← Product Code [MMH](/productcode/MMH) · BK230986 # ePROGESA v5.0.3 (BK230986) _MAK-SYSTEM Group Ltd. London United Kingdom · MMH · Nov 3, 2023 · Hematology · SESE_ **Canonical URL:** https://fda.innolitics.com/device/BK230986 ## Device Facts - **Applicant:** MAK-SYSTEM Group Ltd. London United Kingdom - **Product Code:** [MMH](/productcode/MMH.md) - **Decision Date:** Nov 3, 2023 - **Decision:** SESE - **Regulation:** 21 CFR 864.9165 - **Device Class:** Class 2 - **Review Panel:** Hematology - **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. ## Regulatory 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). ## Predicate Devices - ePROGESA v5.0.1 ([BK080002](/device/BK080002.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} ![img-0.jpeg](img-0.jpeg) **MAK-SYSTEM** enabling individuals to save lives ## Volume 005 ### 510(k) Summary ePROGESA v5.0.3 ---© MAK-SYSTEM Confidential & Proprietary {1} **MAK-SYSTEM** enabling individuals to save lives 510(k) Summary ## Traditional 510(k) Summary ### ePROGESA v5.0.3 In accordance with 21 C.F.R. 807.87(h), a 510(k) Summary is included that meets the conditions as outlined for a 510(k) summary in 21 C.F.R. 807.92. **Date of Summary** 11$^{th}$ August, 2023 #### SUBMITTER INFORMATION **510(k) Owner/Submitter** MAK-SYSTEM Group Ltd. 1 Bartholomew Lane EC2N 2AX London, UK Email: regulatory@mak-system-net**Official Correspondence regarding this 510(k)** Stephane Sajot COO Email: s.sajot@mak-system.net #### DEVICE INFORMATION | **Trade Name** | ePROGESA | | --- | --- | | **Common Name** | Software for Blood Banks, Plasma Centers and Blood Transfusion Centers | | **Device Classification Regulation** | 21 C.F.R. 864.9165 | | **Device Classification Name** | Blood Establishment Computer Software and Accessories | | **ProductCode** | MMH | | **Device Class** | II | #### PREDICATE DEVICE INFORMATION | **Predicate Device** | ePROGESA v5.0.1 (BK080002) | | --- | --- | | **Prior Related Submissions** | No prior submission for this device | No reference devices were used in this submission. © MAK-SYSTEM VOL\_005 510(k) Summary Page 2 of 7 {2} **MAK-SYSTEM** enabling individuals to save lives 510(k) Summary # DEVICE DESCRIPTION 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. ePROGESA is intended to aid/assist qualified and trained personnel to support the major operations within their facilities. ePROGESA is built using JAVA technology and n-tier web architecture which enables the system to be used by a variety of organizations, made available in a client's dedicated environment. ePROGESA is intended to be interfaced with 3rd party systems through standard network connections. ePROGESA supports centralized multi-sites organization structure. The main modules available in ePROGESA include: - Session Planning and Recruitment - Donation Collection Management - Donor Management - Donor, Donation and Blood Component Laboratory Testing - Blood Component Preparation - Product Inventory Management - Quality Control Management - Distribution Management - Traceability and Haemovigilance Management - Consumable Management - Patient Management - Patient Transfusion Service Management - Lookback and Surveillance Management - Interfaces - Utilities - Report Management - Security - System Configuration © MAK-SYSTEM VOL_005 510(k) Summary Page 3 of 7 {3} **MAK-SYSTEM** enabling individuals to save lives 510(k) Summary--- ## 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. ---© MAK-SYSTEM VOL\_005 510(k) Summary Page 4 of 7 {4} **MAK-SYSTEM** enabling individuals to save lives 510(k) Summary--- ### **COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICES** The intended use of ePROGESA v5.0.3 is substantially equivalent to the predicate devices as both software devices are intended to aid/assist qualified and trained personnel to support the major operations, including but not limited to, donor registration, donor collection management, product suitability, and inventory and distribution. The difference in the technological characteristics between the predicate and subject devices are substantially equivalent as the fundamental scientific technology and intended use is unchanged. The proposed ePROGESA v5.0.3 is substantially equivalent to the legally marketed device ePROGESA v5.0.1 in intended use, features and technological characteristics. ---© MAK-SYSTEM VOL\_005 510(k) Summary Page 5 of 7 {5} **MAK-SYSTEM** enabling individuals to save lives 510(k) Summary--- ## NON-CLINICAL PERFORMANCE Extensive software verification and validation testing were conducted, and documentation is provided as recommended by FDA’s Guidance for Industry and FDA Staff, *Guidance for the Content of Premarket Submission for Software Contained in Medical Devices*. The software is considered a major Level of Concern as it qualifies as the Blood Establishment Computer Software. The verification testing was performed at MAK-SYSTEM by conducting predefined verification scripts that contain scenarios created to comprehensively test the device. Validation testing was conducted in order to ensure that ePROGESA software application meets its intended use, including critical safety requirements. The process was performed based on the scripts prepared and traced to the functional requirements and to the risk analysis. Validation activities consists of Alpha, Platform and Beta (user site) testing. Alpha and Platform testing took place at MAK-SYSTEM and Beta testing was performed prior final software release in a user environment. ## CLINICAL PERFORMANCE No clinical testing was performed in support of this premarket notification. ---© MAK-SYSTEM VOL\_005 510(k) Summary Page 6 of 7 {6} **MAK-SYSTEM** enabling individuals to save lives 510(k) Summary--- ## CONCLUSION ePROGESA v5.0.3 is as safe and as effective as the predicate device. The ePROGESA v5.0.3 has substantially the same same intended use and similar indications, as well as technological characteristics and principle of operations as its predicate device. The technological differences do not raise any questions of safety and effectiveness as the performance data demonstrates that ePROGESA v5.0.3 performs as intended in the specified use conditions. Based on the testing results, MAK-SYSTEM concludes that ePROGESA v5.0.3 meets the expectations, fits its intended use and is substantially equivalent to its predicate device. ---© MAK-SYSTEM VOL\_005 510(k) Summary Page 7 of 7 --- **Source:** [https://fda.innolitics.com/device/BK230986](https://fda.innolitics.com/device/BK230986) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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