(112 days)
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)
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.
The provided text describes the PLASMA EDGE System, an endoscopic electrosurgical unit and accessories, and its substantial equivalence to a predicate device (K213135: Plasme EDGE System - manufactured by LAMIDEY NOURY MEDICAL).
Here's an analysis of the acceptance criteria and study information:
1. Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to a predicate device. It addresses performance through various validation and testing activities rather than specific numerical acceptance criteria. The underlying acceptance criteria for each test are implicitly the successful fulfillment of the standards mentioned.
| Acceptance Criteria Category | Reported Device Performance (Study) |
|---|---|
| Risk Analysis | Carried out in accordance with established in-house acceptance criteria based on ISO-14971:2019. Performance tests were conducted to ensure the system functions as intended and meets design specifications. |
| Biocompatibility | Evaluated in accordance with ISO 10993-1:2018. Specific tests performed due to a change in cleaning solution and process (DDM 0723-04): - Acute systemic toxicity test (ISO 10993-11:2018) - Reported as successfully completed.- Pyrogen detection assay (European Pharmacopeia chapter 2.6.8 and ISO 10993-11:2018) - Reported as successfully completed.- Acute skin irritation test (ISO 10993-23:2021) - Reported as successfully completed.- Skin sensitization test on Guinea pig (ISO 10993-10:2021) - Reported as successfully completed.- ISO MTS cytotoxicity test (ISO 10993-5:2009) - "Nettoyage X3_Cytotoxicité_QP2" & "Nettoyage X3 Cytotoxicité QP3" - Reported as successfully completed. Previous biocompatibility tests were also available. |
| Electrical Safety | Tested by an independent laboratory according to IEC 60601-1: 2012 and IEC 60601-2-2:2009. - Implied successful completion to meet substantial equivalence. |
| Electromagnetic Compatibility (EMC) | Tested by an independent laboratory according to 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. - Implied successful completion to meet substantial equivalence. |
| Cleaning & Sterilization Validation (Reusable Working Element) | Tested by an independent laboratory following ISO 17664 and AAMI TIR Nº30 (manual cleaning). Steam sterilization validation tested following AAMI TIR Nº12, ISO 17664, and ISO 17665 (132ºC for 4 min). - Implied successful completion. |
| Sterilization Validation & Shelf-Life (Single-Use Electrode) | Validated sterilization method: ethylene oxide. Product has a shelf life of four (4) years. - Implied successful validation. |
| Bench Top Validation Testing | End of life simulation report, breakdown simulation report, working element compatibility report, and test on ex vivo tissues. These were tested on the Plasma Edge System to demonstrate product safety and efficiency on Gyrus Superpulse electrosurgical unit and MCB electrosurgical unit. - Implied successful demonstration of safety and efficiency, performing as well as or better than the predicate. |
The document states: "Comparative performance testing demonstrate that the device performed as well as, or better than, the predicate device." This is the ultimate reported performance outcome relative to acceptance (substantial equivalence).
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for any of the performance tests. For biocompatibility, tests are typically conducted on a small number of samples to represent the device materials. For electrical/EMC, typically one or a few devices are tested. For cleaning/sterilization, a specified number of cycles/samples are used based on the standard, but the exact number isn't provided here. For bench top validation, no specific sample size is mentioned.
- Data Provenance: Not specified (e.g., country of origin). The studies appear to be internal or contracted out to independent laboratories, as indicated by phrases like "established in-house acceptance criteria" and "tested by an independent laboratory." The document mentions European Pharmacopeia, suggesting some European standard compliance. The submission itself is from France. The studies are essentially retrospective in the context of the device's development and marketing submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The studies described are primarily technical performance validations against established standards, not clinical studies requiring expert ground truth for interpretation (e.g., imaging diagnostic devices).
4. Adjudication method for the test set:
This information is not applicable and therefore not provided, as the studies are not clinical trials that would typically involve adjudication of endpoints or diagnoses by multiple experts. The validation is against technical specifications and standard requirements.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for diagnostic imaging AI, where human readers interpret cases with and without AI assistance. The PLASMA EDGE System is a surgical tool, and its efficacy is evaluated through bench testing, biocompatibility, and electrical safety, not by human reader interpretation. No effect size improvement with AI assistance for human readers is mentioned as it's not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is an electrosurgical system, not an AI algorithm. Its performance is inherently "standalone" in mechanical and electrical testing, but it requires a human surgeon for operation (human-in-the-loop for its clinical use, but not in the context of AI performance evaluation).
7. The type of ground truth used:
- For Risk Analysis, Electrical Safety, EMC, Cleaning, Sterilization, and Bench Top Validation: The "ground truth" is defined by the requirements of the specified international and national standards (e.g., ISO 14971, IEC 60601 series, ISO 10993 series, AAMI TIRs) and internal design specifications. Successful adherence to these standards constitutes the "ground truth" for compliance and performance.
- For Biocompatibility: The "ground truth" is established by the biological response observed in standardized in vitro and in vivo tests as per ISO 10993 series, with criteria for acceptable biological reactions.
8. The sample size for the training set:
Not applicable. This device is a medical instrument (hardware with integrated controls), not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as no training set for an AI/ML model is involved.
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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"
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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
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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
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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.
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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 MedicalZ.A. Les Godets, 3 rue des Petits RuisseauxF-91370 Verrières le BuissonFRANCE |
|---|---|
| Contacts | Guillaume NouryCEOregulatory@orange.frPhone : +33 169 20 30 21Fax : +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 : FASSubsequent product code : GEI / FDC |
| CFR section | 876.4300 / 878.4400 / 876.1500 |
| Device panel | Regulation Medical Specialty : Gastroenterology / Urology510k Review Panel : General & Plastic Surgery |
| Legally marketed predicate devices | K213135: Plasme EDGE System - manufactured by LAMIDEYNOURY 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 withina risk management process |
| ISO 10993-5 | Biological evaluation of medical devices -- Part 5: Tests for In Vitrocytotoxicity |
| ISO 10993-7 | Biological evaluation of medical devices - part 7: ethylene oxide sterilizationresiduals [including: technical corrigendum 1 (2009)] |
| ISO 10993-10 | Biological evaluation of medical devices - Part 10: Tests for irritation and skinsensitization |
| 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 thedevelopment, validation and routine control of a sterilization process formedical devices |
| ISO 11607-1 | Packaging for terminally sterilized medical devices - Part 1: Requirements formaterials, sterile barrier systems and packaging systems |
| ISO 11607-2 | Packaging for terminally sterilized medical devices -requirements for forming, sealing and assembly processesPart 2: Validation |
| ISO 17664 | Sterilization of medical devices - Information to be provided by themanufacturer for the processing of resterilizable medical devices |
| ISO 17665-1 | Sterilization of health-care products - Moist heat - Part 1: Requirements forthe development, validation and routine control of a sterilization process formedical devices |
| AAMI TIR Nº12 | Designing, testing, and labeling reusable medical devices for reprocessing inhealth-care facilities: A guide for medical device manufacturers |
| AAMI TIR Nº30 | A compendium of processes, materials, test methods, and acceptance criteriafor cleaning reusable medical devices |
| IEC 60601-1 | Medical electrical equipment - Part 1: General requirements for basic safetyand essential performance |
| IEC 60601-1-2 | General requirements for basic safety and essential performance - CollateralStandard: Electromagnetic disturbances- Requirements and tests |
| IEC 60601-1-6 | Medical electrical equipment - Part 1-6: General requirements for basic safetyand essential performance - Collateral standard: Usability |
| IEC 60601-2-2 | Medical electrical equipment - Part 2-2: Particular requirements for the basicsafety and essential performance of high frequency surgical equipment andhigh frequency surgical accessories |
| IEC 60601-2-18 | Medical electrical equipment - Part 2-18: Particular requirements for the basicsafety and essential performance of endoscopic equipment |
| IEC 62366-1 | Medical Electrical Equipment - Part 1: Application of usability engineering tomedical 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, andinformation 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 devicePlasma EDGE System (Waiting for 510Knumber) | Predicate devicePlasma EDGE System (K213135) | Substantial EquivalenceAnalysis | |
|---|---|---|---|
| ELECTRODE | |||
| Indications foruse | - Transurethral resection of prostate(TURP)- Transurethral incision of the prostate(TUIP) or bladder neck- Transurethral resection of bladdertumours (TURBT)- Cystodiathermy-Transurethral electrovaporization of theprostate | - Transurethral resection of prostate(TURP)- Transurethral incision of the prostate(TUIP) or bladder neck- Transurethral resection of bladdertumours (TURBT)- Cystodiathermy-Transurethral electrovaporization of theprostate | 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 inConductiveMedia | The electrode is to be activated onlywhen immersed in a conductive mediasuch as standard saline solution | The electrode is to be activated onlywhen immersed in a conductive mediasuch as standard saline solution | SAME |
| Electrodemanipulation | Working element | Working element | SAME |
| Proposed devicePlasma EDGE System (Waiting for 510Knumber) | Predicate devicePlasma EDGE System (K213135) | Substantial EquivalenceAnalysis | |
| Workingelementcompatibility | StorzOlympus | StorzOlympus | SAME |
| Sterilization ofworkingelement | Steam sterilization(autoclave) | Steam sterilization(autoclave) | SAME |
| MATERIALS OF ELECTRODES | |||
| Active tip ofthin and thickloop-WIRE | Tungsten wire99,95% | Tungsten wire99,95% | SAME |
| Active wire-WIRE | Platinum iridium | Platinum iridium | SAME |
| Insulation | Ceramic ZTA10 | Ceramic ZTA10 | SAME |
| Wire insulation | PTFEAWG28 | PTFEAWG28 | SAME |
| Heat-shrinktubing | 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 devicePlasma EDGE System (Waiting for 510Knumber) | Predicate devicePlasma EDGE System (K213135) | Substantial EquivalenceAnalysis | |
| Glue | Loctite M-121HP | Loctite M-121HP | SAME |
| Sealing gasket | Silicone | Silicone | SAME |
| Inner insulator | PEEK 450G | PEEK 450G | SAME |
| Connectorover-moulding(SIDE load) | PolypropyleneISPLEN PP 080 | PolypropyleneISPLEN PP 080 | SAME |
| HF Cables ofthe 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® Co7502887C | - One side coated TYVEK® 1073B® Co7502887C | 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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Image /page/12/Picture/1 description: The image shows the logo for Lamidey Noury Medical. The logo features the company name in bold, black letters, with "LAMIDEY" stacked above "NOURY." Below the name, the word "MEDICAL" is written in a smaller, lighter font. A partial circle in light purple is above the company name, and a similar partial circle in light blue is below the name, framing the text.
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Image /page/13/Picture/1 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 name, the word "MEDICAL" is written in a smaller, lighter 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.
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.
§ 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).