(123 days)
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No
The device description focuses on hardware components (generator, pump, electrodes, tubing, return pads) and basic control mechanisms (manual and impedance control, monitoring of impedance, current, power, and temperature). There is no mention of AI, ML, or any advanced algorithms for decision-making, image analysis, or adaptive control beyond basic feedback loops based on measured parameters.
Yes
The device is intended for the coagulation and ablation of tissue to treat conditions like non-resectable liver lesions and osteoid osteoma tumors, which is a therapeutic purpose.
No
The device is described as an ablation system used for coagulation and ablation of tissue. While it monitors certain parameters like impedance and temperature during energy delivery, its primary function is therapeutic (tissue destruction), not diagnosing a condition.
No
The device description clearly outlines multiple hardware components including a generator, peristaltic pump, electrodes, tubing, and return pads, in addition to the software controlling the system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "percutaneous, laparoscopic, intraoperative coagulation and ablation of tissue." This describes a therapeutic procedure performed directly on the patient's body to treat a condition.
- Device Description: The description details a system that generates radiofrequency energy to heat and destroy tissue. This is a physical intervention, not a diagnostic test performed on samples taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition. The device's function is to treat, not to diagnose.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
"The Valleylab Cool-tip RF System (generator and accessories) is intended for the use in percutaneous, laparoscopic, intraoperative coagulation and ablation of tissue, such as partial or complete ablation of non-resectable liver lesions and osteoid osteoma tumors within bone."
Product codes
GEI
Device Description
The Cool-tip™ RF Ablation System consists of a microprocessor based RF generator, a peristaltic pump, electrodes, inflow and outflow tubing for electrode cooling, and return pads. The generator, pump and electrodes are designed to produce local tissue heating at the tip of the clectrodes causing the coagulation (ablation) of the tissue.
The Cool-tip™ RF Ablation System generator is capable of delivering up to 200 watts (into a 50 Ohm resistive load) while monitoring tissue impedance and electrode tip temperature during the delivery of the RF energy. The generator includes manual and impedance control and displays/monitors impedance, current, power and temperature.
The Cool-tip™ electrodes are available in either a single electrode or a cluster electrode configuration. The electrodes are monopolar devices. The cluster electrode is three electrode shafts combined into one handle in a triangular patter with approximately 0.5 cm. separation. The electrodes are provided sterile, for single use only. The shaft of the electrode is stainless steel that is insulated to various lengths from the tip of the electrode. Embedded within the tip of each electrode is a thermocouple for temperature measurement. Cooling of the electrode is provided by chilled sterile water which is pumped (using the peristaltic pump) through the inflow tubing, the electrode and out through the outflow tubing. This is an enclosed system within the electrode and the sterile water does not contact the patient. Because of the monopolar nature of the electrodes, electrical current flows through the tip of the electrode, through the target tissue and to the return pad.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
non-resectable liver lesions and osteoid osteoma tumors within bone
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Independent Clinical data have shown the Cool-tip™ RF Ablation System to be safe and effective with regard to ablation of osteoid osteoma lesions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
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