility through system logic or trained facility staff interpretation.
Configure Donor History Questionnaire
Trained facility staff are able to configure a DHQ, which covers general health information,
55 Post Road West 2nd Floor Westport CT 06880
BuoySoftware.com
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history of infectious diseases, lifestyle/behavioral factors, travel history, medical conditions, and other criteria to assess the donor's eligibility for donation.
#### Collection of Donor History Information
Donors use a native iPad application to authenticate their identity, answer questions, and confirm receipt of blood product donor/donation education materials.
The SaMD determines if a donor is eligible to take a DHQ by ensuring the donor does not have an active deferral or is in violation of the establishment's donation frequency rules.
A deferral refers to the temporary or permanent prevention of donation due to certain conditions or circumstances.
Donation frequency rules refer to how often a donor can donate.
If a donor is eligible to take a DHQ, the donor completes the DHQ and provides 'Yes', 'No', or 'I Don't Know' responses to all of the questions.
The application allows the donor to exit at any point and will only store and manage donor data for a completed DHQ. The DHQ provides step-by-step prompts to guide the donor through the process.
#### Determine Visit Requirements
The SaMD also provides the visit requirements a donor must complete as a part of their donation. In addition to completing a DHQ, this includes but is not limited to determining when donors are required to provide a specific test or set of tests and to receive a physical with trained facility staff.
#### Donor Evaluation Process
After the donor completes the DHQ, the next steps of the evaluation depend on the status of the responses provided by the donor. Either the responses are acceptable, and the donor is eligible to donate, or the answers are reviewed by trained facility staff and the SaMD uses the trained staff's responses to determine if the donor is eligible to donate on that day.
#### Intended Use/Indications for Use
The Blood Product Questionnaire Module supports single and/or multi-site blood establishment collection facilities' creation of a donor history questionnaire, the collection of donor history, the determination of visit requirements, and the determination of donor eligibility through system logic or via analysis by trained facility staff members.
55 Post Road West 2nd Floor Westport CT 06880
BuoySoftware.com
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## Indications for Use Comparison
Both the subject device and the predicate device are intended for use in blood establishment collection facilities, whether single-site or multi-site. Both devices are specifically intended to assist knowledgeable, trained staff in the process of documenting, querying, and accessing integrated information pertaining to blood donors.
The predicate device, SoftDonor Version 4.5.5, offers additional functionality and indications as compared to the subject device. For example, the predicate device is capable of capturing various steps and events, encompassing the manufacturing of blood and blood components, and authorizing the release of products for transfusion purposes. The subject device solely focuses on determining the eligibility of donors to donate. In other words, the subject device's indications for use are a subset of the predicate device's indications, as the latter encompasses additional functionality.
In summary, both devices have the same intended use and similar indications for use. They both support the incorporation of user or donor-administered history questionnaire functionality, accompanied by system logic for determining donor eligibility.
## Technological Comparison
The subject device and the predicate device have equivalent technological characteristics:
- Both the subject device and the predicate device are web-based.
- Both the subject device and the predicate device use industry standard operating systems.
- Both the subject device and the predicate device use industry standard browsers / Applications.
- Both the subject device and the predicate device use industry standard computing equipment.
- Both the subject device and the predicate device support the English language.
- Both the subject device and the predicate device can adjust the font / size on the hardware.
The differences between the subject device and the predicate device do not raise different questions of safety and effectiveness, and are listed below:
- The subject device solely focuses on determining the eligibility of donors to donate. The
55 Post Road West 2nd Floor Westport CT 06880
BuoySoftware.com
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predicate device offers additional functionality. Specifically, the predicate device includes component production, inventory control, and inventory distribution.
- The subject device does not utilize peripheral hardware as its output is to another application. The predicate device utilizes peripheral hardware to support the additional functionalities.
### **Non-Clinical and/or Clinical Tests Summary & Conclusions**
Software verification and validation testing as well as human factors and usability testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.'
Clinical tests are not applicable to the device.
The software verification and validation testing verified that the design requirements were successfully met. The Intended use and user needs were successfully validated.
55 Post Road West 2nd Floor Westport CT 06880
BuoySoftware.com
