(303 days)
The LIV MEDICA CPR Face Mask is a non-invasive, non-prescription face shield with an integral non-rebreathing valve. The face shield serves as a physical barrier, intended to prevent direct mouth contact with the patient's face when providing mouth-to-mouth resuscitation.
The LIV MEDICA CPR Face Mask is a non-invasive, non-prescription face shield with an integral non-rebreathing valve.
I am sorry, but based on the provided document, there is no information regarding the acceptance criteria, device performance, or any studies related to the LIV Medica CPR Face Mask.
The document is a 510(k) clearance letter from the FDA, which primarily states that the device is substantially equivalent to legally marketed predicate devices and is cleared for marketing. It does not contain details about specific performance metrics, clinical studies, or acceptance criteria that would typically be found in a study report or technical documentation.
Therefore, I cannot populate the table or answer the specific questions you've asked about acceptance criteria and studies for this device based on the given text.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 7 2006
LIV Medica Products Pvt. Ltd. C/O Mr. Michael Holstein Official Correspondent/President LIV Medica, Incorporated 458 Briarcreek Drive Hockessin, Delaware 19707
Re: K052458
Trade/Device Name: LIV Medica CPR Face Mask Regulation Number: 21 CFR 868.5870 Regulation Name: Nonrebreathing Valve Regulatory Class: II Product Code: CBP Dated: July 6, 2006 Received: July 6, 2006
Dear Mr. Holstein:
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.
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Page 2 - Mr. Holstein
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 of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic 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 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sinette y. Michael Ems
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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INDICATIONS FOR USE FORM
Not Known at this time 510(k) Number (if Known):
LIV Medica CPR Face Mask Device Name:
Indications for Use:
Page 1 of 1_
1< 052458 510(k) Number (if known): _
Device Name: LIV Medica CPR Face Mask
Indications For Use:
The LIV MEDICA CPR Face Mask is a non-invasive, non-prescription face shield with an integral non-rebreathing valve. The face shield serves as a physical barrier, intended to prevent direct mouth contact with the patient's face when providing mouth-to-mouth resuscitation.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use X (Optional Format 1-2-96)
Cun Sotion
n of Anesthesiology, General Hospital, Control. Denta
§ 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).