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BK120084 Summary

Section 15

510(k) Summary

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Date: December 19, 2012

Submitter:
Haemonetics Software Solutions
4925 Robert J Mathews Pkwy., Suite 100
El Dorado Hills, CA 95762, USA

Contact:
Chris Thomas
Senior Manager, Regulatory Affairs
Phone: 916-404-8421
Fax: 916-404-8484
Email:christina.thomas@haemonetics.com

Device Information:
Trade Name: Phlebotomy System version 1.0.0
Regulation Number: 21 CFR 864.9175
Classification Name: Software, Blood-Bank, Stand Alone Products
Regulatory Class: Class II
Product Code: MMH

Predicate Device Information:

  1. Trade Name: Haemonetics Symphony System 3.0
    510(k) Number: BK090041
    Regulation Number: 21 CFR 864.9175
    Classification Name: Software, Blood-Bank, Stand Alone Products
    Regulatory Class: Class II
    Product Code: MMH
  2. Trade Name: 5D Information Management (now Haemonetics Software Solutions) eLynx 1.0.0
    510(k) Number: BK060051
    Regulation Number: 21 CFR 864.9175
    Classification Name: Software, Blood-Bank, Stand Alone Products
    Regulatory Class: Class II
    Product Code: MMH

 Device Description:
Phlebotomy System is an interactive application that automates data collection during the phlebotomy process. Phlebotomy System will support manual entry of draw data from a user or accept data transmitted on the donation floor, consistent with the Intended Use of the application.  Information collected in this application will be shared with a host system. Configurable workflow per collection type allows a user to record donation details. This software will allow a phlebotomist to identify a donor and associate them to a unit number. The application supports all aspects of phlebotomy and provides the ability to run reports.

Phlebotomy System receives and sends data from the donation collection facility’s Information System and processes the donors through the phlebotomy process.

Intended Use:
Phlebotomy is a tool that is intended to allow users to collect draw related data. Phlebotomy provides the following:

  • Electronic paperless collection of draw related data with multi-lingual capabilities
  • Provide users the display of additionally available donor identification information that may optionally be used by the phlebotomist to establish positive donor identification
  • Provide phlebotomists the ability to capture notations and staff assessment outcomes associated with unsuitable draw conditions
  • User interface design provides users the option of accessing the tool from commercially available wireless FCC and CE marked devices
  • Exchange of donor information with a collection facility’s Information System. 
  • Configurable workflow per Collection Type
  • Enables workflow enforcement
  • Printing of records and reports
  • Comprehensive auditing and security features

Technological Comparison:
Phlebotomy System 1.0.0 is technologically comparable to the predicate devices. A summary of this comparison is provided below:


Area of Comparison

Symphony System 3.0 (Prelude application)
(Predicate)

eLynx 1.0.0
(Predicate)

Phlebotomy System 1.0.0
(Proposed)

Database

Oracle RDBMS

Not declared

Oracle RDBMS

Server Operating System

Windows 2000, Windows XP, Windows 2003

Windows XP, Windows 2000

MS Windows Server

Workstation Operating System

Windows 2000, Windows XP, Windows 2003

Windows XP, Windows 2000

Windows 7

Handheld or Tablet Operating System

Windows 2000, Windows XP, Windows 2003

Microsoft Mobile 2003 SE

Windows 7

Browser-based application support

Yes

Yes

Yes

Wireless Network

Yes

Yes

Yes

Functional Comparison:
Phlebotomy System 1.0.0 is functionally comparable to the predicate devices. A summary of this comparison is provided below:


Areas of Comparison

Symphony System 3.0 (Prelude application)
(Predicate)

eLynx 1.0.0
(Predicate)

Phlebotomy System 1.0.0
(Proposed)

Electronic paperless collection of draw related data with multi-lingual capabilities

Yes

Yes

Yes

Provide users the display of additionally available donor identification information that may optionally be used by the phlebotomist to establish positive donor identification

Yes

Yes

Yes

User interface design provides users the option of accessing the tool from commercially available CE marked or equivalent portable devices

Yes

Yes

Yes

Exchange of donor information with a collection facility’s Information System

Yes

Yes

Yes

Configurable workflow per Collection Type

Yes

Yes

Yes

Enables workflow enforcement

Yes

Yes

Yes

Printing of records and reports

Yes

Yes

Yes

Comprehensive auditing and security features.

Yes

Yes

Yes

Safety and Effectiveness Data:
Phlebotomy System 1.0.0 was designed, developed and maintained using an established procedure for development, encompassing all phases from project initiation through testing, change control and implementation and product release. Verification and validation testing, including regression, was performed to ensure that the software meets the requirements for its intended use.

Conclusions:
Based on the comparison of The Phlebotomy System 1.0.0 to its predicate devices, The Phlebotomy System 1.0.0 is substantially equivalent to the predicates. The results of testing demonstrate that the device is safe and effective for its intended use.