Sequence Group supported the complete development lifecycle for the SRT-100 Plus Empyrean Medical's next-generation superficial radiation therapy system from design inception through successful FDA 510(k) clearance and commercial launch.
FDA 510(k) Clearance
The SRT-100+ System is a low energy x-ray system, intended for superficial radiotherapy treatments of primary malignant epithelial neoplasms of the skin and keloids. Applications include basal cell carcinoma, squamous cell carcinoma, and Kaposi's sarcoma.
View FDA 510(k) Decision Letter (K173425) ↗The Challenge
The SRT-100+ required demonstrating substantial equivalence to the predicate SRT-100 Vision (K150037) while adding significant new capabilities including an expanded energy range, remote diagnostics, live cameras, and EMR integration. A comprehensive technical file meeting FDA and IEC 60601 requirements was required under an aggressive development timeline.
Our Solution
Sequence Group established design controls from inception, capturing user needs, design inputs/outputs, and V&V protocols. We coordinated biocompatibility testing, IEC 60601-1 electrical safety testing, electromagnetic compatibility (EMC) testing, and compiled a complete clinical evaluation report. The 510(k) submission documented substantial equivalence to the SRT-100 Vision predicate.
The Outcome
The SRT-100+ received FDA 510(k) clearance (K173425) on March 23, 2018. The device launched commercially and treated patients across the US. As part of Empyrean Medical's product expansion, the SRT-100+ contributed to treating over 400,000 skin cancer and keloid patients worldwide.
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Client
Empyrean Medical
Services Provided
- New Product Development
- 510(k) Submission
- Design History File (DHF)
- Clinical Literature Review
- IEC 60601 Testing Coordination
- Risk Management (ISO 14971)
