BK231036 · Haemonetics Corporation Boston, MA · MMH · Mar 15, 2024 · Hematology
Device Facts
Record ID
BK231036
Device Name
NexLynk DMS® Donor Management System 4.10.0
Applicant
Haemonetics Corporation Boston, MA
Product Code
MMH · Hematology
Decision Date
Mar 15, 2024
Decision
SESE
Regulation
21 CFR 864.9165
Device Class
Class 2
Attributes
Software as a Medical Device
Indications for Use
The NexLynk DMS® Donor Management System is intended for use at source plasma donation centers to determine donor eligibility for a donation, calculate donor nomograms, crossmatch immunogens for immunizing specialty plasma donors, and support product releasability for further manufacturing into therapies.
Device Story
NexLynk DMS® is a configurable software system for source plasma donation centers; automates manual processes; manages donor visits, health questionnaires, and donation records; tracks test samples and results; manages specialty plasma donor immunization programs; supports unit release and shipment for further manufacturing. System includes safety checks for donor suitability and unit releasability. Operated by plasma center staff to facilitate center workflows and regulatory compliance. Output used by staff to verify eligibility and manage inventory. Benefits include increased efficiency, standardized record keeping, and enhanced safety through automated suitability checks.
Clinical Evidence
No clinical testing was performed. Evidence consists of non-clinical verification and validation testing conducted in accordance with FDA Guidance, General Principles of Software Validation (2002).
Technological Characteristics
Blood Establishment Computer Software (BECS). Configurable database and record management software. Functions as a centralized system for donor and unit management. No changes to underlying technology or principle of operation compared to predicate.
Indications for Use
Indicated for use in Source Plasma establishments to determine donor eligibility, manage component collection/processing/testing/labeling/storage, crossmatch immunogens for specialty plasma donors, and conduct unit inventory lookbacks. Not indicated for patient management, treatment, or clinical care at a health care facility.
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).
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NexLynk DMS® 4.10.0
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# HAEMONETICS®
## 510(k) Summary
### Date
December 20, 2023
### Submitter
Haemonetics Corporation
125 Summer Street
Boston, MA 02110
### Contact
Samantha Schroeder
Senior Regulatory Affairs Specialist
Phone: 913-548-2288
Email: SSchroeder@Haemonetics.com
### Device Information
| *TRADE Name:* | NexLynk DMS® Donor Management System |
| --- | --- |
| *Common Name:* | Blood Establishment Computer Software |
| *Classification Name:* | Blood Establishment Computer Software and Accessories |
| *Regulation Number:* | 21 CFR 864.9165 |
| *Review Panel:* | Hematology |
| *Product Code:* | MMH |
| *Device Class:* | 2 |
### Legally Marketed Predicate Device
| Predicate # | Predicate Trade Name | Product Code |
| --- | --- | --- |
| BK150330 | NextGen 3.0.0 | MMH |
### Device Description Summary
The Haemonetics NexLynk DMS® Donor Management System is configurable software that automates the previously manual processes at a source plasma donation center. The software manages the donor visits, presents the donor health questionnaire and records donor answers, maintains records of the donation procedures, tracks test samples, processes test results, manages immunizing donors in specialty plasma donation programs, and manages the release and shipment of units out of the source plasma donation center for further manufacturing. The software includes safety checks to help ensure donor suitability and unit releasability requirements are met.
### Intended Use
The NexLynk DMS® Donor Management System is intended for use at source plasma donation centers to determine donor eligibility for a donation, calculate donor nomograms, crossmatch immunogens for immunizing specialty plasma donors, and support product releasability for further manufacturing into therapies.
---Haemonetics Corporation | 125 Summer Street | Boston, MA 02110
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HAEMONETICS®
# Indications for Use
The NexLynk DMS® Donor Management System is a record management software tool and database of information for use in Source Plasma establishments. The software assists in the manufacture of Source Plasma by performing the following functions:
- Determine donor eligibility and component suitability for release
- Manage component collection, processing, testing, labeling, and storage
- Crossmatch immunogens for immunizing specialty plasma donors
- Conduct unit inventory lookbacks
The NexLynk DMS® Donor Management System is not indicated for patient management, treatment, or clinical care at a health care facility.
# Indications for Use Comparison
The Indications for Use for the NexLynk DMS® Donor Management System are different from the predicate device, NextGen 3.0.0, because the indications for use were clarified. No new functionality has been added to the product that would cause a change to the indications for use. The currently cleared indications of the predicate (BK150330) continue to be supported.
# Technological Comparison
There is no change to the underlying technology, or principle of operation from the predicate NextGen 3.0.0 (BK150330). The device functions with the same intended use for the electronic facilitation and management of the source plasma collection center processes. Through the discussion on substantial equivalence, the risk management documentation, and the testing provided, it is concluded that the changes associated with NexLynk DMS 4.10.0 do not change the risk-benefit profile of the NexLynk DMS® Donor Management System.
# Non-Clinical and/or Clinical Tests
The non-clinical testing performed to support this premarket submission was performed in accordance with the FDA Guidance, General Principles of Software Validation (2002). The software testing consisted of thorough verification and validation testing to ensure the subject device is as safe, as effective, and performed as well as or better than the predicate device.
No clinical testing was performed in support of this premarket submission for the NexLynk DMS® Donor Management System.
# Summary & Conclusions
The non-clinical testing and comparison to the predicate device show the subject NexLynk DMS® Donor Management System 4.10.0 to be substantially equivalent to the predicate device and that there is no impact to the safety and effectiveness of the device.
Results from the non-clinical testing demonstrate that the NexLynk DMS® Donor Management System 4.10.0 is as safe and effective, and it performs as well as its proposed predicate device.
In conclusion, the NexLynk DMS® Donor Management System 4.10.0 is substantially equivalent to the predicate device in terms of functionality, performance, technological characteristics, and Indications for Use, including for safety and effectiveness.
Haemonetics Corporation | 125 Summer Street | Boston, MA 02110
