PLASMATRODE SALINE SAFE TUR ELECTRODE

K122716 · Cook Ireland, Ltd. · GEI · Apr 17, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K122716
• Device Name: PLASMATRODE SALINE SAFE TUR ELECTRODE
• Applicant: Cook Ireland, Ltd.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Apr 17, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Monopolar electrosurgical electrode for vaporization and coagulation of soft prostatic tissue in BPH treatment. Device comprises tip assembly (active electrode, tip insulator, floating electrode), ceramic shields, conductive shaft, and insulating heat shrink. Operated by physician via compatible resectoscope (ACMI USA/Elite, Olympus OES, Karl Storz) connected to general-purpose electrosurgical generator. Radio frequency energy delivered to tissue to achieve vaporization/coagulation. Single-use, sterile device. Clinical benefit: effective tissue removal/hemostasis during BPH surgery.

Clinical Evidence

Bench and animal testing only. Bench testing included electrosurgical safety, simulated use (reliability/activation), resectoscope interaction, tensile testing, and shelf life. Biocompatibility testing performed per ISO 10993-1. Testing conducted in accordance with FDA guidance for BPH devices. Results demonstrate device functions as intended.

Technological Characteristics

Monopolar electrosurgical electrode. Materials: ceramic shields, conductive shaft, insulating heat shrink. Energy source: external general-purpose electrosurgical generator. Compatibility: ACMI, Olympus, Karl Storz resectoscopes. Single-use, sterile. Biocompatibility per ISO 10993-1.

Indications for Use

Indicated for patients requiring vaporization and coagulation of soft prostatic tissue during the treatment of Benign Prostatic Hyperplasia (BPH). Compatible with specific resectoscopes.

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

• COOK® Single-Use RF Electrode (COOK® Coagulator Probe, K935874)
• Gyrus PK® Plasma V™ Vaporization Electrode (K990628)
• Olympus PK® Plasmabutton™ Vapourization Electrode (K100275, K102781)

Submission Summary (Full Text)

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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 Road<br>National Technology Park<br>Limerick, Ireland |
| Phone: | 011 353 61 334440 |
| Fax: | 011 353 61 239293 |
| Contact Persons: | Nora O'Connor, Regulatory Affairs Specialist<br>Sinead 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 (21<br>CFR 878.4400, Product Code: GEI) |
| Predicate Devices: | COOK® Single-Use RF Electrode (COOK® Coagulator Probe,<br>K935874), Gyrus PK® Plasma V™ Vaporization Electrode<br>(K990628 - Gyrus Endourology System) and the Olympus PK®<br>Plasmabutton™ Vapourization Electrode (K100275 and<br>K102781 - HF-Resection and Vaporization Electrode Series). |
| Description of the<br>Device: | The Plasmatrode™ Saline Safe TUR Electrode (also known as<br>the Plasmatrode™) is a monopolar electrode used to deliver<br>radio frequency energy supplied by a general purpose<br>electrosurgical generator for the purpose of vaporization and<br>coagulation of soft prostatic tissue during the treatment of<br>Benign Prostatic Hyperplasia (BPH). The Plasmatrode™<br>comprises of the following:<br>- A tip assembly, which in turn consists of an active<br>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<br>Olympus OES and Karl Storz Single Stem and Double Stem<br>resectoscopes. |
| Indications for use: | This device is used to vaporize and coagulate soft prostatic<br>tissue during the treatment of Benign Prostatic Hyperplasia<br>and for use with a compatible resectoscope. |
| Comparison of<br>Characteristics: | The PlasmatrodeTM is substantially equivalent to the currently<br>marketed predicate devices, COOK® Single-Use RF Electrode<br>(COOK® Coagulator Probe, K935874), Gyrus PK® Plasma V™ |
| | Vaporization Electrode (K990628 - Gyrus Endourology<br>System) and the Olympus PK® Plasmabutton™ Vapourization<br>Electrode (K100275 and K102781 - HF-Resection and<br>Vaporization Electrode Series). |
| | The proposed device shares many technological<br>characteristics with at least one of the predicate devices (or<br>fall 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 supplied<br>sterile |
| | • Endoscopically used |

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#### K122716

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Cook Ireland Plasmatrode™ Saline Safe TUR Electrode

Page 9 of 91

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Cook Ireland Plasmatrode™ Saline Safe TUR Electrode

Page 10 of 91

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 [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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#### 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