AIRSONETT AIR-4

K130702 · Airsonett AB · FRF · Jul 23, 2013 · General Hospital

Device Facts

• Record ID: K130702
• Device Name: AIRSONETT AIR-4
• Applicant: Airsonett AB
• Product Code: FRF · General Hospital
• Decision Date: Jul 23, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5045
• Device Class: Class 2

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.

Device Story

Airsonett AIR-4 is a mobile air filtration system using Temperature controlled Laminar Airflow (TLA) technology. Device draws ambient room air through a HEPA filter via a blower; filtered air is cooled slightly below ambient temperature. Cooled air, being denser, descends via gravity in a non-turbulent laminar stream from an adjustable nozzle, displacing allergens in the patient's breathing zone during sleep. Warm air byproduct is exhausted separately to manage internal heat. System is microprocessor-controlled, monitoring temperatures, thermoelectric modules, and fan performance. Intended for home use by patients to reduce inhalant allergen exposure. Healthcare providers use the device to support allergen management; output is a localized clean air zone. Benefits include reduced nocturnal allergen load.

Clinical Evidence

Bench testing only. Testing verified filtration efficiency (≥99.5% for particles ≥0.5µm), clean zone stability, and temperature differential (≥0.75°C) between supply and ambient air. Performance confirmed compliance with Class 1000 (FED STD 209E) and Class 6 (ISO 14644-1) standards.

Technological Characteristics

Mobile air cleaner; HEPA filtration; thermoelectric cooling/heating; adjustable air guidance arm. Microprocessor-controlled system; sensors for temperature monitoring. Power: 115-230V (50-60Hz). Standards: IEC 60601-1, IEC 60601-1-2. Airflow: ≥120 m³/h (cool side), ~80 m³/h (warm side).

Indications for Use

Indicated for home use as a mobile air cleaner to remove airborne particles for medical purposes.

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

• Airsonett Airshower Air-3 (K081062)
• BREATHE EASY (Models AD and CD) by RespirAid Ltd (K981841)

Submission Summary (Full Text)

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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 [phone]

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: [phone] [e-mail]

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)

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#### 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.

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### 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<br>Comparison | Subject Device | Claimed SE Device |
|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product | Airsonett AIR-4 | Airsonett Airshower Air-3,<br>(510(k) Number K081062) |
| Manufacturer | Airsonett AB | Airsonett AB |
| Type of Medical<br>Re-circulating<br>Air Cleaner | Mobile Air Filtration system | Mobile Air Filtration system |
| Intended use | The Airsonett AIR-4 is a Mobile<br>Air Cleaner intended to be used to<br>remove particles from the air for<br>medical purposes. The device is<br>intended for home use only. | The Airsonett Airshower Air 3 is a<br>Mobile Air Cleaner intended to be<br>used to remove particles from the air<br>for medical purposes. The device is<br>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<br>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:

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| Airsonett | AIRSONETT AB, Metallgatan, SE-262 72 Ängelholm, Sweden | |
|---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Element of<br>Comparison | Subject Device | Claimed SE Device |
| | Airsonett Airshower makes use of<br>the Airshower characteristics and<br>cools the air outflow; thereby using<br>thermal stratification for guiding<br>the air to a patient's breathing zone. | Airsonett Airshower makes use of the<br>Airshower characteristics and cools<br>the air outflow; thereby using thermal<br>stratification for guiding the air to a<br>patient's breathing zone. |
| Power<br>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):<br>At least 120 m³/h<br>Airflow warm side: Approx. 80 m³/h<br>Total airflow: Approx. 200 m³/h | Airflow in clean air zone (cool side):<br>Approx. 150 m³/h<br>Airflow warm side: Approx. 80 m³/h<br>Total airflow: Approx. 230 m³/h |
| Air Quality<br>in treated air<br>envelope<br>(referred as clean<br>zone in Appendix<br>1.2) | Filtration efficiency 99.5% of<br>particles Ø ≥0.5µm<br>which is equivalent to<br>-Class 1000 according to FED STD<br>209E and<br>-Class 6 according to ISO 14644-1<br>in environments of<br><200 000particles/ft³ | Class 100-1000 according to FED<br>STD 209E |
| Rate of Air<br>Changed | At least 435 changes per hour | ~1500 changes per hour |
| Sound Level | <38 dB(A) | ~38 dB(A) |

| Element of<br>Comparison | Subject Device | Claimed SE Device | Previous 510(k)<br>SE Device<br>for<br>Airsonett Airshower<br>Air-3 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|
| Manufacturer | Airsonett AB | Airsonett AB | RespirAid Ltd. |
| Air Flow | Airflow in clean air zone<br>(cool side):<br>At least 120 m³/h<br>Airflow warm side:<br>Approx. 80 m³/h<br>Total airflow:<br>Approx. 200 m³/h | Airflow in clean air zone<br>(cool side):<br>Approx. 150 m³/h<br>Airflow warm side:<br>Approx. 80 m³/h<br>Total airflow:<br>Approx. 230 m³/h | 20-40 m³/h |
| Rate of Air<br>Changed | At least 435 changes<br>per hour | ~1500 changes per hour | 400-600 changes per<br>hour |

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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

| Study<br>endpoint | Description of Test | Acceptance<br>criteria | Conclusion |
|-----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Air quality in<br>treated air<br>envelope<br>(clean zone) | Efficiency test results of filter. | Filter Filtration<br>efficiency ≥99.5% of<br>particles with size<br>Ø≥0.5µm | Conforms with filtration<br>efficiency ≥99.5%. |
| Air quality in<br>treated air<br>envelope<br>(clean zone) | Particle cleanliness of clean<br>zone of Airsonett AIR-4.<br>Test method: Laser counter of<br>particles Ø≥0.5µm/ft³ air flow<br>over 1 minute. | Clean zone Filtration<br>efficiency ≥99.5% of<br>particles with size<br>Ø≥0.5µm<br>which is equivalent to<br>-Class 1000 according<br>to FED STD 209E and<br>- Class 6 according to<br>ISO 14644-1<br>in environments of<br><200 000particles/ft³. | Conforms with filtration<br>efficiency ≥99.5%.<br>⇒<br>Class 1000 according<br>to FED STD 209E and<br>Class 6 according to ISO<br>14644-1 in environments<br>of ≤200 000particles/ft³.<br>AIR-4 is equivalent or<br>better than previous<br>version AIR-3, with regard<br>to Air quality in treated air<br>envelope (clean zone). |
| | Particle cleanliness of clean<br>zone of Airsonett AIR-4. | Stability of the clean<br>zone shall be<br>preserved. Filter<br>efficiency shall be<br>preserved. | The stability of the clean<br>zone is preserved and the<br>filter does not<br>deteriorate on efficiency<br>over a normal working life. |
| Temperature<br>difference<br>between<br>supply air and<br>ambient air | The cooler/heater unit has been<br>individually tested against<br>temperature sensors to calibrate<br>and verify the temperature<br>difference between supply air<br>and ambient air. | Temperature difference<br>between supply air and<br>ambient air: ≥0.75°C<br>(1.35 degrees F). | Conforms with<br>temperature difference<br>between supply air and<br>ambient air: ≥0.75°C (1.35<br>degrees 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 [phone] or [phone] 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 [phone] or [phone] 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) |