(30 days)
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.
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
The provided text is a 510(k) summary for the MCB UNIT Model: V10GMCBUS electrosurgical unit. It includes information about the device, its intended use, and the studies conducted to demonstrate substantial equivalence to a predicate device. However, it does not contain the detailed acceptance criteria and a specific study proving the device meets those criteria, as typically found in clinical performance studies.
The document primarily focuses on non-clinical testing and regulatory compliance, not on clinical performance metrics with acceptance criteria.
Therefore, I cannot fulfill all parts of your request based on the provided text. I can, however, extract the relevant non-clinical performance data and what is described regarding the validation studies.
Here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly state numerical acceptance criteria for specific device performance metrics in a format that would allow for a table comparing "acceptance criteria" against "reported device performance" in a clinical context (e.g., sensitivity, specificity, accuracy for an AI device).
Instead, the non-clinical performance data section refers to validation studies based on recognized standards and FDA guidance for electrosurgical devices. The conclusion states that "Slight differences do not raise any questions regarding safety and effectiveness," implying that the device's performance, as evaluated against these standards, demonstrated sufficient safety and effectiveness to be substantially equivalent to the predicate.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The document mentions "Thermal Effect studies on representative tissues for urological Application" in the "Summary of the Non-Clinical performance data" section. However, it does not provide any details regarding:
- The sample size of these "representative tissues."
- The data provenance (e.g., country of origin, retrospective or prospective nature of the tissue samples).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
This information is not provided in the document. The studies mentioned are non-clinical, focusing on the electrosurgical unit's physical characteristics and compliance with electrical safety and usability standards. The concept of "ground truth" established by experts, as it would apply to diagnostic AI devices, does not directly apply here.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided as the studies are non-clinical and do not involve human interpretation of diagnostic data requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This device is an electrosurgical unit, not an AI diagnostic tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study to assess human reader improvement with AI assistance is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This is an electrosurgical hardware device, not an AI algorithm. So, a standalone algorithm performance study is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the non-clinical performance data, the "ground truth" would be established by the physical and electrical safety standards outlined (e.g., IEC 60601-2-2 for Safety of Electrosurgical Generator, IEC 60601-1-2 for EMC). The "Thermal Effect studies on representative tissues" would presumably use objective measurements of tissue effects (e.g., lesion depth, coagulation extent) against expected outcomes based on the device's settings and the predicate device's known performance. However, the specific methodology and objective measures are not detailed.
8. The sample size for the training set:
This device is an electrosurgical unit. There is no mention of a training set as it is not an AI/ML device that requires data for training algorithms.
9. How the ground truth for the training set was established:
As there is no training set for an AI/ML algorithm, this question is not applicable.
Summary of what is present:
- Non-clinical performance data: Validation studies were based on recognized standards (ISO 14971, IEC 62304, IEC 62366-1, IEC 60601-2-2, IEC 60601-1-2) and FDA guidance for electrosurgical devices (March 9, 2020), specifically for "Thermal Effect studies on representative tissues for urological Application."
- Software validation: Based on "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005), with the software considered a "Moderate Level of Concern."
- Usability: Assessed and found to be safe and effective for its intended uses.
- Overall Conclusion: Substantial equivalence to the predicate device (GYRUS ACMI Inc. PK SUPERPULSE SYSTEM GENERATOR MODEL 744000, 510k Number : K100816) based on same Indications for Use, similar technological and technical characteristics, and results of non-clinical tests.
The document primarily demonstrates compliance with regulatory and safety standards, rather than clinical performance against specific acceptance criteria like an AI diagnostic device would.
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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 SASZA des Godets, 3 rue des petits ruisseaux 91370 Verrières le BuissonPhone Number: +33 1 69 20 69 69Email Address: g.noury@lamidey-noury.fr |
|---|---|
| Contact Person | Imane OUIKENEQuality & Regulatory Manageri.ouikene@lamidey-noury.fr |
| 510(k) Summary prepared on | 2022-05-27 |
| Device Name | Trade Name: MCBCommon Name: MCBModel: 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 744000Product Code: GEI/KNS510k Number : K100816 |
| Device description | MCB is a reusable, non-sterile electrosurgical bipolar generator with cutting andcoagulation modes. The maximum output power is 500 W.The front panel GUI (graphical user interface) features soft keys and digitaldisplays for:• the connection status of accessories connected to the electrosurgicalgenerator.• the current settings of the chosen output mode (Cut/ Coag), andpossibility to adjust it• Sound Level adjustment and LEDs (Green for Sound and Yellow/Blue foroutput activation)• Electrode shortcut Alarm resetAt switch on, Serial Number and Software Version are displayed |
| Indications for UseIntended Use | MCB is intended to be used with Plasma Edge System electrodes (K213135) forendoscopic urological surgical procedures.Electrosurgical unit « MCB » is intended for use for the ablation, removal,resection, and coagulation of soft tissue, and where associated hemostasis isrequired in endoscopic urological surgical procedures.The device is intended for use by qualified medical personnel trained in the useof electrosurgical equipment |
| Summary of the technologicalcharacteristics | MCB is an electromedical equipment, driven and controlled by Software whichis able to provide to electrodes:- Clinical Performance: HF electrical power in order to generate thermalenergy which induces- Clinical Benefit: Cutting/Coagulation effect for ablation, removal,resection, and coagulation of soft tissue, and hemostasis. |
| Electrical safety andelectromagnetic compatibilitytesting | 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 SoftwareContained in Medical Devices" (May 11, 2005). The device software isconsidered a "Moderate Level ofConcern". |
| Usability | The MCB unit usability was assessed and found to be safe and effective for itsintended uses, by the intended users, in its intended use environment. |
| Summary of the Clinicalperformance data | No other Clinical data are included in this submission |
| Summary of the Non-Clinicalperformance data | Validation study for this submission are based on this guidance:- FDA Guidance Premarket Notification (510(k)) Submissions forElectrosurgical Devices for General Surgery (March 9, 2020).in particularfor Thermal Effect studies on representative tissues for urologicalApplication |
| Overall Conclusions | Comparison between device described in this 510(k) and predicate deviceshows a substantial equivalence based on :- Same Indications for Use,- Same technological and technical characteristics (Principle ofoperations)- Results of non-clinical testsSlight differences do not raise any questions regarding safety and effectiveness.Therefore, it can be concluded that device described in this 510(k) is « as Safeand effective as the predicate device. |
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§ 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).