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.
Indications for Use
Indicated for use by qualified and trained personnel in plasma donor centers and organizations to manage plasma donation operations, including donor registration, health screening, donation tracking, sample management, inventory control, and regulatory compliance.
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).
{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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Learn the FDA Browser
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
