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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Airsonett device, based on the provided text:

Acceptance Criteria and Device Performance

Study Endpoint	Acceptance Criteria	Reported Device Performance
Air quality in treated air envelope (clean zone)	Filter Filtration efficiency ≥99.5% of particles with size Ø≥0.5µm	Conforms with filtration efficiency ≥99.5%.
Air quality in treated air envelope (clean zone)	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 <200 000particles/ft³.	Conforms with filtration efficiency ≥99.5%. ⇒ Class 1000 according to FED STD 209E and Class 6 according to ISO 14644-1 in environments of ≤200 000particles/ft³. AIR-4 is equivalent or better than previous version AIR-3, with regard to Air quality in treated air envelope (clean zone).
Air quality in treated air envelope (clean zone)	Stability of the clean zone shall be preserved. Filter efficiency shall be preserved.	The stability of the clean zone is preserved and the filter does not deteriorate on efficiency over a normal working life.
Temperature difference between supply air and ambient air	Temperature difference between supply air and ambient air: ≥0.75°C (1.35 degrees F).	Conforms with temperature difference between supply air and ambient air: ≥0.75°C (1.35 degrees F).

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state a sample size for the test set. The performance tests appear to be conducted on the device itself, rather than using patient data. For example, "Efficiency test results of filter" and "Particle cleanliness of clean zone of Airsonett AIR-4."
- Data Provenance: Not applicable as the tests are on device performance, not patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The ground truth for the device's technical performance is established by standardized measurement methods (e.g., laser counters for particles, temperature sensors for temperature difference) and engineering specifications, rather than expert consensus on medical images or diagnoses.
Adjudication method for the test set:
- Not applicable. The tests are objective measurements of the device's physical and mechanical performance characteristics against predefined standards, not subjective interpretations requiring adjudication.
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:
- No MRMC study was done. This device is a "Mobile Air Cleaner" and does not involve AI or human readers for diagnostic interpretation. Its function is to physically clean air.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- A standalone performance assessment of the device (without human intervention in its function) was done, as evidenced by the "Performance Tests" section. The device's filtration efficiency and temperature control were measured directly.
The type of ground truth used:
- Objective Measurement/Engineering Standards: The ground truth for the Airsonett device's performance is based on objective measurements against established engineering and environmental control standards (e.g., particle counts, temperature differential) and filtration efficiency as defined by industry norms (e.g., FED STD 209E, ISO 14644-1).
The sample size for the training set:
- Not applicable. This device is an air cleaner, not an AI/machine learning algorithm, so there is no concept of a "training set" in the context of these performance tests.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.

Summary

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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:

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Airsonett AIRSONETT AB, Metallgatan, SE-262 72 Ängelholm, Sweden

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 ofComparison	Subject Device	Claimed SE Device
Product	Airsonett AIR-4	Airsonett Airshower Air-3,(510(k) Number K081062)
Manufacturer	Airsonett AB	Airsonett AB
Type of MedicalRe-circulatingAir Cleaner	Mobile Air Filtration system	Mobile Air Filtration system
Intended use	The Airsonett AIR-4 is a MobileAir Cleaner intended to be used toremove particles from the air formedical purposes. The device isintended for home use only.	The Airsonett Airshower Air 3 is aMobile Air Cleaner intended to beused to remove particles from the airfor medical purposes. The device isintended for home use only.
Type of device	Over the counter use	Over the counter use
Labeling	Airsonett AIR-4	Airsonett Airshower Air-3
ProductDescription	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:

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Airsonett	AIRSONETT AB, Metallgatan, SE-262 72 Ängelholm, Sweden
Element ofComparison	Subject Device	Claimed SE Device
	Airsonett Airshower makes use ofthe Airshower characteristics andcools the air outflow; thereby usingthermal stratification for guidingthe air to a patient's breathing zone.	Airsonett Airshower makes use of theAirshower characteristics and coolsthe air outflow; thereby using thermalstratification for guiding the air to apatient's breathing zone.
PowerRequirements	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/hAirflow warm side: Approx. 80 m³/hTotal airflow: Approx. 200 m³/h	Airflow in clean air zone (cool side):Approx. 150 m³/hAirflow warm side: Approx. 80 m³/hTotal airflow: Approx. 230 m³/h
Air Qualityin treated airenvelope(referred as cleanzone in Appendix1.2)	Filtration efficiency 99.5% ofparticles Ø ≥0.5µmwhich is equivalent to-Class 1000 according to FED STD209E and-Class 6 according to ISO 14644-1in environments of<200 000particles/ft³	Class 100-1000 according to FEDSTD 209E
Rate of AirChanged	At least 435 changes per hour	~1500 changes per hour
Sound Level	<38 dB(A)	~38 dB(A)

Element ofComparison	Subject Device	Claimed SE Device	Previous 510(k)SE DeviceforAirsonett AirshowerAir-3
Manufacturer	Airsonett AB	Airsonett AB	RespirAid Ltd.
Air Flow	Airflow in clean air zone(cool side):At least 120 m³/hAirflow warm side:Approx. 80 m³/hTotal airflow:Approx. 200 m³/h	Airflow in clean air zone(cool side):Approx. 150 m³/hAirflow warm side:Approx. 80 m³/hTotal airflow:Approx. 230 m³/h	20-40 m³/h
Rate of AirChanged	At least 435 changesper hour	~1500 changes per hour	400-600 changes perhour

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Airsonett

Summary of Testing:

Listing of standards applied

IEC 60601-1, Second edition, 1988 with Amendment 1, 1991 and Amendment 2, . 1995, Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2, Third edition, 2007, Medical Electrical Equipment Part 1-2: . General Requirements for basic safety and essential performance; Electromagnetic Compatibility - Requirements and tests.

Performance Tests

Studyendpoint	Description of Test	Acceptancecriteria	Conclusion
Air quality intreated airenvelope(clean zone)	Efficiency test results of filter.	Filter Filtrationefficiency ≥99.5% ofparticles with sizeØ≥0.5µm	Conforms with filtrationefficiency ≥99.5%.
Air quality intreated airenvelope(clean zone)	Particle cleanliness of cleanzone of Airsonett AIR-4.Test method: Laser counter ofparticles Ø≥0.5µm/ft³ air flowover 1 minute.	Clean zone Filtrationefficiency ≥99.5% ofparticles with sizeØ≥0.5µmwhich is equivalent to-Class 1000 accordingto FED STD 209E and- Class 6 according toISO 14644-1in environments of<200 000particles/ft³.	Conforms with filtrationefficiency ≥99.5%.⇒Class 1000 accordingto FED STD 209E andClass 6 according to ISO14644-1 in environmentsof ≤200 000particles/ft³.AIR-4 is equivalent orbetter than previousversion AIR-3, with regardto Air quality in treated airenvelope (clean zone).
	Particle cleanliness of cleanzone of Airsonett AIR-4.	Stability of the cleanzone shall bepreserved. Filterefficiency shall bepreserved.	The stability of the cleanzone is preserved and thefilter does notdeteriorate on efficiencyover a normal working life.
Temperaturedifferencebetweensupply air andambient air	The cooler/heater unit has beenindividually tested againsttemperature sensors to calibrateand verify the temperaturedifference between supply airand ambient air.	Temperature differencebetween supply air andambient air: ≥0.75°C(1.35 degrees F).	Conforms withtemperature differencebetween supply air andambient air: ≥0.75°C (1.35degrees F).

Conclusion: Airsonett AIR-4 is substantially equivalent to Airsonett Air-3 and Breathe Easy regarding technology, intended use and performance.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the circumference.

July 23, 2013

Public Health Service

Food and Drug Administration 10903 New Hamosbire Avenue Document Control Center ~ WO66-G609 Silver Spring, MID-20993-0002

Airsonett, AB C/O Ms. Constance G. Bundy C.G. Bundy Associates, Incorporated 435 Rice Creek Terrace, North East FRIDLEY MN 55432

Re: K130702

Trade/Device Name: Airsonett. Version AIR-4 Regulation Number: 21 CFR 880.5045 Regulation Name: Medical Recirculating Air Cleaner Regulatory Class: II Product Code: FRF Dated: July 1, 2013 Received: July 2, 2013

Dear Ms. Bundy:

We have reviewed vour 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. 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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Page 2 - Ms. Bundy

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.
Clinical Deputy Director
DAGRID

FOR

Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Airsonett

AIRSONETT AB, Metallgatan. SE-262 72 Ängelholm, Sweden

INDICATIONS FOR USE

510(k) Number (if known):

Device Name: Airsonett, version AIR-4

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.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

X_____________________________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth F. Claverie	Page 1 of ___
2013.07.23 14:26:39 -04'00'
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number:	K130702
	4(28)

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).