(78 days)
Not Found
Not Found
No
The provided text does not contain any keywords or descriptions related to AI or ML technology. The device appears to be an air purification system.
No.
The device's intended use is to remove and mineralize airborne contaminants in various environments, not to treat a patient's disease or condition directly.
No
The device's intended use is to remove and mineralize airborne contaminations, not to diagnose medical conditions or diseases.
No
The provided text describes a device intended for removing and mineralizing airborne contaminations. This function strongly suggests a physical device (like an air purifier or similar system) rather than a software-only application. There is no mention of software, data processing, or any other characteristic typically associated with a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes removing and mineralizing airborne contaminants in various environments. This is an environmental control function, not a diagnostic test performed on biological samples from a human body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition
- Using reagents or assays to detect specific analytes
The device appears to be an air purification or decontamination system intended for environmental use.
N/A
Intended Use / Indications for Use
Potential applications include removing and mineralizing airborne contaminations of pathogens and/or harmful molds and volatile organic compounds present in rooms or enclosed areas: treatment rooms, hospital wards, intensive care hospital wards, holding areas in jails, operating rooms, homeless shelters, pediatric waiting areas, command and control vehicles, embalming rooms in funeral homes, postal facilities, etc.
Product codes
FRA
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is an abstract symbol that resembles an eagle or a bird in flight, with stylized lines representing its wings and body.
FFB 0 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
·Mr. John Hayman, Jr. President KES Science & Technology, Incorporated 3625 Kennesaw North Industrial Parkway Kennesaw, Georgia 30144
Re: K023830
Trade/Device Name: AiroCide TiO2 Regulation Number: 880.6500 Regulation Name: Medical Ultraviolet Air Purifier Regulatory Class: II Product Code: FRA Dated: November 6, 2003 Received: November 18, 2003
Dear Mr. Hayman:
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 - Mr. Hayman
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions 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 Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Susan Runne
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows a logo with the words "The Power of Freshness" arranged in a circular fashion around an atom-like symbol. To the right of this symbol, there is a stylized abbreviation "RES" and the words "Science & Technology, Inc."
0025 Kennesan North Industrial Play. Kennessan, BA 30144 USA PHONE (800) 627-4913 FAX (770) 425-0837 www.kesmist.com
January 31, 2003
Food and Drug Administration Center for Devices and Radiological Health (HFZ-308) Office of Compliance Information Processing and Office Automation Branch 9200 Corporate Boulevard Rockville, MD 20850-4015
501(k) Notification
Dear Sir/Madam,
AiroCide TiO2 INTENDED USE: Potential applications include removing and mineralizing airborne contaminations of pathogens and/or harmful molds and volatile organic compounds present in rooms or enclosed areas: treatment rooms, hospital wards, intensive care hospital wards, holding areas in jails, operating rooms, homeless shelters, pediatric waiting areas, command and control vehicles, embalming rooms in funeral homes, postal facilities, etc.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Pcr 21 CFR 801.109) OR
Over-The-Counter Use
Qius S. Lim
(Optional Format 1-2-96)
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K0223830