PROSTIVA RF THERAPY HAND PIECE PROSTIVA RF THERAPY RF GENERATOR

K113380 · Medtronic, Inc. · GEI · Nov 15, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K113380
• Device Name: PROSTIVA RF THERAPY HAND PIECE PROSTIVA RF THERAPY RF GENERATOR
• Applicant: Medtronic, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Nov 15, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Prostiva RF Therapy System is a minimally invasive device for treating benign prostatic hyperplasia (BPH). It utilizes precisely focused radio frequency (RF) energy to ablate prostate tissue. The system comprises a handpiece, RF generator, return electrode, tubing system, and telescope. Used in a clinical setting by a physician, the device delivers RF energy to the prostate to reduce obstruction. The physician monitors the procedure via the telescope. By ablating obstructive tissue, the device aims to alleviate urinary symptoms and improve patient quality of life.

Clinical Evidence

Bench testing only. No clinical data was required or provided to evaluate the impact of the design and labeling changes on safety and effectiveness.

Technological Characteristics

Endoscopic electrosurgical unit. Components include RF generator, handpiece, return electrode, tubing, and telescope. Operates via radio frequency energy for tissue ablation. Materials evaluated for patient contact safety. No mandatory performance standards or special controls apply.

Indications for Use

Indicated for treatment of urinary outflow obstruction symptoms secondary to benign prostatic hyperplasia (BPH) in men >50 years old with prostate volumes 20-50 cm3.

Regulatory Classification

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.

Predicate Devices

• 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)

Submission Summary (Full Text)

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K113380

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: [phone] Fax: [phone] (fax) Email: [e-mail] 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: [phone] Fax: [phone] (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.

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#### 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.

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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.

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## 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 [phone] or [phone] 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

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# 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 |
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