(181 days)
Not Found
Not Found
No
The provided text does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML medical devices. The description focuses solely on air filtration.
No.
The device is described as an air filtration system for filtering out airborne particles for medical purposes, which is a supportive function rather than directly treating or diagnosing a medical condition.
No
Explanation: The device is an air filtration system used for filtering airborne particles from the air for medical purposes. It does not appear to diagnose any medical conditions or diseases.
No
The device is described as an "air filtration system," which inherently implies a physical hardware component for filtering air. The summary does not mention any software-only functionality.
Based on the provided information, the MICROCON air filtration system is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "filtering out airborne particles from air for medical purposes." This describes a physical process applied to the environment, not a test performed on biological samples (like blood, urine, tissue, etc.) to diagnose, monitor, or screen for diseases or conditions.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or screening.
IVDs are specifically designed to be used in vitro (outside the body) to examine biological specimens. An air filtration system operates in situ (in place) to purify the air.
N/A
Intended Use / Indications for Use
The MICROCON air filtration system is used for filtering out airborne particles from air for medical purposes.
Product codes (comma separated list FDA assigned to the subject device)
FRA
Device Description
Not Found
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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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
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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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 1 1997
Mr. Gary D. Messina ·President Biological Controls Incorporated One Industrial Way West Building E, Unit M 07724 Eatontown, New Jersey
Re : K972064 Microcon 800MUV, Microcon 400MUV, Microcon Trade Name: EXC-BUV Requlatory Class: II Product Code: FRA Dated: September 25, 1997 Received: September 29, 1997
Dear Mr. Messina:
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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the qeneral 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does
1
Page 2 - Mr. Messina
not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic emroagn 312 or on Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acincine in your tial equivalence of your device to a legally marketed predicate device results in a classification for your markets production overmits 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) 594-4618. 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.fdalgov/cdrh/dsmamain.html".
Sincerely yours,
Timothy Ulatowski
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
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a person with outstretched arms.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 1 1997
Mr. Gary D. Messina ·President Biological Controls Incorporated One Industrial Way West Building E, Unit M 07724 Eatontown, New Jersey
Re : K972064 Microcon 800MUV, Microcon 400MUV, Microcon Trade Name: EXC-BUV Requlatory Class: II Product Code: FRA Dated: September 25, 1997 Received: September 29, 1997
Dear Mr. Messina:
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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the qeneral 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does
3
Page 2 - Mr. Messina
not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic emroagn 312 or on Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acincine in your tial equivalence of your device to a legally marketed predicate device results in a classification for your markets production overmits 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) 594-4618. 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.fdalgov/cdrh/dsmamain.html".
Sincerely yours,
Timothy Ulatowski
Timothy A . Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if krown): K972064
Device Name: MICROCON MAP-800MW Air Purifier; MICROCON MAP-400MW Air Purifier; MICROCON EX-BUV AIr Purifier and MICROCON EXC-BUV AIr Purifier Indications For Usc:
The MICROCON air filtration system is used for filtering out airborne particles from air for medical purposes.
(FLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concertificance of CDRH, Office of Device Evaluation (ODE) (Division Sign-O Division of Dental, Info and General Hospital D
510(k) Number .
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Formal 1-2-96)