(39 days)
The MICROCON air filtration system is used for filtering out airborne particles from air for medical purposes.
Not Found
The provided document is a 510(k) clearance letter from the FDA for several air purifier devices (Microcon 800M, 400M, Ex, ExC and Wall-Map Air Purifier). It states that the devices are substantially equivalent to pre-amendment devices for the indication of filtering airborne particles from air for medical purposes.
However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies.
Therefore, I cannot provide the requested information. The letter only grants market clearance based on substantial equivalence, implying that the manufacturer would have submitted data to demonstrate this equivalence in their 510(k) submission, but that data is not part of this letter.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 3 1998
Mr. Gary D. Messina President Biological Controls, Incorporated One Industrial Way West Building E, Unit M Eatontown, New Jersey 07724
Re : K974682 Trade Name: Microcon 800M, 400M, Ex, ExC and Wall-Map Air Purifier Requlatory Class: II Product Code: FRF Dated: December 10, 1997 Received: December 15, 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, 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. ਬੈ 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 regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq 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. Please note: this response to your premarket notification submission does
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Page 2 - Mr. Messina
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 requlations.
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 leqally 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 labelinq 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.fda.qov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Directdr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page__________________________________________________________________________________________________________________________________________________________________________ of
510(k) Number (if krown):
Device Name: _ MICROCON MAP-800M Air Purifier; MICROCON MAP-400M Air Purifier; MICROCC WallMAP Air Purifier; MICROCON EX Air Purifier and MICROCON EXC Air Puri Indications For Usc:
The MICROCON air filtration system is used for filtering out airborne particles from air for medical purposes.
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Concertionce of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off)
Division of Dental, Infection Control, and General Hospital I 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Formal 1-2-96)
§ 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).