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 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.

AI/ML Overview

This document describes the Airsonett Airshower Air 3 Mobile Medical Air Cleaner, a device intended to remove particles from the air for medical purposes in a home setting. The document focuses on demonstrating its substantial equivalence to a predicate device, the BREATHE EASY (Models AD and CD) by RespirAid Ltd (K981841).

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Airsonett Airshower Air 3 are implicitly defined by its comparison to the predicate device, BREATHE EASY. The goal is to show comparable or improved performance for key metrics.

Element of Comparison / Acceptance Criteria (Derived from Predicate)	Airsonett Airshower Air 3 Reported Performance
Intended Use	Mobile Air Cleaner intended to remove particles from the air for medical purposes; for home use only.
Type of Device	Over the counter use
Power Requirements	115 Volts (60Hz), 1.7 Amps
Standard Compliance	IEC 60601-1
Air Quality in treated air envelope (clean zone) Class 100-1000 according to FED STD 209E	Class 100-1000 according to FED STD 209E
Sound Level Maximum 50 dBA or less	~38 dB(A)
Air Flow (Total) (Not explicitly stated as criterion, but for comparison)	Approx. 230 m³/h
Rate of Air Changed (Not explicitly stated as criterion, but for comparison)	~1500 changes per hour

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the traditional sense of a clinical study involving human subjects or a large dataset of patient information. This is a medical device clearance based on substantial equivalence to an existing predicate device. The "test set" in this context refers to the device itself being tested in a laboratory setting to verify its specifications.

Sample Size: The document implies testing was performed on one or more units of the Airsonett Airshower Air 3 to verify its functional and safety specifications. It does not provide a specific number of devices tested.
Data Provenance: The document does not explicitly state the country of origin for the testing data. However, Airsonett Inc. is located in Fort Mill, SC, and the submission date is April 9, 2008, suggesting the testing was likely conducted in the United States or a country with recognized testing standards. The testing appears to be prospective in the sense that physical tests were conducted on the manufactured device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

There is no mention of external experts establishing a "ground truth" for the performance metrics in this 510(k) submission regarding the device's technical specifications. The performance claims (e.g., airflow, sound level, air quality) are derived from engineering tests and measurements conducted on the device itself by the manufacturer or a certified testing laboratory. These are objective measures, not subjective interpretations requiring expert consensus as might be the case for diagnostic imaging.

4. Adjudication Method for the Test Set

Not applicable. Since the "test set" consists of objective engineering measurements against predefined specifications (or comparison to a predicate device's specifications), there is no human adjudication process involved for establishing ground truth or performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This document does not mention any MRMC comparative effectiveness study. The device is a medical air cleaner, not a diagnostic imaging device that typically uses MRMC studies.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was done

This concept is not applicable to the Airsonett Airshower Air 3. This device is a physical air cleaner, not an algorithm or AI system. Its performance is inherent to its mechanical and electrical design, not an "algorithm only" mode.

7. The Type of Ground Truth Used

The "ground truth" for the acceptance criteria and performance claims are objective engineering measurements and compliance with established standards.

Air Quality: Verified by measuring particle counts (Class 100-1000 according to FED STD 209E) in the treated air envelope.
Sound Level: Measured in dB(A).
Air Flow: Measured in m³/h.
Safety and EMC: Verified by testing against IEC 60601-1 and other relevant standards.

There is no "expert consensus," "pathology," or "outcomes data" used as ground truth for these technical specifications.

8. The Sample Size for the Training Set

Not applicable. As a physical medical device (air cleaner), there is no 'training set' in the context of machine learning or AI. The design and manufacturing processes are refined through engineering, prototyping, and testing, not by training an algorithm on a dataset.

9. 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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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 has been designed to meet the following product safety standards:

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K081062

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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 ofComparison	Subject Device	Claimed SE Device
	Airsonett AB	RespirAid Ltd.
Type of Medical Re-circulating AirCleaner	Mobile Air Filtration system	Mobile Air Filtration system
Intended use	The Airsonett Airshower Air3 is a Mobile Air Cleanerintended to be used toremove particles from the airfor medical purposes. Thedevice is intended for homeuse only.	The BREATHE EASY device isa medical recirculating air cleanerdesigned to remove airborneparticles and allergens, such as:dust, smoke, pollen, mold spores,animal hair and dander, dustmites and harmful fibers, thatmay 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 AirOutlet	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:

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K681062

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Element ofComparison	Subject Device	Claimed SE Device
	Airsonett Airshower makesuse of the Airshowercharacteristics and cools theair outflow; thereby usingthermal stratification forguiding the air to a patient'sbreathing zone.	The Breathe Easy uses a flowguide to isolate the respiratorypassages of a user from ambientair. Method for guiding thetreated air outflow so as to obtaina flow distribution in closeproximity to the head of the user,thereby forming a treated airenvelope surrounding hisrespiratory 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 (coolside): Approx. 150 m³/hAirflow warm side: Approx. 80m³/hTotal airflow: Approx. 230 m³/h	20-40 m³/h
Air Qualityin treated airenvelope(referred as cleanzone in appendix1.7)	Class 100-1000 according toFED STD 209E	Class 100-1000 according to FEDSTD 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.

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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.

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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); 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

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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

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).