(42 days)
The Pro-Flow MultiPurpose Cannula may be intended for use for simultaneous detection of respiratory airflow and sampling, or delivery, of gases, such as EtC02 or oxygen.
Not Found
The provided text is a 510(k) premarket notification approval letter for a medical device (Pro-Flow MultiPurpose Cannula), along with its indication for use. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert involvement, or any of the detailed study parameters requested in the prompt.
Therefore, I cannot provide the requested information based on the input text. The document confirms that the device is substantially equivalent to a legally marketed predicate device but does not include any performance data or a description of a study.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling three stylized human figures or birds in flight, stacked on top of each other.
Public Health Service
DEC 1 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Neil Sheller Pro-Tech Services, Incorporated 4338 Harbour Pointe Boulevard, S.W. Mukilteo, Washington 98275
Re: K053063
Trade/Device Name: Pro-Flow MultiPurpose Cannula Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK Dated: October 20, 2005 Received: November 3, 2005
Dear Mr. Sheller:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the received above and have and have a molosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device merslate commerce prior to way to was reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket the I cuclar I vou, Drag, and Osbu may, therefore, market the device, subject to the general approval uppreadion (The Act. The general controls provisions of the Act include controls providens of an 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 If your device is classified (oos assile) in a controls. Existing major regulations affecting (1 Mr), it may of subject to the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear of toundsh further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Sheller
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. or the rice of any a with all the Act's requirements, including, but not limited to: registration 1 od into compry 7 11 CFR Part 801); labeling (21 CFR Part 801); good manufacturing practice and ifsing (s 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) rrent reter 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), n from and 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 maj obtain 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/industry/support/index.html.
Sincerely yours,
Cluts
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
Enclosure
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510(k) Number (if known): K053063
Device Name: Pro-Flow MultiPurpose Cannula
Indication for Use:
indocuses not of the may be intended for use for simultaneous detection of respiratory airflow
MultiPurpose of the county as a such as EfC02 or oxygen Pro-Flow MultiPurpose - Cannalde are International and sampling, or oxygen.
and sampling, or delivery, of gases, such as EtC02 or oxygen.
Prescription Use ____________ Over-The-Counter Use_________________________________________________________________________
(Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
(Posted July 1, 1998)
Arny Safram
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental B 510(k) Number:
§ 868.1400 Carbon dioxide gas analyzer.
(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).