Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece, Prostiva RF Therapy Return Electrode, Prostiva RF Therapy Tubing System, Prostiva RF Therapy Telescope

K142248 · Urologix, Inc. · GEI · Feb 20, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K142248
• Device Name: Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece, Prostiva RF Therapy Return Electrode, Prostiva RF Therapy Tubing System, Prostiva RF Therapy Telescope
• Applicant: Urologix, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Feb 20, 2015
• 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 lower urinary tract symptoms caused by benign prostatic hyperplasia (BPH). The system utilizes radio frequency (RF) energy to ablate prostate tissue. It consists of a generator, hand piece, return electrode, tubing system, and telescope. The device is operated by a clinician in a clinical setting. The system delivers focused RF energy to the prostate; the ablation process reduces obstructive tissue to improve urinary flow. The modification in this version involves the addition of lubricant within the hand piece to ensure mechanical and electrical integrity. The device is substantially equivalent to the predicate Prostiva RF Therapy System (K113380).

Clinical Evidence

Bench testing only. Performance testing included cycle testing, deployment/retraction testing, and simulated lesion testing. Biocompatibility testing included cytotoxicity, irritation, and sensitization. All tests yielded passing results.

Technological Characteristics

Electrosurgical system using radio frequency (RF) energy for tissue ablation. Components include generator, hand piece, return electrode, tubing, and telescope. Modification involves additional internal lubricant. Class II device.

Indications for Use

Indicated for men >50 years old with urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) and prostate sizes 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 System (K113380)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 20, 2015

Urologix, Inc. Georgiann Keyport Regulatory Affairs Consultant 14405 21st Avenue North Minneapolis, MN 55447

Re: K142248

> Trade/Device Name: Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece, Prostiva RF Therapy Return Electrode, Prostiva RF Therapy Tubing System, Prostiva RF Therapy Telescope Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulaton device and accessories Regulatory Class: II Product Code: GEI, KNS Dated: January 9, 2015 Received: January 12, 2015

Dear Georgiann Keyport,

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.

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

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with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions 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 Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Herbert P. Lerner -S

Benjamin R. Fisher, Ph.D. for Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|-----------------------------------------|--|
| Food and Drug Administration | |

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

## Indications for Use

510(k) Number (if known)

K142248

Device Name

Prostiva RF Therapy System

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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FORM FDA 3881 (1/14)

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PSC Publishing Services [phone]

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# UROLOGIX®

# 510(k) Summary

| Date Prepared | January 9, 2015 |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | Urologix, Inc.<br>14405 21st Avenue N.<br>Minneapolis, MN 55447<br>Establishment Registration Number: 2133936 |
| Contact | Margaret Batchelder |
| Device Name | Prostiva RF Therapy System |
| Classification<br>Regulation | 878.4400<br>876.4300 |
| Classification<br>Name | Endoscopic Electrosurgical Unit and Accessories |
| Common Name | Trans-urethral needle ablation |
| Product Code | GEI, KNS |
| Classification | Class II |
| Panel | Gastroenterology/Urology |
| Predicate Device<br>Name | Prostiva RF Therapy System (K113380) |
| Device<br>Description | Prostiva RF Therapy is a minimally invasive treatment for<br>patients with lower urinary tract symptoms due to benign<br>prostatic hyperplasia (BPH). The Prostiva RF Therapy<br>System uses precisely focused radio frequency (RF)<br>energy to ablate prostate tissue. |
| Indications for<br>Use | The Prostiva RF Therapy System is indicated for the<br>treatment of symptoms due to urinary outflow obstruction<br>secondary to benign prostatic hyperplasia (BPH) in men<br>over the age of 50 with prostate sizes between 20 and 50<br>cm³. |

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| Summary of<br>Technological<br>Characteristics<br>Compared to the<br>Predicate | The modified Prostiva RF Therapy System incorporates<br>lubricant in additional locations within the Hand Piece. This<br>same lubricant is also used in the predicate device. The<br>modified Prostiva RF Therapy System has the same<br>fundamental design, operating principal and intended use<br>as the predicate Prostiva RF Therapy System (K113380).<br>No new issues regarding safety and effectiveness have<br>been raised. |
|--------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial<br>Equivalence | The modified The modified Prostiva RF Therapy System is<br>substantially equivalent to the predicate device, Prostiva<br>RF Therapy System (K113380). |
| Summary of<br>Testing | Performance bench testing and biocompatibility testing<br>were conducted on the proposed Prostiva Hand Piece to<br>ensure that the Prostiva Hand Piece maintains mechanical<br>and electrical integrity with application of additional<br>lubricant and demonstrating that the required design<br>specifications were met. The following performance bench<br>tests were performed.<br>Cycle testing Deployment/retraction testing Simulated lesion testing The following biocompatibility testing were performed. Cytotoxicity Irritation Sensitization. All of the testing yielded passing results. |
| Conclusion | Based on the similarities in the indications for use and<br>fundamental scientific technology, the modified Prostiva<br>RF Therapy System is substantially equivalent to the<br>predicate device, Prostiva RF Therapy System (K113380). |