Sequence Group provided full regulatory and quality support for the Sculptura™ Empyrean Medical's groundbreaking robotic Intraoperative Radiation Therapy (IORT) system with patented Beam Sculpting™ capabilities.
FDA 510(k) Clearance
The Empyrean IORT System (Sculptura) is indicated for radiation therapy treatments. It is a mobile robotically-guided low-energy intraoperative radiotherapy device for treating cancer lesions and tissue beds during and post-surgery.
View FDA 510(k) Decision Letter (K182641) ↗The Challenge
The Sculptura is one of the most sophisticated radiation therapy devices ever submitted to the FDA a mobile robotic system with a 6-axis robotic arm, cybernetic respiratory motion tracking, and a beam-shaping Morpheus X-ray source. The submission required extensive software documentation per IEC 62304, robotic safety testing, and coordination of a companion TPS submission.
Our Solution
Sequence Group developed the complete 510(k) regulatory submission covering device description, performance testing, IEC 60601-1 electrical safety, robotic arm safety, software validation per IEC 62304, and risk management per ISO 14971. The Sculptura (K182641) submission was coordinated with the companion TVM Balloon Applicator (K190255) and TPS Workstation (K182665) submissions.
The Outcome
FDA cleared the Sculptura IORT System (K182641) on February 21, 2019 the same day as the companion TVM Balloon Applicator clearance. Empyrean Medical announced the clearance publicly, with Sculptura becoming the company's flagship IORT platform capable of eliminating weeks of post-operative radiation therapy for surgical oncology patients.
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Client
Empyrean Medical
Services Provided
- 510(k) Regulatory Strategy
- Software Documentation (IEC 62304)
- Risk Management (ISO 14971)
- Cybernetic Respiratory Tracking Validation
- IEC 60601 Testing
- Design History File
