(112 days)
Not Found
No
The summary describes a manual surgical device that uses high-frequency energy to create plasma for tissue manipulation. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is used for ablation, hemostasis, cutting, coagulation, and vaporization of tissues during endoscopic surgeries, which are all therapeutic interventions aimed at treating medical conditions.
No
This device is described as a "manual surgical device" used for "ablation and hemostasis of tissues." Its intended uses, such as "Transurethral resection of prostate (TURP)" and "Transurethral Vaporization of the prostate (TUVP/TVP)", are all therapeutic surgical procedures, not diagnostic ones.
No
The device description explicitly states it is a "manual surgical device, consisting of a single-use electrode, an active and passive working element reusable and an adaptor or only socket with memory (fixed cable)". This indicates the device is primarily hardware-based, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Device Function: The Plasma Edge System is a surgical device used for the ablation, hemostasis, and vaporization of tissues within the body during endoscopic procedures. It directly interacts with tissue inside the patient.
- Intended Use: The intended use clearly describes surgical procedures performed on the prostate and bladder, not laboratory testing of samples.
- Device Description: The description details a surgical electrode and associated components for delivering energy to tissue, not for analyzing biological samples.
Therefore, the Plasma Edge System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Plasma Edge System single use bipolar resection electrodes are used for the ablation and hemostasis of tissues under endoscopic control, in association with endoscopic accessories. They are intended for endoscopic surgeries with saline irrigation, in the field of urology. The use of the Plasma Edge System is restricted to surgeons, specialized in urological surgery, for specific use in: - Transurethral resection of prostate (TURP) for benign prostatic hypertrophy - Transurethral incision of the prostate (TUIP) or bladder neck - Transurethral resection of bladder tumors (TURBT) - Cystodiathermy - Transurethral Vaporization of the prostate (TUVP/TVP) for benign prostatic hypertrophy, and for Transurethral Vaporization of bladder tumors. (MVVS models only)
Product codes (comma separated list FDA assigned to the subject device)
FAS, GEI, FDC
Device Description
The Plasma Edge system is a manual surgical device, consisting of a single-use electrode, an active and passive working element reusable and an adaptor or only socket with memory (fixed cable) to connect them to an HF generator compatible. The electrodes consist of an active tip, two wires threaded through ceramic tubes to connect the active tip to the body of the loop, allowing the HF energy to reach the active tip. It has to be used with continuous flow irrigation of saline solution (NaCl 0,9%) that reaches the operative site through a resectoscope. The HF energy delivered from the generator to the electrode ionizes the gas of the saline solution, creating a plasma for the cutting, coagulation and vaporization of tissues.
a. Electrodes range: The SIDE LOAD electrode range is composed by 4 electrodes with 4 actives tips: thin, thick, knife (or needle) and vaporization. The SIDE LOAD electrodes are dedicated to being used with working element compatible with STORZ and OLYMPUS resectoscopes.
b. Working element range: The SIDE LOAD working elements are compatible with STORZ and OLYMPUS resectoscope. Electrodes are mechanically connected into a working element, used to move the electrode by a linear translation. - With an active working element, action is pulling the electrode - With a passive working element, action is pushing the electrode
c. Adaptor: This will allow to connect the Plasma EDGE electrode range to a bipolar HF generator system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
prostate, bladder, bladder neck
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons, specialized in urological surgery
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)
a. Risk analysis: Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO-14971:2019. Performance tests were carried out to ensure that the system functions as intended and meets design specifications.
b. Biocompatibility testing: The biocompatibility evaluation for the subject device was conducted in accordance with the standard ISO 10993-1:2018. Tests performed: Acute systemic toxicity test, Pyrogen detection assay, Acute skin irritation test, Skin sensibilization test on Guinea pig, ISO MTS cytotoxicity test.
c. Electrical safety: Tested by an independent laboratory according to IEC 60601-1: 2012 and IEC 60601-2-2:2009.
d. Electromagnetic compatibility (EMC): Tested by an independent laboratory according to the standard IEC 60601-1-2:2007. Electrode Plasma Edge was tested on the HF generator Gyrus and a comparison was realized with the assembly Electrode Gyrus on the HF generator Gyrus.
e. Cleaning and sterilization validation for the reusable working element range: Cleaning and disinfection validation tested by an independent laboratory following standards ISO 17664 and AAMI TIR Nº30: manual cleaning. Steam sterilization validation tested by an independent laboratory following standards AAMI TIR Nº12, ISO 17664 and ISO 17665: 132ºc for 4 min.
f. Sterilization validation and Shelf-Life Discussion for single use electrode: Validated sterilization method is ethylene oxide. Shelf life of four (4) years.
g. Bench top validation testing: End of life simulation report, breakdown simulation report, working element compatibility report and test on ex vivo tissues have been tested on the Plasma Edge System to demonstrate the product safety and the efficiency on Gyrus Superpulse electrosurgical unit and MCB electrosurgical unit.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 12, 2024
Lamidey Noury Medical Guillaume Noury CEO Z.A Les godets, 3 rue des petits ruisseaux Verrières le buisson, 91370 FRANCE
K240504 Re:
Trade/Device Name: PLASMA EDGE System Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic Electrosurgical Unit and Accessories Regulatory Class: II Product Code: FAS, GEI, FDC Dated: February 19, 2024 Received: February 21, 2024
Dear Guillaume Noury:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
2
the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark R. Kreitz -S
for Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
PLASMA EDGE System
Indications for Use (Describe)
The Plasma Edge System single use bipolar resection electrodes are used for the ablation and hemostasis of tissues under
endoscopic control, in association with endoscopic accessories.
They are intended for endoscopic surgeries with saline irrigation, in the field ofurology.
The use of the Plasma Edge System is restricted to surgeons, specialized in urological surgery, for specific use in:
- · Transurethral resection of prostate (TURP) for benign prostatic hypertrophy
- · Transurethral incision of the prostate (TUIP) or bladder neck
- · Transurethral resection of bladder tumors (TURBT)
- · Cystodiathermy
- · Transurethral Vaporization of the prostate (TUVP/TVP) for benign prostatic hypertrophy, and for Transurethral
- Vaporization of bladder tumors. (MVVS models only)
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/4/Picture/0 description: The image shows a logo for "LAMIDEY NOURY MEDICAL". The logo consists of the text "LAMIDEY NOURY" in bold, black letters, with the word "MEDICAL" underneath in a smaller font size. The text is surrounded by a partial circle, with the top half of the circle in a light purple color and the bottom half in a light blue color.
510(k) Summary
| Submitter | Lamidey Noury Medical
Z.A. Les Godets, 3 rue des Petits Ruisseaux
F-91370 Verrières le Buisson
FRANCE |
|------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Contacts | Guillaume Noury
CEO
regulatory@orange.fr
Phone : +33 169 20 30 21
Fax : +33 160 13 97 47 |
| Date prepared | 12/07/2023 |
| Trade Name | Plasma EDGE System |
| Common name | Bipolar electrodes |
| Classification Name | Endoscopic Electrosurgical Unit and Accessories |
| Class | II |
| Product Code | Classification product code : FAS
Subsequent product code : GEI / FDC |
| CFR section | 876.4300 / 878.4400 / 876.1500 |
| Device panel | Regulation Medical Specialty : Gastroenterology / Urology
510k Review Panel : General & Plastic Surgery |
| Legally marketed predicate devices | K213135: Plasme EDGE System - manufactured by LAMIDEY
NOURY MEDICAL |
.. Product Description
The Plasma Edge system is a manual surgical device, consisting of a single-use electrode, an active and passive working element reusable and an adaptor or only socket with memory (fixed cable) to connect them to an HF generator compatible. The electrodes consist of an active tip, two wires threaded through ceramic tubes to connect the active tip to the body of the loop, allowing the HF energy to reach the active tip.
It has to be used with continuous flow irrigation of saline solution (NaCl 0,9%) that reaches the operative site through a resectoscope. The HF energy delivered from the generator to the electrode ionizes the gas of the saline solution, creating a plasma for the cutting, coagulation and vaporization of tissues.
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Image /page/5/Picture/0 description: The image is a logo for Lamidey Noury Medical. The logo consists of the words "LAMIDEY NOURY" in bold, black letters, stacked on top of each other. Below the name is the word "MEDICAL" in a smaller, sans-serif font. The text is surrounded by a partial circle, with the top half of the circle in a light purple color and the bottom half in a light blue color.
a. Electrodes range:
The SIDE LOAD electrode range is composed by 4 electrodes with 4 actives tips: thin, thick, knife (or needle) and vaporization. The SIDE LOAD electrodes are dedicated to being used with working element compatible with STORZ and OLYMPUS resectoscopes.
b. Working element range:
The SIDE LOAD working elements are compatible with STORZ and OLYMPUS resectoscope.
Electrodes are mechanically connected into a working element, used to move the electrode by a linear translation.
- With an active working element, action is pulling the electrode
- With a passive working element, action is pushing the electrode
c. Adaptor:
This will allow to connect the Plasma EDGE electrode range to a bipolar HF generator system.
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Image /page/6/Picture/0 description: The image is a logo for "LAMIDEY NOURY MEDICAL". The logo consists of the text "LAMIDEY NOURY" in bold, black letters, stacked on top of each other. Below the name is the word "MEDICAL" in a smaller, sans-serif font. The text is surrounded by a partial circle, with the top half of the circle in a light purple color and the bottom half in a light blue color.
ii. Indications for use
The Plasma Edge System single use bipolar resection electrodes are used for the ablation and hemostasis of tissues under endoscopic control, in association with endoscopic accessories.
They are intended for endoscopic surgeries with saline irrigation, in the field of urology. The use of the Plasma Edge System is restricted to surgeons, specialized in urological surgery, for specific use in:
- Transurethral resection of prostate (TURP) for benign prostatic hyperplasia ●
- Transurethral incision of the prostate (TUIP) or bladder neck
- Transurethral resection of bladder tumors (TURBT)
- Cystodiathermy
- Transurethral Vaporization of the prostate (TUVP/TVP) for benign prostatic hyperplasia, and for Transurethral Vaporization of bladder tumors. (MVVS models only)
iii. Performance testing
a. Risk analysis:
Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO-14971:2019.
Performance tests were carried out to ensure that the system functions as intended and meets design specifications. The following performance tests and usability studies were conducted.
b. Biocompatibility testing
The biocompatibility evaluation for the subject device was conducted in accordance with the standard ISO 10993-1:2018. To assess the impact on devices following DDM 0723-04 (change of cleaning solution and cleaning process) these tests have been performed:
- Rapport d'évaluation biologique Résection (Biological evaluation report Resection)
- . Acute systemic toxicity test according to ISO 10993-11:2018. See report named "Report Acute Systemic Toxicity test -ISO 10993-11 Resection electrode 09-2023″.
- Pyrogen detection assay according to European Pharmacopeia chapter 2.6.8 and ISO 10993-11:2018. See report named "Report Pyrogen detection-ISO 10993-11_Resection electrode_09-2023".
- . Acute skin irritation test according to ISO 10993-23:2021. See report "Report Acute skin irritation-ISO 10993-23_ Resection electrode_09-2023".
- Skin sensibilization test on Guinea pig according to ISO 10993-10:2021. See report ●
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Image /page/7/Picture/0 description: The image is a logo for "LAMIDEY NOURY MEDICAL". The text is in bold, black font and is stacked on top of each other. The word "MEDICAL" is smaller than the other two words. The text is surrounded by a partial circle that is light purple on the top and light blue on the bottom.
"Report Skin sensitization test-ISO-10993-10_Resection electrode_09-2023″.
- ISO MTS cytotoxicity test - ISO 10993-5 (2009): "Nettoyage X3_Cytotoxicité_QP2" & "Nettoyage X3 Cytotoxicité QP3",
The previous biocompatibility test are available on previous versions of these documents.
c. Electrical safety
Electrical Safety was tested by an independent laboratory according to IEC 60601-1: 2012; Medical Electrical Equipment - Part 1.1 General requirements for safety and essential performance, and IEC 60601-2-2:2009- Medical Electrical Equipment - Part 2 Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories.
d. Electromagnetic compatibility (EMC)
Electromagnetic compatibility was tested by an independent laboratory according to the standard IEC 60601-1-2:2007. Electrode Plasma Edge was tested on the HF generator Gyrus and a comparison was realized with the assembly Electrode Gyrus on the HF generator Gyrus.
e. Cleaning and sterilization validation for the reusable working element range:
Cleaning and disinfection validation was tested by an independent laboratory following standards ISO 17664 and AAMI TIR Nº30: manual cleaning.
Steam sterilization validation was tested by an independent laboratory following standards AAMI TIR Nº12, ISO 17664 and ISO 17665: 132ºc for 4 min.
f. Sterilization validation and Shelf-Life Discussion for single use electrode
The electrodes are delivered in a sterile state and are intended for single patient use only. The validated sterilization method used is ethylene oxide. The product has a shelf life of four (4) years.
g. Bench top validation testing
End of life simulation report, breakdown simulation report, working element compatibility report and test on ex vivo tissues have been tested on the Plasma Edge System to demonstrate the product safety and the efficiency on Gyrus Superpulse electrosurgical unit and MCB electrosurgical unit.
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Image /page/8/Picture/0 description: The image is a logo for Lamidey Noury Medical. The logo features the text "LAMIDEY NOURY MEDICAL" in bold, black letters. The word "MEDICAL" is smaller than the other two words. The text is surrounded by a partial circle, with the top half of the circle being purple and the bottom half being light blue.
iv. List of standards
| Standards | Description |
|---|---|
| ISO 10993-1 | Biological evaluation of medical devices - Part 1: Evaluation and testing within |
| a risk management process | |
| ISO 10993-5 | Biological evaluation of medical devices -- Part 5: Tests for In Vitro |
| cytotoxicity | |
| ISO 10993-7 | Biological evaluation of medical devices - part 7: ethylene oxide sterilization |
| residuals [including: technical corrigendum 1 (2009)] | |
| ISO 10993-10 | Biological evaluation of medical devices - Part 10: Tests for irritation and skin |
| sensitization | |
| ISO 10993-11 | Biological evaluation of medical devices - Part 11: Tests for systemic toxicity |
| ISO 10993-23 | Biological evaluation of medical devices - Part 23: Tests for irritation |
| ISO 11135 | Sterilization of health-care products - ethylene oxide - requirements for the |
| development, validation and routine control of a sterilization process for | |
| medical devices | |
| ISO 11607-1 | Packaging for terminally sterilized medical devices - Part 1: Requirements for |
| materials, sterile barrier systems and packaging systems | |
| ISO 11607-2 | Packaging for terminally sterilized medical devices - |
| requirements for forming, sealing and assembly processes | |
| Part 2: Validation | |
| ISO 17664 | Sterilization of medical devices - Information to be provided by the |
| manufacturer for the processing of resterilizable medical devices | |
| ISO 17665-1 | Sterilization of health-care products - Moist heat - Part 1: Requirements for |
| the development, validation and routine control of a sterilization process for | |
| medical devices | |
| AAMI TIR Nº12 | Designing, testing, and labeling reusable medical devices for reprocessing in |
| health-care facilities: A guide for medical device manufacturers | |
| AAMI TIR Nº30 | A compendium of processes, materials, test methods, and acceptance criteria |
| for cleaning reusable medical devices | |
| IEC 60601-1 | Medical electrical equipment - Part 1: General requirements for basic safety |
| and essential performance | |
| IEC 60601-1-2 | General requirements for basic safety and essential performance - Collateral |
| Standard: Electromagnetic disturbances |
- Requirements and tests |
| IEC 60601-1-6 | Medical electrical equipment - Part 1-6: General requirements for basic safety
and essential performance - Collateral standard: Usability |
| IEC 60601-2-2 | Medical electrical equipment - Part 2-2: Particular requirements for the basic
safety and essential performance of high frequency surgical equipment and
high frequency surgical accessories |
| IEC 60601-2-18 | Medical electrical equipment - Part 2-18: Particular requirements for the basic
safety and essential performance of endoscopic equipment |
| IEC 62366-1 | Medical Electrical Equipment - Part 1: Application of usability engineering to
medical devices |
| ISO 14971 | Medical devices - application of risk management to medical devices |
| ISO 15223-1 | Medical devices - symbols to be used with medical device labels, labeling, and
information to be supplied - part 1 : general requirements |
| ISO 11737-1 | Sterilization of health care products - Microbiological methods - Part 1:
Determination of a population of microorganisms on products |
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Image /page/9/Picture/0 description: The image is a logo for Lamidey Noury Medical. The logo features the words "LAMIDEY NOURY" in bold, black letters, stacked on top of each other. Below the names, the word "MEDICAL" is written in a smaller, sans-serif font. The text is surrounded by a partial circle, with the top half of the circle in a light purple color and the bottom half in a light teal color.
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Image /page/10/Picture/0 description: The image shows a logo for Lamidey Noury Medical. The logo consists of the words "LAMIDEY NOURY" in bold, black letters, stacked on top of each other. Below the name is the word "MEDICAL" in smaller, red letters. The text is surrounded by a circular design with the top half in purple and the bottom half in light blue.
Comparison of Technological characteristics: V.
| | Proposed device
Plasma EDGE System (Waiting for 510K
number) | Predicate device
Plasma EDGE System (K213135) | Substantial Equivalence
Analysis |
|------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| ELECTRODE | | | |
| Indications for
use | - Transurethral resection of prostate
(TURP)
- Transurethral incision of the prostate
(TUIP) or bladder neck - Transurethral resection of bladder
tumours (TURBT) - Cystodiathermy
-Transurethral electrovaporization of the
prostate | - Transurethral resection of prostate
(TURP) - Transurethral incision of the prostate
(TUIP) or bladder neck - Transurethral resection of bladder
tumours (TURBT) - Cystodiathermy
-Transurethral electrovaporization of the
prostate | SAME |
| Sterilization | Eto | Eto | SAME |
| Single use | Yes | Yes | SAME |
| Energy type | High frequency | High frequency | SAME |
| Mode | Bipolar | Bipolar | SAME |
| User interface | Footswitch | Footswitch | SAME |
| Use only in
Conductive
Media | The electrode is to be activated only
when immersed in a conductive media
such as standard saline solution | The electrode is to be activated only
when immersed in a conductive media
such as standard saline solution | SAME |
| Electrode
manipulation | Working element | Working element | SAME |
| | Proposed device
Plasma EDGE System (Waiting for 510K
number) | Predicate device
Plasma EDGE System (K213135) | Substantial Equivalence
Analysis |
| Working
element
compatibility | Storz
Olympus | Storz
Olympus | SAME |
| Sterilization of
working
element | Steam sterilization
(autoclave) | Steam sterilization
(autoclave) | SAME |
| MATERIALS OF ELECTRODES | | | |
| Active tip of
thin and thick
loop
WIRE | Tungsten wire
99,95% | Tungsten wire
99,95% | SAME |
| Active wire
WIRE | Platinum iridium | Platinum iridium | SAME |
| Insulation | Ceramic ZTA10 | Ceramic ZTA10 | SAME |
| Wire insulation | PTFE
AWG28 | PTFE
AWG28 | SAME |
| Heat-shrink
tubing | MT 3000 | MT 3000 | SAME |
| Skeleton | Stainless Steel 316L | Stainless Steel 316L | SAME |
| Telescope clip | Polypropylene
(DDM 0721-02) | Polypropylene
(DDM 0721-02) | SAME |
| | Proposed device
Plasma EDGE System (Waiting for 510K
number) | Predicate device
Plasma EDGE System (K213135) | Substantial Equivalence
Analysis |
| Glue | Loctite M-121HP | Loctite M-121HP | SAME |
| Sealing gasket | Silicone | Silicone | SAME |
| Inner insulator | PEEK 450G | PEEK 450G | SAME |
| Connector
over-moulding
(SIDE load) | Polypropylene
ISPLEN PP 080 | Polypropylene
ISPLEN PP 080 | SAME |
| HF Cables of
the electrodes | Silicone | Silicone | SAME |
| Plug | Tin-plated copper | Tin-plated copper | SAME |
| Crimp tube | Titanium | Titanium | SAME |
| Packaging material of Electrode | | | |
| Pouch material | - One side coated TYVEK® 1073B® Co
7502887C | - One side coated TYVEK® 1073B® Co
7502887C | SAME |
| | -One side PET/PE 60 Pharma (transparent) | -One side PET/PE 60 Pharma (transparent) | |
| Blister material | PETG | PETG | SAME |
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Image /page/11/Picture/1 description: The image contains a logo for "LAMIDEY NOURY MEDICAL". The logo features the text "LAMIDEY NOURY" in bold, stacked on top of each other. Below that, the word "MEDICAL" is written in a smaller font size. The text is surrounded by a partial circle, with the top portion of the circle in a light purple color and the bottom portion in a light blue color.
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At a high level, the subject and predicate devices are based on the same technological principle with the same elements:
- The indications for use (TURP; TUIP or bladder neck; TURBT; Cystodiathermy; Transurethral electrovaporization)
- The method of use (compatibility working element, conductive media, etc...)
- The material characteristics
- The modification of the cleaning solution and cleaning process parameters did not change the technological characteristics, the design nor fundamental operating principles of modified device compared to the predicate. The modification of the cleaning process were validated and did not lead to the identification of any new risk.
Since the indications for use and the technological characteristics are the same between the predicate device and the modified device subject of this Special 510(k), the modified device is substantially equivalent to the predicate device.
Conclusion: vi.
There is no difference between the Plasma EDGE resection system and the predicate devices in terms of intended use, principle of operation, and the technology used for device performance based upon the changes reported in this Special 510(k). In other words, there is no difference technically, clinically and biologically from the predicate.
The Plasma EDGE resection system was subjected to verification testing to confirm device performance. There is no new technology and differences that would raise new or different questions of safety or efficiency. Comparative performance testing demonstrate that the device performed as well as, or better than, the predicate device.