Table of Contents
510(K) SUMMARY: 2
OWNERS PARTICULARS: 2
CONTACT PERSON: 2
DEVICE NAME: 2
PREDICATE DEVICE: 2
DEVICE DESCRIPTION: 2
INTENDED USE: 3
TECHNILOGICAL CHARACTERISTICS COMPARED TO PREDICATE DEVICE 3
SAFETY AND EFECTIVENESS DATA 4
Device Name: eOrders, Version 1
Device Code: 81 MMH
Predicate Device: BBCS Hospital Interface Application (BBCSH), H1.0.0 (BK090081)
Contact Person: Sam Waran CPA, CRISC, CISM, CGEIT, MBA, OCP, MCSE
Contact: firstname.lastname@example.org; 415-505-9961
510(k) owner's name:
Calimex USA Corporation
Address: 258 Hollister Avenue, Alameda, CA 94501
Phone: 415 505 9961
Fax: 413 669 4047
Date the summary prepared: November 11, 2011
Sam Waran CPA, CRISC, CISM, CGEIT, MBA, OCP, MCSE
Common Name Online Blood Orders; Online Hospital Orders.
Classification Name Software, blood bank, stand alone products
BBCS Hospital Interface Application (BBCSH), H1.0.0 (BK090081)
eOrders is a web based, online ordering system for use in blood banks, laboratories and hospitals to order blood and related products and services. The system can be local to the blood banks, laboratories, hospitals and pharmacies or hosted in the cloud. Buyers and sellers connect securely through the internet to transact business. Options to do business by old ways of telephone, fax, emails are included. In this way the full, final status of all orders are available in real time.
Blood banks, laboratories, hospitals and pharmacies get their own web pages (Home Pages) when they login with their user name and password. Orders are entered using an Order Form. Orders are received when they are submitted. Acknowledgements of orders received are sent immediately. Orders are filled. Further acknowledgments are sent and order status updated when orders are shipped. Order acknowledgement is by way of email, text and phone, depending on the choices selected. Dashboards are provided for management reporting.
eOrders reaches out to third party blood bank, lab, hospital and pharmacy software applications via ODBC and SQL query to check products, product availability, inventory, inventory levels and re-order levels to fill orders. Orders can be automated based on re-order levels. Option by authorized staff to review and correct orders before filling is provided. Escalation process is built-in.
The system provides an electronic two-way communications on each other home pages. It also provides an online chat service for buyers and sellers to connect in real time to ask questions or seek help.
Internet transmissions are secured and encrypted over SSL (secured socket layer). This allows safe and secured completion of orders remotely. Completed orders are stored in local servers or in the cloud, allowing authorized users access to them online.
eOrders is a web based, online ordering system for use in blood banks, laboratories and hospitals to order blood, blood-tests and related products and services. The system can be local to the blood banks, laboratories, hospitals and pharmacies or hosted in the cloud. Buyers and sellers connect securely through the internet to transact business. Options to do business by way of telephone, fax, emails are included. In this way the final status of all orders are available in real time. Orders submitted are acknowledged within agreed time period by an automated feedback process. Authorized users can check status of orders, shipments, expected delivery, fill rates and management reports online anytime, from anywhere.
TECHNOLOGICAL CHARACTERISTICS COMPARED TO PREDICATE DEVICE:
BBCS Hospital Interface Application (BBCSH), H1.0.0 (BK090081):
|Software||Standalone software with ODBC and SQL query hooks to blood banks, laboratories, hospitals and pharmaceutical information systems. Data outputs generated from this system are handed over to blood establishment software, hospital and pharmaceutical information systems for their mapping and upload.||The BBCSH Application is an adjunct software application for use with their Blood Bank Control System Application (BBCS). It is an accessory to BBCS V 5.0 and is installed in conjunction with an existing BBCS V 5.0 installation|
|Server Platform||Windows Server 2003, Windows Server 2008.||IBM iSeries Hardware and Operating System V5R3|
|Client Platform||Windows XP, Windows 7 with Internet Explorer 8||IBM iSeries Hardware and Operating System V5R3|
|Database||Microsoft SQL Server 2005 and 2008||DB2|
|Programming languages||Microsoft ASP.NET||IBM RPG III and Java 2 SE 1.4|
|Networking||Standard computer networks using TCPIP. Web Services using Secured Socket Layer (SSL).||TCPIP and HL7 messages Secured Socket Layer (SSL).|
eOrders software is similar to the predicate device of Hospital Ordering Website (HOW) and as far as receiving, selecting and transfer of blood and patient orders from hospital information systems into the blood bank system. eOrders goes further to include blood related orders, lab-test orders for blood transfusion, pharmaceuticals and bi-directional electronic communications of blood banks, labs, hospitals and pharmacies.
SAFETY AND EFFECTIVENESS DATA:
eOrders was developed using established procedure for software development. Unit tests and systems tests were done by our software team. Completed systems are tested and validated using test scripts for defined scenarios and included in appropriate sections.
Non Clinical System Testing:
The system was tested for validation and verification of functions and the results are contained in Section 16 of this 510(k) Notification. No critical failures were detected.
Clinical System Testing:
The system was tested in a blood bank user environment and the results are contained in Section 20 of this 510(k) Notification. No critical failures were detected.
Beta Testing and Performance Testing:
Beta Testing was done at the Blood Centers of the Pacific in San Francisco. The results are attached to Section 18 of this 510(k) Notification. No critical failures were detected.
The conclusions drawn from the clinical, non-clinical and beta testing demonstrate that the system has met the expectation of high product quality and is safe and effective for its intended use.