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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Precision™ TUNA® Office System and PROVU™ TUNA® System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The device's intended use is to treat symptoms of Benign Prostatic Hyperplasia (BPH) and improve uroflow. The efficacy was evaluated by measuring AUA (American Urological Association) symptom scores, Quality of Life (QOL) scores, and Peak Flow Rate. Acceptance criteria are implicitly tied to a demonstrable improvement in these metrics, and the device's performance is compared against a predicate device (TURP) and baseline.

Parameter	Baseline (TUNA)	6 Month (TUNA)	12 Month (TUNA)	Baseline (TURP)	6 Month (TURP)	12 Month (TURP)	Outcome / Acceptance
AUA Symptom Score	23.8	10.6	11.9	24.1	7.9	7.8	Significant reduction in symptoms shown by TUNA (reduction of ~50% from baseline at 12 months) and comparable to TURP.
Peak Flow Rate (Qmax)	8.9	13.4	14.8	8.9	21.0	21.1	Improvement in flow shown by TUNA (increase of ~66% from baseline at 12 months) with TURP showing greater improvement.
Post Void Residual Volume	91.4	63.6	65.9	81.9	45.6	47.1	Reduction in residual volume shown by TUNA (reduction of ~28% from baseline at 12 months) with TURP showing greater reduction.
Quality of Life (QOL) Score	4.7	1.9	1.9	4.8	1.6	1.4	Significant improvement in QOL shown by TUNA (reduction of ~60% from baseline at 12 months) and comparable to TURP.

Safety Data: The clinical trials demonstrated that the TUNA® procedure can be performed without the need for general anesthesia (only regional/spinal), and is associated with few side effects and adverse events. Specific adverse event rates are provided in Table 1-1, showing rates for obstruction, catheterization, bleeding, pain/discomfort, urinary tract infection, and dysuria. The acceptance criteria here would be that these adverse event rates are within acceptable clinical limits and comparable or better than alternative treatments. The trials concluded that no increased risks were associated with the shortened needle length across the median lobe.

2. Sample Size Used for the Test Set and Data Provenance

Original TUNA® vs. TURP Study (Test Set):
- Total Patients Enrolled: 167 men over 50 years of age with symptomatic BPH.
- Randomized Group: 121 patients (65 treated with TUNA®, 56 underwent TURP).
- Additional Non-randomized TUNA Patients: 46
- Total TUNA® Treated Population: 111 (in this specific study for efficacy comparison against TURP).
- Data Provenance: Multi-center clinical trials conducted across the United States. Prospective.
Additional Studies (PMT and PO1 - for lateral and median lobe enlargement):
- Total Patients Enrolled: 50, with 2 additional studies.
- Number with 6-month follow-up: 40
- Number with 1-year follow-up: 24
- Data Provenance: Multi-center clinical studies performed in the United States. Prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number or qualifications of experts used to establish "ground truth" in the traditional sense of image analysis or diagnostic studies. Instead, the "ground truth" for this device appears to be the clinical outcomes and patient-reported symptoms, as measured by standardized clinical tools (AUA symptom score, QOL score, uroflowmetry) and physician assessment of adverse events. These are inherent clinical measures conducted by healthcare professionals involved in the study sites, though their specific qualifications are not detailed beyond "medical institutions."

4. Adjudication Method for the Test Set

The document describes a "multicenter, single blind, randomized study comparing transurethral needle ablation (TUNA) of the prostate with transurethral resection of the prostate (TURP)." It does not explicitly mention an adjudication method (like 2+1 or 3+1 decision rules) for the clinical outcomes data. In clinical trials, the primary outcome measures (AUA score, QOL, uroflow) are typically collected directly from patients or objective measurements, and adverse events are reported by investigators based on defined study protocols. Data review and monitoring would have occurred, but a formal "adjudication" committee for ground truth agreement in the way it's described for, say, imaging studies, is not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs. without AI assistance

An MRMC study was not applicable as this is a medical device for treatment of BPH, not a diagnostic or AI-assisted diagnostic tool involving "human readers" or "AI assistance" in interpretation. The study compares a device-based treatment (TUNA) to another treatment (TURP) or baseline, focusing on patient outcomes.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable as the device (TUNA system) is a treatment device, not a standalone algorithm. Its performance is directly measured by its clinical effect on patients.

7. The Type of Ground Truth Used

The ground truth used is primarily clinical outcomes data and patient-reported symptoms, including:

AUA Symptom Score (patient-reported severity of BPH symptoms)
Quality of Life (QOL) Score (patient-reported impact on daily life)
Peak Flow Rate (objective measurement of urinary flow)
Post Void Residual Volume (objective measurement of urine retention)
Adverse Events (clinician-reported and objective complications)

8. The Sample Size for the Training Set

The document describes pre-market clinical trials for efficacy and safety. There is no separate "training set" as would be applicable for machine learning models. The clinical studies involving 167 patients (original TUNA vs TURP) and 50 patients (additional median lobe studies) served as the primary data for demonstrating safety and efficacy for the device.

9. How the Ground Truth for the Training Set was Established

As there is no separate "training set" in the context of an algorithm, this question is not applicable. The "ground truth" or evidence for the device's performance was established through the collection of clinical outcome measures and adverse event data in the aforementioned prospective, multi-center clinical trials.

Summary

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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 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.

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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 andMedian Lobe Studies	PM1 Lateral andMedian Lobe Studies
Obstruction	44%	0%	0%
Catheterization (forurinary 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%*(irritativesymptoms)	6%*(irritativesymptoms)
Scarring/Stricture	<2%	0%	0%
Impotence	<2%	0%	0%
Retrograde Ejaculation	<1%	3% (partial)	0%
Incontinence	0%	0%	0%

In the lateral & median lobe studies, Dysuria was described as irritative voiding symptoms, which include pain, discomfort urgency, or frequency.

Efficacv Data

Entery Data
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 symonmatic 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.

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	Timepoint
Parameter	Baseline	6 month	12 month
AUA Symptom Score
TUNA	23.8	10.6	11.9
TURP	24.1	7.9	7.8
Peak Flow Rate
TUNA	8.9	13.4	14.8
TURP	8.9	21.0	21.1
Post Void Residual Volume
TUNA	91.4	63.6	65.9
TURP	81.9	45.6	47.1
Quality of Life
TUNA	4.7	1.9	1.9
TURP	4.8	1.6	1.4

Efficacy Data of the TUNA* vs. TURP Study Table 1-2

TUNA treated 111 patients

Similar results were seen from the additional studies (lateral and median lobes). Tables 1-3 and 1-4 demonstrated the efficacy results of the all studies.

Table 1-3 Total Symptom Score Overview
Visit	Original TUNALateral Lobe Studies(American UrologicalAssociation Symptom Score)	P01 Lateral andMedian Lobe Studies(International ProstateSymptom Score)	PM1 Lateral andMedian Lobe Studies(International ProstateSymptom Score)
Pretreatment	24.6	21.0	24.0
1 Month	12.5	16.0	13.0
3 Month	9.6	10.0	10.0
6 Month	10.1	10.0	5.0
12 Month	10.6	11.0	N/A

Visit	Original TUNALateral LobeStudies	P01 Lateral andMedian Lobe Studies	PM1 Lateral andMedian Lobe Studies
Pretreatment	8.306	8.6	6.4
1 Month	16.565	10.2	11.4
3 Month	15.024	12.0	15.1
6 Month	14.748	13.7	11.0
12 Month	13.432	12.7	N/A

Table 1-4 Peak Uroflow Rate (Qmax) Overview

As of 2000, over 25,000 patients worldwide have been treated with TUNA®, with over 6,000 in the United States. TUNA® has proved to be a successful minimally invasive therapy.

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Public Health Service

DEC 1 1 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville . MD 20850

Dr. Yi Chen, R.A.C. Director of Regulatory Affairs and Quality Assurance VIDAMED® 46107 Landing Pkwy FREMONT CA 94538

Re: K012587

Trade/Device Name: As identified in Enclosure 1 Regulation Number: 21 CFR §876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories

Regulatory Class: II Product Code: 78 KNS Regulation Number: 21 CFR §878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II

Product Code: 79 GEI Dated: September 27, 2001 Received: September 28, 2001

Dear Dr. Chen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surver in the encreations of the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease of a a made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket I his letter will anow you to begin marketing your device to a legally marketed Ilouitcation. The I Drice results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please IT you desire spoolilo active act your an of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616)
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616)
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654)
Other	(301) 594-4692)

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on any promote the regulation entitled, "Misbranding Offically of Compilance at (2017 e att 807.97). Other general information on by recence to promation nearly be obtained from the Division of Small Manufacturers, your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures (1) Trade/Device Name

(2) Indications for Use

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INDICATIONS FOR USE

Page

510 (k) Number (if known): _

Device Name:

TUNA® System Product Family, including Precision™ TUNA® Office System PROVu™ TUNA® System

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.

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use		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

Regulation Number and Section

§ 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).