Device Information
The VIVA Combo RF System is a medical device designed for tissue coagulation and ablation using radiofrequency (RF) energy. It can deliver up to 200W of power with software-controlled limits. It includes a generator, active electrode, grounding pad, and a peristaltic pump for electrode cooling. The system utilizes chilled water in a closed-loop system to prevent patient contact. The system monitors power, resistance, current, and temperature to ensure precise control during procedures.
Indications
The VIVA Combo RF System is used for percutaneous and intraoperative coagulation and ablation of tissue.
Intended Use
The device is intended for trained surgeons or physicians to perform tissue ablation and coagulation during surgeries. It operates through an RF generator, delivering up to 200W of power, and software monitors its operation.
Availability
The VIVA Combo RF System is available by prescription only.
Contraindications
The regulatory report does not mention any explicit contraindications. The device must not be used for purposes other than its intended tissue ablation and coagulation functions.
Limitations
The system requires monitoring of impedance, current, and temperature during use. It must be used with appropriate cooling mechanisms (e.g., peristaltic pump for water-cooled electrodes).
Study Results
No clinical studies were conducted as the device underwent software validation and verification. The updated software (STAR Logger) was evaluated for safety and passed applicable testing standards.
Regulatory Information
- Regulation Number: 21 CFR 878.4400
- Regulatory Class: Class II
- Product Code: GEI
- 510(k) Number: K234140
The VIVA Combo RF System complies with the regulatory requirements for medical devices under the FDA’s Quality Systems (QS) regulations. It is substantially equivalent to its predicate device.
Manufacturer Information
- Manufacturer: STARmed Co., Ltd.
- Address: B-dong, 4F & 12F, 158 Haneulmaeul-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do, South Korea
- Contact Name: Honggeun Lee
Predicate Device Information
- Predicate Device Name: VIVA Combo RF System
- 510(k) Number: K183538
- Predicate Device Relation: The predicate device is an earlier version of the same device.
- Differences: The primary change is replacing the VIVA Logger software with STAR Logger software, which allows interaction via tablet. No changes were made to the hardware.
Implications
The device improves user interaction by allowing tablets to monitor RF output parameters in real-time, enhancing the ease of use without compromising safety or efficacy.
References
- VIVA Combo RF System. 510(k) Number K234140. FDA Summary: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K234140
- http://www.starmed4u.com
- https://starmed-america.com/
Medical Keywords
- Medical Specialties: General Surgery, Electrosurgery, Coagulation, Ablation
- All Others: RF generator, STAR Logger, software validation, tissue heating, water-cooled electrodes
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