SmartDMS

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).

Predicate Devices

• GDS 1.0 (Grifols Donation System) (BK180240)
• NextGen 3.0.0 (BK150330)
• ePROGESA 5.0.1 (BK080002)

Submission Summary (Full Text)

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**Life Plasma, Inc.**
5438 Perkiomen Ave
Reading, PA 19606
Tel: [phone]
Fax: [phone]

**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:** [phone]

**Fax:** [phone]

**Email:** [e-mail]

**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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**Life Plasma, Inc.**
5438 Perkiomen Ave
Reading, PA 19606
Tel: [phone]
Fax: [phone]

# **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.

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# **Life Plasma, Inc.**

5438 Perkiomen Ave

Reading, PA 19606

Tel: [phone]

Fax: [phone]

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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