The RIA SafeGuard is intended as a room recirculating air cleaner. The system is used for filtering out airborne particles PM2.5 from the air for medical purposes, and is intended for over-the-counter use.

The RIA SafeGuard has wind speed of 1.3 m/s and airflow of 135 CMH (m3/h). Using the HEPA H13 filter, it provides a 4 log (99.99%) reduction in suspended particulate PM2.5 in 120 minutes within a 29.75 m³ room.

Device Description

RIA SafeGuard (SG020MS120) is an air purifier that contains the highefficiency HEPA technology and Bi-Polar Ionization (BPI) unit to remove 99.99% of particles as small as 2.5 microns from the air stream. SafeGuard addresses suspended particles with a single wind speed of 1.3 m/s, providing a 4 log reduction in PM2.5 particulates within 120 minutes in a 29.75 m³ space. The airflow is 135 CMH (m3/h). It is intended to be placed in a room such as medical care institutions and hospitals etc. RIA SafeGuard is a product that is designed as one-touch, easy to use, and no contact with patients. RIA SafeGuard has built in a blue LED as the switch-on indicator. All the maintenance should be done by a trained technician. Changing the HEPA is the only recommended maintenance to do by a non-trained technician, recommended renewing every 12 months.

AI/ML Overview

The provided text describes the mechanical and electrical performance of an air purification device, not an AI/ML-enabled medical device. Therefore, the information typically required for an AI/ML device's acceptance criteria, such as details about ground truth, expert adjudication, MRMC studies, or training set data, is not present in this document.

However, I can extract the acceptance criteria and study details relevant to this specific device based on the provided text.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, according to the document:

1. A table of acceptance criteria and the reported device performance:

Test Name	Purpose	Acceptance Criteria	Reported Performance
Filtration of Particles	Demonstration of Device Air Cleaner Efficacy for 4 Log Reduction of PM2.5 Air Particulates in 120 minutes in a 29.75 m³ room.	Reduction rate > 99.99% (4 log reduction)	Pass
Ozone Emissions UL867	Determine the ozone emissions of the device.	The maximum ozone concentration emitted is below the 0.050 ppm standard.	Pass
Electrical Safety Testing IEC 60601-1:2005, IEC 60601-1:2005+AMD1:2012, IEC 60601-1:2005+AMD1:2012+AMD2:2020	Determine the general requirements for basic safety and essential performance of the device.	Meet the test specification according to the standards.	Pass
Electromagnetic Compatibility (EMC) Testing IEC 60601-1-2:2014	Determine the electromagnetic compatibility, emissions and immunity of the device.	Meet the test specification according to the standards.	Pass

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

Sample Size: The document does not specify a "sample size" in the context of a test set for an AI/ML model. Instead, it refers to a single device (RIA SafeGuard, Model Number: SG020MS120) that underwent non-clinical testing.
Data Provenance: The tests were conducted on the subject device, RIA SafeGuard. The exact location or origin of the testing data is not explicitly stated, but the manufacturer is RIA Tech Co., Ltd. located in Taipei City, Taiwan (R.O.C.). The tests were "non-clinical," implying they were conducted in a laboratory or controlled environment, rather than involving patient data (retrospective or prospective).

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

This information is not applicable to this device's testing. "Ground truth" in the context of an AI/ML model usually refers to labeled data verified by human experts. For a physical device like an air cleaner, the "ground truth" is established through direct physical measurements against predefined engineering and safety standards (e.g., measuring particle reduction with sensors, ozone concentration with detectors). No human experts were involved in establishing the "ground truth" for these physical performance metrics.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable. Adjudication methods are relevant for subjective interpretations of data, typically in AI/ML model validation where multiple experts might disagree on labels. For the physical performance tests conducted, the results are objective measurements that do not require 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 information is not applicable. An MRMC study is relevant for evaluating the impact of an AI/ML system on human performance (e.g., how radiologists improve diagnostic accuracy with AI assistance). The RIA SafeGuard is an air cleaning device, not an AI/ML diagnostic tool, and therefore, an MRMC study was not performed.

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

This information is not applicable. This question pertains to AI/ML algorithm performance. The "Filtration of Particles" test can be considered an analogue to a standalone performance test for the device in that it measures the device's inherent ability to clean air without human interaction determining its efficacy. However, it's not an "algorithm-only" test.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" for this device's performance was established through objective physical measurements against established standards and design specifications.

For "Filtration of Particles": The ground truth was the measured reduction of PM2.5 particulates using scientific instruments.
For "Ozone Emissions": The ground truth was the measured ozone concentration.
For "Electrical Safety" and "Electromagnetic Compatibility": The ground truth was compliance with the specified IEC standards determined through testing.

8. The sample size for the training set:

This information is not applicable. This device is a physical product, not an AI/ML model that undergoes training with a dataset.

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

This information is not applicable, as there is no training set for this type of device.

Summary

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May 1, 2023

RIA Tech Co., Ltd. David Chao President 5f., No. 25-2, Sec. 4, Ren-ai Rd., Da-an Dist. Taipei City, 106073 Taiwan

Re: K222416

Trade/Device Name: RIA Safeguard Regulation Number: 21 CFR 880.5045 Regulation Name: Medical Recirculating Air Cleaner Regulatory Class: Class II Product Code: FRF Dated: March 13, 2023 Received: March 27, 2023

Dear David Chao:

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. You must comply with all the Act's

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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 (OS) 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, Christopher K. Dugard -S for Clarence W. Murray, III, PhD

Assistant Director DHT4B: Division of Infection Control and Plastic 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) K222416

Device Name RIA SafeGuard

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801

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Subpart C)

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510(k) SUMMARY

1. Submitter

RIA Tech Co., Ltd.
Address:	5F., NO. 25-2, SEC. 4, REN-AI RD., DA-AN DIST.,
	TAIPEI CITY 106073, TAIWAN (R.O.C.)
Phone:	+886-2-2521-1220
Fax:	+886-2-8773-1130
Contact:	David Chao, President (david@riatechgroup.com)
Date Prepared:	April 27, 2023

2. Identification of the Device

Proprietary/Trade name:	RIA SafeGuard
Model Number:	SG020MS120
Classification Product Code:	FRF
Regulation Number:	880.5045
Regulation Description:	Medical recirculating air cleaner
Review Panel:	General Hospital
Device Class:	II

3. Identification of the Predicate Device

Predicate Device Name:	HEPAir X100
Manufacturer:	Air Innovations, Inc.
Classification Product Code:	FRF
Regulation number:	880.5045
Device Class:	II
510(k) Number:	K112728

4. Identification of the Reference Device

Predicate Device Name:	Novaerus NV1050
Manufacturer:	Novaerus US Inc.
Classification Product Code:	FRF
Regulation number:	880.5045
Device Class:	II
510(k) Number:	K200321

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5. Device Description

6. Indications for Use

The RIA SafeGuard has wind speed of 1.3 m/s and airflow of 135 CMH (m'/h). Using the HEPA H13 filter, it provides a 4 log (99.99%) reduction in suspended particulate PM2.5 in 120 minutes within a 29.75 m3 room.

7. Comparison of Technological Characteristics with the Predicate Device

The RIA SafeGuard submitted in this 510(k) file is compared with the predicate device (HEPAir X100, K112728) and reference device (Novaerus NV1050, K200321). A technological comparison evaluating the subject, predicate and reference devices are cited as below.

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Item	Subject Device	Predicate Device
Manufacturer	RIA Tech Co., Ltd.	Air Innovations, Inc.	Comparison
Trade Name	RIA SafeGuard	HEPAir X100
510(k) No.	K222416	K112728
Product Code	FRF	FRF	Same
Indications forUse	The RIA SafeGuard isintended as a roomrecirculating air cleaner. Thesystem is used for filtering outairborne particles PM2.5 fromthe air for medical purposes,and is intended forover-the-counter use.The RIA SafeGuard has windspeed of 1.3 m/s and airflowof 135 CMH (m³/h). Using theHEPA H13 filter, it provides a4 log (99.99%) reduction insuspended particulate PM2.5in 120 minutes within a 29.75m³ room.	Filtering out airborneparticulates from airfor medical purposes.HEPAir X100 isintended forover-the-counter use.	Similar
DeviceIllustration	Image: RIA SafeGuard	Image: HEPAir X100	Different
Device Size	42 x 28 x 90 cm	55.9 x 55.9 x 73.7 cm
Device Weight	30 kg (66 lb)	53.5 kg (118 lb)
Type ofDevice	Over the counter use	Over the counter use	Identical
Use Location	Medical Facilities	Medical Facilities

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Item	Subject Device	Predicate Device	Comparison
Manufacturer	RIA Tech Co., Ltd.	Air Innovations, Inc.	Comparison
Trade Name	RIA SafeGuard	HEPAir X100
510(k) No.	K222416	K112728
Filtration ofParticles	4 log reduction in PM2.5 in120 minutes in a 29.75 m3sealed room.	HEPA filter with aminimum efficiencyof 99.97% DOPtested on 0.3 $\mu$ mparticles.	Similar

8. Non-clinical Testing

A series of validation activities were conducted on the subject device, RIA SafeGuard (SG020MS120). All the test results demonstrate RIA SafeGuard meets the requirements of its pre-defined acceptance criteria and indication for use.

Test Name	Purpose	AcceptanceCriteria	Result
Filtration of Particles	Demonstration of Device AirCleaner Efficacy for 4 LogReduction of PM2.5 AirParticulates in 120 minutes in a29.75 m³ room.	Reduction rate> 99.99%(4 log reduction)	Pass
Ozone EmissionsUL867	Determine the ozone emissionsof the device.	The maximumozone concentrationemitted is below the0.050 ppm standard.	Pass
Electrical Safety TestingIEC 60601-1:2005,IEC 60601-1:2005+AMD1:2012,IEC 60601-1:2005+AMD1:2012+AMD2:2020	Determine the generalrequirements for basic safetyand essential performance ofthe device.	Meet the testspecificationaccording to thestandards.	Pass

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Test Name	Purpose	AcceptanceCriteria	Result
ElectromagneticCompatibility (EMC)TestingIEC 60601-1-2:2014	Determine the electromagneticcompatibility, emissions andimmunity of the device.	Meet the testspecificationaccording to thestandards.	Pass

9. Clinical Testing

No clinical test data was used to support the current 510(k) submission.

10. Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(k) submission K222416, the RIA SafeGuard, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K112728 and reference device cleared under K200321.

Regulation Number and Section

§ 880.5045 Medical recirculating air cleaner.

(a)
Identification. A medical recirculating air cleaner is a device used to remove particles from the air for medical purposes. The device may function by electrostatic precipitation or filtration.(b)
Classification. Class II (performance standards).