510(k) Summary (in accordance with 21 CFR )

Size: px

Start display at page:

Download "510(k) Summary (in accordance with 21 CFR 807.92)"

Martina Brooks
8 years ago
Views:

1 Section 5 510(k) Summary (in accordance with 21 CFR ) Date: December 19, 2013 Submitter: Haemonetics Corporation Software Solutions 4925 Robert J Mathews Pkwy., Suite 100 El Dorado Hills, CA 95762, USA Contact: Christina Thomas Senior Manager, Regulatory Affairs Phone: Fax: christina.thomas@haemonetics.com Proposed Device Information: Trade Name: NextGen Class II Predicate Device Information: 1. Trade Name: Donor Management System (DMS) (Fifth Dimension Information Systems, now Haemonetics Corporation Software Solutions) BK NextGen Version (k) Submission 5-1

, Suite 100 El Dorado Hills, CA 95762, USA Contact: Christina Thomas Senior Manager, Regulatory Affairs Phone: 1-916-404-8421 Fax: 1-916-404-8484 Email:

2 2. Trade Name: E-Interview (eque) (Fifth Dimension Information Systems, now Haemonetics Corporation Software Solutions) BK Trade Name: ElDorado Donor (Wyndgate Technologies, now Haemonetics Corporation Software Solutions). BK Device Description NextGen is a web-based application that is intended to meet the needs of plasma donation centers. NextGen provides the following features: Collection of donor demographic information Donor visit registration Generation of unique donor identification numbers Donor identification including identification via fingerprints Capture and evaluation of donor screening tests Management of donor deferrals Presenting of donor health questionnaires and recording of donor responses Recording of donor questionnaire assessment results, consents, physicals and reviews Assessment of donor suitability and qualification Electronic interface to donor suitability systems NextGen Version (k) Submission 5-2

NextGen provides the following features: Collection of donor demographic information Donor visit registration Generation of unique donor identification numbers Donor identification including

3 Ability to reassign donors between donation programs Transferring of donors between centers Generation of unique unit collection tracking numbers Printing of bleed labels for units and test samples Ability to receive and record of phlebotomy information Management and recording of donor immunizations Management of test samples Ordering of tests via electronic or manual methods Receiving and processing of sample test results and posting of deferrals by electronic or manual methods Posting of deferrals based on results of tests and user-defined configuration Determination of unit releaseability Reassigning of units between product types Recording and management of packing units into cases Recording and management of shipments by electronic or manual methods Printing of case labels and shipping labels Traceability from donor, to units, to shipments Receiving of supplies and recording of supply use by electronic or manual method Management and recording of equipment service and usage Management of security features and data auditing to support customer procedures Configurable donor visit workflow, donor suitability rules, testing requirements, and unit releaseability rules Ability to manage donor financial compensation via electronic or manual methods Ability to electronically interface to external systems for recruitment of donors, management of donor information, screening of donors for suitability, immunizations, and product collection processing. Management of donor and product testing, quality control, product release, product inventory management, logistics, donor compensation and other related administrative center operations including management of information with external systems. Indications for Use NextGen is a web-based application indicated for use by trained personnel to aid and assist in the operation and management of plasma donation centers. NextGen is designed to undertake plasma donation center operations including but not limited to recruitment of donors, management of donor information, screening of donors for suitability, immunizations, and blood product collection processing. NextGen is also NextGen Version (k) Submission 5-3

processing of sample test results and posting of deferrals by electronic or manual methods Posting of deferrals based on results of tests and user-defined configuration Determination of unit

4 designed to manage donor and product testing, quality control, product release, product inventory management, logistics, donor compensation and other related administrative center operations including management of information with external systems. Substantial Equivalence The proposed software device, Haemonetics NextGen is a web-based application that is substantially equivalent to the Predicate 1, Haemonetics Donor Management System (DMS) 1.0.0, in that both products are intended to aid and assist in the operation and management of plasma donation centers. Both software products are designed to aid in the recruitment of donors, as well as manage donor information, including screening of donors for suitability and blood product collection processing. Both the proposed NextGen and Predicate 1, DMS product have device features that are configurable. Both devices were designed this way to allow customers to customize the software to meet their own business operations and practices. Both the proposed NextGen and Predicate 1, DMS software use a relational database management system to store all of the application information to help prevent loss of data or corruption of data. The proposed device NextGen is also substantially equivalent to the software device Predicate 2, Haemonetics E-Interview (eque) for the donor selfadministered questionnaire feature as well as substantially equivalent to Predicate 3, Haemonetics ElDorado Donor 1.0.0, for managing blood product donations. Clinical Trials Clinical performance testing is not applicable for NextGen 2.0.0, as it is a software only product. Performance Bench Testing was performed. See Section 18 for Performance Bench Testing. Conclusion NextGen was developed in accordance with Design Controls as well as the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. The software was thoroughly tested including verification, validation, and user acceptance (Beta) testing for safety to ensure it will be as safe, as effective, and performed as well as each predicate device`s substantially mapped functionality, when utilized within its intended use and in accordance with labeling, as demonstrated by the testing performed. Based on the functionality and performance comparison, technological characteristic comparison and the intended use, the proposed NextGen device performs as NextGen Version (k) Submission 5-4

0 is a web-based application that is substantially equivalent to the Predicate 1, Haemonetics Donor Management System (DMS) 1.0.0, in that both products are intended to aid and assist in the operation and management of plasma donation centers.

5 intended in all aspects of the predicate devices mapped functionality characteristics. The safety aspects of the NextGen device have been thoroughly tested in accordance with validation practices as outlined in , Design Controls. All testing passed. Therefore, the NextGen device is substantially equivalent to the predicate devices in terms of intended use, functionality, performance, technological characteristics as well as safety and effectiveness. NextGen Version (k) Submission 5-5

All testing passed. Therefore, the NextGen 2.0.

Cellular Therapy Liaison Meeting 10 September 2009 BECS. M. Allene Carr-Greer, MT(ASCP)SBB Director, Regulatory Affairs AABB

Cellular Therapy Liaison Meeting 10 September 2009 BECS M. Allene Carr-Greer, MT(ASCP)SBB Director, Regulatory Affairs AABB Definition from October 2007 draft guidance BECS Validation In the User s Facility