APEX MEDICAL CPAP MODEL 9S-003

K041828 · Apex Medical Corp. · BZD · Jul 30, 2004 · Anesthesiology

Device Facts

• Record ID: K041828
• Device Name: APEX MEDICAL CPAP MODEL 9S-003
• Applicant: Apex Medical Corp.
• Product Code: BZD · Anesthesiology
• Decision Date: Jul 30, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is intended to provide continuous positive airway pressure (CPAP) for the treatment of adult obstructive sleep apnea (OSA).

Device Story

Apex Medical CPAP Model 9S-003 provides continuous positive airway pressure to treat adult obstructive sleep apnea. Device operates by delivering pressurized air to patient airway via mask interface; maintains pneumatic splint to prevent airway collapse during sleep. Used in home or clinical settings under physician prescription. Output consists of regulated airflow; healthcare providers use device to manage OSA symptoms and improve patient sleep quality. Device functions as noncontinuous ventilator.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Noncontinuous ventilator (IPPB); CPAP delivery system. Class II device. Technical specifications and materials not detailed in provided documentation.

Indications for Use

Indicated for adult patients diagnosed with obstructive sleep apnea (OSA) requiring continuous positive airway pressure therapy. Prescription use only.

Regulatory Classification

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.

Submission Summary (Full Text)

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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 0 2004

Mr. Alan Chang Quality Assurance Director Apex Medical Corporation 9. Min Sheng Street Tu-Cheng. Taipei County, 236 TAIWAN, R.O.C.

Re: K041828

Trade/Device Name: Apex Medical CPAP Model 9S-003 Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: July 1, 2004 Received: July 7, 2004

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 mour that I D. Fine has or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not I vartal 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 110(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/dsma/dsmamain.html

Sincerely yours,

Chin Lin, Ph.D.

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): __

CPAP 9S-003 Device Name:

Indications for Use:

This device is intended to provide continuous positive airway pressure (CPAP) for the treatment of adult obstructive sleep apnea (OSA).

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ Prescription Use ___ x _______________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D) (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)

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Ouen Sylevan

(Division Sign-OK Division of Anesthesiology, General Hospital, Infection Control, Dental

510(k) Number: