(125 days)
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No
The summary describes a radiofrequency ablation system for BPH and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for the "treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH)". Treatment is a direct indication of therapeutic intent.
No
The device is indicated for treatment (ablation of tissue), not for diagnosis.
No
The device description explicitly states the system includes an RF generator and an accessory catheter, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for the "treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH)". This is a therapeutic use, not a diagnostic one.
- Device Description: The device description details a catheter with electrodes used for delivering energy to ablate tissue. This is a treatment mechanism, not a method for analyzing samples from the body to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.) to provide diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device is directly used for treatment within the body.
N/A
Intended Use / Indications for Use
The TUNA 5 Catheter is indicated for use as part of the VIDAMED TUNA System. 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 (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The VIDAMED TUNA System includes an RF generator and an accessory catheter for delivery of energy to the patient. The TUNA 5 Catheter contains two electrodes which can be deployed through a cystoscopic sheath at various angles between 0° and various lengths between 14 and 22 mm. The needles are insulated at the base to protect the urethra during ablation of 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
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)
Not Found
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 TUNA® 5 Catheter
Indication
The TUNA 5 Catheter is indicated for use as part of the VIDAMED TUNA System. 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 TUNA System includes an RF generator and an accessory catheter for delivery of energy to the patient. The TUNA 5 Catheter contains two electrodes which can be deployed through a cystoscopic sheath at various angles between 0° and various lengths between 14 and 22 mm. The needles are insulated at the base to protect the urethra during ablation of tissue.
Substantial Equivalence
The VIDAMED TUNA System is already cleared for the treatment of BPH. The TUNA 5 Catheter is substantially equivalent to two previously cleared VIDAMED accessory electrodes, the TUNA 3 Catheter which was cleared in 510(k) K960918, and the VIDAMED AEC which was cleared in 510(k) K951245.
Standards / Classifications
The VIDAMED TUNA System is a regulatory Class II medical device.