(125 days)
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.
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.
This 510(k) summary describes a medical device, the TUNA 5 Catheter, but it does not contain the information requested regarding acceptance criteria and a study proving device performance.
The provided text focuses on:
- Indication: What the device is used for (treatment of BPH).
- Device Description: A brief technical overview of the catheter.
- Substantial Equivalence: How it relates to previously cleared devices.
- Standards/Classifications: Its regulatory class.
To answer your request, information regarding a specific study (e.g., clinical trial, bench test, animal study) conducted for the TUNA 5 Catheter to demonstrate its performance against predefined acceptance criteria would be necessary. This summary does not provide details about:
- Acceptance Criteria and Reported Device Performance: There is no table of specific performance metrics (e.g., efficacy rates, safety outcomes, technical success rates) or corresponding acceptance thresholds.
- Sample Sizes and Data Provenance: No mention of any study participants, test sets, or data sources.
- Experts for Ground Truth: No studies are described that would require expert adjudication.
- Adjudication Method: Not applicable as no adjudication is mentioned.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No such study is mentioned; this device is a physical catheter, not an AI diagnostic tool.
- Standalone Performance: Not applicable for this type of device.
- Type of Ground Truth: Not applicable as no diagnostic or predictive study is described.
- Training Set Sample Size: Not applicable as this is not an AI/ML device requiring training.
- Ground Truth for Training Set: Not applicable.
Therefore,Based on the provided 510(k) summary for the TUNA® 5 Catheter, none of the requested information regarding acceptance criteria and a study proving device performance is available.
The summary describes the device's indications, physical characteristics, and its substantial equivalence to previously cleared devices. It does not include details about specific performance metrics, clinical study designs, sample sizes, ground truth establishment, or expert involvement, which are typically found in sections discussing clinical data or performance testing.
To fulfill your request, you would need to consult other sections of the 510(k) submission, such as the "Performance Data" or "Clinical Data" sections, if they exist for this device, which would detail any studies conducted to support its safety and effectiveness.
§ 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.