(84 days)
The Lifeguard Nasal CPAP mask is intended to be used to provide nasal CPAP, when used with devices that provided an exhalation port, devices that provide When about with devices that support the mask against the patient's face. The mask is intended for re-use by a single patient.
Lifeguard Nasal CPAP Mask
I am sorry, but the provided text does not contain information about acceptance criteria, device performance results, or any study details that would allow me to populate the requested table and answer the subsequent questions. The document is an FDA 510(k) clearance letter for a "Lifeguard Nasal CPAP Mask," confirming its substantial equivalence to a predicate device. It defines the product and its intended use but does not include any performance data or study specifics.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 8 2002
Mr. Craig Johnson Lifeguard Medical Products 120 Elm Street Plainfield, IN 46168
Re: K013421
Lifeguard Nasal CPAP Mask Regulation Number: 868.5905 Regulation Name: Non-Continuous Ventilator, Accessory Regulatory Class: Class II (two) Product Code: BZD Dated: October 11, 2001 Received: October 16, 2001
Dear Mr. Johnson:
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. Craig Johnson
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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,
V. Seale Tiller
Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number K013421
Page 1 of 1
20 December 2001
Device Name: Lifeguard Nasal CPAP Mask
Indications for Use:
The Lifeguard Nasal CPAP mask is intended to be used to provide nasal CPAP, when used with devices that provided an exhalation port, devices that provide When about with devices that support the mask against the patient's face. The mask is intended for re-use by a single patient.
Prescription Use
(Per 21 CFR 801.109)
Division of Cardiovascular & Respiratory Devices
510(k) Number K01542
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).