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510(k) Data Aggregation
K Number
K192715Device Name
CRF Radiofrequency Ablation System
Manufacturer
Date Cleared
2020-01-07
(102 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Cambridge Interventional LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The CRF Radiofrequency Ablation System is indicated for use in percutaneous, laparoscopic and intraoperative coagulation and ablation of tissue.
Device Description
The CRF Radiofrequency Ablation System consists of an RF generator, active electrode, grounding pad, and peristallic punp for electrode cooling. This device is designed to cal tissue heating at the tip of the electrode causing coagulation and ablation of tissue. The CRF Generator supplies radiofrequency energy at 480 kHz while monitoring both the tissue imperature at the CRF electrode tip. The CRF Generator monitors the power, resistance, current and temperature during energy delivery to the paient.
The CRF Electrodes are sterile, single-use, hand-held for use in radiofrequency ablation procedures. The electrodes are surgically invasive, transient devices in patient contact typically for less than one hour. Cooling of the electrodes is provided by chilled sterile saline or water that is pumped through the electrode and out via outflow tubing. This is an enclosed system within the electrode and the saline does not contact. The CRF Generator automatically monitors impedance and temperature and adjusts RF output accordingly. The CRF Radiofrequency Ablation System is used in a healthcare facility or hospital setting.
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