← Product Code [MMH](/productcode/MMH) · BK230958

# HemDonER 1.0.1 (BK230958)

_eDonorSoft, LLC Sugarland, TX · MMH · May 31, 2024 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/BK230958

## Device Facts

- **Applicant:** eDonorSoft, LLC Sugarland, TX
- **Product Code:** [MMH](/productcode/MMH.md)
- **Decision Date:** May 31, 2024
- **Decision:** SESE
- **Regulation:** 21 CFR 864.9165
- **Device Class:** Class 2
- **Review Panel:** Hematology
- **Attributes:** Software as a Medical Device

## Indications for Use

HemDonER version 1.0.1 is a web application designed to manage plasma donation center activities. This application aims to improve the accuracy, efficiency, and safety of plasma donations by creating an organized secure system for managing the whole plasma donation process from registration of donors to collection of plasma and to the final distribution of the product. The HemDonER version 1.0.1 provides management controls and information service modules designed to assist the staff in the core functions by addressing various aspects of donor management and operational oversight.

## Device Story

HemDonER 1.0.1 is a web-based Blood Establishment Computer Software (BECS) for plasma collection facilities. It functions as a centralized management system for donor registration, health screening, donation tracking, laboratory test result integration, inventory management, and regulatory compliance. Operated by trained center staff, the system captures donor data, tracks collection metrics, manages sample workflows, and monitors unit suitability based on test results. It provides operational oversight through modules for quality control, equipment maintenance, and lookback/surveillance. By digitizing and organizing the donation lifecycle, the device ensures traceability, enhances safety, and assists staff in maintaining compliance with regulatory standards. It does not perform clinical diagnostics but facilitates the administrative and safety-critical workflows required for plasma product distribution.

## Clinical Evidence

No clinical data. The device is a software-only product; safety and effectiveness were established through non-clinical bench testing, including unit testing, code reviews, and system-level verification and validation against functional requirements and hazard analysis.

## Technological Characteristics

Web application software; operates as a Blood Establishment Computer Software (BECS). Features modular architecture for donor management, inventory, and regulatory tracking. Includes electronic data capture interfaces. Security controls for data protection and privacy. No hardware components; software-only system.

## 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– Version 5.0.1 ([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}

EDONORSOFT

510(k) Summary

In accordance with 21 CFR 807.87(h), a 510(k) summary is included that meets the conditions as outlined for a 510(k) summary in 21 CFR 807.92.

Submitter Information:

Company Name: EDONORSOFT LLC.
Company Address: 1619 Whitfield St, Sugar Land TX 77479

Official Correspondence regarding this 510(k):

Name: Rasiah Jegatheswaran
President
Address: 1619 Whitfield St, Sugar Land TX 77479
Phone: (713) 213-7509
Email: jegathes@edonorsoft.com

Device:

Device Classification Name: Software, Blood Bank, Web Products
Trade Name: HemDonER 1.0.1
Common Name: Blood Establishment Computer Software
Review Panel: Hematology
Classification Product Code: MMH
Device Classification Regulation: 21 CFR 864.9165
Device Class: Class II

Sugar Land TX 77479

713.213.7509

info@edonorsoft.com

{1}

# EDONORSOFT

Predicate Device:

|  Predicate | Trad Name | Manufacturer | 510(k) Number | Classification product code  |
| --- | --- | --- | --- | --- |
|  Predicate 1 | ePROGESA– Version 5.0.1 | MAK-SystemSAS International Group | BK080002 | MMH  |

# Device Description:

The HemDonER is a web application manufactured by EDONORSOFT LLC designed for plasma donor centers and organizations collecting plasma.

It is designed to aid/assist qualified and trained personnel to support the major operations within their facilities, helping ensure plasma unit safety and traceability.

The main modules available in HemDonER include:

- Donation Collection Management
- Donor Management
- Donor, Donation, and Plasma Laboratory Testing
- Plasma Preparation Management
- Product Inventory Management
- Quality Control Management
- Distribution Management
- Traceability
- Equipment Management
- Lookback and Surveillance Management

Sugar Land TX 77479

713.213.7509

info@edonorsoft.com

{2}

# EDONORSOFT

- Sample Storage
- Standard Operating Procedure Management
- Interfaces
- Report Management
- Security

Intended Use:

HemDonER version 1.0.1 is a web application designed to manage plasma donation center activities. This application aims to improve the accuracy, efficiency, and safety of plasma donations by creating an organized secure system for managing the whole plasma donation process from registration of donors to collection of plasma and to the final distribution of the product.

The HemDonER version 1.0.1 provides management controls and information service modules designed to assist the staff in the core functions by addressing various aspects of donor management and operational oversight.

The HemDonER version 1.0.1 medical device includes the following modules:

1. **Donor Registration:** Capture and store donors' personal details, contact information, and medical history and educate donors about the impact of plasma donations and the information related to prior and post-donation care.
2. **Donor Health Screening and Assessment:** Determine donor eligibility by administration, recording, and tracking various screening tests, medical questionnaire information received from a Computer Assisted Self-Interview (CASI) system, consent agreements, and medical evaluations.

Sugar Land TX 77479

713.213.7509

info@edonorsoft.com

{3}

# EDONORSOFT

3. **Donation Tracking:** Monitor donation frequency. Record and track each donation and capture the information on collection time, date, volume, and any incidents that occurred during the collection process.
4. **Samples management:** Manages the tasks required to collect and ship samples, receive test results, and determine donor and unit status and suitability based on the test results received from the lab.
5. **Unit inventory and Shipment Management:** Track the inventory of collected plasma and manage the tasks required to handle units from collection until they are released for shipment based on the test results received and donor eligibility information entered and stored in the application. Capture, track, and report unsuitable units at the center and provide Lookback Reports based on Post donation information.
6. **Regulatory Support:** Record and track equipment calibration, validation, and maintenance. Record and track employee training. Maintain documentation and records necessary for audits and compliance checks.

HemDonER version 1.0.1 provides secure access controls to protect donor information, maintains confidentiality, and ensures data protection and privacy regulations.

## Nonclinical Trials

Numerous unit testing, code reviews, and system-level testing were performed by EDONORSOFT LLC.

The submitted device has undergone comprehensive verification and validation testing. System testing is performed as part of the validation activities to ensure that HemDonER software meets its intended use, including critical safety requirements. This process is based on scripts prepared and traced to the functional requirements and the hazard analysis.

Sugar Land TX 77479

713.213.7509

info@edonorsoft.com

{4}

# EDONORSOFT

This activity takes place at EDONORSOFT following the software installation and qualification procedure. The test cases also encompass electronic data capture functionalities (interfaces) based on data samples built to meet the corresponding requirements.

## Clinical Trials

Clinical performance testing is not applicable for the HemDonER as it is a software-only product.

## Summary of Safety and Effectiveness

The HemDonER device was developed in accordance with relevant regulations. The software was thoroughly tested, including system verification and validation, to ensure it was adequately developed and functioned according to its intended use.

Based on the testing results and the functional and technological comparison, the HemDonER device is safe for its intended use and substantially equivalent to the predicate device in terms of intended use, functionality, technological characteristics, safety, and effectiveness.

Sugar Land TX 77479

713.213.7509

info@edonorsoft.com

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**Source:** [https://fda.innolitics.com/device/BK230958](https://fda.innolitics.com/device/BK230958)

**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. If you're preparing [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/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com