Synergo® Radiofrequency Thermochemotherapy Device 

UDI-DI 07290010121045

Accessory: Transurethral RF Applicator LI932B/LI932B-S: Bio-compatible, single-use, 18F, silicone, custom-made, loaded with antenna and thermocouples

Drug Circulating Unit: Tubing Line PVC, single-use with reservoir
Heat Exchanger Temperature: controlled Peltier system
Pump Peristaltic (variable flow) Steps: 4, 6, 8, 10, 12 and 14 mL/min

RF Generator Frequency 915 MHz (+ 50 KHz)
Maximum Power 60W Range 0-36W in increments of 1W

Thermometry System: Sensors T-type thermocouples Resolution 0.1°C (0.18°F)

​

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 licensed indications and doses.

User population

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. The System should only be operated by trained, qualified, and authorised health professionals. These persons should read and understand this User Manual before using the System.

 

​

Compliance with Standards

ISO 13485:2016 Medical devices - Quality management systems -  Requirements for regulatory purposes

ISO 14971:2019 Medical devices - Application of risk management to medical devices

Electrical Safety IEC 60601-1:2005/AMD1:2012 Medical electrical equipment- Part 1: General requirements for basic safety and essential performance

Electromagnetic Compatibility IEC 60601-1-2: 2015 +A1:2021 Sections 7 and 8 professional healthcare facility environment, group 2 Class A

IEC 60601-2-6:2012 AMDl:2016 Medical electrical equipment -Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment

Usability: IEC 60601-1-6:2010; AMD1:2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

IEC 60601-2-24:2012 Medical electrical equipment – Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers

Software – Life cycle IEC 62304:2006 AMD12015

Graphic Symbols: ISO 15223-1:2021 Medical devices — Symbols to be used with information to be supplied by the manufacturer

Biocompatibility:

ISO 10993-1:2020 Biological evaluation of medical devices - Evaluation and testing within a risk management process

ISO 11135:2014 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices

ISO 11607-1:2017 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems

ISO 11607-2:2017 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes

​

​​