AIRSONNETT AIRSHOWER AIR 3

K081062 · Airsonett, Inc. · FRF · Nov 7, 2008 · General Hospital

Device Facts

• Record ID: K081062
• Device Name: AIRSONNETT AIRSHOWER AIR 3
• Applicant: Airsonett, Inc.
• Product Code: FRF · General Hospital
• Decision Date: Nov 7, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5045
• Device Class: Class 2

Indications for Use

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.

Device Story

Airsonett Airshower Air 3 is a portable, mobile medical air cleaner for home use. Device draws in ambient air, filters it via HEPA filter, and uses an air cooling unit and adjustable guidance arm to create a treated air zone around the user's breathing zone. Principle of operation relies on thermal stratification to guide treated air. System controlled by embedded firmware; user operates via pushbutton controls for airflow and cooling. Output is a localized envelope of clean air (Class 100-1000 per FED STD 209E) to reduce user exposure to airborne particulates. Benefits include improved air quality in the immediate respiratory vicinity.

Clinical Evidence

No clinical data. Bench testing only. Testing included filter functionality and efficiency, software verification and validation, and EMC/safety testing per IEC 60601-1. Air quality performance verified against FED STD 209E (Class 100-1000).

Technological Characteristics

Mobile air filtration system; HEPA filter; air cooling and warming units; adjustable air guidance arm. Power: 115V, 1.7A. Safety standard: IEC 60601-1. Airflow: ~230 m³/h total. Air quality: Class 100-1000 (FED STD 209E). Embedded firmware control.

Indications for Use

Indicated for home use 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

• BREATHE EASY (Models AD and CD) by RespirAid Ltd (K981841)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image contains the word "Airsonett" in a sans-serif font. The text is black and appears to be slightly pixelated. To the left of the word, there is a pattern of small, dark circles that fade out towards the left side of the image.

## 510(k) Summary

#### Submitter:

NOV - 7 2008

Airsonett Inc 1171 Market Streeet, Suite 113 Fort Mill, SC 29708

#### Contact Information:

Constance G. Bundy C. G. Bundy Associates, Inc. 6470 Riverview Terrace Fridley, MN 55432 Phone: [phone] Fax: [phone] E-mail: [e-mail]

#### Submission Date:

April 9, 2008

#### Proprietary Name:

Airsonett Airshower Air 3 Mobile Medical Air Cleaner

#### Device Name and Classification:

Sec. 880.5045 Medical Recirculating Air Cleaner.

#### Equivalent Device Identification:

BREATHE EASY (Models AD and CD) by RespirAid Ltd (K981841)

#### Device Description:

The Airsonett Airshower Air 3 Mobile Medical Air Cleaner is an adjustable, portable, personal system for use in providing a controlled environment for medical applications that require a high degree of airborne particulate control. The system is controlled by embedded firmware and runs on standard 115 volt, 1.7 ampere power. Pushbutton controls include airflow and cooling capacity. Manual controls include till/angle of air outflow.

The Airsonett Airshower Air 3 Mobile Medical Air Cleaner device provides a method, using air cooling, for guiding the treated ambient air so as to obtain an air flow distribution directly to the users breathing zone, thereby forming a treated air zone surrounding the user.

The Airsonett Airshower Air 3 Mobile Medical Air Cleaner has been designed to meet the following product safety standards:

{1}------------------------------------------------

# K081062

7

Image /page/1/Picture/1 description: The image shows the word "Airsonett" in a simple, sans-serif font. To the left of the word is a cluster of small, pixelated shapes that appear to be arranged in a grid-like pattern. The text is the primary focus of the image, with the pixelated shapes serving as a visual element to the side.

- IEC 60601-1 Standard for Medica! Electrical Equipment Part 1 : g 「, General Requirements for safety (IEC 601-1:1988)
### Intended Use

The Airsonett Airshower Air 3 is a Mobilc Air Cleancr 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 |
|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Airsonett AB | RespirAid Ltd. |
| Type of Medical Re-<br>circulating Air<br>Cleaner | Mobile Air Filtration system | Mobile Air Filtration system |
| Intended use | The Airsonett Airshower Air<br>3 is a Mobile Air Cleaner<br>intended to be used to<br>remove particles from the air<br>for medical purposes. The<br>device is intended for home<br>use only. | The BREATHE EASY device is<br>a medical recirculating air cleaner<br>designed to remove airborne<br>particles and allergens, such as:<br>dust, smoke, pollen, mold spores,<br>animal hair and dander, dust<br>mites and harmful fibers, that<br>may lead to allergic reactions. |
| Type of device | Over the counter use | Over the counter use |
| Labeling | Airsonett Airshower Air-3 | BREATHE EASY |
| Product Description | Housing Unit | Housing Unit |
| | Air Inlet and Treated Air<br>Outlet | Air Inlet and Treated Air Outlet |
| | Blower | Blower |
| | HEPA filter | HEPA filter |
| | Air Warming Unit | Air Warming Unit |
| | Air Cooling Unit | - |
| | - | Humidifier |
| | Adjustable Air Guidance Arm | Adjustable Support Arm |
| | Control Panel | - |

#### Comparison Table:

{2}------------------------------------------------

# K681062

Image /page/2/Picture/1 description: The image shows the word "Airsonett" in a simple, sans-serif font. To the left of the word is a faded, pixelated graphic that appears to be a stylized representation of the letters "irii". The text and graphic are presented in a straightforward, unadorned manner.

| Element of<br>Comparison | Subject Device | Claimed SE Device |
|---------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Airsonett Airshower makes<br>use of the Airshower<br>characteristics and cools the<br>air outflow; thereby using<br>thermal stratification for<br>guiding the air to a patient's<br>breathing zone. | The Breathe Easy uses a flow<br>guide to isolate the respiratory<br>passages of a user from ambient<br>air. Method for guiding the<br>treated air outflow so as to obtain<br>a flow distribution in close<br>proximity to the head of the user,<br>thereby forming a treated air<br>envelope surrounding his<br>respiratory openings. |
| Power Requirements | 115 Volts (60Hz), 1.7 Amps | 115 Volts |
| Standard | IEC 60601-1 | IEC 601-1 |
| Air Flow | Airflow in clean air zone (cool<br>side): Approx. 150 m³/h<br>Airflow warm side: Approx. 80<br>m³/h<br>Total airflow: Approx. 230 m³/h | 20-40 m³/h |
| Air Quality<br>in treated air<br>envelope<br>(referred as clean<br>zone in appendix<br>1.7) | Class 100-1000 according to<br>FED STD 209E | Class 100-1000 according to FED<br>STD 209E |
| Rate of Air Changed | ~1500 changes per hour | 400-600 changes per hour |
| Sound Level | ~38 dB(A) | Maximum 50 dBA or less |

Summary of Testing: The device was tested for filter functionality and efficiency. Software functions were verified and validated. The device was EMC and safety tested according to relevant standards. The device functioned according to specifications.

Conclusion: Airsonett Airshower Air-3 is substantially equivalent to Breathe Fasy regarding technology, intended use and performance.

{3}------------------------------------------------

Image /page/3/Picture/11 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized eagle with outstretched wings. The eagle's body is formed by three vertical bars, and its wings are represented by curved lines. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Airsonett, Incorporated C/O Ms. Constance G. Bundy C.G. Bundy Associates, Incorporated 6470 Riverview Terrace Findley, Minnesota 55432

NOV - 7 2008

Re: K081062

Trade/Device Name: Airsonett Airshower Air 3 Regulation Number: 21 CFR 880.5045 Regulation Name: Medical Recirculating Air Cleaner Regulatory Class: II Product Code: FRF Dated: October 13, 2008 Received: October 21, 2008

Dear Ms. Bundy:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

{4}------------------------------------------------

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH' s) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours.

Smitte Y. Michael MD
FOR DR. CHIU

Chiu S. Lin. Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

LIN

Enclosure

{5}------------------------------------------------

### Indications for Use

510(k) Number (if known): K081062

Device Name: Airsonett Airshower Air 3

Indications For Use:

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.

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

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)

Shuli A. Murphy MD

Page 1 of

(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K081062