RIA Safeguard

K222416 · Ria Tech Co., Ltd. · FRF · May 1, 2023 · General Hospital

Device Facts

• Record ID: K222416
• Device Name: RIA Safeguard
• Applicant: Ria Tech Co., Ltd.
• Product Code: FRF · General Hospital
• Decision Date: May 1, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5045
• Device Class: Class 2

Indications for Use

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 Story

RIA SafeGuard is a room recirculating air cleaner; utilizes HEPA H13 filtration and Bi-Polar Ionization (BPI) to remove airborne particles. Device draws air at 135 CMH with 1.3 m/s wind speed; captures particles as small as 2.5 microns. Intended for medical care institutions and hospitals; operated via one-touch interface; blue LED indicates power status. Maintenance includes annual HEPA filter replacement by technician. Device provides 4 log reduction of PM2.5 in 120 minutes within 29.75 m³ space; reduces airborne particulate load to support clinical environment air quality.

Clinical Evidence

No clinical data. Bench testing only: filtration efficacy (4 log reduction of PM2.5 in 120 minutes), ozone emissions (UL867, <0.050 ppm), electrical safety (IEC 60601-1), and EMC (IEC 60601-1-2).

Technological Characteristics

Recirculating air cleaner; HEPA H13 filter; Bi-Polar Ionization (BPI) unit. Airflow 135 CMH; wind speed 1.3 m/s. Dimensions 42 x 28 x 90 cm; weight 30 kg. Standards: IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), UL867 (ozone).

Indications for Use

Indicated for filtering airborne PM2.5 particles in medical facilities and hospitals; intended for over-the-counter use.

Regulatory Classification

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.

Predicate Devices

• HEPAir X100 (K112728)

Reference Devices

• Novaerus NV1050 (K200321)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

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

| Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> |
|----------------------------------------------|-------------------------------------|
| Over-The-Counter Use (21 CFR 801 | <input checked="" type="checkbox"/> |

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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: | [phone] |
| Fax: | [phone] |
| Contact: | David Chao, President ([e-mail]) |
| 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

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.

#### 6. Indications for Use

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 (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 for<br>Use | The RIA SafeGuard is<br>intended as a room<br>recirculating air cleaner. The<br>system is used for filtering out<br>airborne particles PM2.5 from<br>the air for medical purposes,<br>and is intended for<br>over-the-counter use.<br>The RIA SafeGuard has wind<br>speed of 1.3 m/s and airflow<br>of 135 CMH (m³/h). Using the<br>HEPA H13 filter, it provides a<br>4 log (99.99%) reduction in<br>suspended particulate PM2.5<br>in 120 minutes within a 29.75<br>m³ room. | Filtering out airborne<br>particulates from air<br>for medical purposes.<br>HEPAir X100 is<br>intended for<br>over-the-counter use. | Similar |
| Device<br>Illustration | 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 of<br>Device | 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 of<br>Particles | 4 log reduction in PM2.5 in<br>120 minutes in a 29.75 m3<br>sealed room. | HEPA filter with a<br>minimum efficiency<br>of 99.97% DOP<br>tested on 0.3 $\mu$ m<br>particles. | 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 | Acceptance<br>Criteria | Result |
|-------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|--------|
| Filtration of Particles | Demonstration of Device Air<br>Cleaner Efficacy for 4 Log<br>Reduction of PM2.5 Air<br>Particulates in 120 minutes in a<br>29.75 m³ room. | Reduction rate<br>> 99.99%<br>(4 log reduction) | Pass |
| Ozone Emissions<br>UL867 | Determine the ozone emissions<br>of the device. | The maximum<br>ozone concentration<br>emitted is below the<br>0.050 ppm standard. | Pass |
| Electrical Safety Testing<br>IEC 60601-1:2005,<br>IEC 60601-1:2005+<br>AMD1:2012,<br>IEC 60601-1:2005+<br>AMD1:2012+AMD2:2020 | Determine the general<br>requirements for basic safety<br>and essential performance of<br>the device. | Meet the test<br>specification<br>according to the<br>standards. | Pass |

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| Test Name | Purpose | Acceptance<br>Criteria | Result |
|-------------------------------------------------------------------------|------------------------------------------------------------------------------------------|------------------------------------------------------------------|--------|
| Electromagnetic<br>Compatibility (EMC)<br>Testing<br>IEC 60601-1-2:2014 | Determine the electromagnetic<br>compatibility, emissions and<br>immunity of the device. | Meet the test<br>specification<br>according to the<br>standards. | 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.