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Vaccines, Blood & Biologics

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BK110015 Summary

510(k) Summary

Submitter:
Address:
Haemonetics
10025 102a Avenue, Suite 500, Edmonton, Canada T5J 2Z2
Phone number:
Fax number:
Contact person:
Date prepared:
Trade name:
Common name:
Classification name:
916-404-8400
916-404-8484
Debra Csore
May 24, 2011
Nextgen
Blood establishment computer software
Software, blood bank, stand alone products
Substantial equivalence claimed to:Donor Management System (DMS), BK990022


Device Description

Nextgen is a computer software system that is intended to meet the needs of a plasma collection organization. Nextgen provides the following features:

• Collection of donor demographic information
• Donor visit registration
• Generation of unique donor identification numbers
• Capture and evaluation of donor screening tests
• Management of donor deferrals
• Recording of donor questionnaire assessment results, consents, physicals and reviews
• Assessment of donor suitability
• Generation of unique plasma collection tracking numbers
• Printing of bleed labels for plasma units and test samples
• Recording of phlebotomy information
• Management of test samples
• Ordering of test orders and electronic manifest generation and interface
• Receipt and processing of sample test results and posting of deferrals, including electronic interface
• Posting of deferrals based on results of tests and user configuration
• Assessment of unit releasability
• Recording and management of packing units into cases
• Recording and management of shipments
• Printing of case labels and shipping labels
• Traceability from donor, to units, to shipments
• Comprehensive security features and data auditing to support industry standards
• Configurable donor visit work-flow, donor suitability rules, testing requirements, and unit releasability rules

Nextgen is a configurable and interactive computer software application that automates the processes of a plasma collection center. The system manages the donor visits, records the donations, tracks test samples and results, and manages the shipment of plasma units out of the center. The device includes many safety checks to ensure donor suitability and unit releasability requirements are met.
 

Intended Use

Nextgen is a computer software system indicated for use by trained personnel to aid in the management and control of plasma centers. The system manages the capture and recording of donor information, evaluates donor suitability and records the collection of plasma units. The system also manages test samples, processes test results, evaluates the releasability of plasma units, and manages shipments.


Functionality / Intended Use Comparison
 

Nextgen and DMS share most of the same features and intended uses, as shown in the following chart.

Areas of ComparisonNextgenDMS
Collection of donor demographic informationYesYes
Donor visit registrationYesYes
Generation of unique donor identification numbersYesYes
Capture and evaluation of donor screening testsYesYes
Management of donor deferralsYesYes
Recording of donor questionnaire assessment results, consents, physicals and reviewsYesYes
Assessment of donor suitabilityYesYes
Generation of unique plasma collection tracking numbersYesYes
Printing of Bleed labels for plasma units and test samplesYesYes
Recording of phlebotomy informationYesYes
Management of test samplesYesYes
Ordering of test orders and electronic manifest generation and interfaceYesYes
Receipt and processing of sample test results and posting of deferrals, including electronic interfaceYesYes
Posting of deferrals based on results of tests and user configurationYesYes
Ordering of test orders and receipt and processing of sample test results, including electronic interfaceYesYes
Assessment of unit releasabilityYesYes
Recording and management of packing units into casesYesYes
Recording and management of shipmentsYesYes
Printing of case labels and shipping labelsYesYes
Traceability from donor, to units, to shipmentsYesYes
Comprehensive security features and data auditing to support industry standardsYesYes
Configurable donor visit work-flow, donor suitability rules, testing requirements, and unit releasability rulesYesYes


Technological Comparison

Nextgen is technologically similar to the predicate device in operating system, hardware, and database. The primary technological difference is the programming language: Nextgen was programmed in Java and JavaScript, whereas DMS was programmed in PL/SQL.

Area of ComparisonNextgenDMS
Application LanguageJava, JavaScriptPL/SQL
DatabaseOracle DBMSOracle DBMS
Application Server Operating SystemLinuxUnix
Client Operating SystemWindows XPWindows
Client Workstation HardwarePCPC


Safety and Effectiveness Data

Nextgen was developed using an established procedure for software development. The system was verified and validated. Validation test results are available in a supplement to this submission. The results of this testing demonstrated that Nextgen met the specified requirements and functioned as expected.


Conclusions

Based on the comparison of Nextgen to its predicate device, Nextgen is substantially equivalent to the predicate. The results of testing demonstrate that the device is safe and effective for its intended use.