(216 days)
No
The summary describes a radiofrequency ablation system with temperature feedback control, which is a standard control mechanism and does not indicate the use of AI/ML. There are no mentions of AI, ML, image processing, or data sets for training/testing.
Yes
The device is indicated for the "treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH)" which signifies a therapeutic purpose.
No
The description clearly states the TUNA System is "indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH)," indicating a therapeutic, rather than diagnostic, purpose.
No
The device description explicitly lists multiple hardware components including a catheter, RF generator, return electrode, rectal monitoring tape, and optics.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of symptoms due to urinary outflow obstruction secondary to BPH. IVDs are used for the diagnosis or monitoring of diseases or conditions using samples from the human body.
- Device Description: The device is an electrosurgical system that delivers radiofrequency energy to tissue. This is a therapeutic intervention, not a diagnostic test.
- Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information.
Therefore, the TUNA System is a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The 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 (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The TUNA® System consists of the TUNA® 3 Catheter, the VIDAMED Model 7205 RF Generator, the VIDAMED Return Electrode, the VIDAMED Rectal Monitoring Tape, and the TUNA® Optics.
The electrosurgical generator is capable of delivering up to 30W (15W / channel) of power and is designed for use with VIDAMED accessory electrodes including the TUNA® 3 Catheter. When used with VIDAMED accessory electrodes, the electrosurgical generator is capable of reading temperature from thermocouple sensors within the electrode and controlling power output to the tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
prostate
Indicated Patient Age Range
men over the age of 50
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Confirmatory clinical data is also provided to support the safety and effectiveness of the device for use in the treatment of symptoms due to urinary outflow obstruction secondary to BPH.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
VIDAMED TUNA® (Trans Urethral Needle Ablation) System
Indication
The 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 TUNA® System consists of the TUNA® 3 Catheter, the VIDAMED Model 7205 RF Generator, the VIDAMED Return Electrode, the VIDAMED Rectal Monitoring Tape, and the TUNA® Optics.
The electrosurgical generator is capable of delivering up to 30W (15W / channel) of power and is designed for use with VIDAMED accessory electrodes including the TUNA® 3 Catheter. When used with VIDAMED accessory electrodes, the electrosurgical generator is capable of reading temperature from thermocouple sensors within the electrode and controlling power output to the tissue.
Substantial Equivalence
The VIDAMED TUNA® 3 Catheter and VIDAMED Model 7205 RF Generator is substantially equivalent to devices provided by VIDAMED (K951245 and K955035), and Radionics (pre-amendments). Information is provided in the premarket notification to demonstrate that the properties of the TUNA® 3 Catheter and VIDAMED Model 7205 RF Generator are equivalent to equipment from the manufacturers listed above. Confirmatory clinical data is also provided to support the safety and effectiveness of the device for use in the treatment of symptoms due to urinary outflow obstruction secondary to BPH.
Standards/Classifications
The VIDAMED Model 7205 RF Generator and accessories are designed to be in compliance with ANSI, AAMI, and UL 544 standards. The VIDAMED Model 7205 RF Generator and accessories are Class II medical devices.