← Product Code [FRF](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRF) · K081062 # AIRSONNETT AIRSHOWER AIR 3 (K081062) _Airsonett, Inc. · FRF · Nov 7, 2008 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRF/K081062 ## Device Facts - **Applicant:** Airsonett, Inc. - **Product Code:** [FRF](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRF.md) - **Decision Date:** Nov 7, 2008 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5045 - **Device Class:** Class 2 - **Review Panel:** General Hospital ## 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. ## Regulatory 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](/device/K981841.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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: 763-574-1976 Fax: 763-571-2437 E-mail: cgbundy@attglobal.net #### 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
Comparison | Subject Device | Claimed SE Device | |---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Airsonett AB | RespirAid Ltd. | | Type of Medical Re-
circulating Air
Cleaner | Mobile Air Filtration system | Mobile Air Filtration system | | Intended 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. | The BREATHE EASY device is
a medical recirculating air cleaner
designed to remove airborne
particles and allergens, such as:
dust, smoke, pollen, mold spores,
animal hair and dander, dust
mites and harmful fibers, that
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
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
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. | The Breathe Easy uses a flow
guide to isolate the respiratory
passages of a user from ambient
air. Method for guiding the
treated air outflow so as to obtain
a flow distribution in close
proximity to the head of the user,
thereby forming a treated air
envelope surrounding his
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
side): Approx. 150 m³/h
Airflow warm side: Approx. 80
m³/h
Total airflow: Approx. 230 m³/h | 20-40 m³/h | | Air Quality
in treated air
envelope
(referred as clean
zone in appendix
1.7) | Class 100-1000 according to
FED STD 209E | Class 100-1000 according to FED
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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRF/K081062](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRF/K081062) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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