HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004

K062664 · Apex Medical Corp. · BTT · Dec 6, 2006 · Anesthesiology

Device Facts

• Record ID: K062664
• Device Name: HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004
• Applicant: Apex Medical Corp.
• Product Code: BTT · Anesthesiology
• Decision Date: Dec 6, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

HumidCare Heated Humidifier; accessory to Apex Medical Corp. CPAP 9S-003 system. Device increases humidity of air delivered by CPAP to patient. Used to alleviate dry nose and throat symptoms associated with CPAP therapy. Operated by patient in home or clinical setting. Device integrates with CPAP airflow to provide moisture.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Respiratory gas humidifier; heated design; intended for use with CPAP 9S-003 system. Class II device; Product Code BTT.

Indications for Use

Indicated for patients using the Apex Medical Corp. CPAP 9S-003 system to increase air humidity and relieve symptoms of dry nose and throat.

Regulatory Classification

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.

Submission Summary (Full Text)

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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 & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular pattern around the caduceus.

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 [phone]. 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 [phone] or [phone] 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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