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F Care RF System is intended to conduct radio frequency (RF) current for coagulation from the RF electrosurgical generator to target soft tissue in a broad range of surgical procedures. The devices are prescription use (Rx) devices.

F Care RF System is designed for thermocoagulation (RF) of tissue by administration of high frequency energy by means of electrosurgical electrodes of soft tissue in a broad range of surgical procedures. The system consists of:

• MedRF4000, electrosurgical generator (00MEDRF4000US)
• Rafaelo probe, electrosurgical electrode (05RAFAELORPROBE)
• Sphera probe, electrosurgical electrode (05SPHERAPROBE)
• Output cable (06OUTPUTKAB)
• Foot pedal (06PedalST1)

The F Care RF System includes the MedRF4000 generator and two sterile, single-use monopolar electrodes. the Rafaelo and Sphera probes designed to deliver high-frequency radiofrequency (RF) energy to soft tissue for coagulation and hemostasis. The system is for prescription use only and intended for trained healthcare professionals.

The MedRF4000 generator, previously cleared under 510(k) K210077, has been modified to remove the USB interface; no other changes have been made to its performance or design. The Rafaelo probe connects directly to the generator, while the Sphera probe connects via a reusable handle. Only one probe is used per procedure. The Rafaelo probe consists of a handle, output cable, and a stainless-steel tube with a sharp, insulated tip. The Sphera probe includes a handle and a rounded, ball-shaped insulated tip. Both feature anti-adhesive coated tips and are intended for external communication with limited (<24-hour) contact duration.

Radiofrequency energy from the generator is delivered through the probe tip and converted into heat in the tissue, causing coagulation. Visual and audible signals from the MedRF4000, including beeps every 2 seconds and energy alerts at 500 J and 1500 J, help track treatment. If these indicators fail, treatment must be stopped to avoid thermal injury.

The Rafaelo and Sphera probes are substantially equivalent to the predicate device HPR45i in design, function, materials, and intended use. Both subject and predicate devices use similar biocompatible materials, are activated via foot pedal, and are EO-sterilized under the same sterilization cycle. They do not have power regulation or diagnostic features.Functionally, the Rafaelo probe is used internally with a sharp tip, while the Sphera probe is used externally with a rounded tip. The Rafaelo probe is packaged in a double sterile pouch, and the Sphera probe in a single sterile pouch. Overall, the F Care RF System, including the updated MedRF4000 and both probes, is safe, effective, and substantially equivalent to the predicate device for soft tissue coagulation in surgical procedures.

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