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, the determination of donor eligibility, and unit suitability as determined through system logic or via analysis by trained facility staff members.
Device Story
Blood Product Questionnaire Module (v2.0.0) is a cloud-based SaMD for blood collection facilities; used by trained staff and donors. Inputs include donor questionnaire responses, laboratory test results, and equipment status data. System uses deterministic, rules-based logic configured by facility staff to evaluate inputs against standard operating procedures. Outputs include donor eligibility determinations, unit suitability status, deferral records, and operational readiness flags. Staff use outputs to manage donor flow and blood product quality. Benefits include standardized, automated compliance with facility-specific eligibility and safety protocols.
Clinical Evidence
Bench testing only. Verification performed at unit, integration, and system levels per ANSI/AAMI/IEC 62304:2006 & A1:2016. Human factors and usability testing conducted. No clinical data required.
Technological Characteristics
Cloud-based SaMD; deterministic, rules-based logic; supports current OS and browser versions. Software life cycle compliant with ANSI/AAMI/IEC 62304:2006 & A1:2016.
Indications for Use
Indicated for blood establishment collection facilities to manage donor history questionnaires, collect donor history, determine visit requirements, assess donor eligibility, and evaluate blood unit suitability.
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 | 811 Barton Springs Road, Suite 510 Austin TX 78704 United States |
| Applicant Contact Telephone: | 513-314-4653 |
| Applicant Contact: | Mrs. Christina Miracle |
| Applicant Contact Email: | christina@buoysoftware.com |
### Device Name
| Device Trade Name: | Blood Product Questionnaire Module (v2.0.0) |
| --- | --- |
| 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 #: | BK231004 |
| --- | --- |
| Predicate Trade Name: | Blood Product Questionnaire Module (v1.0.0) |
| 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
811 Barton Springs Road Suite 510 Austin TX 78704
BuoySoftware.com
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donor history information, determine visit requirements, determine donor eligibility, and unit suitability as determined through system logic or trained facility staff interpretation.
The device functions as a deterministic, rules-based evaluation system in which qualified facility staff define the decision criteria governing eligibility, suitability, and related quality determinations. The device evaluates structured inputs including clinical questionnaire responses, laboratory test results, and operational data against those staff-configured criteria to produce structured outputs, including eligibility and suitability determinations, deferral records, unit status assignments, lookback initiations, and operational readiness flags. All device outputs are produced through rule-based logic consistent with the facility's standard operating procedures.
The device is deployed as a secure, cloud-based software application accessed through industry standard computers and mobile devices at blood establishment collection facilities. It is intended for use by trained blood establishment collection facility staff or by blood donors.
### Features Cleared Under Predicate Submission (BK231004)
BPQM v2.0 retains the following features previously cleared under BK231004:
- Configure Donor History Questionnaire: Trained facility staff configure a DHQ covering general health information.
- Collection of Donor History Information: Donors authenticate their identity and complete the DHQ via a web application. The SaMD verifies the donor's donation status.
- Determine Visit Requirements: The SaMD determines the visit requirements a donor must fulfill as part of their donation.
- Donor Evaluation Process: After DHQ completion, the SaMD evaluates donor responses against configured eligibility criteria.
### New Features Introduced in BPQM v2.0
BPQM v2.0 introduces four new features within the Helm module.
- Test Result Configuration: Trained staff configure the actions the SaMD will perform when specific test panel results are received, in accordance with the blood establishment's standard operating procedures.
- Test Result Evaluation / Assessment of Blood Product Suitability: When test panel results are received from a laboratory, the SaMD evaluates whether the results are acceptable or unacceptable and automatically applies the actions configured by trained staff.
- Equipment Readiness Configuration: Designated staff define equipment readiness requirements within the SaMD.
811 Barton Springs Road Suite 510 Austin TX 78704
BuoySoftware.com
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- Equipment Readiness: The Equipment Readiness feature ensures that all medical equipment involved in the collection of blood products is regularly assessed and verified as functional, safe, and ready for use.
### 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, the determination of donor eligibility, and unit suitability as determined through system logic or via analysis by trained facility staff members.
### Indications for Use Comparison
Both the subject device and the predicate device are blood establishment computer software intended to document, query, and access integrated information pertaining to blood product.
The subject device offers additional functionality and indications as compared to the predicate device. Specifically, the subject device includes unit suitability.
This new indication is accomplished using the same technological elements and the difference does not raise different questions of safety and effectiveness.
### Technological Comparison
While there are minor differences in technological characteristics between the proposed device and its predicate device related to the test results and equipment readiness features, none of these differences raise new types of safety or effectiveness questions. The equivalent differences are as follows:
- The subject device supports the newest operating system versions.
- The subject device supports the newest browser versions released within the last year.
### Non-Clinical and/or Clinical Tests Summary & Conclusions
The subject device meets the applicable requirements of ANSI/AAMI/IEC 62304:2006 & A1: 2016 Medical device software— Software life cycle processes. Software testing was performed at the unit, integration, and system levels as well as human factors and usability testing. All applicable requirements were met.
Testing for the Blood Product Questionnaire Module v2.0 verified the system is safe and effective and performs as well or better than the predicate device when utilized within its intended use.
811 Barton Springs Road Suite 510 Austin TX 78704
BuoySoftware.com
