BK241062 · Haemonetics Corporation Boston, MA · MMH · Jun 21, 2024 · Hematology
Device Facts
Record ID
BK241062
Device Name
BloodTrack Software 4.16.0
Applicant
Haemonetics Corporation Boston, MA
Product Code
MMH · Hematology
Decision Date
Jun 21, 2024
Decision
SESE
Regulation
21 CFR 864.9165
Device Class
Class 2
Attributes
Software as a Medical Device
Indications for Use
The BloodTrack software is an electronic information management system intended to monitor the reception, handling, transportation and transfusion of blood and blood products. The BloodTrack software assists in the selection of blood products for patients by providing positive patient identification for transfusion, and verifying that the identified blood product was obtained.
Device Story
BloodTrack 4.16.0 is an electronic information management system for healthcare or collection facilities; manages inventory of blood, blood products, and plasma derivatives; facilitates transfusion administration at patient bedside; maintains electronic records for traceability and auditing. System provides positive patient identification and verifies blood product selection/acquisition. Used by clinical staff in hospital environments to ensure correct blood product delivery to patients; improves safety by reducing transfusion errors through electronic verification.
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). Functions as an electronic information management system for inventory and transfusion tracking. No changes to underlying technology or principle of operation from predicate. Software-based system; connectivity and platform details not specified.
Indications for Use
Indicated for use to assist in positive patient identification for transfusion, to assist in the selection of blood products for patients and verify that the identified blood product was obtained.
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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BloodTrack 4.16.0
ATTACHMENT 38
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**HAEMONETICS®**
# 510(k) Summary
# **Date**
March 25, 2024
# **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:* | BloodTrack® Software |
| --- | --- |
| *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 |
| --- | --- | --- |
| BK140133 | BloodTrack 4.7.0 | MMH |
# **Device Description Summary**
The BloodTrack® 4.16.0 is software designed to be used in a healthcare or collection facility to manage the inventory of blood, blood products and plasma derivatives (collectively referred to as Units), to manage the transfusion administration process at the patient bedside and to maintain electronic records for end-to-end traceability and auditing.
# **Intended Use**
The BloodTrack software is an electronic information management system intended to monitor the reception, handling, transportation and transfusion of blood and blood products.
The BloodTrack software assists in the selection of blood products for patients by providing positive patient identification for transfusion, and verifying that the identified blood product was obtained.
# **Indications for Use**
The BloodTrack software is indicated for use to assist in positive patient identification for transfusion, to assist in the selection of blood products for patients and verify that the identified blood product was obtained.
---Haemonetics Corporation | 125 Summer Street | Boston, MA 02110
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# HAEMONETICS®
## Indications for Use Comparison
The Indications for Use for the BloodTrack® Software 4.16.0 are different from the predicate device, BloodTrack 4.7.0, because the indications for use were clarified to describe only the medical functionality and to remove non-medical functionality, which were not critical to the safety and effectiveness of the software device when used as labeled. The currently cleared indications of the predicate (BK140133) continue to be supported.
## Technological Comparison
There is no change to the underlying technology, or principle of operation from the predicate BloodTrack 4.7.0 (BK140133). The device functions with the same intended use to monitor the reception, handling, transportation and transfusion of blood, blood products and plasma derivatives (collectively referred to as Units). Through the discussion on substantial equivalence, the risk management documentation, and the testing provided, it is concluded that the changes associated with BloodTrack 4.16.0 do not change the risk-benefit profile of the BloodTrack® Software.
## 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 BloodTrack® Software.
## Summary & Conclusions
The non-clinical testing and comparison to the predicate device show the subject BloodTrack® Software 4.16.0 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 BloodTrack® Software 4.16.0 is as safe and effective, and it performs as well as its proposed predicate device.
In conclusion, the BloodTrack® Software 4.16.0 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
