BK120002 Summary

510(k) Summary

Submitter:	Haemonetics, Software Solutions
Address:	10025 102A Avenue, Suite 500, Edmonton, Alberta, Canada T5J 2Z2
Phone number:	916-404-8400
Fax number:	916-404-8484
Contact person:	Debra Csore
Date prepared:	April 18, 2012
Trade name:	LOGIC version 3.0.0
Common name:	Blood establishment computer software
Classification name:	Unclassified, Device Code MMH
Substantial equivalence claimed to: LOGIC 2.0, BK040040

 

Device Description

LOGIC 3.0.0 is a software application used to support daily operations of product logistics primarily organizing and controlling the movement of plasma units between facilities such as warehouses and fractionators. The application also communicates observations or post donation information on units. Additionally, LOGIC 3.0.0 provides interface functionality which supports the sending and receiving of message files to and from external applications.

The detailed features of LOGIC 3.0.0 are listed below:

• Receive unit, sample, container (e.g., carton), pallet, and shipment information through an interface from collection facility data systems.
• Receive shipments from facilities and verify containers received.
• Place and manage orders for product.
• Format and generate container labels and pallet labels.
• Generate shipping documentation, such as packing lists and bill of lading.
• Specify shipping statements including testing statements as required by the fractionators to receive shipments for processing.
• Create and send shipments to facilities such as fractionators and warehouses.
• Create and report unit, container and shipment discrepancies.
• Create and manage the status of observations and post donation information to resolution.
• Prevent unsuitable units from shipping by configuring shipment release rules.
• Transfer pallets and containers (inventory management) between storage locations within a facility.
• Record pool and manufactured lot information.
• Receive observations, test results, and unit applicant status through interfaces from external data systems.
• Generate shipment information, observations, unit assessments and lookback unit responses to be sent to external data systems.
• Secure internal security controls via the assignment and configuration of security roles and the creation of staff members (users) who are authorized to access LOGIC.
• Receive lookback information through interface from external data system.
• Streamlined observation management including ability to define lookback search criteria, additional definition of observation types, and means for capturing and displaying related comments.
• Enhanced reporting including additional content, default report templates and customization.
• Updated shipment and observation reports.
• Expanded timezone control including display and data entry in the user's local zone, country-specific timezones, and updated Daylight Savings Time management.
• Support for unit number of ISBT128 and Eurocode standards.
• Ability to create and manage a facility certification which can be checked by the shipment release rules.
• Extended staging functionality to include additional statuses, unit and container management, location specific rules, and option to require that all staged units are verified prior to shipment.

The LOGIC 3.0.0 limitations are documented in the labeling, see LOGIC-OT-0001 in Appendix D, Tab 1.

 

Intended Use

The intended use of LOGIC is to organize and control the transport of units between facilities such as collection sites, warehouses and fractionators. LOGIC also communicates observations or post donation information, status and recalls between collection, warehouse and fractionation facilities.

 

Functionality / Intended Use

Comparison LOGIC 3.0.0 and LOGIC 2.0 share the same features and intended uses, as shown in the following charts.

LOGIC 3.0.0 Intended Use	LOGIC 2.0 Intended Use, 510(k) cleared under BK040040
The intended use of LOGIC is to organize and control the transport of units between facilities such as collection sites, warehouses and fractionators. LOGIC also communicates observations or post donation information, status and recalls between collection, warehouse and fractionation facilities.	The intended use of LOGIC is to organize and control the transport of units between facilities such as collection sites, warehouses and fractionators. LOGIC also communicates observations or post donation information, status and recalls between collection, warehouse and fractionation facilities.

 

Features for Comparison	LOGIC 3.0.0	LOGIC 2.0 510(k) cleared under BK040040
Receive unit, sample, container (e.g., carton), pallet, and shipment information through an interface from collection facility data systems.	Yes	Yes
Receive shipments from facilities and verify containers received.	Yes	Yes
Place and manage orders for product.	Yes	Yes
Format and generate container labels and pallet labels.	Yes	Yes
Generate shipping documentation, such as packing lists and bill of lading.	Yes	Yes
Specify shipping statements including testing statements as required by the fractionators to receive shipments for processing.	Yes	Yes
Create and send shipments to facilities such as fractionators and warehouses.	Yes	Yes
Create and report unit, container and shipment discrepancies.	Yes	Yes
Create and manage the status of observations and post donation information to resolution.	Yes	Yes
Prevent unsuitable units from shipping by configuring shipment release rules.	Yes	Yes
Transfer pallets and containers (inventory management) between storage locations within a facility.	Yes	Yes
Record pool and manufactured lot information.	Yes	Yes
Receive observations, test results, and unit applicant status through interfaces from external data systems.	Yes	Yes
Generate shipment information, observations, unit assessments and lookback unit responses to be sent to external data systems.	Yes	Yes
Secure internal security controls via the assignment and configuration of security roles and the creation of staff members (users) who are authorized to access LOGIC.	Yes	Yes
Receive lookback information through interface from external data system.	Yes	Yes
Streamlined observation management including ability to define lookback search criteria, additional definition of observation types, and means for capturing and displaying related comments.	Yes	No
Enhanced reporting including additional content, default report templates and customization. Updated shipment and observation reports.	Yes	No
Expanded timezone control including display and data entry in the user's local zone, country-specific timezones, and updated Daylight Savings Time management.	Yes	No
Support for unit number of ISBT128 and Eurocode standards.	Yes	No
Ability to create and manage a facility certification which can be checked by the shipment release rules.	Yes	No
Extended staging functionality to include additional statuses, unit and container management, location specific rules, and option to require that all staged units are verified prior to shipment.	Yes	No

 

Technological Comparison

LOGIC 3.0.0 is technologically similar to the predicate device in operating system, hardware, and database.

Area of Comparison	LOGIC 3.0.0	LOGIC 2.0, 510(k) cleared under BK040040
Application Language	PL/SQL	PL/SQL
Database	Oracle DBMS	Oracle DBMS
Application Server Operating System	Windows 2008 Server	Windows 2000 Server
Database Server Operating System	HPUX	Windows 2000 Server -OR- HPUX
Client Operating System	Windows XP	Windows XP
Client Workstation Hardware	PC	PC

 

Safety and Effectiveness Data

LOGIC 3.0.0 was developed using established procedures for software development and testing. The software was extensively tested, including verification, validation, and user acceptance (Beta) testing. The results of testing demonstrated that LOGIC 3.0.0 met the specified requirements and functioned as expected.

LOGIC 3.0.0 will be as safe, as effective, and will perform as well as the predicate device when utilized within its intended use and in accordance with labeling, as demonstrated by the testing performed.

 

Conclusions

Based on the comparison of LOGIC 3.0.0 to its predicate device, LOGIC 3.0.0 is substantially equivalent to the predicate. The test results demonstrate that LOGIC 3.0.0 will be as safe and effective as the predicate device.