BK241061 · IT Synergistics, LLC Flowood, MS · MMH · Oct 25, 2024 · Hematology
Device Facts
Record ID
BK241061
Device Name
bexWISE API v1.0
Applicant
IT Synergistics, LLC Flowood, MS
Product Code
MMH · Hematology
Decision Date
Oct 25, 2024
Decision
SESE
Regulation
21 CFR 864.9165
Device Class
Class 2
Attributes
Software as a Medical Device
Indications for Use
The bexWISE API (v1.0) is for use in blood establishments to facilitate communication between 510(k) cleared Blood Establishment Computer Systems (BECS), allowing the exchange of donor and donation-related data used to determine donor eligibility and donation suitability.
Device Story
Software-only device; facilitates data exchange between 510(k) cleared Blood Establishment Computer Systems (BECS). Inputs: donor and donation-related data. Processing: API facilitates communication/transfer of data between systems; includes 'bexWISE API Portal' GUI for monitoring transfers and identifying errors/warnings. Output: data transfer status, error/warning notifications. Used in blood establishments; operated by blood bank personnel. Benefits: streamlines data exchange; assists in determining donor eligibility and donation suitability.
Clinical Evidence
No clinical data; clinical performance testing not applicable for this software-only device.
Technological Characteristics
Software-only medical device accessory; API architecture; includes GUI portal for data monitoring; facilitates interoperability between cleared Blood Establishment Computer Systems (BECS).
Indications for Use
Indicated for use in blood establishments to facilitate data exchange between cleared Blood Establishment Computer Systems (BECS) for determining donor eligibility and donation suitability.
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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IT Synergistics, LLC
### 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:
Company Name: IT Synergistics, LLC
Company Address: 115 Tree Street Flowood MS 39232
#### Official Correspondence:
Name: Kalman Grof-Tisza
Address: 115 Tree Street Flowood MS 39232
Phone: 509-495-1000
Email: kalman@itsynergistics.com
#### Device:
Device Classification Name: Software, Blood Bank, Web Products
Trade Name: bexWISE API v1.0
Common Name: Blood Establishment Computer Software
Review Panel: Hematology
Classification Product Code: MMH
Device Classification Regulation: 21 CFR 864.9165
Device Class: Class II
#### Predicate Device:
| 510(k) Number | Predicate Trade Name | Manufacturer | Product Code |
| --- | --- | --- | --- |
| BK140091 | DoVac Elite v2.0 | IT Synergistics, LLC | MMH |
| BK140149 | Donor-IDTM ver. 3.2.6 | Healthcare-ID, Inc. | MMH |
IT SYNERGISTICS
115 Tree Street • Flowood, MS 39232 | TEL 509-495-1000 | www.itsynergistics.com
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IT Synergistics, LLC
**Device Description:**
The bexWISE Application Programming Interface (API) is a software only Medical Device Accessory, streamlining the exchange of donor and donation-related data among 510(k) cleared Blood Establishment Computer Systems (BECS). This API includes a user-friendly graphical user interface (GUI) labeled as the "bexWISE API Portal," enabling users to monitor transferred data and identify any errors or warnings that might have occurred.
**Intended Use/Indications for Use:**
The bexWISE API (v1.0) is for use in blood establishments to facilitate communication between 510(k) cleared Blood Establishment Computer Systems (BECS), allowing the exchange of donor and donation-related data used to determine donor eligibility and donation suitability.
**Non-Clinical Testing**
IT Synergistics' activities to assure adherence to design control include determining new risks and analyzing those risks. Hazards are mitigated by identifying new requirements to reduce the hazard, providing appropriate errors or warnings to the user. Based on the identified hazards and requirements, test cases are written and executed to verify that all conditions identified to mitigate identified hazards have been implemented as stated by the requirements.
**Clinical Testing:**
Clinical performance testing is not applicable for the bexWISE API v1.0 as it is a software only device.
**Conclusion:**
The bexWISE API v1.0 was developed using design controls incorporated in IT Synergistics development processes. The non-clinical data supports the safety of the device and indicate that the software device will perform as well as the predicate device as demonstrated by supporting validation activities performed and verifies that the device performs as designed, per the functional requirements, when utilized within its intended use.
115 Tree Street • Flowood, MS 39232 | TEL 509-495-1000 | www.itsynergistics.com
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