(46 days)
Aladdin Monitoring Oxygen/Air Mixer is intended to mix and air and oxygen gases and provide the mixed gas at the prescribed oxygen concentration level via flowmeter (1 to 10 LPM). the device is intended for use within the hospital or institutional environment.
Aladdin Monitoring Oxygen/Air Mixer is intended to mix and air and oxygen gases and provide the mixed gas at the prescribed oxygen concentration level via flowmeter (1 to 10 LPM).
This document is a 510(k) premarket notification letter from the FDA to Hamilton Medical, Inc. for the Aladdin II Monitoring Oxygen/Air Mixer. It primarily discusses the regulatory classification and marketing authorization for the device. It does not contain information about acceptance criteria or a study proving the device meets those criteria, nor does it include details about device performance, sample sizes, ground truth establishment, or expert reviews as requested in the prompt.
Therefore, I cannot provide the requested information based on the given text. The text does not describe a study or device performance data.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure, represented by three overlapping profiles facing to the right. The profiles are black and have a flowing, abstract design. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 6 2002
Mr. Timothy Y. Cowart Hamilton Medical, Inc. 3371 Lenora Church Road Snellville, GA 30039
K990293 Re:
Aladdin II Monitoring Oxygen/Air Mixer Regulation Number: 868.5330 Regulation Name: Mixer, Breathing Gases, Anesthesia Inhalation Regulatory Class: II (two) Product Code: 73 BZR
Dear Mr. Cowart:
This letter corrects our substantially equivalent letter of March 16, 1999, regarding the Aladdin II Monitoring Oxygen/Air Mixer. Our letter identified the product code as 73 BZD. This is in error; the correct product code is 73 BZR as indicated above.
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.
{1}------------------------------------------------
Page 2 - Mr. Timothy Y. Cowart
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) 594-4648. 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" (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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Daula Talk
Bram D. Zuckerman, M.D.
Acting Director
Division of Cardiovascular and
Respiratory Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
{2}------------------------------------------------
Page 1 of 1
kg40293 510(k) Number (if known)
Device Name: Aladdin Monitoring Oxygen/Air Mixer
Indications for Use
CONFIDENTIAL
Aladdin Monitoring Oxygen/Air Mixer is intended to mix and air and oxygen gases and provide the mixed gas at the prescribed oxygen concentration level via flowmeter (1 to 10 LPM). the device is intended for use within the hospital or institutional environment.
(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
(Optional Format 1-2-96)
All A. Call
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K990293
6
{3}------------------------------------------------
K990293 510(k) Number (if known)______________________________________________________________________________________________________________________________________________________
Device Name: Aladdin Monitoring Oxygen/Air Mixer
Indications for Use:
CONFIDENTIAL
Aladdin Monitoring Oxygen/Air Mixer is intended to mix and oxygen gases and provide the mixed gas at the prescribed oxygen concentration level via flowmeter (1 to 10 LPM). the device is intended for use within the hospital or institutional environment.
(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 _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Ah. A. Cish.
(Division Sign-Off) Division of Cardiovascular. Respiratory, and Neurological Devices
4980293 510(k) Number ................................................................................................................................................................
§ 868.5330 Breathing gas mixer.
(a)
Identification. A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of gases that are to be breathed by a patient.(b)
Classification. Class II (performance standards).