Sequence Group led the regulatory strategy and complete documentation package for the Empyrean TPS Workstation a Software as a Medical Device (SaMD) for treatment planning of intraoperative radiation therapy with the Sculptura IORT System.
FDA 510(k) Clearance
Empyrean TPS Workstation is a software system intended for treatment planning and analysis of intraoperative radiation therapy administered with the Empyrean IORT System. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment.
View FDA 510(k) Decision Letter (K182665) ↗The Challenge
The TPS Workstation is a high-risk SaMD requiring rigorous IEC 62304 software lifecycle documentation, FDA software guidance compliance, and cybersecurity risk analysis. The software calculates and displays estimated radiation dose distributions, making accuracy and validation critical. The submission needed to coordinate with the companion Sculptura hardware clearance.
Our Solution
Sequence Group established a complete IEC 62304-compliant software development lifecycle, creating Software Requirements Specifications, Software Architecture Documentation, and a comprehensive V&V plan. Cybersecurity risk analysis was performed per FDA pre-market guidance. The 510(k) submission was prepared concurrently with the Sculptura hardware submission (K182641).
The Outcome
The Empyrean TPS Workstation received FDA 510(k) clearance (K182665) on February 21, 2019 the same day as the Sculptura IORT System, enabling the complete IORT platform to go to market simultaneously. The cleared software supported Sculptura's commercial launch as a complete, integrated intraoperative radiation therapy solution.
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Client
Empyrean Medical
Services Provided
- SaMD Regulatory Strategy
- IEC 62304 Software Lifecycle
- Software V&V Documentation
- Cybersecurity Analysis
- 510(k) Submission
- Risk Management (ISO 14971)
