EvaQMax Smoke Evacuation System

K192035 · Bio Protech, Inc. · FYD · Aug 29, 2019 · General, Plastic Surgery

Device Facts

• Record ID: K192035
• Device Name: EvaQMax Smoke Evacuation System
• Applicant: Bio Protech, Inc.
• Product Code: FYD · General, Plastic Surgery
• Decision Date: Aug 29, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5070
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

To remove and filter smoke and aerosols from a surgical site produced during electrosurgical and laser procedures.

Device Story

The EvaQMax Smoke Evacuation System is a surgical air-handling apparatus designed to remove and filter smoke and aerosols generated during electrosurgical and laser procedures. The device operates by suctioning surgical smoke from the operative site, passing it through a filtration system to remove particulates and aerosols, and exhausting the cleaned air. It is intended for use in surgical operating rooms by healthcare professionals. By effectively clearing the surgical field of smoke and potentially hazardous aerosols, the device improves visibility for the surgeon and reduces exposure to surgical plume for the surgical team.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Air-handling apparatus for surgical operating rooms. Consists of a suction mechanism and filtration system for smoke and aerosol removal. Class II device, Product Code FYD. Operates via standard electrical power. Designed for integration into surgical environments.

Indications for Use

Indicated for the removal and filtration of surgical smoke and aerosols generated during electrosurgical and laser procedures in a clinical setting. Prescription use only.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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August 29, 2019

Bio Protech, Inc. % Prithul Bom Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K192035

Trade/Device Name: EvaQMax Smoke Evacuation System Regulation Number: 21 CFR 878.5070 Regulation Name: Air-handling apparatus for a surgical operating room Regulatory Class: Class II Product Code: FYD Dated: July 26, 2019 Received: July 30, 2019

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.

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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. 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 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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## Indications for Use

510(k) Number (if known) K192035

## Device Name EvaQMax Smoke Evacuation System

Indications for Use (Describe)

To remove and filter smoke and aerosols from a surgical site produced during electrosurgical and laser procedures.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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