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BK090054 510K Summary

PDF Version (90KB)

OWNERS PARTICULARS:
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:      September 19th. 2009
Date the summary Revised:       December 19th. 2009
  
CONTACT PERSON:
Sam Waran  CPA, CITP, CISM, CGEIT, MBA, OCP, MCSE
 
DEVICE NAME:
Trade Name                              Picture-ID
Common Name                           Picture-ID
Classification Name                   Software, blood bank, stand alone products
 
PREDICATE DEVICE:
1.  Quality Donor System v2.1, 510(k) # BK070020;
2.  E-Interview (eQue) 1.0.0, 510(k) # BK050060;
3.  Donor-ID 3.0, 510(k) # BK060058;
4.     ElDorado Donor Doc 1.0.0, 510(k) # BK070010
 
DEVICE DESCRIPTION:
Picture-ID is a new biometrics, web services-based, blood donor identity verification software that incorporates donor self-administered electronic health history questionnaire.  It positively verifies donor identity using Fingerprint, date of birth and gender and then matches the identified donor to their picture on file.  Options to use State ID or Donor ID is included. Positively identified donors are allowed to edit their demographic data and are checked for visit eligibility.
 
Picture-ID reaches out to third party 510(k) approved donor management applications via ODBC and SQL query to check if positively identified donors have been deferred in that donor management system.  If donors are not deferred, they are eligible to a visit in Picture-ID. These visit-eligible donors are presented with an electronic FDA recognized, AABB Uniform Donor History Questionnaire (DHQ) for completion online.  This is a fillable pdf form (eDHQ).

Sample attached in Appendix1.    All questions must  be answered online.    After donor completes all the questions the eDHQ can be electronically signed and an electronic workflow is initiated.  Options are available for printing the DHQ by authorized blood bank staff for donor signature in which case the printed DHQ becomes a physical control document. Picture-ID supports multi-lingual text display and donors’ digital signature to enable a paperless process.  The completed and donor-signed eDHQ is used by qualified and trained blood bank staff, according to their SOPs, to interview the donor in a secured confidential area.  The interviewer comments on the eDHQ document and takes necessary actions, such as taking vitals and determining donation eligibility.

 

The entire system is web services based.  Donor access to the application can be over LAN (local Area Network), Wan (Wide Area Network) or through the Internet.  Internet transmissions are secured and encrypted over SSL (secured socket layer).  This allows safe and secured completion of the eDHQ remotely.  Completed eDHQs are stored on local servers allowing donors to pre-complete DHQs remotely on day of donation, come to the blood or mobile center, identify and verify themselves by our three factor authentication review their eDHQ and submit.  This must be done on the day of donation or the donor will have to complete a new DHQ.  The reviewed and donor-signed eDHQ is used by qualified and trained blood bank staff, according to their SOPs, to interview the donor in a secured confidential area.

 

[The Internet Quality Donor System (iQDS) from Talisman Ltd. is an extension of their QDS (FDA 510(k) number BK070020 cleared on 4/30/2007), allows donors to complete the health history interview online from their home, school or office before going to the Blood drive. The only requirement, imposed by FDA, is that the medical interview must be done the same day as the blood drive.  Please refer: http://www.talmed.com/talmed/products/iQDS.htm.]

 

Picture-ID is taking the same approach for eDHQ.  In Picture-ID additional controls are introduced to positively identify donors by fingerprint (biometrics), date of birth and gender combination.  Identified donors are matched to their pictures on file. Only then pre-filled eDHQs appear for donor review and signature. Pre-filled eDHQ can only be signed at blood bank or mobile drive and are only available on day of donation.
 
INTENDED USE:
Picture Picture-ID is a new biometrics, web services-based, blood donor identity verification software that incorporates donor self-administered electronic health history questionnaire.  It positively verifies donor identity using Fingerprint, date of birth and gender and then matches the identified donor to their picture on file.  Options to use State ID or Donor ID is included.  Positively identified donors are checked for visit eligibility.  Visit-eligible donors are allowed to edit their demographic data and are presented with an FDA recognized, AABB Uniform electronic Donor History Questionnaire (eDHQ) in pdf form for completion online.
 
TECHNOLOGICAL CHARACTERISTICS COMPARED TO PREDICATE DEVICE:
 
Predicate Device
Quality Donor System v2.1, 510(k) number BK070020:
 
Characteristic
Picture-ID
Predicate Device
Quality Donor System v2.1,
510(k) number BK070020
Biometrics
Three factor authentication.
Uses fingerprint identification with donor picture verification
No Biometrics.  Has picture verification .
Server Platform
Microsoft Windows XP, Server
2003, Server 2008
Microsoft Windows XP, Server 2003
Client Platform
Microsoft Windows XP,
Microsoft Windows XP,
Client Terminal
Touch-screen PC, or Tablets
Touch-screen Tablets
Peripherals
Bar-code readers, Fingerprint scanners, Web-cams,
Magnetic Strip Card Readers.
Bar-code readers, Signature pads,
Database
Microsoft SQL Server 2005
SQL Server 2005 Express
Networking
Standard computer networks using TCPIP.
Web Services using Secured
Socket Layer (SSL).
Standard computer networks; Internet using Secured Socket
Layer (SSL).
 
Predicate Device
E-Interview (eQue) 1.0.0, 510(k) number BK050060:
 
Characteristic
Picture-ID
Predicate Device
Quality Donor System v2.1,
510(k) number BK070020
Biometrics
Three factor authentication.
Uses fingerprint identification with donor picture verification
Three factor identification. Uses fingerprint identification
with donor picture verification
Server Platform
Microsoft Windows XP, Server
2003, Server 2008
Microsoft Windows XP, Server 2003
Client Platform
Microsoft Windows XP,
Microsoft Windows XP,
Client Terminal
Touch-screen PC, or Tablets
Touch-screen Tablets
Peripherals
Bar-code readers, Fingerprint scanners, Web-cams,
Magnetic Strip Card Readers.
Signature pads, webcams.
Database
Microsoft SQL Server 2005
Oracle Database
Networking
Standard computer networks using TCPIP.
Web Services using Secured
Socket Layer (SSL).
Standard computer networks;
 
Predicate Device
Donor-ID 3.0, 510(k) number BK060058:
 
Characteristic
Picture-ID
Predicate Device
Quality Donor System v2.1, 510(k) number BK070020
 
Biometrics
Three factor authentication.
No Biometrics.  Has picture
 
Uses fingerprint identification with
verification
donor picture verification
Server Platform
Microsoft Windows XP, Server
Microsoft Windows XP,
 
2003, Server 2008
Server 2003
Client Platform
Microsoft Windows XP,
Microsoft Windows XP,
Windows Vista
Client Terminal
Touch-screen PC, or Tablets
Touch-screen Tablets
Peripherals
Bar-code readers, Fingerprint scanners, Web-cams,
Signature pads, webcams.
Magnetic Strip Card Readers.
Database
Microsoft SQL Server
SQL Server
Networking
Standard computer networks using TCPIP.
Web Services using Secured
Socket Layer (SSL).
Standard computer networks;
 
Predicate Device
ElDorado Donor Doc 1.0.0, 510(k) number BK070010:
  
CharacteristicPicture-ID                             
 Predicate Device
Quality Donor System v2.1, 510(k) number BK070020
 Biometrics
Three factor authentication.
Uses fingerprint identification with donor picture verification
 
No Biometrics.  Has picture verification
Server Platform
Microsoft Windows XP, Server
2003, Server 2008
Microsoft Windows XP, Server 2003
Client Platform
Microsoft Windows XP, Windows Vista
Microsoft Windows XP, Windows Vista
Client Terminal
Touch-screen PC, or Tablets
Touch-screen Tablets
Peripherals
Bar-code readers, Fingerprint scanners, Web-cams,
Magnetic Strip Card Readers.
Signature pads, webcams
Database
Microsoft SQL Server 2005
SQL Server 2005
Networking
Standard computer networks using TCPIP.
Web Services using Secured
Socket Layer (SSL).
Standard computer networks;
 
Discussion:
Technologically the Picture-ID is similar to the predicate devices, combined and does not raise new types of safety or effectiveness questions. The comparison of the above devices in the
above tables demonstrates equivalence.
 
SAFETY AND EFFECTIVENESS DATA:
Picture-ID 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 16.9.2 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.
 
 
CONCLUSION:
Based on the above comparison of the Picture-ID to the predicate devices, Picture-ID is substantially equivalent to the predicates combined. The results of testing demonstrate that the system has met the expectation of high product quality and is safe and effective for its intended use.