(130 days)
Not Found
No
The device description mentions a "microprocessor controlled supervisory system" that controls basic functions like temperature, fan speed, and timers. This is standard embedded system control, not AI/ML. There are no mentions of AI, DNN, or ML in the provided text.
No.
The device is described as a "Mobile Air Cleaner intended to be used to remove particles from the air for medical purposes." While it is designed to mitigate environmental factors that may contribute to medical conditions (allergies), it does not directly treat a disease or condition in the body.
No
Explanation: The device is an air cleaner that removes particles from the air, which is a therapeutic function, not a diagnostic one. It doesn't analyze a patient's condition or provide diagnostic information.
No
The device description clearly outlines physical components such as filters, blowers (fans), cooler/heater units, air guidance arms, and circuit boards, indicating it is a hardware device with embedded software control.
Based on the provided information, the Airsonett AIR-4 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The Airsonett AIR-4's intended use is to remove particles from the air for medical purposes, specifically to reduce inhalant allergens in the breathing zone. It does not analyze any biological samples from a patient.
- The device description focuses on air filtration and temperature control. The mechanism of action involves filtering air and creating a localized clean air zone, not performing diagnostic tests on bodily fluids or tissues.
- The performance studies and key metrics relate to air quality and device function. The metrics provided are about filtration efficiency, temperature difference, airflow, air changes, and sound level, all of which are related to the device's ability to clean and manage air, not to diagnose a medical condition.
Therefore, the Airsonett AIR-4 is a medical device, but it falls under a different category than In Vitro Diagnostics. It is an air cleaner intended for therapeutic or preventative purposes related to respiratory health by reducing exposure to airborne allergens.
N/A
Intended Use / Indications for Use
The Airsonett AIR-4 is a Mobile Air Cleaner intended to be used to remove particles from the air for medical purposes. The device is intended for home use only.
Product codes (comma separated list FDA assigned to the subject device)
FRF
Device Description
Airsonett is based on the Temperature controlled Laminar Airflow (TLA) technology. The air from the room enters the Airsonett and passes a filter that captures allergens and other particles. The filtered air is cooled to slightly below the ambient room temperature and is supplied with a low velocity from the air supply nozzle. Since the filtered air is slightly cooler, and therefore heavier than the surrounding air, the filtered air will descend slowly from the air supply nozzle by means of gravity in a laminar manner (non-turbulent). This descending colder air counteracts the body convection, displaces the allergen load in the breathing zone and thus dramatically reduces the level of inhalant allergens for the patient all through the night.
Air is drawn in through the air intake at the floor level and through the HEPA filter. A silent Blower (fan) brings airflow through the filter. The air is directed through the Cooler/Heater and divided into a cool respectively warm air flow. The cool air flow is directed through the Air guidance arm (neck) and out through the Airshower (Air Supply Nozzle). The Airshower can be altered in height, by adding/removing and combining the neck parts, to adapt to different types of environments. The warm air flow is directed to the Warm air outlet. On its way to the outlet the air flow passes the electronics and transports away the extra heat produced by the electronics.
Airsonett is based on a microprocessor controlled supervisory system. This system controls the device behaviour by measuring temperatures, controlling thermoelectric modules and fan unit, monitoring user interaction as well as management of internal timers to keep track of the total ontime for the system and time since last filter change. The control functions (Front Panel Board) and power distribution function (Power Electronics Board) are allocated on two separate circuit boards.
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
home use only.
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)
Study endpoint: Air quality in treated air envelope (clean zone)
Description of Test: Efficiency test results of filter.
Acceptance criteria: Filter Filtration efficiency ≥99.5% of particles with size Ø≥0.5µm
Conclusion: Conforms with filtration efficiency ≥99.5%.
Study endpoint: Air quality in treated air envelope (clean zone)
Description of Test: Particle cleanliness of clean zone of Airsonett AIR-4. Test method: Laser counter of particles Ø≥0.5µm/ft³ air flow over 1 minute.
Acceptance criteria: Clean zone Filtration efficiency ≥99.5% of particles with size Ø≥0.5µm which is equivalent to -Class 1000 according to FED STD 209E and - Class 6 according to ISO 14644-1 in environments of
§ 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
Airsonett
AIRSONETT AB, Metallgatan, SE-262 72 Ängelholm, Sweden
510(k) SUMMARY
Submitter: Airsonett AB Metallgatan SE-262 72 Angelholm Sweden +46 431 402470
JUL 2 3 2013
Contact Information: Constance G. Bundy C. G. Bundy Associates, Inc. 435 Rice Creek Terrace NE Fridley, MN 55432 USA 763-574-1976 Fax: 763-571-2437 cgbundy@live.com
Submission Date: March 15, 2013
Device Name and Classification: Airsonett, version AIR-4, Class II 21 CFR 880.5045 Product Code: FRF
Equivalent Device Identification: Airsonett Airshower Air-3, K081062, BREATHE EASY (Models AD and CD) by RespirAid Ltd (K981841)
--
Device Description:
Airsonett is based on the Temperature controlled Laminar Airflow (TLA) technology. The air from the room enters the Airsonett and passes a filter that captures allergens and other particles. The filtered air is cooled to slightly below the ambient room temperature and is supplied with a low velocity from the air supply nozzle. Since the filtered air is slightly cooler, and therefore heavier than the surrounding air, the filtered air will descend slowly from the air supply nozzle by means of gravity in a laminar manner (non-turbulent). This descending colder air counteracts the body convection, displaces the allergen load in the breathing zone and thus dramatically reduces the level of inhalant allergens for the patient all through the night.
Air is drawn in through the air intake at the floor level and through the HEPA filter. A silent Blower (fan) brings airflow through the filter. The air is directed through the Cooler/Heater and divided into a cool respectively warm air flow. The cool air flow is directed through the Air guidance arm (neck) and out through the Airshower (Air Supply Nozzle). The Airshower can be altered in height, by adding/removing and combining the neck parts, to adapt to different types of environments. The warm air flow is directed to the Warm air outlet. On its way to the outlet the air flow passes the electronics and transports away the extra heat produced by the electronics.
1
Airsonett AIRSONETT AB, Metallgatan, SE-262 72 Ängelholm, Sweden
Airsonett is based on a microprocessor controlled supervisory system. This system controls the device behaviour by measuring temperatures, controlling thermoelectric modules and fan unit, monitoring user interaction as well as management of internal timers to keep track of the total ontime for the system and time since last filter change. The control functions (Front Panel Board) and power distribution function (Power Electronics Board) are allocated on two separate circuit boards,
Intended Use: The Airsonett AIR-4 is a Mobile Air Cleaner intended to be used to remove particles from the air for medical purposes. The device is intended for home use only.
| Element of
| Comparison | Subject Device | Claimed SE Device |
|---|---|---|
| Product | Airsonett AIR-4 | Airsonett Airshower Air-3, |
| (510(k) Number K081062) | ||
| Manufacturer | Airsonett AB | Airsonett AB |
| Type of Medical | ||
| Re-circulating | ||
| Air Cleaner | Mobile Air Filtration system | Mobile Air Filtration system |
| Intended use | The Airsonett AIR-4 is a Mobile | |
| Air Cleaner intended to be used to | ||
| remove particles from the air for | ||
| medical purposes. The device is | ||
| intended for home use only. | The Airsonett Airshower Air 3 is a | |
| Mobile Air Cleaner intended to be | ||
| used to remove particles from the air | ||
| for medical purposes. The device is | ||
| intended for home use only. | ||
| Type of device | Over the counter use | Over the counter use |
| Labeling | Airsonett AIR-4 | Airsonett Airshower Air-3 |
| Product | ||
| Description | Housing Unit | Housing Unit |
| Air Inlet and Treated Air Outlet | Air Inlet and Treated Air Outlet | |
| Blower | Blower | |
| HEPA filter | HEPA filter | |
| Air Warming Unit | Air Warming Unit | |
| Air Cooling Unit | Air Cooling Unit | |
| Adjustable Air Guidance Arm | Adjustable Air Guidance Arm | |
| Control Panel | Control Panel |
Comparison Table:
2
| Airsonett | AIRSONETT AB, Metallgatan, SE-262 72 Ängelholm, Sweden | |
|---|---|---|
| Element of | ||
| Comparison | Subject Device | Claimed SE Device |
| Airsonett Airshower makes use of | ||
| the Airshower characteristics and | ||
| cools the air outflow; thereby using | ||
| thermal stratification for guiding | ||
| the air to a patient's breathing zone. | Airsonett Airshower makes use of the | |
| Airshower characteristics and cools | ||
| the air outflow; thereby using thermal | ||
| stratification for guiding the air to a | ||
| patient's breathing zone. | ||
| Power | ||
| Requirements | 115-230V~(60-50Hz), 1.7-1.0A | 115 V-230V~(60-50Hz), 1.7-1.0 A |
| Standard | IEC 60601-1 | IEC 60601-1 |
| Air Flow | Airflow in clean air zone (cool side): | |
| At least 120 m³/h | ||
| Airflow warm side: Approx. 80 m³/h | ||
| Total airflow: Approx. 200 m³/h | Airflow in clean air zone (cool side): | |
| Approx. 150 m³/h | ||
| Airflow warm side: Approx. 80 m³/h | ||
| Total airflow: Approx. 230 m³/h | ||
| Air Quality | ||
| in treated air | ||
| envelope | ||
| (referred as clean | ||
| zone in Appendix | ||
| 1.2) | Filtration efficiency 99.5% of | |
| particles Ø ≥0.5µm | ||
| which is equivalent to | ||
| -Class 1000 according to FED STD | ||
| 209E and | ||
| -Class 6 according to ISO 14644-1 | ||
| in environments of |