This device is used to vaporize and coagulate soft prostatic tissue during the treatment of Benign Prostatic Hyperplasia and for use with a compatible resectoscope.

Device Description

The Plasmatrode™ Saline Safe TUR Electrode (also known as the Plasmatrode™) is a monopolar electrode used to deliver radio frequency energy supplied by a general purpose electrosurgical generator for the purpose of vaporization and coagulation of soft prostatic tissue during the treatment of Benign Prostatic Hyperplasia (BPH). The Plasmatrode™ comprises of the following: - A tip assembly, which in turn consists of an active electrode, a tip insulator and a floating electrode. • Ceramic shields • A conductive shaft • Insulating heat shrink The PlasmatrodeTM is compatible for use with ACMI USA/Elite Olympus OES and Karl Storz Single Stem and Double Stem resectoscopes.

AI/ML Overview

The Cook Ireland Plasmatrode™ Saline Safe TUR Electrode is a monopolar electrode designed to deliver radio frequency energy for the vaporization and coagulation of soft prostatic tissue during the treatment of Benign Prostatic Hyperplasia (BPH). The device's acceptance criteria and performance were established through a series of non-clinical tests.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Standard	Acceptance Criteria	Reported Device Performance	Comments
Functional Performance	Electrosurgical Safety	Conformance to applicable electrosurgical safety standards.	Successfully completed.	Provides assurance of safe electrical operation.
Functional Performance	Simulated Use (Reliability/Activation Testing)	Device functions as intended during simulated use.	Successfully completed.	Demonstrates device's ability to activate and fulfill its intended function reliably.
Functional Performance	Resectoscope Interaction	Compatibility and proper interaction with compatible resectoscopes (ACMI USA/Elite Olympus OES and Karl Storz Single Stem and Double Stem resectoscopes).	Successfully completed.	Ensures the device can be used effectively with designated resectoscopes.
Mechanical Performance	Tensile Testing	Device integrity and strength under specified tensile loads.	Successfully completed.	Demonstrates structural integrity and resistance to breakage during use.
Stability	Shelf Life Testing	Maintains safety and effectiveness over its specified shelf life.	Successfully completed.	Ensures the device remains viable and safe for use throughout its shelf life.
Biological Safety	Biocompatibility	Conformance to ISO 10993-1 and FDA Guidance for BPH devices.	Successfully completed.	Supports the biological safety of the device when in contact with human tissue.
Therapeutic Effect	Animal Testing	Demonstrate intended therapeutic effect (vaporization and coagulation of prostatic tissue).	Successfully completed.	Provides evidence of the device's ability to achieve its primary clinical function in a biological model.

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

The provided document does not explicitly state specific sample sizes for each bench or animal test. The tests were "successfully completed," implying sufficient samples were used to meet the predetermined validation requirements for each study.

The data provenance is from non-clinical testing (bench and animal testing) conducted by Cook Ireland Ltd. The country of origin for the data generation would therefore be Ireland. The data is retrospective in the sense that it was collected and analyzed as part of the premarket notification process to demonstrate substantial equivalence.

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

The document does not mention the involvement of "experts" in establishing ground truth for individual test results within the non-clinical studies. The ground truth for bench tests would be defined by the specifications and measurable outcomes against established ASTM standards. For animal testing, the ground truth would be based on direct observation and pathological assessment of the tissues post-procedure. Compliance with FDA Guidance for BPH devices and ISO 10993-1 for biocompatibility also implicitly sets the standard for "ground truth" in these areas.

4. Adjudication Method for the Test Set

Not applicable. The tests performed are objective, measurable outcomes of physical and biological interactions, not subjective assessments requiring expert adjudication.

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

No multi-reader multi-case (MRMC) comparative effectiveness study was mentioned. The device is a surgical instrument, and its performance is evaluated through objective physical and biological tests rather than diagnostic interpretation by multiple readers.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Not applicable. The device is a physical electrosurgical electrode, not an algorithm or AI system. Its performance is inherently tied to human operative skill and does not function in a standalone, automated capacity.

7. Type of Ground Truth Used

The ground truth used for performance evaluation included:

Standards-based measurements: For electrosurgical safety, resectoscope interaction, tensile testing, and shelf-life testing, the ground truth was adherence to specified ASTM standards and internal performance specifications.
Biological/Pathological outcomes: For animal testing, the ground truth would be the observable and measurable effect of vaporization and coagulation on prostatic tissue, likely assessed histologically or macroscopically.
Regulatory guidance compliance: For biocompatibility, the ground truth was conformance to ISO 10993-1 and FDA Guidance for BPH devices.

8. Sample Size for the Training Set

Not applicable. The device is a physical medical device, not an AI or machine learning algorithm, and therefore does not have a "training set" in the computational sense. The data generated from performance testing serves as verification and validation data.

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

Not applicable, as there is no training set for this device.

Summary

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K122716 page 1 of 3

Cook Ireland Plasmatrode™ Saline Safe TUR Electrode

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APR 1 7 2013

	Section 5.0 510(k) Summary
Name:	Cook Ireland Ltd
Address:	O'Halloran RoadNational Technology ParkLimerick, Ireland
Phone:	011 353 61 334440
Fax:	011 353 61 239293
Contact Persons:	Nora O'Connor, Regulatory Affairs SpecialistSinead Burke, Regulatory Affairs Manager
Date:	September 03, 2012
Trade Name:	Plasmatrode™ Saline Safe TUR Electrode
Common Name:	Vaporization and Coagulation Electrode
Classification Name:	Electrosurgical, Cutting & Coagulation & Accessories (21CFR 878.4400, Product Code: GEI)
Predicate Devices:	COOK® Single-Use RF Electrode (COOK® Coagulator Probe,K935874), Gyrus PK® Plasma V™ Vaporization Electrode(K990628 - Gyrus Endourology System) and the Olympus PK®Plasmabutton™ Vapourization Electrode (K100275 andK102781 - HF-Resection and Vaporization Electrode Series).
Description of theDevice:	The Plasmatrode™ Saline Safe TUR Electrode (also known asthe Plasmatrode™) is a monopolar electrode used to deliverradio frequency energy supplied by a general purposeelectrosurgical generator for the purpose of vaporization andcoagulation of soft prostatic tissue during the treatment ofBenign Prostatic Hyperplasia (BPH). The Plasmatrode™comprises of the following:- A tip assembly, which in turn consists of an activeelectrode, a tip insulator and a floating electrode.
	• Ceramic shields
	• A conductive shaft
	• Insulating heat shrink
	The PlasmatrodeTM is compatible for use with ACMI USA/EliteOlympus OES and Karl Storz Single Stem and Double Stemresectoscopes.
Indications for use:	This device is used to vaporize and coagulate soft prostatictissue during the treatment of Benign Prostatic Hyperplasiaand for use with a compatible resectoscope.
Comparison ofCharacteristics:	The PlasmatrodeTM is substantially equivalent to the currentlymarketed predicate devices, COOK® Single-Use RF Electrode(COOK® Coagulator Probe, K935874), Gyrus PK® Plasma V™
	Vaporization Electrode (K990628 - Gyrus EndourologySystem) and the Olympus PK® Plasmabutton™ VapourizationElectrode (K100275 and K102781 - HF-Resection andVaporization Electrode Series).
	The proposed device shares many technologicalcharacteristics with at least one of the predicate devices (orfall within the range of predicates) in terms of the following:
	• Energy Type
	• FDA Classification
	• Tip Design
	• Tip materials
	• Conductive Shaft
	• Device Length
	• Polarity
	• Irrigant
	• Resectoscope Compatibility
	• Intended Use
	• All devices are intended for single use and are suppliedsterile
	• Endoscopically used

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K122716

Cook Ireland Plasmatrode™ Saline Safe TUR Electrode

Page 9 of 91

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Cook Ireland Plasmatrode™ Saline Safe TUR Electrode

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Differences include: Tip width Distal end to conductive shaft design and matcrials Performance Data: Performance testing was carried out to determine the substantial equivalence of the Plasmatrode™ and to verify the safety and effectiveness of the device. Performance Testing-Bench and Animal: The bench testing was conducted in accordance with various applicable ASTM standards and in accordance with FDA 's Guidance for the Non-Clinical and Clinical Investigations of Devices used for the Treatment of Benign Prostatic Hyperplasia (BPH) (August 17, 2010). The following tests were carried out: electrosurgical safety testing, simulated use (reliability/activation testing), resectoscope interaction, tensile testing, shelf life testing and animal testing. The performance testing was successfully completed. Results of the testing provide reasonable assurance that the Plasmatrode" Saline Safe TUR Electrode will function as intended. Biocompatibility: Biocompatibility testing in compliance with ISO 10993-1, and FDA's Guidance for the Non-Clinical and Clinical Investigations of Devices used for the Treatment of Benign Prostatic Hyperplasia (BPH) (August 17, 2010) supports the

safety of the Plasmatrode ".

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol.

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

April 17, 2013

Cook Ireland Ltd. % Ms. Nora O'Connor Regulatory Affairs Specialist O'Halloran Road, National Technology Park LIMERICK IRELAND

Re: K122716

Trade/Device Name: Plasmatrode™ Saline Safe TUR Electrode Regulation Number: 21 CFR§ 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: March 7, 2013 Received: March 11, 2013

Dear Ms. O'Connor:

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.

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· Page 2 -- Ms. Nora O'Connor

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); medical device reporting (reporting of medical device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 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

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Section 4.0 Indications for Use

K122716 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Plasmatrode™ Saline Safe TUR Electrode

Indications for Use:

This device is used to vaporize and coagulate soft prostatic tissue during the treatment of Benign Prostatic Hyperplasia and for use with a compatible resectoscope.

Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Benjamin R. Fisher -S 2013.04.17 11:13:15 -04'00'

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(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K122716 510(k) Number

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.