(30 days)
No
The document describes a standard electrosurgical generator with basic controls and displays. There is no mention of AI, ML, or any features that would suggest intelligent processing or learning capabilities. The performance studies are based on thermal effect studies, not algorithmic performance.
Yes
The device is used for the "ablation, removal, resection, and coagulation of soft tissue, and where associated hemostasis is required in endoscopic urological surgical procedures," which are therapeutic interventions.
No
The device is described as an "Electrosurgical unit" and an "electrosurgical bipolar generator" intended for the "ablation, removal, resection, and coagulation of soft tissue." These functions are therapeutic, not diagnostic.
No
The device description clearly states it is a reusable, non-sterile electrosurgical bipolar generator with cutting and coagulation modes, indicating it is a hardware device with integrated software for control and display.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "ablation, removal, resection, and coagulation of soft tissue... in endoscopic urological surgical procedures." This describes a surgical intervention performed directly on a patient's body.
- Device Description: The description details an "electrosurgical bipolar generator" with cutting and coagulation modes, used for applying energy to tissue. This is consistent with a surgical device, not a device used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis. The device's function is to physically alter tissue.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
Electrosurgical unit « MCB » is intended for use for the ablation, removal, resection, and coagulation of soft tissue, and where associated hemostasis is required in endoscopic urological surgical procedures.
The device is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
Product codes (comma separated list FDA assigned to the subject device)
KNS
Device Description
MCB is a reusable, non-sterile electrosurgical bipolar generator with cutting and coagulation modes. The maximum output power is 500 W.
The front panel GUI (graphical user interface) features soft keys and digital displays for:
• the connection status of accessories connected to the electrosurgical generator.
• the current settings of the chosen output mode (Cut/ Coag), and possibility to adjust it
• Sound Level adjustment and LEDs (Green for Sound and Yellow/Blue for output activation)
• Electrode shortcut Alarm reset
At switch on, Serial Number and Software Version are displayed
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue; urological surgical procedures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified medical personnel trained in the use of electrosurgical equipment
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)
Electrical safety and electromagnetic compatibility testing: Validation studies for this submission are based on recognized standards: - ISO 14971 for Risks management - IEC 62304 for Software development - IEC 62366-1 for Usability - IEC 60601-2-2 for Safety of Electrosurgical Generator - IEC 60601-1-2 for EMC
Software validation: Software validation for this submission are based on this guidance: "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005). The device software is considered a "Moderate Level of Concern".
Usability: The MCB unit usability was assessed and found to be safe and effective for its intended uses, by the intended users, in its intended use environment.
Summary of the Clinical performance data: No other Clinical data are included in this submission
Summary of the Non-Clinical performance data: Validation study for this submission are based on this guidance: - FDA Guidance Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery (March 9, 2020). in particular for Thermal Effect studies on representative tissues for urological Application
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.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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September 21, 2022
Lamidey Noury Medical % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive. Suite 510k Saint Paul, MN 55114
Re: K222542
Trade/Device Name: MCB UNIT Model: V10GMCBUS Regulation Number: 21 CFR§ 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: KNS Dated: August 22, 2022 Received: August 22, 2022
Dear Prithul Bom:
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. 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 located 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.
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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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 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,
Reginald K. Avery, Ph.D. Acting 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
510(k) Number (if known) K222542
Device Name MCB UNIT Model: V10GMCBUS
Indications for Use (Describe)
Electrosurgical unit « MCB » is intended for use for the ablation, removal, resection, and coagulation of soft tissue, and where associated hemostasis is required in endoscopic urological surgical procedures.
The device is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
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) |
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510(k) SUMMARY
| 510(k) Owner | LAMIDEY NOURY MEDICAL SAS
ZA des Godets, 3 rue des petits ruisseaux 91370 Verrières le Buisson
Phone Number: +33 1 69 20 69 69
Email Address: g.noury@lamidey-noury.fr |
|-------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Imane OUIKENE
Quality & Regulatory Manager
i.ouikene@lamidey-noury.fr |
| 510(k) Summary prepared on | 2022-05-27 |
| Device Name | Trade Name: MCB
Common Name: MCB
Model: V10GMCBUS |
| Classification | 876.4300: Endoscopic electrosurgical unit and accessories |
| Product Code | KNS: unit, electrosurgical, endoscopic (with or without accessories) |
| Panel | Gastroenterology/Urology |
| Class | 2 |
| Predicate devices | Manufacturer: GYRUS ACMI Inc.
Device Name: PK SUPERPULSE SYSTEM GENERATOR MODEL 744000
Product Code: GEI/KNS
510k Number : K100816 |
| Device description | MCB is a reusable, non-sterile electrosurgical bipolar generator with cutting and
coagulation modes. The maximum output power is 500 W.
The front panel GUI (graphical user interface) features soft keys and digital
displays for:
• the connection status of accessories connected to the electrosurgical
generator.
• the current settings of the chosen output mode (Cut/ Coag), and
possibility to adjust it
• Sound Level adjustment and LEDs (Green for Sound and Yellow/Blue for
output activation)
• Electrode shortcut Alarm reset
At switch on, Serial Number and Software Version are displayed |
| Indications for Use
Intended Use | MCB is intended to be used with Plasma Edge System electrodes (K213135) for
endoscopic urological surgical procedures.
Electrosurgical unit « MCB » is intended for use for the ablation, removal,
resection, and coagulation of soft tissue, and where associated hemostasis is
required in endoscopic urological surgical procedures.
The device is intended for use by qualified medical personnel trained in the use
of electrosurgical equipment |
| Summary of the technological
characteristics | MCB is an electromedical equipment, driven and controlled by Software which
is able to provide to electrodes:
- Clinical Performance: HF electrical power in order to generate thermal
energy which induces - Clinical Benefit: Cutting/Coagulation effect for ablation, removal,
resection, and coagulation of soft tissue, and hemostasis. |
| Electrical safety and
electromagnetic compatibility
testing | Validation studies for this submission are based on recognized standards: - ISO 14971 for Risks management
- IEC 62304 for Software development
- IEC 62366-1 for Usability
- IEC 60601-2-2 for Safety of Electrosurgical Generator
- IEC 60601-1-2 for EMC |
| Software validation | Software validation for this submission are based on this guidance:
"Guidance for the Content of Premarket Submissions for Software
Contained in Medical Devices" (May 11, 2005). The device software is
considered a "Moderate Level ofConcern". |
| Usability | The MCB unit usability was assessed and found to be safe and effective for its
intended uses, by the intended users, in its intended use environment. |
| Summary of the Clinical
performance data | No other Clinical data are included in this submission |
| Summary of the Non-Clinical
performance data | Validation study for this submission are based on this guidance: - FDA Guidance Premarket Notification (510(k)) Submissions for
Electrosurgical Devices for General Surgery (March 9, 2020).in particular
for Thermal Effect studies on representative tissues for urological
Application |
| Overall Conclusions | Comparison between device described in this 510(k) and predicate device
shows a substantial equivalence based on : - Same Indications for Use,
- Same technological and technical characteristics (Principle of
operations) - Results of non-clinical tests
Slight differences do not raise any questions regarding safety and effectiveness.
Therefore, it can be concluded that device described in this 510(k) is « as Safe
and effective as the predicate device. |
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