(491 days)
Not Found
Not Found
No
The summary describes a simple air filter and contains no mention of AI, ML, or related concepts.
No
The device is described as "Filtering out airborne particulates from air for medical purposes." While this serves a health-related purpose, it acts on the air, not directly on the body or to treat a specific medical condition. Therapeutic devices are typically defined by their direct interaction with the body for the purpose of treatment, prevention, or diagnosis of a disease or condition. This device seems more akin to a medical air purifier.
No
The device is described as filtering airborne particulates from the air for medical purposes, which is a therapeutic or preventative function, not a diagnostic one. There is no mention of it analyzing, detecting, or predicting a medical condition.
No
The 510(k) summary describes a device for filtering airborne particulates, which is a hardware function, not a software-only function. The lack of a device description further supports this conclusion.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Filtering out airborne particulates from air for medical purposes." This describes a device that acts on the air itself, not on biological specimens (like blood, urine, tissue, etc.) taken from the human body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body to detect diseases, conditions, or infections.
The description clearly indicates a device that purifies air, which falls outside the scope of IVD devices.
N/A
Intended Use / Indications for Use
Filtering out airborne particulates from air for medical purposes.
HEPAirX 100 is intended for over-the-counter use.
Product codes
FRF
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
over-the-counter use
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
§ 880.5045 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).
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The text is in all caps and is oriented to follow the curve of the circle. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 23, 2013
Mr. Lawrence Wetzel Chairman Air Innovations, Incorporated 7000 Performance Drive NORTH SYRACUSE NY 13212
Re: K112728
Trade/Device Name: HEPAirX 100 Regulation Number: 21 CFR 880.5045 Regulation Name: Medical Recirculating Air Cleaner Regulatory Class: II Product Code: FRF Dated: January 9, 2013 Received: January 15, 2013
Dear Mr. Wetzel:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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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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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucml15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthony De min
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 4.0 of Original Application
Indications for Use
510(k) Number (if known): KU2728
Device Name: HEPAirX 100
Indications for Use:
Filtering out airborne particulates from air for medical purposes.
HEPAirX 100 is intended for over-the-counter use.
Prescription Use NO (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use YES (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shula A. Murphy @ Arts TMCB. Chf 1/23/2013
Sign-On)
of Anesthesiology, General Hospital on Control, Dental Devices
510(k) Number:
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