BK241136 · BioLife Plasma Services LP Bannockburn, IL · MMH · Feb 20, 2025 · Hematology
Device Facts
Record ID
BK241136
Device Name
Lookback Notification System version 2.0
Applicant
BioLife Plasma Services LP Bannockburn, IL
Product Code
MMH · Hematology
Decision Date
Feb 20, 2025
Decision
SESE
Regulation
21 CFR 864.9165
Device Class
Class 2
Attributes
Software as a Medical Device
Indications for Use
The Lookback Notification System is intended to generate and maintain electronic lookback records and allows for the automated creation, distribution and updating of applicable consignee notifications to assist in effectively identifying and removing unsuitable units (Source Plasma), prior to manufacturing.
Device Story
LNS v2.0 is a cloud-based SaaS application hosted on Salesforce; manages electronic lookback records for Source Plasma. Inputs include post-donation information, manufacturing errors, positive test results, and brokered plasma data, entered manually or electronically via interfaces with APDS, DIS, and ODS databases. System automates creation, distribution, and updating of consignee notifications to facilitate removal of unsuitable plasma units before manufacturing. Used in office environments at corporate headquarters and plasma centers by Regulatory Affairs, Lookback, Center, and QA staff. Output consists of electronic records and notifications; assists healthcare/plasma facility personnel in identifying and quarantining unsuitable products, ensuring safety of plasma supply.
Clinical Evidence
No clinical data. Evidence consists of non-clinical bench testing, including software verification and validation per ANSI AAMI IEC 62304, cybersecurity risk assessment, and functional performance/usability testing. Testing confirmed system performance at standard and high capacities.
Technological Characteristics
Cloud-based SaaS application hosted on Salesforce. Interfaces with APDS, DIS, and ODS databases via Informatica/MuleSoft. Operates on company-managed workstations using supported OS and Google Chrome. Connectivity via wired network or Wi-Fi (min 3Mbps, <150ms latency). Complies with ANSI AAMI IEC 62304.
Indications for Use
Indicated for use by Regulatory Affairs, Lookback, Center, and QA personnel to manage lookback records and consignee notifications for Source Plasma units identified as unsuitable due to post-donation information, manufacturing errors, positive test results, or brokered plasma information.
Regulatory Classification
Identification
Blood establishment computer software (BECS) is a device used in the manufacture of blood and blood components to assist in the prevention of disease in humans by identifying ineligible donors, by preventing the release of unsuitable blood and blood components for transfusion or for further manufacturing into products for human treatment or diagnosis, by performing compatibility testing between donor and recipient, or by performing positive identification of patients and blood components at the point of transfusion to prevent transfusion reactions. This generic type of device may include a BECS accessory, a device intended for use with BECS to augment the performance of the BECS or to expand or modify its indications for use.
Special Controls
*Classification.* Class II (special controls). The special controls for these devices are:(1) Software performance and functional requirements including detailed design specifications (
*e.g.,* algorithms or control characteristics, alarms, device limitations, and safety requirements).(2) Verification and validation testing and hazard analysis must be performed.
(3) Labeling must include:
(i) Software limitations;
(ii) Unresolved anomalies, annotated with an explanation of the impact on safety or effectiveness;
(iii) Revision history; and
(iv) Hardware and peripheral specifications.
(4) Traceability matrix must be performed.
(5) Performance testing to ensure the safety and effectiveness of the system must be performed, including when adding new functional requirements (
*e.g.,* electrical safety, electromagnetic compatibility, or wireless coexistence).
Predicate Devices
Lookback Notification System version 1.0 (BK150347)
Submission Summary (Full Text)
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BioLife
Plasma Services
# 510(k) Summary
DATE SUBMITTED
November 04, 2024
SUBMITTER
BioLife Plasma Services L.P.
1200 Lakeside Drive
Bannockburn, IL 60015
(224) 940-7611
CONTACT
Jennifer Burton
Lead, Global Regulatory Affairs Device
DEVICE INFORMATION
Trade Name of Device: Lookback Notification System version 2.0
Regulation: 864.9165
Product Classification: Blood Establishment Computer Software and Accessories
Device Classification: Class II (special controls)
Product Code: MMH
LEGALLY MARKETED PREDICATE DEVICE
Trade Name of Device: Lookback Notification System version 1.0
Relevant 510(k) Number: BK150347
Product Code: MMH
Manufacturer and 510(k) holder: BioLife Plasma Services L.P.
DEVICE DESCRIPTION SUMMARY
The Lookback Notification System version 2.0, hereafter referred to as LNS, is an internal Software as a Service (SAAS) cloud-based software application hosted on Salesforce. LNS is intended to generate and maintain electronic lookback records and allows for the automated creation, distribution, and updating of applicable consignee notifications to assist in effectively identifying and removing unsuitable product units (Source Plasma) before manufacturing.
LNS creates and maintains electronic lookback records based on post-donation information, manufacturing errors, positive test results data, and brokered plasma information, either electronically or manually entered. In addition, LNS allows the automated creation, distribution, and updating of applicable lookback consignee notifications.
INTENDED USE
The Lookback Notification System is intended to generate and maintain electronic lookback records and allows for the automated creation, distribution and updating of applicable consignee
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notifications to assist in effectively identifying and removing unsuitable units (Source Plasma), prior to manufacturing.
## INTENDED USE COMPARISON
The Intended Use for the Lookback Notification System version 2.0, hereafter referred to as LNS, differs from the predicate device, the Lookback Notification System v 1.0. The intended use was updated for clarity. No new functionality has been added to the product that would change the intended use of the device.
## COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
| Characteristics | Predicate Device: LNS version 1.0 | Subject Device: LNS version 2.0 |
| --- | --- | --- |
| Environment of Use | LNS is a computer system used in an office environment at BioLife Plasma Services corporate headquarters in Northern Illinois. | LNS is a computer system used in an office environment at BioLife Plasma Services corporate headquarters in Northern Illinois and the BioLife Plasma Services centers. |
| Intended Users | Regulatory Affairs and Lookback Department | Regulatory Affairs, Lookback, Center, and QA. |
| Interfaces | Automated Plasma Dispositioning System (APDS) | Automated Plasma Dispositioning System (APDS) via Informatica Donor Information System (DIS) via Operational Data Store (ODS) Database (DB) via Informatica or MuleSoft |
| Local Area Network | **Desktop/WorkStation:** Isolated network | **Desktop/Laptop (wired network):** Isolated network **Salesforce (Wi-Fi):** Network latency of 150 ms or less and download speed of 3Mbps or greater. |
| Operating System | Microsoft Windows 7 | Company-managed workstation using company-supported |
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| Characteristics | Predicate Device: LNS version 1.0 | Subject Device: LNS version 2.0 |
| --- | --- | --- |
| | | operating systems with access to the latest version of Google Chrome |
| Platform | Microsoft Windows environment | Salesforce SAAS (Software as a Service) based application |
The differences in the principles of operation and technology characteristics between the proposed LNS software device and the predicate device do not raise new questions of safety or effectiveness.
### COMPARISON OF FUNCTIONAL CHARACTERISTICS
| Areas of Comparison | Predicate | Subject Device |
| --- | --- | --- |
| Ability to create and maintain Post Donation Information (PDI) Lookback records | ✓ | ✓ |
| Ability to create and maintain Positive Test Result (PTR) Lookback records | ✓ | ✓ |
| Ability to create and maintain non-conformance (NCR) Lookback records | ✓ | ✓ |
| Ability to create and maintain Brokered Plasma (BP) Lookback records | ✓ | ✓ |
| BPDR Assessments | ✓ | ✓ |
| Requests for Clarification and/or Additional Documentation (ReCADs) | ✓ | ✓ |
| UDR, Lab Results, and Lab Deferrals Positive/Reactive Reports | ✓ | ✓ |
| Assessment Codes | ✓ | ✓ |
| Consignee notifications | ✓ | ✓ |
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BioLife
## NON-CLINICAL AND/OR CLINICAL TESTS
The following non-clinical testing was provided in support of the substantial equivalence determination:
- Cybersecurity
- Software Verification and Validation
- Function Performance Testing (Bench)
### Cybersecurity
All identified cybersecurity risks were sufficiently mitigated to a controlled state by using the cybersecurity controls designed and implemented by BioLife.
### Software Verification and Validation
Software verification and validation testing was performance in accordance with the FDA Guidance, General Principles of Software Validation. The system complies with ANSI AAMI IEC 62304.
### Function Performance Testing (Bench)
Bench verification testing for LNS consisted of performance and usability/human factors testing. The testing demonstrated that LNS will perform consistently at standard and high capacities with no delays and is safe and effective for the intended users, uses, and use environments.
## SUMMARY AND CONCLUSIONS
Based upon the comparison of the labeling and the technological and functional characteristics, the information provided in this submission – including results from risk assessments and testing activities related to cybersecurity, verification, validation, performance, and usability/human factors – demonstrates that the proposed LNS device functions as intended and is substantially equivalent to the predicate device. Differences between the proposed and predicate devices do not raise any different questions about safety or effectiveness. Therefore, BioLife concludes that the proposed device, LNS version 2.0, is substantially equivalent to the predicate device (BK150347).
