(123 days)
Not Found
No
The document does not mention AI, ML, or any related concepts in the device description, intended use, or performance studies. The technology described is RF energy for tissue ablation.
Yes
The device is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to Benign Prostatic Hyperplasia (BPH), which aligns with the definition of a therapeutic device designed to treat a medical condition.
No
The device is indicated for the "treatment of symptoms due to urinary outflow obstruction secondary to Benign Prostatic Hyperplasia (BPH)". It is a therapeutic device, not a diagnostic one.
No
The device description explicitly lists multiple hardware components including an RF Generator, Cartridge, Handle, Telescope, Return Electrode, Tubing set, and other accessories.
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 BPH. IVDs are used for the diagnosis or monitoring of diseases or conditions using samples from the human body.
- Device Description: The device description details a system for delivering radiofrequency energy to prostatic tissue. This is a therapeutic intervention, not a diagnostic test.
- Anatomical Site: The device acts on prostatic tissue within the body, not on a sample taken from the body.
- Performance Studies: The performance studies focus on clinical outcomes like symptom scores, flow rates, and residual volume, which are measures of treatment efficacy, not diagnostic accuracy.
The TUNA System is a therapeutic device used to treat BPH, not a diagnostic device used to analyze samples.
N/A
Intended Use / Indications for Use
The TUNA® System Product Family, including Precision™ TUNA® Office System and PROVu™ TUNA® System, is indicated for use in 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
KNS, GEI
Device Description
Each System of the TUNA System Product Family consists of a RF Generator, a sterile single-use Cartridge attached to a reusable Handle, a reusable Telescope, a single-use Return Electrode, a sterile single-use Tubing set, and other accessories.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
prostatic tissue
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
Clinical studies using the TUNA® procedure were performed at multiple medical institutions throughout the United States. Patients with lower urinary tract symptoms secondary to benign prostate hyperplasia were enrolled into these studies to determine the safety and efficacy of TUNA®. An arm of this clinical study included a multicenter, single blind, randomized study comparing transurethral incision of the prostate (TUIP) with TUNA® System and TURP. Of the 107 patients treated in the study, few reported adverse events. Efficacy was evaluated by measuring peak flow rate and AUA symptom score.
Patients 45 years or older with lower urinary tract symptoms secondary to the diagnosis of BPH with both lateral and median lobe involvement were enrolled in additional 2 studies (PMT and PO1) to determine safety and efficacy. The prostate glands were between 30 to 100 grams. Of the 50 patients, 46 had up to 6 months and 24 had up to 1 year follow-up data.
The clinical trials demonstrated that the TUNA® procedure can be performed without the need for general anesthesia or prolonged hospital stay. Treatment with TUNA® procedure is associated with few side effects and adverse events.
The original prospective clinical trial (lateral lobe only) was performed at eight (8) medical centers across the United States. One hundred and sixty seven (167) men over 50 years of age or older with symptomatic BPH were enrolled in this original trial. One hundred and twenty one (121) of these patients were randomized to either TUNA® or TURP: sixty five (65) were treated with TUNA® and fifty six (56) underwent TURP. Forty six (46) additional non-randomized patients were treated with TUNA, making the total TUNA® treated population one hundred and eleven (111).
Mean change and percentage change from baseline and between the two groups for AUA (American Urological Association) symptom score, quality of life (QOL) score and post void residual urine volume were measured at 12 months following treatment.
Key Metrics
Safety Data:
| Adverse Event | Original TUNA® Lateral Lobe Studies | P01 Lateral and Median Lobe Studies | PM1 Lateral and Median Lobe Studies |
|---|---|---|---|
| Obstruction | 44% | 0% | 0% |
| Catheterization (for urinary retention) | 41% | 15% | 6% |
| Bleeding | 29% | 9% | 6% |
| Pain/Discomfort | 23% | * (included in Dysuria) | * (included in Dysuria) |
| Urgency | 8% | * (included in Dysuria) | * (included in Dysuria) |
| Frequency | 8% | * (included in Dysuria) | * (included in Dysuria) |
| Urinary Tract Infection | 6% | 12% | 0% |
| Dysuria | 2% | 15%*(irritative symptoms) | 6%*(irritative symptoms) |
| Scarring/Stricture |
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).
0
DEC 1 1 2001
K012587
Page 1 of 3
510 (K) SUMMARY
Precision™ TUNA® Office System
Electrosurgical Generator and Accessories
Coagulation Devices and Accessories
The same products listed above
Manufacturer:
VidaMed, Inc. 46107 Landing Parkway Fremont, CA 94538 510-492-4900 510-492-4999 (fax)
Dr. Yi Chen, RAC
GEI
KKS
878.4400
876.4300
November 30, 2001
PROVU™ TUNA® System
Electrosurgical Cutting and
Contact
Date of Preparation
Trade Name
Common Name
Classification Name
Substantial Equivalence
Product Code
21 CFR Section
Device Description
Indication for Use
Technology Characteristics
Test Summary
Each System of the TUNA System Product Family consists of a RF Generator, a sterile single-use Cartridge attached to a reusable Handle, a reusable Telescope, a single-use Return Electrode, a sterile single-use Tubing set, and other accessories.
Each System of the TUNA System Product Family 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.
Each System of the TUNA System Product Family delivers low levels of 460 KHz RF energy up to 15 W from each of the 2 needles directly into prostatic tissue to produce a localized necrotic lesion to treat the symptoms associate with BPH.
In two multi-centers clinical studies a total of 50 patients with both lateral and median lobe enlargement were treated with the VidaMed Tuna System to relieve their symptoms of BPH and improve their uroflow. The studies demonstrated safety and efficacy in using the VidaMed TUNA system. It was further demonstrated that a shortened needle length across the median lobe starting 1 cm down from the bladder neck and penetrating directly into the adenoma and applying RF energy has not increased the risks associated with the use of the TUNA system from that of treating the lateral lobes. Therefore, it was concluded that the contraindication of patient's with an enlarged middle lobe can be deleted.
1
K012587
Page 2 of 3
Clinical Study Design
Clinical studies using the TUNA® procedure were performed at multiple medical institutions throughout Clinical studies using the TONA procedure were performs secondary to benign prostate hyperplasia the United States. Pauents with lower unnaly and symptoms safety and efficacy of TUNA®
An arm of this clinical study included a multicenter, single blind, randomiced study comparing transis in the An arm of this clinical study included a multidenter, oling ransonsely with many of were treated with TURP. Of the 107 pallens treated in the stably, F.F. Rele beetse events. Efficacy was evaluated by measuring peak flow rate and AUA symptom score.
Patients 45 years or older with lower urinary tract symptoms secondary to the diagnosis of BPM with have both lateral and median lobe involvement were enrolled in additional 2 studies (PMT and PO1) to SS actions determine safety and efficacy. The prostate glands were between 30 to 100 grams. Of the 50 patients delemine salely and encacy. The problement genere months and 24 had up to 1 year follow-up data.
Safety Data
Safety Data
The clinical trials demonstrated that the TUNA® procedure can be performed without the need tor general in The cimical thats demonstrated that the TONA proceed. Treatment with TUNA® procedure is of regional (spinal) and adverse events. The following table summaries the safety data of associated with lew Side eneolas and advonoted only) and that from the 2 additional studies patients librit the onginer TONA VS. FOR tiles (Lasing a degree of median lobe hyperplasia.
| Table 1-1 Adverse Events | |||
|---|---|---|---|
| Adverse Event | Original TUNA® | ||
| Lateral Lobe Studies | P01 Lateral and | ||
| Median Lobe Studies | PM1 Lateral and | ||
| Median Lobe Studies | |||
| Obstruction | 44% | 0% | 0% |
| Catheterization (for | |||
| urinary retention) | 41% | 15% | 6% |
| Bleeding | 29% | 9% | 6% |
| Pain/Discomfort | 23% | * (included in Dysuria) | * (included in Dysuria) |
| Urgency | 8% | * (included in Dysuria) | * (included in Dysuria) |
| Frequency | 8% | * (included in Dysuria) | * (included in Dysuria) |
| Urinary Tract Infection | 6% | 12% | 0% |
| Dysuria | 2% | 15%*(irritative | |
| symptoms) | 6%*(irritative | ||
| symptoms) | |||
| Scarring/Stricture | OR | Over-The-Counter Use ______ | |
| ---------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------- | ---- | ----------------------------- |
| (Per 21 CFR 801.109) |
Nancy Broadon
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K012587 |
(Optional Format 1-2-9)
Enclosure 2
(Optional Format 1-2-96)
Enclosure 2
00003