(264 days)
No
The description focuses on standard air filtration technologies (HEPA, Bi-Polar Ionization) and performance metrics related to particle reduction and safety. There is no mention of AI, ML, or any adaptive or learning capabilities.
Yes
The device is intended for filtering airborne particles from the air for "medical purposes" and is designed to create a safer environment, which aligns with the definition of a therapeutic device.
No
The device is an air cleaner designed to filter out airborne particles. It does not perform any diagnostic function.
No
The device description clearly indicates it is a physical air purifier containing HEPA technology and a Bi-Polar Ionization unit, which are hardware components. The performance studies also focus on the efficacy of this physical device.
Based on the provided information, the RIA SafeGuard is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is clearly stated as a "room recirculating air cleaner" for "filtering out airborne particles PM2.5 from the air for medical purposes." This describes a device that acts on the environment (the air) rather than on biological specimens (like blood, urine, or tissue) to provide diagnostic information.
- Device Description: The description focuses on the physical mechanism of air purification (HEPA filtration, Bi-Polar Ionization) and its performance in reducing airborne particles. It does not mention any interaction with biological samples or the generation of diagnostic results.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The RIA SafeGuard does not perform any such function.
- Performance Studies: The performance studies described focus on the device's ability to filter air, its ozone emissions, and its electrical and electromagnetic safety. These are relevant to an air purification device, not an IVD.
In summary, the RIA SafeGuard is an air purification device intended for use in medical settings to improve air quality by removing airborne particles. It does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FRF
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.
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
RIA SafeGuard is intended to be placed in a room such as medical care institutions and hospitals etc.
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:
- Filtration of Particles:
- Purpose: Demonstration of Device Air Cleaner Efficacy for 4 Log Reduction of PM2.5 Air Particulates in 120 minutes in a 29.75 m³ room.
- Acceptance Criteria: Reduction rate > 99.99% (4 log reduction)
- Result: Pass
- Ozone Emissions UL867:
- Purpose: Determine the ozone emissions of the device.
- Acceptance Criteria: The maximum ozone concentration emitted is below the 0.050 ppm standard.
- Result: Pass
- Electrical Safety Testing IEC 60601-1:2005, IEC 60601-1:2005+AMD1:2012, IEC 60601-1:2005+AMD1:2012+AMD2:2020:
- Purpose: Determine the general requirements for basic safety and essential performance of the device.
- Acceptance Criteria: Meet the test specification according to the standards.
- Result: Pass
- Electromagnetic Compatibility (EMC) Testing IEC 60601-1-2:2014:
- Purpose: Determine the electromagnetic compatibility, emissions and immunity of the device.
- Acceptance Criteria: Meet the test specification according to the standards.
- Result: Pass
Clinical Testing:
No clinical test data was used to support the current 510(k) submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Reduction rate > 99.99% (4 log reduction) for PM2.5 particulates.
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
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
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) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 |
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Subpart C)
3
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 |
4
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.
5
| 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 | |||
| 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. | Filtering out airborne | ||
| particulates from air | |||
| for medical purposes. | |||
| HEPAir X100 is | |||
| intended for | |||
| over-the-counter use. | Similar | ||
| Device | |||
| 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 | |||
| Device | Over the counter use | Over the counter use | Identical |
| Use Location | Medical Facilities | Medical Facilities |
6
| 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 | |||
| Particles | 4 log reduction in PM2.5 in | ||
| 120 minutes in a 29.75 m3 | |||
| sealed room. | HEPA filter with a | ||
| minimum efficiency | |||
| of 99.97% DOP | |||
| tested on 0.3 $\mu$ m | |||
| 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
Criteria | Result |
|-------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|--------|
| 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 |
7
| Test Name | Purpose | Acceptance
Criteria | Result |
|-------------------------------------------------------------------------|------------------------------------------------------------------------------------------|------------------------------------------------------------------|--------|
| 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 |
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.