ORION NASAL CPAP SYSTEM

K020730 · Bird Products Corp. · BZD · May 22, 2002 · Anesthesiology

Device Facts

• Record ID: K020730
• Device Name: ORION NASAL CPAP SYSTEM
• Applicant: Bird Products Corp.
• Product Code: BZD · Anesthesiology
• Decision Date: May 22, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Orion Nasal CPAP System 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 through a sleep study. The study obtains the optimum level of pressure required to maintain airway pressure to the obstructed airway. The positive pressure allows the airway to stay open. The Orion CPAP System is intended only for spontaneously breathing patients.

Device Story

Orion Nasal CPAP System provides continuous positive airway pressure to treat obstructive sleep apnea; intended for spontaneously breathing patients. Device consists of plastic enclosure housing power supply, brushless DC motor/impeller, microprocessor, motor controller, display, and membrane switches. Clinician adjusts pressure settings and optional timed rise to set pressure. Device connects to 22mm smooth-bore air delivery hose and user-selected nasal or face mask. Microprocessor manages motor speed and display output. Used in clinical or home settings to maintain airway patency during sleep; helps prevent airway collapse. Healthcare provider uses sleep study data to determine optimal pressure settings; patient uses device during sleep to alleviate apnea symptoms.

Clinical Evidence

Bench testing only. Laboratory performance testing confirmed compliance with device specifications, including pressure ranges and accuracies. Electrical safety and electromagnetic compatibility testing performed by an NRTL confirmed compliance with international standards.

Technological Characteristics

System includes 24 Vdc brushless motor, 8-bit microcontroller (4.0 mHz), and Motorola MC33035 motor controller. Power input 90-260 Vac. User interface features 4-digit multiplexed display and 5 membrane push-button switches. Designed for use with 22mm smooth-bore air delivery hose. Enclosure is plastic. Operates via microprocessor-controlled motor speed to maintain set pressure.

Indications for Use

Indicated for adult patients with Obstructive Sleep Apnea (OSA) who are spontaneously breathing. Contraindicated for patients who are not spontaneously breathing.

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.

Predicate Devices

• Softaire/Alura Nasal CPAP System (K990856)

Submission Summary (Full Text)

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KC20730

## Summary of Safety and Effectiveness

Date of Preparation: March 4, 2002

Submitter: Bird Products Corporation 1100 Bird Center Drive Palm Springs, CA 92262

Earl Draper Contact: Telephone: [phone]

Device Trade Name: Orion Nasal CPAP System

Device Common/Classification Name: The Orion Nasal CPAP System is a Bird Products Corporation device classified under 73 BZD, "Non-Continuous Ventilator, per Regulation No. 868.5905.

Predicate Device: The Bird Products Corporation Softaire/Alura Nasal CPAP System

Intended Use: The Orion Nasal CPAP System is intended for treatment of Obstructive Sleep Apnea (OSA). Obstructive Sleep Apnea is defined as the absence of air movement in ten seconds during sleep. Obstructive Sleep Apnea is usually diagnosed through a sleep study. The study obtains the optimum level of pressure required to maintain airway pressure to the obstructed airway. The positive pressure allows the airway to stay open. The Orion Nasal CPAP System is intended only for spontaneously breathing patients.

Device Description: The Orion 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 designed operating range, and a clinicianadjustable time allows at timed rise to the set pressure. The user controls are limited to an On/Off switch and the optional pre-set time rise to the set pressure. This device is designed to be used with a 22-millimeter, smooth-bore air delivery hose and user-selected nasal or face mask. The Orion consists of a plastic enclosure that surrounds a power supply, impeller and motor, microprocessor, motor controller, display and switch inputs.

Power Supply Input Voltage: 90-260 Vac

Motor & Impeller: Papst 24 Vdc brushless motor

- Microprocessor: 8-bit micro-controller with 8K of program space and 368 bytes of RAM, running at 4.0 mHz.
- Motor Controller: Motorola MC33035 controller for brushless D.C. motor, operating from 10 to 30 Vdc.
- Display: Four-digit display controlled by the microprocessor; digits are multiplexed so that only one digit is on at a time.
- Switch Inputs: There are 5 membrane push-button switches used for input of Mode, Plus and Minus pressure, Rise to Pressure On, and Rise to Pressure Off.

Comparison to Predicate Device: The Orion Nasal CPAP System is not significantly different from the predicate device, the Softaire/Alura Nasal CPAP System as cleared for market under 510(k) 990856.

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Summary of Performance Testing: Performance testing was conducted in the laboratory to confirm compliance to device specifications; all functions were verified to operate as designed and intended, and measured parameters met required ranges and accuracies. Testing to internationally accepted standards for electrical safety and electro-magnetic compatibility were performed by a Nationally Recognized Testing Laboratory (NRTL); the Orion complied with the requirements of these standards.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850

**MAY 22 2002**

Mr. Earl Draper Bird Products Corp. 1100 Bird Center Drive Palm Springs, CA 92262

Re: K020730

Orion Nasal CPAP System Regulation Number: 868.5905 Regulation Name: Non-continuous ventilator Regulatory Class: Class II (two) Product Code: BZD Dated: May 7, 2002 Received: May 13, 2002

Dear Mr. Draper:

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. Earl Draper

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) 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Dakota Tell

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): Ko20730

Device Name: Orion Nasal CPAP System .

Indications For Use:

The Orion Nasal CPAP System 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 through a sleep study. The study obtains the optimum level of pressure required to maintain airway pressure to the obstructed airway. The positive pressure allows the airway to stay open. The Orion CPAP System is intended only for spontaneously breathing patients.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K020730

Prescription Use " (Per21 CFR8O1.109)

OR

Over-The-Counter Use _

(Optional Format 1-2-96).