MCB UNIT Model: V10GMCBUS

K222542 · Lamidey Noury Medical · KNS · Sep 21, 2022 · Gastroenterology, Urology

Device Facts

• Record ID: K222542
• Device Name: MCB UNIT Model: V10GMCBUS
• Applicant: Lamidey Noury Medical
• Product Code: KNS · Gastroenterology, Urology
• Decision Date: Sep 21, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended 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.

Device Story

MCB is a reusable, non-sterile bipolar electrosurgical generator; max output 500W. Used in endoscopic urological procedures by trained medical personnel. Device delivers high-frequency (HF) electrical power to compatible electrodes (e.g., Plasma Edge System) to generate thermal energy for tissue cutting, coagulation, and hemostasis. Front panel GUI allows clinicians to monitor connection status, adjust output modes (Cut/Coag), set sound levels, and reset alarms. Device provides visual feedback via LEDs for output activation. Clinical benefit includes precise tissue management during urological surgery.

Clinical Evidence

No clinical data included. Substantial equivalence supported by non-clinical bench testing, including thermal effect studies on representative tissues for urological applications, electrical safety (IEC 60601-2-2), and electromagnetic compatibility (IEC 60601-1-2).

Technological Characteristics

Electromedical generator; bipolar output. Standards: ISO 14971 (risk), IEC 62304 (software), IEC 62366-1 (usability), IEC 60601-2-2 (safety), IEC 60601-1-2 (EMC). Features GUI with soft keys and digital displays. Software-controlled power delivery.

Indications for Use

Indicated for ablation, removal, resection, and coagulation of soft tissue and associated hemostasis in endoscopic urological surgical procedures. Intended for use by qualified medical personnel trained in electrosurgical equipment.

Regulatory Classification

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.

Predicate Devices

• PK SUPERPULSE SYSTEM GENERATOR MODEL 744000 (K100816)

Reference Devices

• Plasma Edge System electrodes (K213135)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

| <span></span> | Prescription Use (Part 21 CFR 801 Subpart D) |
|---------------|----------------------------------------------|
| <span></span> | Over-The-Counter Use (21 CFR 801 Subpart C) |

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## 510(k) SUMMARY

| 510(k) Owner | LAMIDEY NOURY MEDICAL SAS<br>ZA des Godets, 3 rue des petits ruisseaux 91370 Verrières le Buisson<br>Phone Number: [phone]<br>Email Address: [e-mail] |
|-------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Imane OUIKENE<br>Quality & Regulatory Manager<br>[e-mail] |
| 510(k) Summary prepared on | 2022-05-27 |
| Device Name | Trade Name: MCB<br>Common Name: MCB<br>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.<br>Device Name: PK SUPERPULSE SYSTEM GENERATOR MODEL 744000<br>Product Code: GEI/KNS<br>510k Number : K100816 |
| Device description | MCB is a reusable, non-sterile electrosurgical bipolar generator with cutting and<br>coagulation modes. The maximum output power is 500 W.<br><br>The front panel GUI (graphical user interface) features soft keys and digital<br>displays for:<br>• the connection status of accessories connected to the electrosurgical<br>generator.<br>• the current settings of the chosen output mode (Cut/ Coag), and<br>possibility to adjust it<br>• Sound Level adjustment and LEDs (Green for Sound and Yellow/Blue for<br>output activation)<br>• Electrode shortcut Alarm reset<br><br>At switch on, Serial Number and Software Version are displayed |
| Indications for Use<br>Intended Use | MCB is intended to be used with Plasma Edge System electrodes (K213135) for<br>endoscopic urological surgical procedures.<br><br>Electrosurgical unit « MCB » is intended for use for the ablation, removal,<br>resection, and coagulation of soft tissue, and where associated hemostasis is<br>required in endoscopic urological surgical procedures.<br>The device is intended for use by qualified medical personnel trained in the use<br>of electrosurgical equipment |
| Summary of the technological<br>characteristics | MCB is an electromedical equipment, driven and controlled by Software which<br>is able to provide to electrodes:<br>- Clinical Performance: HF electrical power in order to generate thermal<br>energy which induces<br>- Clinical Benefit: Cutting/Coagulation effect for ablation, removal,<br>resection, and coagulation of soft tissue, and hemostasis. |
| Electrical safety and<br>electromagnetic compatibility<br>testing | Validation studies for this submission are based on recognized standards:<br>- ISO 14971 for Risks management<br>- IEC 62304 for Software development<br>- IEC 62366-1 for Usability<br>- IEC 60601-2-2 for Safety of Electrosurgical Generator<br>- IEC 60601-1-2 for EMC |
| Software validation | Software validation for this submission are based on this guidance:<br>"Guidance for the Content of Premarket Submissions for Software<br>Contained in Medical Devices" (May 11, 2005). The device software is<br>considered a "Moderate Level ofConcern". |
| Usability | The MCB unit usability was assessed and found to be safe and effective for its<br>intended uses, by the intended users, in its intended use environment. |
| Summary of the Clinical<br>performance data | No other Clinical data are included in this submission |
| Summary of the Non-Clinical<br>performance data | Validation study for this submission are based on this guidance:<br>- FDA Guidance Premarket Notification (510(k)) Submissions for<br>Electrosurgical Devices for General Surgery (March 9, 2020).in particular<br>for Thermal Effect studies on representative tissues for urological<br>Application |
| Overall Conclusions | Comparison between device described in this 510(k) and predicate device<br>shows a substantial equivalence based on :<br>- Same Indications for Use,<br>- Same technological and technical characteristics (Principle of<br>operations)<br>- Results of non-clinical tests<br>Slight differences do not raise any questions regarding safety and effectiveness.<br>Therefore, it can be concluded that device described in this 510(k) is « as Safe<br>and effective as the predicate device. |

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