(41 days)
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No
The document describes a standard RF generator with data recording capabilities and software for controlling energy output, with no mention of AI or ML technologies.
Yes
The device is indicated for the treatment of symptoms due to urinary outflow obstruction, which means it is used to alleviate or cure a medical condition.
No
The device is an RF generator used to deliver energy for the treatment of BPH, not for diagnosis. While it records patient treatment data, this is for treatment purposes, not for diagnosing a condition.
No
The device description explicitly states it is an "RF Generator" capable of delivering RF energy and designed for use with accessory electrodes, indicating it is a hardware device with integrated software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The VIDAMED Model 7600 RF Generator is used to deliver energy directly to tissue (the prostate) for treatment. It also records data from sensors within the electrode, but this data is related to the treatment process itself, not the analysis of a biological specimen.
- Intended Use: The intended use is for the treatment of symptoms due to BPH, not for diagnosing or analyzing a condition based on a biological sample.
The device is a therapeutic device that uses RF energy for treatment.
N/A
Intended Use / Indications for Use
The VIDAMED Model 7600 RF Generator is indicated for use as part of the VIDAMED TUNA System to deliver RF energy and record patient treatment data. The VIDAMED TUNA System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cc.
Product codes
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Device Description
The VIDAMED Model 7600 RF Generator is capable of delivering up to 30W (15W/channel) of RF energy and is designed for use with VIDAMED accessory electrodes including the TUNA Catheter. When used with VIDAMED accessory electrodes, the VIDAMED Model 7600 RF Generator is capable of reading, recording, and storing data obtained from thermocouple sensors within the electrode. Software within the RF generator and controls the RF energy output to the tissue.
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
prostate
Indicated Patient Age Range
men over the age of 50
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
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Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
0
1965061
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS VIDAMED Model 7600 RF Generator
Indication
The VIDAMED Model 7600 RF Generator is indicated for use as part of the VIDAMED TUNA System to deliver RF energy and record patient treatment data. The VIDAMED TUNA System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cc.
Device Description
The VIDAMED Model 7600 RF Generator is capable of delivering up to 30W (15W/channel) of RF energy and is designed for use with VIDAMED accessory electrodes including the TUNA Catheter. When used with VIDAMED accessory electrodes, the VIDAMED Model 7600 RF Generator is capable of reading, recording, and storing data obtained from thermocouple sensors within the electrode. Software within the RF generator and controls the RF energy output to the tissue.
Substantial Equivalence
The VIDAMED TUNA System is already cleared for the treatment of BPH. The VIDAMED Model 7600 RF Generator is substantially equivalent to two previously cleared VIDAMED devices, the VIDAMED Model 7205 RF Generator, and the VIDAMED Model 7312 RF Generator Data Recorder. The VIDAMED Model 7600 RF Generator is substantially equivalent to the VIDAMED Model 7205 RF Generator which was cleared in 510(k) K960918. In addition, the features of the VIDAMED Model 7312 RF Generator Data Recorder previously cleared in 510(k) K963180 have been incorporated into the VIDAMED Model 7600 RF Generator.
Standards / Classifications
The VIDAMED TUNA Model 7205 RF Generator is designed to be in compliance with ANSI, AAMI and UL electrical safety standards. The VIDAMED TUNA System is a regulatory Class II medical device.