The Megadyne Smoke Evacuator is designed to provide smoke evacuation in open and Laparoscopic procedures for the removal of surgical smoke. Using a scroll pump and 4 stages of filtration, the Megadyne Smoke Evacuator is designed to evacuate surgical smoke both quietly and effectively. An intuitive front panel design allows users to customize both the rate of suction FLOW and the length of RUN TIME after the active electrode is deactivated. Push button selections for OPEN, LAP (laparoscopic), and MANUAL modes are also clearly marked and easily accessible. The Megadyne smoke evacuator provides evacuation of smoke plume via a smoke evacuation device and tubing (e.g. E-Z Clear Smoke Evacuation Electrosurgical Pencil under K141587 on February 18, 2015) connected to the face of the Filter.

AI/ML Overview

The Megadyne Smoke Evacuator has undergone non-clinical testing to demonstrate its safety and effectiveness. The acceptance criteria and reported device performance are summarized below:

1. Table of Acceptance Criteria and Reported Device Performance

Title of Test	Purpose of Test	Acceptance Criteria	Reported Device Performance
Electrical Safety Testing	Evaluate Electrical Safety	Fulfill the requirements of IEC 60601-1: 2012 reprint as applicable	Passed
Electromagnetic Compatibility	Evaluate Electromagnetic compatibility	Fulfill the requirements of 60601-1-2 4th edition as applicable	Passed
Software Validation	Evaluate device software	All test cases shall pass or deviations explained as to why it is acceptable	Passed
Flow Rate Testing	Evaluate flow rate against design requirement	The flow rates at each FLOW setting in LAP mode of the MESE1 units are within the defined tolerances.	Passed
Filter life Testing	Evaluate filter life against design requirement	The filter life testing shall be successful if time-based filter requirement is met	Passed
Design Validation	Objective evidence that the subject device meets the needs of the user	There shall be no pattern of use error, close calls or difficulty using the device	Passed
Tissue Effects in Laparoscopic procedures	Tissue effects of unintended high vacuum	Effects on tissue shall be minimal	Passed

2. Sample size used for the test set and the data provenance:

The document provided does not specify the sample sizes used for each individual test set. The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. The tests listed are non-clinical, implying laboratory-based testing rather than patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

For the non-clinical tests described, the concept of "ground truth" established by human experts, as typically seen in AI/ML performance studies for medical image analysis, does not directly apply. The acceptance criteria for these tests are based on established engineering standards (e.g., IEC standards) and design requirements. Therefore, the "ground truth" is defined by these objective measures rather than expert consensus on medical diagnoses.

4. Adjudication method for the test set:

Not applicable in the context of these non-clinical engineering and performance tests. The results are adjudicated against predefined, objective technical criteria.

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:

Not applicable. This is a medical device (smoke evacuator), not a diagnostic AI device that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device described is a physical medical device (smoke evacuator) with embedded software for control and monitoring. The "software validation" test evaluates the performance of this embedded software, which would be considered a standalone assessment of the algorithm's functionality within the device.

7. The type of ground truth used:

Electrical Safety, Electromagnetic Compatibility, Mechanical Safety, Thermal Safety: Ground truth is established by the requirements of international standards (e.g., IEC 60601-1, IEC 60601-1-2).
Software Validation: Ground truth is established by the functional design specifications and expected behavior of the software, with test cases designed to verify these.
Flow Rate Testing, Filter Life Testing: Ground truth is established by internal design requirements and specifications for these performance metrics.
Design Validation: Ground truth involves meeting user needs and avoiding use errors, likely assessed through usability testing and adherence to design specifications.
Tissue Effects in Laparoscopic procedures: Ground truth would be based on scientific and medical understanding of minimal tissue effects during surgical procedures, likely observed and documented in a controlled setting.

8. The sample size for the training set:

Not applicable. This is a physical medical device, and the testing described is not for an AI/ML algorithm that requires a training set in the conventional sense. The "software validation" refers to verifying the embedded software, not training a machine learning model.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for an AI/ML model in this context.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 26, 2020

Megadyne Medical Products, Inc. % Kweku Biney Senior Regulatory Affairs Program Lead Ethicon Endo-Surgery, Inc 4545 Creek Road Cincinnati, Ohio 45242

Re: K200250

Trade/Device Name: Megadyne Smoke Evacuator Regulation Number: 21 CFR 878.5070 Regulation Name: Air-handling apparatus for a surgical operating room Regulatory Class: Class II Product Code: FYD Dated: May 14, 2020 Received: May 18, 2020

Dear Kweku Biney:

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 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 medical devices and radiation-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,

Christopher K. Dugard, M.S. Assistant Director (acting) DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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510(k) Summary -- K200250

Company Megadyne Medical Products, Inc. 11506 South State St. Draper, UT 84020
Contact Kweku Biney Regulatory Affairs Program Lead Ethicon Endo-Surgery, Inc. Telephone: (513) 337-3135 Email: kbiney@its.jnj.com

Date Prepared

June 25, 2020

Device Name

Trade Name: Megadyne Smoke Evacuator Common Name: Smoke Evacuation System

Classification Name

Air-handling apparatus for surgical operating room (21 CFR 878.5070. Product Code FYD)

Regulatory Class

Class II

Predicate Devices

Crystal Vision cleared under K163659 on October 30, 2017

Device Description

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Indications for Use

The Megadyne Smoke Evacuator with accessories is intended to remove smoke created in surgical procedures at the surgical site.

Technological Characteristics

The Megadyne Smoke Evacuator is a microprocessor controlled, smoke evacuation and filtration device. It has push button controls for flow, time and mode. It can be used in open or laparoscopic surgery. It has a replaceable filter to remove smoke particulates. This filter contains a feature to keep track of filter life. An optional accessory fluid trap is available to trap fluids from surgery that can decrease filter function. In addition to the power cord, Megadyne Connect cable is supplied. This cable attaches to an ESU (Electrosurgical Unit) or other advanced energy hardware allowing the Megadyne Smoke Evacuator to activate when the ESU (Electrosurgical Unit) activates. As an alternative method for activation, Megadyne RF sensor is available for use.

Device & PredicateDevice(s):	K200250	K163659
General Device Characteristics
Indications for Use	The Megadyne SmokeEvacuator with accessories isintended to remove smokecreated in surgical proceduresat the surgical site.	The Crystal Vision SmokeEvacuator System withAccessories is intended toremove smoke created insurgical procedures.
Sterility Method	Non-Sterile	Same
Voltage Input	100-240V, 50/60 Hz	Same
Maximum Flow Rates	Open Mode: 118 LPMLap Mode: 41 LPM	Open Mode: 90 LPMLap Mode: 18 LPM
Time Control	Open Mode: Adjustable 3 to 30Seconds Lap Mode: Adjustable2 to 10 seconds	Adjustable from 2 to 35 seconds
Filter specification	Filter Efficiency of 99.999% at0.1 to 0.2 microns	Same
Filter life	Lap Mode: 35 hrsOpen Mode: 26 hrs	Multiple use: Change whenCHANGE FILTER illuminateson front panel (no filter life data)
Accessories	Tubing1)Fluid TrapFilterConnect CablesRF sensorNA	TubingThe ULPA Filter & Water TrapCharcoal Output FilterNA2)SensorFootswitch
	Materials ofconstruction	Powered-Coated AluminumHousing, ABS-PVC Thermal	Powered-Coated AluminumHousing, ABS-PVC Thermal

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(Non-patient contact)	Plastic, Insulation, Glass microfiber filter media, granularactivated carbon	Plastic, Insulation, Glass microfiber filter media, granularactivated carbon
Electrical Safety	Tested and compliant with IEC60601-1 and IEC 60601-1-2	Same
Mechanical Safety	Tested and compliant with IEC60601-1 and IEC 60601-1-2	Same
Biocompatibility Safety	Non-patient contact	Same
Thermal Safety	Operation of device does notresult in harmful temperatures.Tested and compliant with IEC60601-1 and IEC 60601-1-2	Same
Radiation Safety	Non-radioactive	Same

Non-clinical Tests

Non-clinical testing was conducted to demonstrate that the Megadyne Smoke Evacuator with its accessories functions as intended. Below is a summary of testing conducted on the subject device.

Title of Test	Purpose of Test	Acceptance Criterial	Results
Electrical Safety Testing	Evaluate Electrical Safety	Fulfil the requirements of IEC 60601-1: 2012 reprint as applicable	Passed
Electromagnetic Compatibility	Evaluate Electromagnetic compatibility	Fulfil the requirements of 60601-1-2 4th edition as applicable	Passed
Software Validation	Evaluate device software	All test cases shall pass or deviations explained as to why it is acceptable	Passed
Flow Rate Testing	Evaluate flow rate against design requirement	The flow rates at each FLOW setting in LAP mode of the MESE1 units are within the defined tolerances.	Passed

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Title of Test	Purpose of Test	AcceptanceCriterial	Results
Filter life Testing	Evaluate filter lifeagainst designrequirement	The filter lifetesting shall besuccessful if time-based filterrequirement is met	Passed
Design Validation	Objective evidence thatthe subject device meetsthe needs of the user	There shall be nopattern of use error,close calls ordifficulty using thedevice	Passed
Tissue Effects inLaparoscopicprocedures	Tissue effects ofunintended high vacuum	Effects on tissueshall be minimal	Passed

Conclusion

The conclusions drawn from the nonclinical testing of Megadyne Smoke Evacuator demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device.

Regulation Number and Section

§ 878.5070 Air-handling apparatus for a surgical operating room.

(a)
Identification. Air-handling apparatus for a surgical operating room is a device intended to produce a directed, nonturbulent flow of air that has been filtered to remove particulate matter and microorganisms to provide an area free of contaminants to reduce the possibility of infection in the patient.(b)
Classification. Class II (special controls). The device, when it is an air handling bench apparatus, an air handling room apparatus, or an air handling enclosure apparatus, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.