HERITAGE NASAL CPAP SYSTEM, MODEL P/N 15682

{0}------------------------------------------------ # 510(K) SUMMARY ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ # SoftAire Nasal CPAP System Bird Products Corporation Tom Gutierrez P.E. Regulatory Compliance Engineer Bird Products Corporation 1100 Bird Center Drive Palm Springs, CA 92262-6267 760.778.7341 (voice) 760.778.7274 (fax) June 18, 1999 {1}------------------------------------------------ 510(k) Summary for the tem, page 2 of 4 ## General Information . . . Device Trade Name: SoftAire Nasal CPAP System #### Device Common/Classification Name: The SoftAire Nasal CPAP System is Bird Products Corporation ventilator classified under 73 BZD "Non-Continuous Ventilator" - · 868.5905 Non-Continuous Ventilator, 73 BZD | Predicate Device: | ResMed Sullivan III Nasal CPAP System<br>FDA 510(k) No: 930656 | |--------------------------|-----------------------------------------------------------------------------------------------------------------------------| | Year 2000 Compatibility: | The SoftAire Nasal CPAP System does not perform any date<br>calculation or processing and is therefore year-2000 compliant. | ### Device Description The SoftAire Nasal CPAP System is intended to provide continuous positive airway pressure for the care and treatment of individuals suffering from obstructive sleep apnea. The positive pressure is clinician adjustable within the designated operating range and a clinician adjustable timer will allow timed rise to pressure ("Ramp" mode). The user controls will be limited to an on/off switch and option of using the timed pressure rise. This product is designed to be used with a 22 millimeter (smooth bore) tube air delivery system and user selected nasal mask. This mask is not marketed by Bird. Power will be provided by AC to DC adapter s which accommodate a variety of input voltages and frequencies. This adapter will plug into a 12 VDC connector on the side of the unit. Image /page/1/Picture/12 description: The image shows a close-up of a black electrical box with a label on it. The label contains the model number 15682 and serial number KJTC00313. It also includes electrical requirements of 12VDC 2 amps and several warnings and cautions. The label also has several certification logos. Bottom View of SoftAire Nasal CPAP System {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows a close-up of a gas mask. The mask is black and has a boxy shape. Two corrugated tubes extend from the mask, one on each side. The tubes are also black and appear to be made of a flexible material. SoftAire Nasal CPAP System with tube and nasal mask. The SoftAire Nasal CPAP System does not utilize an actively controlled exhalation valve. The patient circuit consists of two essential parts: a large-bore tube from the ventilator to the patient and a required exhaust port. The exhaust is an orifice which may be part of the adapter between the tubing an the patient mask, or may be an orifice which is part of the patient mask. #### Electrical/Pneumatic System Image /page/2/Figure/5 description: This image is a block diagram of a system. The system includes a 100 PPI filter, a muffler, and a 12 VDC blower with a 22 MM outlet. The system also includes a power supply that can accept either 110 VAC or 220 VAC, a connector that is 2.5MM x 5.5MM, an electronic module, a user input, and a temp fuse. Flow to the patient is provided via 12 VDC Brushless Motor driving an impeller. Air intake passes through a filter and muffler into the motor, which operates at a preset speed established by the (clinical) operator. Patient tubing pressure is verified by an independent pressure measurement. An external 12-Volt power source supplies a 5-Volt regulator, which provides power to all interval components. The CPU runs at 4 MHz. There are 5 switches underneath the unit for Mode, Plus, Minus, "Ramp Mode On" and "Ramp Mode Off", {3}------------------------------------------------ #### Comparison to Predicate Device The SoftAire Nasal CPAP System is not significantly different from the predicate device, the ResMed Sullivan III Nasal CPAP, first cleared for market under 510(k) K930656. Both devices utilize Blower type flow generators with the Bird SoftAire Nasal CPAP having a maximum working pressure of 22cmH,O. ---- ### Summary of Performance Testing Performance testing was conducted in the laboratory to confirm operation compliance to the device specifications. Testing to Environmental, EMI/RFI and Electrical Safety Standards were performed by certified test facilities. The following table specifies all SoftAire Nasal CPAP functions. All functions were verified to operate as designed and intended, as denoted by the checkmark. | Specification | Requirement | | |------------------------------------------|--------------------------------------------------------------------------|---| | Adjustable Therapeutic<br>Pressure Range | 4-18 cmH2O. | ☑ | | Adjustable Beginning<br>Pressure Range | 4 and 18 cmH2O and below therapeutic range. | ☑ | | Pressure Accuracy | $\pm$ 10% to the nearest displayed digit (claibrated at 500ft elevation) | ☑ | | Timer | 0, 5, 10, 15, 20 minutes, $\pm$ 2 minutes | ☑ | | Input Voltage | 12 $\pm$ 10% VDC, 2A | ☑ | | Noise Level | < 38dB | ☑ | | Dimensions | 11X8X4 inches | ☑ | | Weight | 5.2 lb | ☑ | | Tubing | 6 ft, 22mm female connectors | ☑ | | Electrical Safety | EN 60601-1 | ☑ | | EMI/RFI | EN 60601-1-2 & Draft Reviewers Guidance for Ventilators 1995 | ☑ | | Environmental | IEC 68-2 | ☑ | | Operating Temperature | +10 to +40°C, 30 to 75% RH | ☑ | | Storage Temperature | -20 to +60°C, up to 95% RH | ☑ | Performance testing verified that the SoftAire Nasal CPAP meets all of it's performance requirements and that this device is substantially equivalent to medical devices currently legally marketed in the United States. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare, featuring a staff with a serpent entwined around it. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 1 1 2000 Mr. Tom Gutierrez Bird Products Corporation 1100 Bird Center Drive Palm Springs, CA 92262 Re: K990856 SoftAire Nasal CPAP System Regulatory Class: II (two) Product Code: 73 BZD Dated: October 13, 1999 Received: October 14, 1999 Dear Mr. Gutierrez: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 aqainst misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {5}------------------------------------------------ Page 2 - Mr. Tom Gutierrez This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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, Jeanroth W. Westerhausen for, Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ | Page | | of | | |-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----|--| | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | | | Acres of Children | l | 1 | | | | 1 | | | 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications for Use: The nasal CPAP unit is intended for treatment of adult Obstructive Sleep Apnea (OSA). Obstructive sleep apnea is defined as the absence of air movement for ten seconds during sleep. Obstructive sleep apnea is usually diagnosed by a sleep study. The study obtains the optimum level of pressure required to maintain an unobstructed airway, the positive pressure allows the is ve or prosuropen. The nasal CPAP unit is intended only for spontaneously breathing adult patients. #### (PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF REQUIRED) * ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ----------------------------------------------------------- Concurrence of CDRH, Office of Device Evaluation (ODE) Wutcherson (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K990856 510(k) Number ________________________________________________________________________________________________________________________________________________________________ Prescription Use ✓ OR Over-the-Counter Use (Per 21 CFR 801.109) ----------------------- (Optional format 1-2-96)