(224 days)
None
No
The summary describes a monopolar electrode for delivering radio frequency energy and does not mention any AI or ML components or functionalities.
Yes.
Explanation: The device is described as being used for "vaporization and coagulation of soft prostatic tissue during the treatment of Benign Prostatic Hyperplasia," which is a medical treatment for a disease.
No
The device is described as an electrode used to "vaporize and coagulate soft prostatic tissue during the treatment of Benign Prostatic Hyperplasia," indicating a therapeutic rather than diagnostic purpose.
No
The device description clearly outlines physical components like a tip assembly, ceramic shields, a conductive shaft, and insulating heat shrink, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "vaporize and coagulate soft prostatic tissue during the treatment of Benign Prostatic Hyperplasia." This is a therapeutic procedure performed in vivo (within the body) on a patient.
- Device Description: The device is a "monopolar electrode used to deliver radio frequency energy" for surgical purposes. This is consistent with a surgical instrument, not a diagnostic test performed on samples in vitro (outside the body).
- Anatomical Site: The device is used on "soft prostatic tissue," which is an anatomical site within the body.
- Performance Studies: The performance studies involve "bench testing" and "animal testing," which are relevant to the safety and effectiveness of a surgical device used in vivo. There is no mention of studies involving human biological samples for diagnostic purposes.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device directly treats tissue within the body.
N/A
Intended Use / 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.
Product codes
GEI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
prostatic tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 ".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K935874, K990628, K100275, K102781
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
K122716 page 1 of 3
Cook Ireland Plasmatrode™ Saline Safe TUR Electrode
Page 8 of 91
APR 1 7 2013
:
| Section 5.0 510(k) Summary | |
|---|---|
| Name: | Cook Ireland Ltd |
| Address: | O'Halloran Road |
| National Technology Park | |
| Limerick, Ireland | |
| Phone: | 011 353 61 334440 |
| Fax: | 011 353 61 239293 |
| Contact Persons: | Nora O'Connor, Regulatory Affairs Specialist |
| 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 |
| CFR 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 and | |
| K102781 - HF-Resection and Vaporization Electrode Series). | |
| Description of the | |
| Device: | 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. |
| 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. |
| Comparison of
Characteristics: | The PlasmatrodeTM is substantially equivalent to the currently
marketed 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 and K102781 - HF-Resection and
Vaporization Electrode Series). |
| | The proposed device shares many technological
characteristics with at least one of the predicate devices (or
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
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 ".
3
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.
4
· 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
5
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'
Page __ _ of _1
(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K122716 510(k) Number