(90 days)
HumidCare Heated Humidifier is for use with Apex Medical Corp.'s CPAP 9S-003 system. It is designed to increase the humidity of the air from the CPAP thereby relieving the symptoms of a dry nose and throat that some people may experience.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a device called "HumidCare Heated Humidifier." This document does not contain information regarding acceptance criteria or a study proving the device meets those criteria. It is a regulatory approval letter that confirms substantial equivalence to a predicate device.
Therefore, I cannot extract the requested information.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Alan Chang Management Representative/Director of President Office Apex Medical Corporation No. 9, Min Sheng Street, Tucheng City Taipei County 236, TAIWAN, R.O.C.
DEC - 6 2006
Re: K062664
Trade/Device Name: HumidCare Heated Humidifier Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: II Product Code: BTT Dated: November 7, 2006 Received: November 9, 2006
Dear Mr. Chang:
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. Chang
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,
Clu C
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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Indications for Use
510(k) Number (if known): 062664
HumidCare Heated Humidifier Device Name:
HumidCare Heated Humidifier is for use with Apex Medical Indications for Use:
Corp.'s CPAP 9S-003 system. It is designed to increase the humidity of the air from the
CPAP thereby relieving the symptoms of a dry nose and throat that some people may
experience.
Prescription Use _ x (Part 21 CFR 801 Subpart D)
Over-The-Counter Use __ AND/OR (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Qul
1 Sen-Cin of Anesthesiology, General Hospital, n Control, Dental Devic
KOLLEGE
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2006/8/8
§ 868.5450 Respiratory gas humidifier.
(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(b)
Classification. Class II (performance standards).