(365 days)
Not Found
No
The summary describes a device that uses radio frequency energy for tissue ablation and does not mention any AI or ML components.
Yes
The device is indicated for the "treatment of symptoms due to urinary outflow obstruction" and "uses precisely focused radio frequency (RF) energy to ablate prostate tissue," which are therapeutic actions.
No
The device description and intended use clearly state that it is for "treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH)" using "radio frequency (RF) energy to ablate prostate tissue," indicating a therapeutic rather than diagnostic purpose.
No
The device description explicitly states it uses "precisely focused radio frequency (RF) energy to ablate prostate tissue," which requires hardware components (RF generator, handpiece, electrodes, etc.) as evidenced by the listed predicate devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for the treatment of symptoms due to BPH by ablating prostate tissue. IVDs are used for the diagnosis or monitoring of conditions by examining samples from the human body (like blood, urine, tissue).
- Device Description: The description details a system that uses radio frequency energy to treat tissue, not to analyze samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
This device is a therapeutic device used for a surgical procedure.
N/A
Intended Use / Indications for Use
The Prostiva RF Therapy 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 cm3.
Product codes
KNS, GEI
Device Description
Prostiva RF Therapy is a minimally invasive treatment for patients with lower urinary tract symptoms due to benign prostatic hyperplasia (BPH). Prostiva® RF Therapy System uses precisely focused radio frequency (RF) energy to ablate prostate tissue.
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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The device design and labeling changes discussed in this document have been verified and/or validated through proper Design Verification/Validation and/or Design Assurance Testing where deemed necessary and applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
NOV 1 5 2012
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510(k) Summary
Date Prepared: Applicant:
Contact:
Alternate Contact:
Trade Name:
Patrick Johnson Senior Director Regulatory Affairs Phone: 763-526-6735 Fax: 763-367-1694 (fax) Email: patrick.1.johnson@medtronic.com Prostiva RF Therapy Model 8929 Hand Piece Prostiva RF Therapy Model 8930 RF Generator Prostiva RF Therapy Model 8934 Return Electrode Prostiva RF Therapy Model 6101 Tubing System Prostiva RF Therapy Model 8099 Telescope Prostiva RF Therapy Model 8099TU15 Telescope
Establishment Registration Number: 2182207
21 CFR 876.4300 & 21 CFR 878.4400 Classification Name: Endoscopic electrosurgical unit and accessories Regulatory Name:
November 15, 2011
Thomas Reichel
Phone: 763-526-9693 Fax: 763-367-1694 (fax)
Medtronic Neuromodulation
Regulatory Affairs Specialist
Email: tom.j.reichel(@medtronic.com
7000 Central Ave., N.E.
Minneapolis, MN 55432
Regulatory Classification: Class II
Product Code: KNS and GEI
Name of Predicate Device: Prostiva RF Therapy Model 8929 Hand Piece (K101139) TUNA Therapy Model 8930 RF Generator (K052413) TUNA Therapy Model 8934 Return Electrode (K052413) TUNA Therapy Model 6101 Tubing System (K002583) TUNA Therapy Model 8099 Telescope (K002583)
Device Description
Prostiva RF Therapy is a minimally invasive treatment for patients with lower urinary tract symptoms due to benign prostatic hyperplasia (BPH). Prostiva® RF Therapy System uses precisely focused radio frequency (RF) energy to ablate prostate tissue.
Indications for Use
The Prostiva RF Therapy 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 cm3.
1
Performance Standards
No applicable mandatory performance standards or special controls exist for this device.
Substantial Equivalence
The historical changes in this submission did not involve changes to control mechanism, operating principles, energy type, indications, or sterilization process. None required clinical evidence to evaluate impact to safety and effectiveness. The changes were considered to be routine changes to maintain or improve device performance based on internal or external feedback and the information generated as part of design verification and validation activities or technical assessments confirmed these change did not adversely affect the device's safety or effectiveness.
For the proposed change to the manufacturing process of a potentially patient contacting material, an evaluation of supplier testing information confirms that the proposed change does not impact the safety or effectiveness of the device.
The currently marketed products are substantially equivalent to the previously submitted and cleared predicate products.
Summary of Testing
The device design and labeling changes discussed in this document have been verified and/or validated through proper Design Verification/Validation and/or Design Assurance Testing where deemed necessary and applicable.
Conclusion
The modifications to the Prostiva RF Therapy System described in this submission have not altered the fundamental scientific principle or indication of the devices. The current devices are substantially equivalent to the previously submitted and cleared predicate Prostiva RF Therapy and TUNA Therapy devices.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-002
November 15, 2012
Medtronic, Inc. Neuromodulation % Mr. Thomas Reichel Senior Regulatory Affairs Specialist 7000 Central Ave., N.E. MINNEAPOLIS MN 55432
Re: K113380
Trade/Device Name: Prostiva RF Therapy Model 8929 Hand Piece Prostiva RF Therapy Model 8930 RF Generator Prostiva RF Therapy Model 8934 Return Electrode Prostiva RF Therapy Model 6101 Tubing System Prostiva RF Therapy Model 8099 Telescope Prostiva RF Therapy Model 8099TU15 Telescope Regulation Number: 21 CFR§ 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: KNS, GEI Dated: November 8, 2012
Received: November 13, 2012
Dear Mr. Reichel:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
3
Page 2 - Mr. Thomas Reichel
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease of advised hat I DA 3 ibsualles syour device complies with other requirements of the Act that I DA has made a and regulations administered by other Federal agencies. or ally Federal statutes and regulations administs, but not limited to: registration and 1 ou must compy with an the rece requentions)
Iisting (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of ilsung (21 CFR 807), laboring (21 CFR 803); good manufacturing practice requirements Inconcal device-related ad relies of the ) regulation (21 CFR Part 820); and if applicable, the as set form in the quality of clons (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you desire specific advice for your do necessor correces/CDRH/CDRHOffices/ucm115809.htm for go to mup.//www.lua.gov.rtRadiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 1000 the regulations regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the I va may oount of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement Form
510(k) Number (if known): K113380
Prostiva RF Therapy Model 8929 Hand Piece Device Name: Prostiva RF Therapy Model 8930 RF Generator Prostiva RF Therapy Model 8934 Return Electrode Prostiva RF Therapy Model 6101 Tubing System Prostiva RF Therapy Model 8099 Telescope Prostiva RF Therapy Model 8099TU15 Telescope
Indications for Use:
The Prostiva RF Therapy 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 cm3.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR Prescription Use X Per 21 CFR 801.109
Over-The-Counter Use _
Benjamin R. Fisher -S 2012.11.15 18:04:44 -05'00'
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
| 510(k) Number | K113380 |
|---|---|
| --------------- | --------- |