(28 days)
The Precision™ Plus TUNA® Office 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.
The Precision™ Plus TUNA® Office System 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. The Precision™ Plus TUNA® Office System 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. Each lesion takes 3.0 minutes.
The provided text is a 510(k) summary for the Precision™ Plus TUNA® Office System. This document is primarily focused on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study evaluating the device's performance against specific acceptance criteria.
Therefore, the requested information regarding acceptance criteria, a specific study proving device performance against those criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be fully extracted from the provided text.
Here's an analysis of what can be gleaned and what is missing:
Inability to Fully Address Request
The provided 510(k) summary for the Precision™ Plus TUNA® Office System focuses on demonstrating substantial equivalence to a predicate device (PROVu™ TUNA® System) primarily through "lab bench testing" for "lesion equivalence." It does not contain the detailed clinical study design, performance metrics, acceptance criteria, or ground truth establishment typically found in a clinical trial report or a submission designed to prove device performance against predefined criteria.
Available Information (and what's missing)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not explicitly stated as such) | Reported Device Performance |
|---|---|
| Lesion equivalence with predicate device | "Lesion equivalence between the Precision™ Plus TUNA® Office System and the PROVu™ TUNA® System has been established through lab bench testing." |
| Other specific performance metrics (e.g., success rate, symptom improvement, complication rates, % reduction in prostate size, etc.) | Not reported in this document. |
2. Sample Sizes and Data Provenance
- Test Set Sample Size: Not provided. The text refers to "lab bench testing," which implies physical tests rather than patient studies. If it involved simulated tissue or animal models, the sample size of those would not be explicitly stated here.
- Data Provenance: "Lab bench testing." This implies in-vitro or simulated environment testing, not human patient data. No country of origin is specified for this lab testing, nor is it identified as retrospective or prospective patient data.
3. Number of Experts and Qualifications for Ground Truth of Test Set
- Not applicable / Not provided. Since the "test" mentioned is "lab bench testing" for "lesion equivalence," there's no indication of human experts establishing ground truth in the context of clinical outcomes. The equivalence would likely be determined by physical measurements or similar objective laboratory metrics.
4. Adjudication Method for Test Set
- Not applicable / Not provided. Given the nature of "lab bench testing" for "lesion equivalence," an adjudication method for a test set of patient cases is not relevant or described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. The document does not describe any MRMC study. The device is an electrosurgical generator and accessories, not an AI or imaging diagnostic tool that would typically involve human readers.
6. Standalone (Algorithm Only) Performance Study
- Not applicable. This device is a medical instrument (electrosurgical unit), not an algorithm or AI. Its performance is intrinsic to its physical and functional operation, not a computational output.
7. Type of Ground Truth Used
- For "lesion equivalence" in lab bench testing: The ground truth would likely be objective physical measurements of the created lesions (e.g., size, depth, necrosis characteristics) using standard laboratory methods, rather than expert consensus, pathology in a clinical setting, or patient outcomes data. The specific methods are not described.
8. Sample Size for Training Set
- Not applicable. This document describes a physical medical device, not a machine learning model, so there is no concept of a "training set" in the context of an algorithm.
9. How Ground Truth for Training Set was Established
- Not applicable. As above, no training set for an algorithm exists here.
Summary Limitations:
The provided 510(k) summary is a regulatory document focused on demonstrating that the new device is "substantially equivalent" to a previously cleared predicate device. This process often relies on comparisons of technical characteristics and performance data from internal testing (like the "lab bench testing" mentioned) rather than comprehensive clinical trials with detailed acceptance criteria and outcome measures, especially for devices like electrosurgical generators. Therefore, it does not contain the level of detail requested for a deep dive into clinical study design and performance metrics.
{0}------------------------------------------------
KCi4224
PAGE 1 OF 1
JAN 2 3 2002 510 (K) SUMMARY Manufacturer: VidaMed, Inc. 46107 Landing Parkway Fremont, CA 94538 510-492-4900 510-492-4999 (fax) Dr. Yi Chen, RAC Contact December 21, 2001 Date of Preparation Precision™ Plus TUNA® Office System Trade Name Electrosurgical Generator and Accessories Common Name Classification Name Electrosurgical Cutting and Coagulation Devices and Accessories Precision™ TUNA® Office System Substantial Equivalence PROVu™ TUNA® System Product Code GEI KNS 21 CFR Section 878.4400 876.4300 Device Description The Precision™ Plus TUNA® Office System 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. The Precision™ Plus TUNA® Office System is indicated for Indication for Use 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. Technology Characteristics The Precision™ Plus TUNA® Office System 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. Each lesion takes 3.0 minutes. Test Summary Lesion equivalence between the Precision™ Plus TUNA® Office System and the PROVu™ TUNA® System has been established through lab bench testing.
############
{1}------------------------------------------------
Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular arrangement of text around a central symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The central symbol is a stylized representation of a human figure embracing a globe.
JAN 2 3 2002
Dr. Yi Chen, R.A.C. Director of Regulatory Affairs and Quality Assurance · VIDAMED® 46107 Landing Pkwy FREMONT CA 94538
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K014224
Trade/Device Name: Precision™ Plus TUNA® Office System with Model 7900 RF Generator, Model 6900 Cartridge, and Model 6198 Handle 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: December 21, 2001 Received: December 26, 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 commerce prior to May 28, 1976, 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 that FDA has 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.
{2}------------------------------------------------
Page 2
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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 contact the Office of Compliance at one 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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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
Enclosure
{3}------------------------------------------------
INDICATIONS FOR USE
Page of
510 (k) Number (if known): ___________________________________________________________________________________________________________________________________________________
Precision™ Plus TUNA® Office System
Indications For Use:
Device Name:
The Precision™ Plus TUNA® Office System is indicated for use in the treatment of symptoms due to urinary outflow obstruction secondary to Benign Prostatio of Symptoms ude to unnary outher. So on 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 /
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
David A. Lygum
00004
§ 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.