BK230986 · MAK-SYSTEM Group Ltd. London United Kingdom · MMH · Nov 3, 2023 · Hematology
Device Facts
Record ID
BK230986
Device Name
ePROGESA v5.0.3
Applicant
MAK-SYSTEM Group Ltd. London United Kingdom
Product Code
MMH · Hematology
Decision Date
Nov 3, 2023
Decision
SESE
Regulation
21 CFR 864.9165
Device Class
Class 2
Attributes
Software as a Medical Device
Indications for Use
ePROGESA is a modular, stand-alone blood bank, plasma centers and blood transfusion service software application that is specially designed to meet the needs of organizations collecting blood, plasma, platelets, cord blood, and/or transfusion services organizations to aid/assist qualified and trained personnel to support the major operations within their facilities. ePROGESA is designed to undertake typical blood bank operations on fixed and mobile sites including but not limited to session planning and recruitment of donors; donor eligibility status including deferrals management, interactive donor health questionnaire (Computer Assisted Self Interviews (CASI)), also called SAHH feature, completed by staff or donors or remote donors and reviewed by a blood center-trained staff; immunization traceability for plasma donors; donation collection; component preparation and transformation; donor and donation laboratory testing; blood unit stage release; blood inventory, and distribution of blood products and manufactured products, product quality control including bacterial screening; blood products lookback and donor surveillance; HLA/RBC searching and matching. ePROGESA is also intended to support typical blood transfusion operations of order management, patient management, inventory selection, testing, further manufacturing, release, and distribution of blood products and manufactured products, track product disposition and keep transfusion history. Orders and reporting of patient results can be managed by interface with the Hospital Information System. ePROGESA also includes interfaces for the National Deferred Donor Register (NDDR), collection and manufacturing devices, LIMS, quality control and Laboratory Instruments which assist trained personnel in the transfer and integration of data to the ePROGESA software.
Device Story
ePROGESA is a modular, stand-alone software application for blood banks, plasma centers, and transfusion services. It manages end-to-end operations: donor recruitment, health questionnaires (CASI/SAHH), collection, lab testing, component preparation, inventory, distribution, and transfusion history. Operated by trained personnel in fixed or mobile clinical settings. Integrates with third-party systems (LIMS, Hospital Information Systems, collection/manufacturing devices) via standard network connections. Provides centralized multi-site management. Output includes donor eligibility status, inventory tracking, and transfusion records, aiding clinical decision-making by ensuring blood product safety, traceability, and regulatory compliance.
Clinical Evidence
No clinical testing was performed in support of this premarket notification. Evidence consists of software verification and validation testing (Alpha, Platform, and Beta testing) conducted per FDA guidance for Blood Establishment Computer Software.
Technological Characteristics
Modular, stand-alone software; JAVA technology; n-tier web architecture; supports centralized multi-site structure; interfaces with third-party systems via standard network connections. Software is classified as a major Level of Concern.
Indications for Use
Indicated for use by blood banks, plasma centers, and blood transfusion services to support operations including donor recruitment, eligibility screening (via CASI/SAHH), donation collection, laboratory testing, component preparation, inventory management, distribution, lookback/surveillance, and transfusion service management.
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).
