← Product Code [MMH](/productcode/MMH) · BK251188 # Patient Health Software (P.H.S) v11.0.0.0 (BK251188) _MAK-SYSTEM Group Ltd. London United Kingdom · MMH · Jun 11, 2025 · Hematology · SESE_ **Canonical URL:** https://fda.innolitics.com/device/BK251188 ## Device Facts - **Applicant:** MAK-SYSTEM Group Ltd. London United Kingdom - **Product Code:** [MMH](/productcode/MMH.md) - **Decision Date:** Jun 11, 2025 - **Decision:** SESE - **Regulation:** 21 CFR 864.9165 - **Device Class:** Class 2 - **Review Panel:** Hematology - **Attributes:** Software as a Medical Device ## Indications for Use The eTraceLine / Patient Health Software (P.H.S) application is a modular, stand-alone blood transfusion, testing laboratory software dedicated to blood centers or community blood banks with transfusion services centers, hospitals transfusion services, reference labs, testing laboratories. eTraceLine/P.H.S is designed to aid and assist qualified and trained personnel to support the operations within their facilities. eTraceLine/P.H.S software supports single, centralized multi-sites and multi-organizations to be used centrally or in standalone. eTraceLine/P.H.S undertakes process controls for laboratory testing and transfusion service operations, manages, tracks and determines the suitability of the blood components and blood derivatives to reduce human error and contribute to patient safety. eTraceLine/P.H.S is intended to address all phases of laboratory activities and/or transfusion services operations at the laboratory department, transfusion service departments, hospital wards, and patient bedside. Functionality is provided for: - Patient identification at bedside and patient record management; - Supporting Patient immunohematology, virology, histocompatibility laboratory testing used for suitability and including reagent quality control; - Supporting HLA, HNA, and HPA laboratory testing; - Blood components preparation, release, and labelling (ISBT 128); - Blood components selection, testing, and issue of blood components under normal and emergency conditions, including serological crossmatch, electronic crossmatch, and remote crossmatch of blood components; - Tracking of blood components inventory, transformation, disposition, record transfusion details and related outcomes, and record-keeping of patient transfusion history for lookback; - Supporting therapeutic bleed orders. eTraceLine/P.H.S interfaces with Hospital Information Systems (HIS), laboratory testing instruments, BECS, Laboratory Information Systems (LIS), and blood storage devices. ## Device Story P.H.S is a modular, stand-alone software system for blood transfusion and laboratory testing management. It integrates with HIS, LIS, and laboratory instruments to manage patient records, immunohematology/virology/histocompatibility testing, blood component inventory, and transfusion tracking. Operated by trained personnel in clinical and laboratory settings, it supports bedside patient identification and electronic crossmatching. The system aids in reducing human error by automating process controls and tracking blood component suitability. It functions as a centralized or standalone platform, supporting multi-site operations via web-based architecture. Output includes test results, inventory status, and transfusion records, which assist clinicians in blood component selection and transfusion decision-making, ultimately enhancing patient safety. ## Clinical Evidence No clinical testing was performed. Evidence consists of software verification and validation, including Alpha and Beta (user site) testing to demonstrate performance under specified use conditions. ## Technological Characteristics Modular, stand-alone software using JAVA technology and 3-tier web architecture. Supports on-premise and cloud deployment. Interfaces with HIS, LIS, and laboratory instruments via standard network connections. Complies with ISBT 128 labeling standards. Software classification: Blood Establishment Computer Software (Enhanced Documentation). ## 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 - Patient Health Software (P.H.S) Version 2.0 ([BK180232](/device/BK180232.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 ## Section 5 ### 510(k) Summary Patient Health Software (P.H.S) v11.0.0.0 ---© MAK-SYSTEM Confidential & Proprietary {1} MAK-SYSTEM enabling individuals to save lives 510(k) Summary # Traditional 510(k) Summary # P.H.S v11.0.0.0 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 Mar. 28, 2025 # SUBMITTER INFORMATION 510(k) Owner/Submitter MAK-SYSTEM Group Ltd. 1 Bartholomew Lane EC2N 2AX London, UK Official Correspondence regarding this 510(k) Stephane Sajot COO Email: s.sajot@mak-system.net # DEVICE INFORMATION Trade Name Patient Health Software (P.H.S) Common Name Transfusion Safety and Blood Traceability Software for Health Care Organizations Device Classification Regulation 21 C.F.R. 864.9165 Device Classification Name Blood Establishment Computer Software and Accessories Product Code MMH Device Class II # PREDICATE DEVICE INFORMATION Predicate Device Patient Health Software (P.H.S) Version 2.0 (BK180232) Prior Related Submissions No prior submission for this device No reference devices were used in this submission. © MAK-SYSTEM Section 5 510(k) Summary Page 2 of 5 {2} MAK-SYSTEM enabling individuals to save lives 510(k) Summary # DEVICE DESCRIPTION The Patient Health Software (P.H.S) application is a modular, stand-alone blood transfusion, testing laboratory software dedicated to blood centers or community blood banks with transfusion services centers, hospitals transfusion services, reference labs, testing laboratories, and Histocompatibility and Immunogenetics (H&I) laboratories. P.H.S is designed to aid and assist qualified and trained personnel to support the operations within their facilities. P.H.S software supports single, centralized multi-sites and multi-organizations to be used centrally or in standalone. P.H.S is built using JAVA technology and 3-tier web architecture, which enables the system to be used by a variety of organizations, made available in a client's dedicated environment. P.H.S is intended to be interfaced with 3rd party systems through standard network connections. P.H.S supports centralized multi-site and multiorganization structures, including both on-premise and on-cloud deployment. The main modules available in P.H.S include: Patient Management Patient and Blood Component Laboratory Testing Patient Transfusion Management - Blood Components and Derivatives Inventory Management Distribution Management Haemovigilance Management Transformation and Pooling Management - Consumables Management Blood Tracking System (BTS) Positive Patient Identification (PPID) Security Utilities P.H.S can also be configured in LIS mode. When configured in LIS mode, the P.H.S functionalities are limited to the test orders and results created for patient's and blood donations. # INDICATIONS FOR USE The eTraceLine / Patient Health Software (P.H.S) application is a modular, stand-alone blood transfusion, testing laboratory software dedicated to blood centers or community blood banks with transfusion services centers, hospitals transfusion services, reference labs, testing laboratories. eTraceLine/P.H.S is designed to aid and assist qualified and trained personnel to support the operations within their facilities. eTraceLine/P.H.S software supports single, centralized multi-sites and multi-organizations to be used centrally or in standalone. eTraceLine/P.H.S undertakes process controls for laboratory testing and transfusion service operations, manages, tracks and determines the suitability of the blood components and blood derivatives to reduce human error and contribute to patient safety. © MAK-SYSTEM Section 5 510(k) Summary Page 3 of 5 {3} MAK-SYSTEM enabling individuals to save lives 510(k) Summary eTraceLine/P.H.S is intended to address all phases of laboratory activities and/or transfusion services operations at the laboratory department, transfusion service departments, hospital wards, and patient bedside. Functionality is provided for: - Patient identification at bedside and patient record management; - Supporting Patient immunohematology, virology, histocompatibility laboratory testing used for suitability and including reagent quality control; - Supporting HLA, HNA, and HPA laboratory testing; - Blood components preparation, release, and labelling (ISBT 128); - Blood components selection, testing, and issue of blood components under normal and emergency conditions, including serological crossmatch, electronic crossmatch, and remote crossmatch of blood components; - Tracking of blood components inventory, transformation, disposition, record transfusion details and related outcomes, and record-keeping of patient transfusion history for lookback; - Supporting therapeutic bleed orders. eTraceLine/P.H.S interfaces with Hospital Information Systems (HIS), laboratory testing instruments, BECS, Laboratory Information Systems (LIS), and blood storage devices. # COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICES The intended use of P.H.S v11.0.0.0 is substantially equivalent to the predicate device as both software devices are intended to aid/assist qualified and trained personnel to support the operations within their facilities, including but not limited to, patient management, patient transfusion management, transformation and pooling management, patient and blood components laboratory testing, hemovigilance, distribution management, and others. The proposed software device, P.H.S v11.0.0.0, uses similar technology to its predicate device. Technological upgrades, including addressing obsolescence and enabling cloud deployment, enhance the subject device, and none of these pose device safety or effectiveness concerns. The difference in the technological characteristics between the predicate and subject devices is substantially equivalent, as the fundamental scientific technology is unchanged. These differences are assessed through risk analysis and tested to ensure that they do not pose any risk to the substantial equivalence between the predicate and the subject device. The proposed Patient Health Software (P.H.S) v11.0.0.0 is substantially equivalent to the legally marketed device Patient Health Software (P.H.S) Version 2.0 in intended use, features, and technological characteristics. # 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, Content of Premarket Submission for Device Software Functions. The Documentation Level of P.H.S is Enhanced Documentation as it qualifies as the © MAK-SYSTEM Section 5 510(k) Summary Page 4 of 5 {4} MAK-SYSTEM enabling individuals to save lives 510(k) Summary Blood Establishment Computer Software. No security-related hazards persist at an unacceptable risk level, as substantiated by justifications, and ongoing risk management protocols ensure perpetual oversight and enhancement during both production and post-production stages. The non-clinical testing, conducted to support this submission, consisted of verification and validation testing activities. The validation includes Alpha and Beta (user site) testing events. Both Alpha and Beta testing data support the safety and effectiveness of the subject device and demonstrate that P.H.S v11.0.0.0 performs as intended in the specified use conditions. # CLINICAL PERFORMANCE No clinical testing was performed in support of this premarket notification. # CONCLUSION The modified Patient Health Software (P.H.S) v11.0.0.0 is as safe and as effective as the predicate device. This Traditional 510(k) is submitted to modify legally a marketed, predicate device. The P.H.S v11.0.0.0 has substantially the same intended use and similar indications. The technological differences do not raise any questions of safety and effectiveness as these differences are assessed through risk analysis and tested to ensure that they do not pose any risk to the substantial equivalence between the predicate and the subject device. MAK-SYSTEM concludes that Patient Health Software (P.H.S) v11.0.0.0 meets the expectations, fits its intended use, and is substantially equivalent to its predicate device. © MAK-SYSTEM Section 5 510(k) Summary Page 5 of 5 --- **Source:** [https://fda.innolitics.com/device/BK251188](https://fda.innolitics.com/device/BK251188) **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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