BK230814 · Life Plasma, Inc. Reading, PA · MMH · Apr 16, 2024 · Hematology
Device Facts
Record ID
BK230814
Device Name
SmartDMS
Applicant
Life Plasma, Inc. Reading, PA
Product Code
MMH · Hematology
Decision Date
Apr 16, 2024
Decision
SESE
Regulation
21 CFR 864.9165
Device Class
Class 2
Attributes
Software as a Medical Device
Indications for Use
Smart DMS is a BECS used in Source Plasma donation centers. The device assists in the management of data related to donors, their suitability to donate, collection of Source Plasma, product testing, storage, manufacturing, and shipping.
Device Story
SmartDMS 1.0.0 is a stand-alone Blood Establishment Computer Software (BECS) for Source Plasma centers. It manages donor visits, health assessments, and suitability; records donation details; tracks test samples and results; manages inventory and shipping. System incorporates safety checks for donor suitability and unit releasability. Operates as stand-alone software; does not interface with apheresis devices. Interfaces with external registries (NDDR, CDCS). Healthcare providers use system to track donor status, ensure regulatory compliance, and manage product lifecycle. Benefits include automated data management, standardized safety checks, and streamlined donor/product tracking.
Clinical Evidence
No clinical data. Device is software-only; clinical performance testing is not applicable. Safety and effectiveness established via verification, validation, and user acceptance testing per 21 CFR 820.30.
Technological Characteristics
Stand-alone BECS software. Functions include database management, barcode scanning, and external registry interfacing (NDDR, CDCS). Operates as a centralized management system for donor and product data. No hardware components. Software developed under 21 CFR 820.30 design controls.
Indications for Use
Indicated for use in Source Plasma donation centers to capture medical screening information, donor health assessment, donation details, donor status management, lookback capabilities, lab testing results, barcode scanning, quality assurance, inventory, shipping, and product release.
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}
**Life Plasma, Inc.**
5438 Perkiomen Ave
Reading, PA 19606
Tel: +1-484-772-8687
Fax: +1-484-842-5865
**5. 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:**
**510(k) Owner/Submitter:** Life Plasma, Inc.
**Official Correspondence regarding this 510(k):**
**Name:** Nagesh Ramesh, *Ph.D.*
President & Head of Regulatory Affairs/Quality Assurance
**Address:** 5438 Perkiomen Ave, Reading PA 19606
**Phone:** +1-508-439-0844
**Fax:** +1-484-842-5865
**Email:** Nagesh.ramesh@lifeplasma.com
**FEI:** 3021916912
**Proposed Device Information:**
**Trade Name:** SmartDMS 1.0.0 (Life Plasma, Inc.)
**Common Name:** Blood Establishment Computer Software (BECS)
**Product Code:** MMH
**Device:** Stand-alone Blood Bank Software
**Review Panel:** Hematology
**Device Class:** Class II
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{1}
**Life Plasma, Inc.**
5438 Perkiomen Ave
Reading, PA 19606
Tel: +1-484-772-8687
Fax: +1-484-842-5865
# **Predicate Device Information:**
| Predicate | Trade Name | Manufacturer | 510(k) Number | Classification Product Code |
| --- | --- | --- | --- | --- |
| **Predicate-1** | GDS 1.0 (Grifols Donation System) | Biomat USA, Inc. | BK180240 | MMH |
| **Predicate-2** | NextGen 3.0.0 | Haemonetics Corporation Software Solutions | BK150330 | MMH |
| **Predicate-3** | ePROGESA 5.0.1 | MAK-System SAS International Group | BK080002 | MMH |
# **Device Description:**
The proposed Smart Donor Management System (SmartDMS) version 1.0.0 is a Blood Establishment Computer Software (BECS) that assists in the management of donors and blood products. The software automates the processes of a Source Plasma center. The system manages the donor visits, records the donations, tracks test samples and results, and manages the shipment of units out of the center. The device includes many safety checks to ensure donor suitability and unit releasability requirements are met.
# **Intended Use:**
Smart DMS is a BECS used in Source Plasma donation centers. The device assists in the management of data related to donors, their suitability to donate, collection of Source Plasma, product testing, storage, manufacturing, and shipping.
# **Indications for Use:**
SmartDMS is a stand-alone BECS that is used to capture medical screening information, donor health assessment, capturing donation details, donor status management and for lookback capabilities. Additionally, SmartDMS is also used to capture lab testing results, barcode scanning, quality assurance, inventory, shipping, and product release. The SmartDMS operates as a stand-alone system and does not interface or interfere with the apheresis device or software.
Page 2 of 3
{2}
# **Life Plasma, Inc.**
5438 Perkiomen Ave
Reading, PA 19606
Tel: +1-484-772-8687
Fax: +1-484-842-5865
SmartDMS interfaces with PPTA’s National Donor Deferral Registry (NDDR) and Cross-Donation Check System (CDCS).
# **Substantial Equivalence:**
The proposed software device, SmartDMS 1.0.0, is substantially equivalent to the software devices GDS 1.0 (Predicate-1), NextGen 3.0.0 (Predicate-2) and ePROGESA 5.0.1 (Predicate-3).
The proposed SmartDMS 1.0.0 uses similar technology as its predicate devices. While there are minor differences in technological characteristics and principles of operation between the proposed device and its predicate devices, none of these differences raise new types of safety or effectiveness questions. This demonstrates that the technology used in the proposed SmartDMS 1.0.0 software device is substantially equivalent to the technology used in one or more of the predicate devices.
The proposed SmartDMS 1.0.0 software device and its predicates are equivalent to or the same with respect to mapped intended use, functionality, performance, and technological characteristics, as well as safety and effectiveness.
# **Clinical Trials**
Clinical performance testing is not applicable for Smart DMS 1.0.0, as it is a software only product.
# **Conclusion:**
The proposed device, SmartDMS 1.0.0, was developed in accordance with 820.30 Design Controls as well as the “*FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005).*” The software was thoroughly tested including verification, validation, and user acceptance testing to ensure it is as safe, as effective, and performed as well as each predicate device’s functionality, when utilized within its intended use and in accordance with labeling, as demonstrated by the testing performed.
Based on the functionality and performance comparison, technological characteristics comparison and the intended use, the proposed Smart DMS 1.0.0 device performs as intended in all aspects of the predicate devices mapped functionality characteristics. The safety aspects of the proposed Smart DMS 1.0.0 device have been thoroughly tested in accordance with validation practices as outlined in 820.30, Design Controls. The proposed Smart DMS 1.0.0 software device is substantially equivalent to the predicate devices in terms of intended use, functionality, performance, technological characteristics as well as safety and effectiveness.
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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.
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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).
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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.
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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.
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Reading rule for every project: how many summaries do you read in full?
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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.
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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.
