(144 days)
No
The description focuses on mechanical components (scroll pump, filtration), user-controlled settings (FLOW, RUN TIME, modes), and standard performance testing (electrical safety, EMC, software validation, flow rate, filter life). There is no mention of AI, ML, or any features that would suggest adaptive learning or data-driven decision-making beyond user input.
No.
A therapeutic device is one that treats or prevents a disease or condition. This device removes surgical smoke, which is a supportive function during surgery, not a therapeutic one.
No
The device is described as a smoke evacuator designed to remove smoke created during surgical procedures. There is no indication that it is used to diagnose any medical condition.
No
The device description clearly outlines hardware components like a scroll pump, filtration stages, and a front panel with buttons, indicating it is a physical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "remove smoke created in surgical procedures at the surgical site." This is a physical process happening during a surgical procedure on a patient's body.
- Device Description: The description details a system for evacuating smoke using a pump and filters. This is a mechanical and filtration process, not a diagnostic test performed on a sample in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, urine, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely to manage the surgical environment by removing smoke.
N/A
Intended Use / Indications for Use
The Megadyne Smoke Evacuator with accessories is intended to remove smoke created in surgical procedures at the surgical site.
Product codes (comma separated list FDA assigned to the subject device)
FYD
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Non-clinical testing was conducted to demonstrate that the Megadyne Smoke Evacuator with its accessories functions as intended.
- 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.
- 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.
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
§ 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.
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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
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.
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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 & Predicate
| Device(s): | K200250 | K163659 | |
|---|---|---|---|
| General Device Characteristics | |||
| Indications for Use | The Megadyne Smoke | ||
| Evacuator with accessories is | |||
| intended to remove smoke | |||
| created in surgical procedures | |||
| at the surgical site. | The Crystal Vision Smoke | ||
| Evacuator System with | |||
| Accessories is intended to | |||
| remove smoke created in | |||
| surgical procedures. | |||
| Sterility Method | Non-Sterile | Same | |
| Voltage Input | 100-240V, 50/60 Hz | Same | |
| Maximum Flow Rates | Open Mode: 118 LPM | ||
| Lap Mode: 41 LPM | Open Mode: 90 LPM | ||
| Lap Mode: 18 LPM | |||
| Time Control | Open Mode: Adjustable 3 to 30 | ||
| Seconds Lap Mode: Adjustable | |||
| 2 to 10 seconds | Adjustable from 2 to 35 seconds | ||
| Filter specification | Filter Efficiency of 99.999% at | ||
| 0.1 to 0.2 microns | Same | ||
| Filter life | Lap Mode: 35 hrs | ||
| Open Mode: 26 hrs | Multiple use: Change when | ||
| CHANGE FILTER illuminates | |||
| on front panel (no filter life data) | |||
| Accessories | Tubing1) | ||
| Fluid Trap | |||
| Filter | |||
| Connect Cables | |||
| RF sensor | |||
| NA | Tubing | ||
| The ULPA Filter & Water Trap | |||
| Charcoal Output Filter | |||
| NA2) | |||
| Sensor | |||
| Footswitch | |||
| Materials of | |||
| construction | Powered-Coated Aluminum | ||
| Housing, ABS-PVC Thermal | Powered-Coated Aluminum | ||
| Housing, ABS-PVC Thermal |
5
| (Non-patient contact) | Plastic, Insulation, Glass micro
fiber filter media, granular
activated carbon | Plastic, Insulation, Glass micro
fiber filter media, granular
activated carbon |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Electrical Safety | Tested and compliant with IEC
60601-1 and IEC 60601-1-2 | Same |
| Mechanical Safety | Tested and compliant with IEC
60601-1 and IEC 60601-1-2 | Same |
| Biocompatibility Safety | Non-patient contact | Same |
| Thermal Safety | Operation of device does not
result in harmful temperatures.
Tested and compliant with IEC
60601-1 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 | Acceptance
Criterial | Results |
|-------------------------------------------------|------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|---------|
| 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 |
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.