e-Delphyn Donor

BK220791 · GPI USA, Inc. Houston, TX · MMH · Jun 26, 2023 · Hematology

Device Facts

• Record ID: BK220791
• Device Name: e-Delphyn Donor
• Applicant: GPI USA, Inc. Houston, TX
• Product Code: MMH · Hematology
• Decision Date: Jun 26, 2023
• Decision: SESE
• Regulation: 21 CFR 864.9165
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

e-Delphyn Donor is a web enabled modular computerized system intended to be used by trained personnel to aid in donor management. The functionalities include: • Registering, deferring, merging and qualifying donors. • Registering bags. • Recording the outcomes of the Donor History Questionnaire (DHQ). • Recording medical screening data and phlebotomy information. • Entering and evaluating test results in accordance with the decision rules. • Processing units in components. • Phenotype RBC/HLA searching and matching. • Managing storage, inventory and distribution of units. • Managing therapeutic and autologous/directed donations requests.

Device Story

e-Delphyn Donor v11.2 (US) is a web-enabled SaMD for blood establishment management; operated by trained personnel in clinical/blood bank settings. System inputs include donor registration data, medical screening results, Donor History Questionnaire (DHQ) outcomes, and laboratory test results. The software processes these inputs via rule-based decision logic to manage donor qualification, component processing, inventory control, and distribution. Key features include phenotype RBC/HLA searching and matching. Output consists of managed records, inventory status, and labeling support compliant with ISBT 128 standards. The system aids healthcare providers in ensuring regulatory compliance and operational efficiency in blood banking workflows.

Clinical Evidence

No clinical data. Performance established via bench testing, including functional verification and validation of software requirements and risk control measures. Testing confirmed compliance with predetermined specifications and FDA guidance documents.

Technological Characteristics

Web-enabled modular software architecture built on Java technology. Supports ISBT 128 standards for blood product labeling. Features include donor management, inventory control, and HLA/RBC phenotype matching. Software development follows ISO 14971:2019 risk management standards.

Indications for Use

Indicated for use by trained personnel in blood establishments to manage and document the donation, processing, storage, and distribution of blood components.

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

• e-Delphyn Donor v11.0.0.1 (BK200515)

Submission Summary (Full Text)

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# **510(k) Summary**
*(in accordance with 21 CFR §807.92)*

**Submission Date:** 02 May 2023

**Submitter:**
GPI USA, Inc.
4900 Woodway Drive, Suite 680
Houston, TX 77056
United States of America

**Submitter Correspondent**
Ms. Kimberly Jimenez
Phone: [phone]
Email: (b) (6) @gpiusa.com

**Application Correspondent**
Speed To Market, Inc.
PO Box 3018
Nederland, CO 80466
United States of America

Mr. Thomas Kroenke
Phone: [phone]
Email: (b) (6) @speedtomarket.net

**Manufacturing Site:**
GPI USA, Inc.
4900 Woodway Drive, Suite 680
Houston, TX 77056
United States of America

**Trade Name:** e-Delphyn Donor v11.2 (US)

**Common Name:** Blood establishment computer software and accessories

**Classification Name:** Blood establishment computer software and accessories

**Classification Regulation:** 21 CFR §864.9165

**Product Code:** MMH

| **Substantially Equivalent Devices:** | *New GPI USA Model* | *Predicate 510(k) Number* | *Predicate Manufacturer / Model* |
| --- | --- | --- | --- |
| | e-Delphyn Donor v11.2 (US) | BK200515 | Hemasoft Software S.L. / e-Delphyn Donor v11.0.0.1 (e-Delphyn Donor now owned by GPI USA, Inc.) |

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## **510(k) Summary**
**(in accordance with 21 CFR §807.92)**

**Device Description:**

GPI USA, Inc. e-Delphyn Donor v11.2 (US) (e-Delphyn Donor) is a web-enabled, modular, computerized software as a medical device (SaMD) system that is intended to be used by trained personnel to aid in the management and documentation of donation, processing, storage and distribution processes of all blood components.

The system is built using Java technology and other Java, web-related architecture which enables the system to work from small-scale hospital operations to multiple-site health care providers and supports compliance with the global standard for the terminology, identification, coding and labeling of medical products of human origin (including blood, cell, tissue, milk, and organ products): *International Council for Commonality in Blood Banking Automation (ICCBBA) United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components using ISBT 128 (2013).*

There are three (3) modules in e-Delphyn Donor:

*Blood Bank Module*

The Blood Bank Module provides functionality for:

- registering donors and bags,
- deferring, merging and qualifying donors,
- registering the outcome of the Donor History Questionnaire,
- recording medical screening data,
- phenotype RBC/HLA searching and matching, and
- phlebotomy information and record review.

The Blood Bank Module also provides functionality for:

- entering and evaluating test results in accordance with the decision rules,
- processing units into components,
- managing inventory and distribution of units, and
- managing therapeutic and autologous/directed donations requests.

*User Module*

The User Module provides functionality for:

- configuring facilities, user profiles and individual users, and
- for viewing activities for a particular user.

*Configuration Module*

The Configuration Module provides functionality to:

- allow certain users access to adapt the system to the local terms and processes; and
- to define some lookup or drop-down fields.

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## **510(k) Summary** **(in accordance with 21 CFR §807.92)**

# **Intended Use:**

e-Delphyn Donor is a web enabled modular computerized system intended to be used by trained personnel to aid in donor management. The functionalities include:

- • Registering, deferring, merging and qualifying donors.
- • Registering bags.
- • Recording the outcomes of the Donor History Questionnaire (DHQ).
- • Recording medical screening data and phlebotomy information.
- • Entering and evaluating test results in accordance with the decision rules.
- • Processing units in components.
- • Phenotype RBC/HLA searching and matching.
- • Managing storage, inventory and distribution of units.
- • Managing therapeutic and autologous/directed donations requests.

# **Technology Comparison:**

e-Delphyn Donor v11.2 (US) employs the same technological characteristics as the predicate device.

| *Characteristic* | *Hemasoft Software, S.L. e-Delphyn Donor v11.0.0.1 (BK200515)* | *GPI USA e-Delphyn Donor v11.2 (US) (BK220791)* |
| --- | --- | --- |
| *Indications for Use* | e-Delphyn Donor is a web enabled modular computerized system intended to be used by trained personnel to aid in donor management. The functionalities include: • Registering, deferring, merging and qualifying donors. • Registering bags. • Recording the outcomes of the Donor History Questionnaire (DHQ). • Recording medical screening data and phlebotomy information. • Entering and evaluating test results in accordance with the decision rules. • Processing units in components. • Managing storage, inventory and distribution of units. • Managing therapeutic and autologous/directed donations requests. | e-Delphyn Donor is a web enabled modular computerized system intended to be used by trained personnel to aid in donor management. The functionalities include: • Registering, deferring, merging and qualifying donors. • Registering bags. • Recording the outcomes of the Donor History Questionnaire (DHQ). • Recording medical screening data and phlebotomy information. • Entering and evaluating test results in accordance with the decision rules. • Processing units in components. • Phenotype RBC/HLA searching and matching. • Managing storage, inventory and distribution of units. • Managing therapeutic and autologous/directed donations requests. |

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## 510(k) Summary
(in accordance with 21 CFR §807.92)

**Technology Comparison (continued):**

| Characteristic | Hemasoft Software, S.L. e-Delphyn Donor v11.0.0.1 (BK200515) | GPI USA e-Delphyn Donor v11.2 (US) (BK220791) |
| --- | --- | --- |
| Components | Preparation, manufacturing, testing, labeling. | Same, but testing now includes human leukocyte antigen (HLA) typing. |
| Donor Product Management | Inventory control including • Storage. • Distribution. • Quarantine. • Lookback. • Phenotype RBC searching. | Inventory control including • Storage. • Distribution. • Quarantine. • Lookback. • Phenotype RBC/HLA searching and matching. |

**Predicate Device Comparison:**

e-Delphyn Donor v11.2 (US) employs the same intended use, indications for use and technological characteristics as the predicate device.

**Summary of Performance Testing:**

**Software**

e-Delphyn Donor v11.2 (US) software was designed and developed according to a robust software development process and was rigorously verified and validated.

Software information is provided in accordance with internal requirements and the following guidance documents and standards:

- FDA guidance: The content of premarket submissions for software contained in medical devices, 11 May 05.
- FDA guidance: Off-the-shelf software use in medical devices, 09 Sep 99.
- FDA guidance: General principles of software validation; Final guidance for industry and FDA staff, 11 Jan 02.
- FDA guidance: Content of premarket submissions for management of cybersecurity in medical devices, 02 Oct 14.
- FDA guidance: Cybersecurity for networked medical devices containing off-the-shelf (OTS) software, 14 Jan 05.
- ISO 14971: 2019, Medical devices – Application of risk management to medical devices.

Test results indicate that e-Delphyn Donor v11.2 (US) complies with its predetermined specifications and the guidance documents.

**Performance Testing – Bench**

e-Delphyn Donor v11.2 (US) was tested for performance in accordance with internal requirements including:

- Risk Control Measure Verification.
- Functional Verification and Validation

Verification results indicated that e-Delphyn Donor v11.2 (US) complies with internal requirements.

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# **510(k) Summary**
*(in accordance with 21 CFR §807.92)*

# ***Conclusion***

Verification and validation activities were conducted to establish the performance and safety characteristics of the device modifications made to e-Delphyn Donor v11.2 (US) Donor. The results of these activities demonstrate that e-Delphyn Donor v11.2 (US) is as safe and as effective in comparison to the predicate device when used in accordance with its intended use and labeling. Therefore, e-Delphyn Donor v11.2 (US) is considered substantially equivalent to the predicate device.

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