(57 days)
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No
The summary describes a data recorder for an RF generator, focusing on recording treatment parameters. There is no mention of AI, ML, or any analytical capabilities beyond simple data recording.
No
The device is a data recorder, not a generator or a treatment device. Its intended use states that it "does not control or effect the output of power from the RF Generator, nor is it intended to be used in the treatment or diagnosis of any disease."
No
The "Intended Use / Indications for Use" section explicitly states, "nor is it intended to be used in the treatment or diagnosis of any disease."
No
The device is described as "software" but is explicitly stated to be used "in conjunction with VIDAMED RF Generators" and "designed for use with VIDAMED RF Generators". This indicates it is a component or accessory to a hardware medical device (the RF Generator), not a standalone software-only medical device.
Based on the provided information, the VIDAMED RF Generator Data Recorder is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is for "recording patient treatment data" and "does not control or effect the output of power from the RF Generator, nor is it intended to be used in the treatment or diagnosis of any disease." IVDs are specifically intended for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The description focuses on recording parameters from the RF Generator during treatment, not on analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological specimens, reagents, or diagnostic information derived from such analysis.
Therefore, the VIDAMED RF Generator Data Recorder functions as a data logging device for a therapeutic procedure (RF treatment), not as a diagnostic tool that analyzes in vitro samples.
N/A
Intended Use / Indications for Use
The VIDAMED RF Generator Data Recorder is indicated for use in recording patient treatment data when used in conjunction with VIDAMED RF Generators such as the VIDAMED Model 7205 RF Generator. The data recorder software does not control or effect the output of power from the RF Generator, nor is it intended to be used in the treatment or diagnosis of any disease.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The VIDAMED RF Generator Data Recorder is designed for use with VIDAMED RF Generators such as the VIDAMED Model 7205 RF Generator. When used with VIDAMED RF Generators, the VIDAMED RF Generator Data Recorder Software is capable of recording the lesion temperature, proximal shield (urethral) temperature, needle impedance, power delivered, and total energy delivered.
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
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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).
Not Found
§ 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
uch 1 0 1996
K963180
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
VIDAMED RF Generator Data Recorder
Indication
The VIDAMED RF Generator Data Recorder is indicated for use in recording patient treatment data when used in conjunction with VIDAMED RF Generators such as the VIDAMED Model 7205 RF Generator. The data recorder software does not control or effect the output of power from the RF Generator, nor is it intended to be used in the treatment or diagnosis of any disease.
Device Description
The VIDAMED RF Generator Data Recorder is designed for use with VIDAMED RF Generators such as the VIDAMED Model 7205 RF Generator. When used with VIDAMED RF Generators, the VIDAMED RF Generator Data Recorder Software is capable of recording the lesion temperature, proximal shield (urethral) temperature, needle impedance, power delivered, and total energy delivered.
Substantial Equivalence
The VIDAMED RF Generator Data Recorder Software is considered an accessory to a previously cleared device. The VIDAMED RF Generator Data Recorder is designed solely for use with VIDAMED RF Generators such as the VIDAMED Model 7205 RF Generator which was previously cleared in 510(k) K955035.
Standards/Classifications
No performance standard(s) or special controls applicable to this device have been promulgated under Section 514 of the Act.