(13 days)
Surgical Masks are surgical apparel, identified in 21 CFR, part 878.4040, as a medical device intended to be worn by operating room personnel during surgical procedures to protect both the surgical patients and the operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
Not Found
This document is a 510(k) premarket notification approval letter for surgical masks. It does not contain information on acceptance criteria or a study proving that a device meets such criteria in the manner requested (i.e. for an AI-powered medical device).
Therefore, I cannot provide the detailed information requested in the prompt based on the provided text. The document pertains to a traditional medical device (surgical mask) and its substantial equivalence to a predicate device, not an AI/ML-based device requiring a study with acceptance criteria as described.
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Image /page/0/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an abstract symbol in the center. The symbol appears to be a stylized representation of an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 6 2002
Ms. Brenda Lee Manager of RA/QA Primeline Medical Products, Incorporated 10707-100th Avenue, Suite 300 Edmonton, Alberta, CANADA T5J 3M1
Re: K021076
Trade/Device Name: Primagard Yellow Surgical Mask, Pleated, Tie-On, PM4-307 Regulation Number: 878.4040 Regulation Name: Surgical Mask Regulatory Class: II Product Code: FXX Dated: April 1, 2002 Received: April 3, 2002
Dear Ms. Lee:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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
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Page 2 - Ms. Lee
of the Act or any Federal statutes and regulations administered by other Federal agencies. or the Fee of myly with all the Act's requirements, including, but not limited to: registration 1 od intilet contpry was 807); labeling (21 CFR Part 801); good manufacturing practice and instills (21 et read of the quality systems (QS) regulation (21 CFR Part 820); and if requirements as bettronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 11 mo recei will and if your of substantial equivalence of your device 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Timo Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Statement of Indications for Use
510(k) Number: K O21076
Device Name: PrimeLine Medical Products Inc. Yellow Surgical Mask PrimeLine Medical Products Inc. Anti-Fog Surgical Mask PrimeLine Medical Products Inc. Platypus Surgical Mask
Surgical Masks are surgical apparel, identified in 21 CFR, part 878.4040, as a medical device intended to be worn by operating room personnel during surgical procedures to protect both the surgical patients and the operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
I certify that, in my capacity as Manager of Regulatory Affairs and Quality Assurance of PrimeLine Medical Products Inc., that the intended use of modified masks (PM4-307 and PM4-308, PM4-311, PM4-312, PM3-313) has not changed from the intended use of the marketed masks under the 510K number: K001951.
R. Busenda
Brenda Lee
April 1st, 2002
Date:
Date:
K021076
Premarket Notification (510K Number)
Premarket Notification (510K Number)
Chin S. Lin
(Division Sign-Off) Preision Official, Infection Control, and General Hospital Devices 110(k) Number .
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.