The Surclear 8010 have been designed with a high suction, high flow rate vacuum motor. The ultra-quiet motor is used to draw the surgical smoke from the surgical site through the vacuum tubing and into the Surclear 8010 filter 8QF1 where the surgical smoke is processed by a series of filters. A single disposable filter is used to simplify the installation and removal during filter changes. The filter is completely enclosed to protect the healthcare personnel from potential contamination during filter changes. One 8QF1 filter contains four different stages within to capture the smoke plume.

AI/ML Overview

The provided text describes the acceptance criteria and the results of non-clinical tests for the 8Q10 Surclear Smoke Plume Evacuation System. It does not contain information about a study proving the device meets the acceptance criteria in the context of an AI/human-in-the-loop performance evaluation, which is typically found in submissions for AI-powered devices.

The information provided pertains to the safety and functional performance of a medical device (a smoke plume evacuation system), not an AI/software as a medical device (SaMD). Therefore, many of the requested criteria (like sample size for test set, data provenance, number of experts, MRMC studies, etc.) are not applicable or not provided in this document.

However, I can extract and present the information that is available:

Acceptance Criteria and Reported Device Performance for the 8Q10 Surclear Smoke Plume Evacuation System

This document describes the non-clinical testing conducted to demonstrate the safety and functionality of the 8Q10 Surclear Smoke Plume Evacuation System.

1. Table of Acceptance Criteria and Reported Device Performance

Title of Test	Purpose of Test	Acceptance Criteria	Results
Electrical Safety Testing	Evaluate Electrical Safety	Fulfil the requirement of IEC 60601-1:2012+2020 as applicable	Passed
Electromagnetic Compatibility	Evaluate Electromagnetic Compatibility	Fulfil the requirements of IEC 60601-1-2:2014+2020 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 mode are within the defined tolerances.	Passed
Plume Evacuation Evaluate	Evaluate System for evacuation of plume generated by medical devices	Fulfil the requirements of ISO 16571:2014 as applicable	Passed

Further Technological Characteristics and Comparison to Predicate Device:

Characteristic	Subject Device (K233789)	Predicate Device (K131402)	Discussion
Indications for Use	Remove smoke created in surgical procedures at the surgical site.	Remove and filter smoke and aerosols from a surgical site produced during electrosurgical and laser procedures.	Similar
Static Motor Suction	25.69 kPa	25.69 kPa	Same
Flow rates (Max)	25 cfm (707 lpm) @7/8(22mm) tubing	30 cfm (839 lpm) @7/8(22mm) tubing	Similar, (cfm) 25vs30 is due to different manufacturers' understanding of the maximum flow limit required in actual applications.
Suction control level	10 Level	10 Level	There are 10 control levels of suction rate from 10% to 100%.
Suction blockage warning	Yes	Yes	An occlusion warning safety feature alerts the operator when an occlusion has occurred.
Foot control	Yes	Yes	The operator can foot-control the suction of the device to turn on or off.
Filter life indication	Yes	Yes	Counter indicates filter status and lifetime.
Filter performance	99.99% efficiency at 0.1-to-0.2-micron particle size with a filter life of up to 40 hours.	99.99% efficiency at 0.1-to-0.2-micron particle size with a filter life of up to 35 hours.	Same filter efficiency, larger filters can increase application time from 35 to 40 hrs.
Power Supply	100-120VAC, 50/60Hz, 9A max; 220-240VAC, 50/60Hz, 4.5A max	100/240VAC, 50/60Hz; 220/240 VAC	Same

Information Not Found in the Provided Text:

The following specific requested information is not available in the given document, as it pertains to AI/SaMD performance studies, which is not the subject of this 510(k) submission:

Sample size used for the test set and the data provenance: Not applicable/not provided for a hardware device's functional testing. The tests are against specific engineering and safety standards.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a smoke evacuator's performance is based on physical measurements and compliance with engineering standards.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: For this device, ground truth is based on established international (IEC, ISO) and industry standards for electrical safety, electromagnetic compatibility, software validation, flow rates, and plume evacuation.
The sample size for the training set: Not applicable (not an AI/ML device).
How the ground truth for the training set was established: Not applicable (not an AI/ML device).

Summary

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April 10, 2024

Surnic Corporation Helen Xie Project Director 480 Apollo Street, Ste. D Brea, California 92821

Re: K233789

Trade/Device Name: 8Q10 Surclear Smoke Plume 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: March 11, 2024 Received: March 11, 2024

Dear Helen Xie:

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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).

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Sincerely,

Stephen A. Digitally signed by
Stephen A. stephen A. Anisko -S Anisko -S - S - 10:49:42 -04'00' For:

Christopher Dugard Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control 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) K233789

Device Name

8010 Surclear Smoke Plume Evacuation System

Indications for Use (Describe)

The Surnic Surclear Smoke Plume Evacuation System with accessories is intended to remove smoke created in surgical procedures at the surgical site.

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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510(k) Summary - K233789

Company Surnic Corporation 480 Apollo Street Ste. D Brea, CA 92821 USA
Helen Xie Contact Telephone: (909) 979-9801 Email: helen@surnic.com

1.0 Date Prepared

April 1, 2024

2.0 Device Name

Trade Name: 8Q10 Surclear Smoke Plume Evacuation System Model: 8010 Common Name: Smoke Evacuator

3.0 Classification Name

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

Regulatory Class

Class II

4.0 Predicate Device

The predicate device (K131402) is Visiclear Smoke Evacuation System by Buffalo Filter Co, Inc.

5.0 Device Description

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6.0 Indications for Use

The Surnic Surclear smoke plume evacuation system with accessories is intended to remove smoke created in surgical procedures at the surgical site.

7.0 Technological Characteristics

Device	K233789	K131402	Discussion
	Subject	Predicate
Indications forUse	The Surnic SurclearSmoke Plume EvacuationSystem with accessories isintended to remove smokecreated in surgicalprocedures at the surgicalsite.	The visiclear smokeevacuation system isdesigned to remove andfilter smoke and aerosolsfrom a surgical siteproduced duringelectrosurgical and laserprocedures	Similar
Static MotorSuction	25.69 kPa	25.69 kPa	Same
Flow rates(Max)	25 cfm (707lpm)@7/8(22mm) tubing	30 cfm (839lpm)@7/8(22mm) tubing	Similar, (cfm) 25vs30 is due todifferent manufacturers'understanding of the maximumflow limit required in actualapplications.
Suctioncontrol level	10 Level	10 Level	There are 10 control levels ofsuction rate from 10% to100%.
Suctionblockagewarning	Yes	Yes	An occlusion warning safetyfeature alerts the operatorwhen an occlusion hasoccurred.
Foot control	Yes	Yes	The operator can foot-controlthe suction of the device toturn on or off.
Filter lifeindication	Yes	Yes	Counter indicates filter statusand lifetime.
Filterperformance	The filter is 99.99%efficiency at0.1-to-0.2-micronparticle size with afilter life of up to 40hours.	The filter is 99.99%efficiency at0.1-to-0.2-micronparticle size with afilter life of up to 35hours.	Same filter efficiency, largerfilters can increase applicationtime from 35 to 40 hrs.
PowerSupply	100-120VAC, 50/60Hz9A max220-240VAC, 50/60Hz4.5A max	100/240VAC, 50/60Hz220/240 VAC	Same

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Non-clinical Tests 8.0

Non-clinical testing was conducted to demonstrate that the Surclear Smoke Plume Evacuation System with its accessories functions as intended. Below is a summary of testing conducted on the subject device:

Title of Test	Purpose of Test	Acceptance Criteria	Results
Electrical SafetyTesting	Evaluate ElectricalSafety	Fulfil the requirement of IEC60601-1:2012+2020 asapplicable	Passed
ElectromagneticCompatibility	EvaluateElectromagneticCompatibility	Fulfil the requirements ofIEC 60601-1-2:2014+2020as applicable	Passed
Software Validation	Evaluate DeviceSoftware	All test cases shall pass ordeviations explained as towhy it is acceptable	Passed
Flow Rate Testing	Evaluate flow rateagainst designrequirement	The flow rates at each flowmode are within the definedtolerances.	Passed
Plume EvacuationEvaluate	Evaluate System forevacuation of plumegenerated by medicaldevices	Fulfil the requirements ofISO 16571:2014 asapplicable	Passed

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9.0 Conclusions

The conclusions drawn from the non-clinical testing of Surclear Smoke Plume Evacuation System demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device (K131402).

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.