Sequence Group led the regulatory strategy and 510(k) submission for the Empyrean Medical TVM Balloon Applicator a sterile applicator designed for use with the Empyrean IORT System to deliver intraoperative radiation therapy.
FDA 510(k) Clearance
The TVM Balloon Applicator is indicated for use with the Empyrean IORT System to deliver intracavity or intraoperative brachytherapy wherever the physician chooses to deliver radiation treatment.
View FDA 510(k) Decision Letter (K190255) ↗The Challenge
The TVM Balloon Applicator required a distinct 510(k) clearance as a companion accessory to the Empyrean IORT System. Demonstrating substantial equivalence, building a complete design history file, and coordinating biocompatibility and performance testing within a compressed timeline presented significant regulatory complexity.
Our Solution
Sequence Group developed the full 510(k) submission package including predicate device analysis, performance testing protocols, biocompatibility evaluation per ISO 10993, and labeling review. The submission was coordinated alongside the companion Empyrean IORT System clearance to ensure aligned indications for use.
The Outcome
FDA granted 510(k) clearance (K190255) on February 21, 2019. The device received Class II clearance under 21 CFR 892.5900, enabling commercial sale of the TVM Balloon Applicator as a key component of the Empyrean IORT System platform.
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Client
Empyrean Medical
Services Provided
- Regulatory Strategy
- 510(k) Submission Preparation
- Design Controls
- Risk Management (ISO 14971)
- Quality System Compliance (ISO 13485)
