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 Description

Prostiva RF Therapy is a minimally invasive treatment for patients with lower urinary tract symptoms due to benign prostatic hyperplasia (BPH). The Prostiva RF Therapy System uses precisely focused radio frequency (RF) energy to ablate prostate tissue.

AI/ML Overview

This document is a 510(k) summary for the Prostiva RF Therapy System, which is an electrosurgical cutting and coagulation device. The submission is for a modification to an existing device, primarily involving the incorporation of lubricant in additional locations within the Hand Piece.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes performance bench testing and biocompatibility testing for the modified Prostiva Hand Piece. However, it does not provide specific, quantifiable acceptance criteria or detailed numerical performance data. Instead, it states that the testing ensured the device "maintains mechanical and electrical integrity" and that "required design specifications were met." For the biocompatibility tests, it simply states "All of the testing yielded passing results."

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical integrity	Maintained
Electrical integrity	Maintained
Design specifications met	Met
Cytotoxicity	Passing results
Irritation	Passing results
Sensitization	Passing results

2. Sample Size for the Test Set and Data Provenance:

The document refers to "Performance bench testing" and "biocompatibility testing" but does not specify the sample sizes used for these tests. There is no information regarding data provenance (e.g., country of origin, retrospective or prospective data), as the tests described are laboratory/bench tests, not clinical studies involving patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This information is not applicable as the tests described are bench and biocompatibility tests, not studies requiring expert review for ground truth establishment.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reason as above.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The submission focuses on the substantial equivalence of a modified device through bench and biocompatibility testing, not on comparative effectiveness with human readers or AI assistance.

6. Standalone Performance Study:

The document describes "Performance bench testing" and "biocompatibility testing" of the device itself. While these could be considered standalone tests for the device's physical and functional properties, they do not represent a standalone performance study in the context of an algorithm or AI as you might expect (i.e., algorithm-only performance without human interaction). The device is a physical medical instrument.

7. Type of Ground Truth Used:

For the performance bench testing and biocompatibility testing, the "ground truth" would be established by the predefined engineering specifications and internationally recognized standards for biocompatibility. The tests assess whether the device meets these established physical, mechanical, electrical, and biological safety parameters.

8. Sample Size for the Training Set:

This information is not applicable. This submission is for a physical medical device and its modification, not an AI or algorithm that would require a training set.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable for the same reason as above.

In summary:

The provided document describes a 510(k) submission for a modification to an existing electrosurgical device. The "acceptance criteria" are implied engineering and biological safety standards, and the "study" consists of bench and biocompatibility testing. The document lacks the detailed statistical performance metrics, clinical study design, and AI-specific information that your questions primarily relate to. This is common for predicate device submissions where the focus is on substantial equivalence to an already cleared device, especially when the modification is minor and does not significantly alter the fundamental scientific technology or indications for use.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

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)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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FORM FDA 3881 (1/14)

Page 1 of 1

PSC Publishing Services (301) 443-6740

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UROLOGIX®

510(k) Summary

Date Prepared	January 9, 2015
Applicant	Urologix, Inc.14405 21st Avenue N.Minneapolis, MN 55447Establishment Registration Number: 2133936
Contact	Margaret Batchelder
Device Name	Prostiva RF Therapy System
ClassificationRegulation	878.4400876.4300
ClassificationName	Endoscopic Electrosurgical Unit and Accessories
Common Name	Trans-urethral needle ablation
Product Code	GEI, KNS
Classification	Class II
Panel	Gastroenterology/Urology
Predicate DeviceName	Prostiva RF Therapy System (K113380)
DeviceDescription	Prostiva RF Therapy is a minimally invasive treatment forpatients with lower urinary tract symptoms due to benignprostatic hyperplasia (BPH). The Prostiva RF TherapySystem uses precisely focused radio frequency (RF)energy to ablate prostate tissue.
Indications forUse	The Prostiva RF Therapy System is indicated for thetreatment of symptoms due to urinary outflow obstructionsecondary to benign prostatic hyperplasia (BPH) in menover the age of 50 with prostate sizes between 20 and 50cm³.

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Summary ofTechnologicalCharacteristicsCompared to thePredicate	The modified Prostiva RF Therapy System incorporateslubricant in additional locations within the Hand Piece. Thissame lubricant is also used in the predicate device. Themodified Prostiva RF Therapy System has the samefundamental design, operating principal and intended useas the predicate Prostiva RF Therapy System (K113380).No new issues regarding safety and effectiveness havebeen raised.
SubstantialEquivalence	The modified The modified Prostiva RF Therapy System issubstantially equivalent to the predicate device, ProstivaRF Therapy System (K113380).
Summary ofTesting	Performance bench testing and biocompatibility testingwere conducted on the proposed Prostiva Hand Piece toensure that the Prostiva Hand Piece maintains mechanicaland electrical integrity with application of additionallubricant and demonstrating that the required designspecifications were met. The following performance benchtests were performed.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 andfundamental scientific technology, the modified ProstivaRF Therapy System is substantially equivalent to thepredicate device, Prostiva RF Therapy System (K113380).

Regulation Number and Section

§ 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.