(219 days)
None
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The device description is also not available, which would be a key place to find such information.
Yes
The device is used for "medical purposes," indicating it is intended to provide a medical benefit, which aligns with the definition of a therapeutic device.
No
The device is described as an air filtration system for filtering airborne particles from the air, which is a treatment or preventive function, not a diagnostic one. It does not identify or detect diseases or conditions.
No
The intended use describes a physical air filtration system, which is a hardware device, not software.
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 particles from the air for medical purposes." This describes a device that acts on the environment (the air) rather than on a biological sample taken 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 samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition based on sample analysis.
- Using reagents or assays.
IVDs are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. Air filtration systems, while used in medical settings, are environmental controls and do not fit this definition.
N/A
Intended Use / Indications for Use
HEPA-CARE Air Filtration Systems Indications for Use: The HEPA-CARE/Air filtration systems are used for filtering out airborne particles from the air for medical purposes.
Product codes
FRF
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
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
§ 880.5045 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/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 4 1999
Mr. David J. Willyard Vice President of Sales Abatement Technologies®, Incorporated 2220 Northmont Parkway, Suite 100 Duluth, Georgia 30096-5895
Re : K984116 HEPA-CARE Air Cleaner, Models Trade Name: HC800F/HFS800F, HC800C/HFS800C, HC400C/HFS400C, HC400CW II Regulatory Class: Product Code: FRF June 8, 1999 Dated: Received: June 11, 1999
Dear Mr. Willyard:
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 of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, qood manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Speciāl 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 Requlations, Title 21, Parts 800 to 895. ਸੈ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Page 2 - Mr. Willyard
this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 through 542 of 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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion 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 premarket notification" (21 CFR 807.97). Other general information 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.fdag.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page _ of _
510(k) Number (if known): K984116
Device Name: Hepacare @ Air Cleaner/American Air Filter
Air Filtration System
Indications For Use:
HEPA-CARE Air Filtration Systems
Indications for Use: The HEPA-CARE/Air filtration systems are used for filtering out airborne particles from the air for medical purposes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Qian S. Lin
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)