Substantially Equivalent 510(k) Device Information
Applicant: Information Data Management, Inc. Rosemont, IL
510(k) number: BK000016
Product: Information Data Management Surround System 2.0
Date: 4/7/2000
Summary of Safety and Effectiveness
510(k) SUMMARY
Prepared March 10, 2000
DEVICE NAME:
Proprietary Name: IDM SURROUND System, version 2.0
Common Name: Surround
Classification Name: Software, Blood-Bank, Stand Alone Products
PREDICATE DEVICE:
IDM SURROUND System, version 1.0
DEVICE DESCRIPTION:
The IDM Surround System is a stand-alone blood bank software device that aids in the interpretation and management of laboratory test results. The software assists laboratories by collecting and collating sample IDs and their test results, and transferring the results automatically to configurable, sample specific locations. A variety of reporting option are available, e.g. facsimile, electronic mail, File Transfer Protocol (FTP), serial transfer (direct-cable), print/mail, etc.
Surround is a secure system requiring a login mark (user ID) and password for system access. Individual capabilities are maintained for each user to control the performance of specific system activities. This information allows Surround to uniquely identify each user as well as which activities multi-level users may perform on the system. In general, users with appropriate capabilities can find, create and inquire about all testing records. The User's Manual (Binder #2) supplied with this submission provide a complete description of the software.
INENDED USE:
The IDM Surround System is a computerized system intended to be used by trained personnel as an aid in the collection, collation and management of data generated by the laboratory testing of donor or patient blood samples.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS OF IDM SURROUND SYSTEM 2.0 TO PREDICATE DEVICE:
| CHARACTERISTIC |
IDM SURROUND 2.0 |
IDM SURROUND 1.0
(Predicate Device) |
| Application Code |
Java |
Java |
| Database |
Oracle RDMS |
Oracle RDMS |
| Operating System |
Microsoft Windows NT |
Microsoft Windows NT |
| Compiler |
Java Development Kit (JDK) 1.1.8 |
Java Development Kit
(JDK) 1.1.2 |
| Minimum Hardware Requirement |
INTEL 300 MHz Pentium, 4GB Hard Disk with CD ROM, Super VGA Color monitor and video board, Network Interface card, mouse, keyboard, Serial communications port |
INTEL 300 MHz Pentium, 4GB Hard Disk with CD ROM, Super VGA color monitor and video board, Network Interface card, mouse, keyboard, Serial communications port |
| Serial Connector |
PC Serial Port |
PC Serial Port |
| Minimum Memory (RAM) |
128 MB RAM |
128 MB RAM |
SAFETY AND EFFECTIVENESS DATA:
The IDM Surround System, version 2.0 has been developed using an established procedure for software development. This system will be as safe, as effective, and will perform as well as or better than the predicate device when utilized within its intended use, as demonstrated by the clinical and non-clinical testing performed.
Non- Clinical Testing: The assessment of the results of non-clinical (unit, integration and system) testing can be found in Binder #1, Tabs #6, #7 and #8.
Clinical Testing: The assessment of the results of clinical (beta) testing can be found in Binder #1, Tab #9.
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