AMERICAN BANTEX HUMIDIFIER, DRY, BUBBLE, MODELS B9000, 3 PSI AND B9100, 6 PSI

{0}------------------------------------------------ # AMERICAN BANTEX CORPORATION 1815 Rollins Road Burlingame, California (650) 697 - 3545 (650) 697 - 3596 Tracy S. Best, Regulatory Affairs Consultant Preparation Date: July 10, 2004 ### Summary of Safety and Effectiveness for the: | Trade Name: | American Bantex Humidifier | |----------------------|--------------------------------------------------------------------------------------------| | Common Name: | Bubble Humidifier, Dry | | Classification Name: | Respiratory gas humidifier, 21 CFR 868.5450, 73BTT, Direct Patient<br>Interface - Class II | #### Legally Marketed Predicate Devices for Substantial Equivalence: *K991484 - Airlife Bubble Humidifier, Allegiance Healthcare Corporation Rationale for SE: The Airlife Bubble Humidifier is a Class II device that is intended to moisten the breathing gases that are delivered directly to the patient for breathing. This predicate device, along with the submitted device operate similarly by having the patient breathing gases pass through distilled water or sterile water in a refiliable plastic jar. Both devices are reusable for not more than 30 days. These are made from acrylic and polypropylene plastics and are intended for single patient use. The material types used in this and in the predicate devices are identical. The materials have previously been tested and accepted for biocompatibility and are widely accepted as industry material standards. Both the submitted device, and the predicate are latex free. ## Description of Submitted Device: The American Bantex Humidifier is device that provides humidity in a non-heated pathway. The American Bantex Humidifier works with most all Oxygen Concentrators or to an oxygen source used in homes, doctors' office, hospital or institutional environments. The inlet uses an easy-to-grab winged styled nut that universally adapts to most all gas connections. The outlet is a push-on standard medical tubing connector with a tapered end. The American Bantex Humidifier is equipped with either a 3 or 6-PS1 safety valve that will alarm if there is a kink or blockage in the delivery system. #### Intended Uses of the American Bantex Humidifier: The American Bantex Humidifier is intended for use with Oxygen Concentrators in a patients home, physicians office or hospital / institutional environment. The humidifier increases the moisture content of the airstream gases for administration to the patient. {1}------------------------------------------------ # Technological Characteristics and Substantial Equivalence: | Component: | American Bantex Humidifier | Airlife Bubble Humidifier | |----------------------|----------------------------|---------------------------| | Humidifier Bottle: | Clear polypropylene | Clear polypropylene | | Lid: | ABS | ABS | | Check valve and lid: | Brass / ABS | Brass / ABS | | Filter tube / bulb: | PVC / PVC | PVC / ABS | | 510(k) Approval | This submission | K991484 | Table I b: Comparison of American Bantex Humidifier to the predicate Airlife Bubble Humidifie The characteristics, method of operation, accessory use and single patient use are equivalent to that of the predicate device. Both have a double helix threaded jar that is impact resistant and seals easily. #### Conclusion: The successful testing demonstrated the device consistently performed within its design parameters, is as safe and effective, and performs as well as, or better than, the predicated device. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an emblem featuring a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it and wings at the top. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT 2 0 2004 American Bantex Corporation C/O Mr. Tracy S. Best Regulatory Affairs Consultant 994 North Main Street Bountiful, Utah 84010 Re: K041963 Trade/Device Name: American Bantex Humidifier Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: II Product Code: BTT Dated: October 4, 2004 Received: October 7, 2004 Dear Mr. Best: 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. {3}------------------------------------------------ Page 2 - Mr. Best 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) 276-0115. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Chiu 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 {4}------------------------------------------------ # Indications for Use 510(k) Number (if known): Device Name: AMERICAN BANTEX HUMIDIFIER Indications for Use: The American Bantex Humidifier is intended for use with oxygen concentrators or gas sources in a patients home, physicians office or hospital / institutional environment. The humidifier increases the moisture content of the airstream gases for administration directly to the patient. Single patient use only Non-sterile Prescription Use (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) Ques (Division Sian-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Device 510(k) Number. K041963 011 Page 1 of *_*_