(6 days)
THIS DISPOSABLE FILTER HAS BEEN DESIGNED FOR SINGLE USE AS A MAIN FLOW FILTER, INSPIRATORY AND EXHALATION FILTER. THIS FILTER IS HYDROPHOBIC. FOR USE WITH RESPIRATORY THERAPY AND ANESTHESIA APPLICATIONS. HELPS PROTECT PATIENTS FROM RESPIRATORY AND ANESTHESIA VENTILATOR CONTAMINANTS. VERSATILE, DISPOSABLE, ENCONOMY OF USE - HELPS PROTECT PATIENT, VENTILATORY EQUIPMENT, AND HOSPITAL STAFF.
One Disposable Breathing Circuit Bacterial Filter. CLEAR PLASTIC SHELL ALLOWS FOR VISUAL INSPECTION OF THE FILTER MEDIUM.
I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA clearance letter for a respiratory filter and does not discuss acceptance criteria, device performance studies, or details about training and test sets as typically seen in AI/ML device submissions.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of a stylized eagle with its wings spread. The eagle is facing to the left.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 23 1998
Mr. Keith A. Roberts Porous Media Corporation 1350 Hammond Road St. Paul, MN 55110
Re: K982127 Porous Media DEF25™ Disposable Respiratory Filter Requlatory Class: II (two) Product Code: 73 CAH Dated: June 16, 1998 Received: June 17, 1998
Dear Mr. Roberts:
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 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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 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.
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Page 2 - Mr. Keith A. Roberts
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) 594-4648. 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 requlation 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.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Collehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices · Office of Device Evaluation Center for Devices and Radiological Health
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Page 1_ of __ 1__
510(k) Number (if known): K964979 (Previously Cleared Device)
Device Name: _DEF25 Disposable Respiratory Filter
Indications For Use:
CONTENTS:
One Disposable Breathing Circuit Bacterial Filter
CAUTION:
FEDERAL (U.S.A.) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON ORDER OF A PHYSICIAN.
INDICATIONS:
•THIS DISPOSABLE FILTER HAS BEEN DESIGNED FOR SINGLE USE AS A MAIN FLOW FILTER, INSPIRATORY AND EXHALATION FILTER. THIS FILTER IS HYDROPHOBIC.
"CLEAR PLASTIC SHELL ALLOWS FOR VISUAL INSPECTION OF THE FILTER MEDIUM.
*FOR USE WITH RESPIRATORY THERAPY AND ANESTHESIA APPLICATIONS. *HELPS PROTECT PATIENTS FROM RESPIRATORY AND ANESTHESIA VENTILATOR CONTAMINANTS.
·VERSATILE, DISPOSABLE, ENCONOMY OF USE - HELPS PROTECT PATIENT, VENTILATORY EQUIPMENT, AND HOSPITAL STAFF.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
or
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.1091)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Mark Kramer
(Division Sign-Off) Division of Cardiovascular, Respira and Neurological Device 510(k) Number
§ 868.5260 Breathing circuit bacterial filter.
(a)
Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.(b)
Classification. Class II (performance standards).