Synergo® SB-TS 101.3 

Disposable sets: LI932B, LI932B-S, CDS932B

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Basic UDI-DI:

7290010121SYN101VJ (SB-TS 101.3 & LI932B/LI932B-S) - Device classification IIb

7290010121CDS932BPM (CDS932B) - classification IIa

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Intended Use
The Synergo® System is intended for the treatment of Non-Muscle Invasive Bladder Cancer (NMIBC).

The device was extensively tested with success in treating NMIBC by instillations of specifically tested pharmaceutical products, to be synergistic with transurethral RF (radio frequency) ablation applicator. Each session takes 40-70 minutes, during which an applicator including antenna and thermocouples is introduced into the bladder through the urethra. A solution of chemotherapeutic drug dissolved in sterile distilled water is instilled into the bladder and RF energy is then applied to the bladder walls. The choice of chemotherapeutic agents is the responsibility of the prescribing physician, who should be aware of the licenced indications and doses.

Intended Users
The Synergo® RITE treatment should be performed by medical personnel (e.g. physician, nurse, medical
technician, etc.) who have undergone training by Medical Enterprises Group in the use of the Synergo® equipment, including practical hands-on training.