(177 days)
The above named device is designed to provide CPR trained individuals with personal protection from disease transmission during Expired Air Resuscitation (mouth to mouth) and during CPR training on manikins.
FACE - 2 - FACE CPR PROTECTION SHIELD
The provided text is an FDA 510(k) clearance letter for the "FACE - 2 - FACE CPR Protection Shield." This document does not contain details about acceptance criteria for device performance or a study demonstrating that the device meets those criteria.
Instead, it's a regulatory letter indicating that the device has been found substantially equivalent to a legally marketed predicate device, thereby allowing it to be marketed. The letter explicitly states: "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... You may, therefore, market the device, subject to the general controls provisions of the Act."
The purpose of a 510(k) submission is to demonstrate substantial equivalence, not necessarily to provide detailed performance data against specific acceptance criteria in the manner one might expect for a novel or high-risk device. The "Indications For Use" section merely describes what the device is designed for, and includes a disclaimer that its use does not "gaurantee complete protection from disease transmission."
Therefore, I cannot provide the requested information based on the given input. The document is a regulatory approval, not a scientific study report.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 3 1999
Mr. Wally Simpson Whiteline Plastics, Inc. 6800 Columbus Road Mississauga, Ontario L5T 2G1 CANADA
Re: K991617 FACE - 2 - FACE CPR Protection Shield Regulatory Class: II (two) Product Code: 73 CBP Dated: September 15, 1999 Received: September 27, 1999
Dear Mr. Simpson:
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 leqally 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, 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 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. Wally Simpson
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 regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other qeneral 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,
from: A. Wackerhausen for,
Ceila M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
K991617 510(k) Number (if known):
CPR PROTECTION SHIELD Device Name: FACE - 2 - FACE
Indications For Use:
The above named device is designed to provide CPR trained individuals with personal protection from disease transmission during Expired Air Resuscitation (mouth to mouth) and during CPR training on manikins.
" The use of this device does not gaurantee complete protection from disease transmission
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
La H Westerhausen
on of Cardiovascular, Respiratory, and Neurological Devices 1991617 510(k) Number
Prescription Use (Per 21 CFR 801.109)
ご
OR
Over-The-Counter Use XXX
(Optional Format 1-2-96)
§ 868.5870 Nonrebreathing valve.
(a)
Identification. A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.(b)
Classification. Class II (performance standards).