APEX MEDICAL MININEB & MINIPLUS

K050104 · Apex Medical Corp. · CAF · Feb 16, 2005 · Anesthesiology

Device Facts

• Record ID: K050104
• Device Name: APEX MEDICAL MININEB & MINIPLUS
• Applicant: Apex Medical Corp.
• Product Code: CAF · Anesthesiology
• Decision Date: Feb 16, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 9R-02X Series, MiniNeb & MiniPlus are designed to provide a compressed air source to aerosolize physician-prescribed liquid medication when used in combination with the packaged Salter Labs 8900 series nebulizer, except for Pentamidine

Device Story

Device provides compressed air source for aerosolizing liquid medications; used with Salter Labs 8900 series nebulizer; excludes Pentamidine. Operated by clinicians or patients in home or clinical settings. Output is aerosolized medication for inhalation; assists in respiratory therapy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Compressed air nebulizer system; includes compressor unit and Salter Labs 8900 series nebulizer kit. Standalone device.

Indications for Use

Indicated for patients requiring aerosolized physician-prescribed liquid medication delivery via a compressed air source, excluding Pentamidine administration.

Regulatory Classification

Identification

A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three wing-like shapes, symbolizing health, services, and people. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

FEB 1 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Alan Chang Quality Assurance Regulatory Affairs Director Apex Medical Corporation No.9, Minsheng Street Tucheng City, Taipei County 236, TAIWAN (R.O.C)

Re: K050104

Trade/Device Name: 9R-02X Series, MiniNeb & MiniPlus Regulation Number: 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: February 5, 2005 Received: February 8, 2005

## 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 he 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. 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 or any I 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) rrarrarket notification. The FDA finding of substantial equivalence of your device to a legally premated 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-_. 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,

Quitte H. Michie MD,

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

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: 9R-02X Series, MiniNeb & MiniPlus

Indications for Use:

The 9R-02X Series, MiniNeb & MiniPlus are designed to provide a compressed air

source to aerosolize physician-prescribed liquid medication when used in combination

with the packaged Salter Labs 8900 series nebulizer, except for Pentamidine

Prescription Use x ___________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR Over-The-Counter Use __ (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)

Cree Taylor

vision Sign-Off)
mision of Anesthesiology, General Hospital,
Infection Controi, Dental Devices
510(k) Number: K050104

Page 1 of 1