(28 days)
KNS
Not Found
No
The document describes a radiofrequency ablation system for BPH and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for "treatment of symptoms due to urinary outflow obstruction secondary to Benign Prostatic Hyperplasia (BPH)" by delivering RF energy to produce a localized necrotic lesion, which directly implies a therapeutic function.
No
Explanation: The device is indicated for treatment of symptoms due to urinary outflow obstruction, not for diagnosis. It delivers RF energy to produce a necrotic lesion, which is a therapeutic action.
No
The device description explicitly lists multiple hardware components including an RF Generator, Cartridge, Handle, Telescope, Return Electrode, and Tubing set.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body. They are used to detect diseases, conditions, or infections.
- Device Function: The Precision™ Plus TUNA® Office System is a therapeutic device that delivers RF energy directly into prostatic tissue to treat symptoms of BPH. It is used in the body for treatment, not on samples taken from the body for diagnosis.
- Intended Use: The intended use clearly states "treatment of symptoms due to urinary outflow obstruction secondary to Benign Prostatic Hyperplasia (BPH)". This is a therapeutic indication, not a diagnostic one.
Therefore, the device described is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
GEI, KNS
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.
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
Office System
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)
Lesion equivalence between the Precision™ Plus TUNA® Office System and the PROVu™ TUNA® System has been established through lab bench testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
PROVu™ TUNA® System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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