(76 days)
Not Found
No
The document describes a radiofrequency (RF) generator and handpieces for treating BPH, with no mention of AI, ML, image processing, or data-driven algorithms.
Yes.
The device is indicated for the "treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH)."
No
The device is indicated for the treatment of symptoms related to benign prostatic hyperplasia (BPH), not for diagnosis. It is a therapeutic device that delivers RF energy for treatment.
No
The device description explicitly lists multiple hardware components (RF Generator, Hand Pieces, Return Electrode) that are part of the system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH)". This describes a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The components listed (RF Generator, Hand Pieces, Return Electrode) are consistent with a device that delivers energy for treatment, not a device that analyzes biological samples.
- Lack of IVD Indicators: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is used to directly treat a condition within the body.
N/A
Intended Use / Indications for Use
The 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.
Product codes (comma separated list FDA assigned to the subject device)
KNS, GEI
Device Description
This premarket notification is being submitted for additional components of the Medtronic TUNA System to create two configurations of the TUNA System, branded Precision Plus and PROSTIVA. These new components include:
- Medtronic TUNA Therapy Model 8930 RF Generator
- Medtronic TUNA Therapy Model 8929 Hand Piece
- Medtronic TUNA Therapy Model 8909 Hand Piece
- Medtronic TUNA Therapy Model 8934 Return Electrode.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
prostate
Indicated Patient Age Range
men over the age of 50
Intended User / Care Setting
Prescription Use
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)
In-vitro testing was performed to support substantial equivalence to the predicate devices. The results of this testing indicate that the additional components of the Medtronic TUNA System meet all of the design and performance requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K014224, K002583, K965061, K960918
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
K052413
page 1 of 2
NOV 1 7 2005
510(k) Summary
| Date Summary Prepared: | August 5, 2005 |
|---|---|
| Applicant: | Medtronic Gastroenterology and Urology |
| 4000 Lexington Ave N | |
| Shoreview, MN 55126 | |
| Contact: | Julie Goode |
| Senior Regulatory Affairs Specialist | |
| Medtronic Gastroenterology and Urology | |
| 4000 Lexington Ave N | |
| Shoreview, MN 55126 | |
| (763) 514-9670 | |
| (763) 514-9703 (fax) | |
| Trade Name: | TUNA Therapy Model 8930 RF Generator |
| TUNA Therapy Model 8929 Hand Piece | |
| TUNA Therapy Model 8909 Hand Piece | |
| TUNA Therapy Model 8934 Return Electrode | |
| Common Name: | Electrosurgical generator and accessories |
| Classification Name: | 878.4400 Electrosurgical cutting and coagulation device and |
| accessories. | |
| 876.4300 Endoscopic electrosurgical unit and accessories | |
| Name of Predicate Device | Precision Plus TUNA Office System (K014224) |
| TUNA Office System (Precision) (K002583) | |
| Model 7600 RF Generator (965061) | |
| TUNA 3 (K960918) |
Device Description
This premarket notification is being submitted for additional components of the Medtronic TUNA System to create two configurations of the TUNA System, branded Precision Plus and PROSTIVA. These new components include:
- Medtronic TUNA Therapy Model 8930 RF Generator ●
- Medtronic TUNA Therapy Model 8929 Hand Piece .
- Medtronic TUNA Therapy Model 8909 Hand Piece .
- Medtronic TUNA Therapy Model 8934 Return Electrode .
Performance Standards
Medtronic TUNA System 510(k) Premarket Notification
1
K052443
page 2 of 2
No applicable mandatory performance standards or special controls exist for this device.
Statement of Intended Use
The 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.
Substantial Equivalence
The components of the Medtronic TUNA System use similar technology and have the same intended uses as the predicated devices.
| Component | Predicates |
|---|---|
| TUNA Therapy Model 8930 RF | |
| Generator | Medtronic Model 7900 RF Generator (K014224) |
| Medtronic Model 7800 RF Generator (K002583) | |
| Medtronic Model 7600 RF Generator (K965061) | |
| TUNA Therapy Model 8929 Hand Piece | Medtronic Model TUNA 3 Cartridge (K960918) |
| Medtronic Model 6900 Cartridge (K014224) | |
| TUNA Therapy Model 8909 Hand Piece | Medtronic Model TUNA 3 Cartridge (K960918) |
| Medtronic Model 6900 Cartridge (K014224) | |
| TUNA Therapy Model 8934 Return | |
| Electrode | Medtronic Model 7011 Return Electrode (K965061) |
Summary of Testing
In-vitro testing was performed to support substantial equivalence to the predicate devices. The results of this testing indicate that the additional components of the Medtronic TUNA System meet all of the design and performance requirements.
Conclusion
Through the data and information presented, as well as similarities to a legally marketed device, Medtronic, Inc. considers the Medtronic TUNA System to be substantially equivalent to the previously discussed legally marketed predicate devices.
2
Image /page/2/Picture/1 description: The image shows a black and white logo. The logo features a stylized bird with three lines representing its wings or feathers. The bird is oriented towards the right. The words "Department of Natural" are arranged in a circular fashion around the left side of the bird, reading upwards.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 7 2005
Medtronic, Incorporated c/o Mr. Casey Conry Project Engineer Underwriters Laboratories, Incorporated 1285 Walt Whitman Road MELVILLE NY 11747
Re: K052413
Trade/Device Name: TUNA System: Models 8909 and 8929 Hand Piece, Model 8930 RF Generator and Model 8934 Return Electrode
Regulation Numbers: 21 CFR §876.4300 and 878.4400 Regulation Names: Endoscopic electrosurgical unit and accessories Electrosurgical cutting and coagulation device and accessories
Regulatory Class: II Product Codes: KNS and GEI Dated: October 12, 2005 Received: October 17, 2005
Dear Mr. Conry:
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 (Premarket Approval), it may be subject to such 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.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter with and h your e FDA finding of substantial equivalence of your device to a legally prematicated 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 11 you ut the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.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
4
Statement of Indications for Use 3
510(k) Number: _
Device Name: Medtronic TUNA Therapy Model 8909 Hand Piece Medtronic TUNA Therapy Model 8929 Hand Piece Medtronic TUNA Therapy Model 8930 RF Generator Medtronic TUNA Therapy Model 8934 Return Electrode
052413
Indications for use:
The 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.
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter-Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David G. Seppman
(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Devices 510(k) Number_
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