(400 days)
The Second Wind Air Purifier was designed to be used in an HVAC system, to improve the indoor air quality. The Second Wind air purifier is recommended to be used in conjunction with a media filter, humidifying device, proper controls to run the fan and the sealing of any ductwork. The Second Wind air purifier may be, but not necessarily used in conjunction with a complete IAQ package. The use is for anyone concerned with his or her indoor air quality. The unit is easily installed within the forced air furnace and/or the air movement device within a home or business.
Second Wind Air Purifier/First Breath Air Purifier Hotel, ultraviolet HVAC mounted
I am sorry, but based on the provided text, there is no information available regarding acceptance criteria for a device, nor any study proving the device meets said criteria.
The document is a 510(k) clearance letter from the FDA for a device called "First Breathe and Second Wind Air Purifier, Trade Name: Ultraviolet HVAC Mounted." This letter primarily addresses the regulatory status of the device, stating that it is "substantially equivalent" to devices marketed prior to May 28, 1976.
The indications for use are also mentioned: "The Second Wind Air Purifier was designed to be used in an HVAC system, to improve the indoor air quality. The Second Wind air purifier is recommended to be used in conjunction with a media filter, humidifying device, proper controls to run the fan and the sealing of any ductwork."
However, the document does not contain any data, study results, acceptance criteria, sample sizes, expert qualifications, or ground truth information that would allow me to answer your specific questions about device performance and the study demonstrating it.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them, resembling a bird or a symbol of human connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 1999
Mr. George C. Monagan President Monagan Enterprises, Incorporated 14247 Ridge Road 14411 Albion, New York
Re: K980745 First Breathe and Second Wind Air Purifier, Trade Name: Ultraviolet HVAC Mounted Requlatory Class: II Product Code: FRA Dated: January 9, 1999 Received: January 14 1999
Dear Mr. Monagan
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
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Page 2 - Mr. Monagan
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA debering of substantial equivalence of your device to a legally rinding of bubbeaneral squaresults in a classification for your marketed production of mits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on compriation and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to che regaracton chorosod) 1.LEFR 807.97) Other general premation on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Patrice Guenatffor
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number: K980745
ultraviolet
HVAC mounted
Device Name: Second Wind Air Purifier/First Breath Air Purifier Hotel
Indications For Use
The Second Wind Air Parifier was designed to be used in an HVAC system, to improve the indoor air quality. The Second Wind air purifier is recommended to be used in conjunction with a media filter, bumidifying device, proper controls to run the fan and the sealing of any ductwork.
The Second Wind air purifier may be, but not necessarity used in conjunction with a complete IAQ package. The use is for anyone concerned with his or her indoor air quality.
The unit is easily installed within the forced air furnace and/or the air movement device within a home or business.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
rescription Use 'ct 21 CFR 801.109)
OR
Over-The-Counter Use X
(Division Sign-Off)
Division
Division of Dental, Infection Control, and General Hospital, Inte 510(k) Number
(Optional Format 1-2-96)
§ 880.6500 Medical ultraviolet air purifier.
(a)
Identification. A medical ultraviolet air purifier is a device intended for medical purposes that is used to destroy bacteria in the air by exposure to ultraviolet radiation.(b)
Classification. Class II (performance standards).