PEGASUS NASAL CPAP SYSTEM

K022192 · Sensor Medics Corp. · BZD · Jan 24, 2003 · Anesthesiology

Device Facts

• Record ID: K022192
• Device Name: PEGASUS NASAL CPAP SYSTEM
• Applicant: Sensor Medics Corp.
• Product Code: BZD · Anesthesiology
• Decision Date: Jan 24, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pegasus™ Nasal CPAP System is intended for treatment of Adult 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 Pegasus™ Nasal CPAP System is intended only for spontaneously breathing patients.

Device Story

Pegasus™ Nasal CPAP System provides regulated, continuous positive airway pressure to treat adult Obstructive Sleep Apnea. Device consists of plastic enclosure housing power supply, brushless DC motor/impeller, microprocessor, motor controller, display, and user controls. Clinician adjusts pressure; user interface includes membrane switches for mode/pressure settings and 4-digit LED display for pressure readout/bar graph. Device connects to 22mm air delivery hose and patient-selected mask. Used in clinical or home settings; operated by patient or clinician. Remote titration possible via RS-232 port. Microprocessor monitors and controls motor speed to maintain prescribed pressure, keeping airway open during sleep. Benefits include improved airway patency for OSA patients.

Clinical Evidence

Bench testing only. Laboratory performance testing confirmed compliance with device specifications, including pressure regulation accuracy. Electrical safety and electromagnetic compatibility testing performed by a Nationally Recognized Testing Laboratory (NRTL) confirmed compliance with international standards.

Technological Characteristics

Plastic enclosure; 24-VDC brushless motor; 16-bit Microchip microcontroller (16K program space, 1536 bytes RAM, 256 bytes EEPROM, 4.0 MHz); Motorola MC33035 motor controller; 4-digit 7-segment LED display; 6 membrane push-button switches; RS-232 port for remote titration; 90-260 VAC power supply. Connectivity: Wired RS-232. Software: Embedded firmware.

Indications for Use

Indicated for treatment of adult patients with Obstructive Sleep Apnea (OSA) who are 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

• Bird Products Corporation Orion (K020730)
• Resprionics Remstar Pro (K993307)
• Resmed S6 Elite (K930656)

Submission Summary (Full Text)

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JAN 2 4 2003

KÖZZ192

## Summary of Safety and Effectiveness

Date of Preparation: July 1, 2002

- Submitter: SensorMedics Corporation 22705 Savi Ranch Parkway Yorba Linda, CA 92887
- Contact: Paul L. Kittinger Telephone: [phone]

## Device Trade Name: Peqasus™ Nasal CPAP System

Device Common/Classification Name: The Pegasus™ Nasal CPAP System is a SensorMedics Corporation device classified under 73 BZD, "Non-Continuous Ventilator, per Requlation No. 868.5905.

Predicate Devices: The Bird Products Corporation Orion, the Resprionics Remstar Pro, and the Resmed S6 Elite Nasal CPAP Systems.

Intended Use: The Pegasus™ Nasal CPAP System is intended for treatment of Adult 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 Pegasus™ Nasal CPAP System is intended only for spontaneously breathing patients.

Device Description: The Pegasus™ Nasal CPAP System is intended to provide a requlated and continuous positive airway pressure for the treatment of adult individuals suffering from obstructive sleep apnea (OSA). The positive pressure is clinicianadiustable within the designed operating range, as is enabling of the bar graph pressure indicator mode. User controls are On/Off switch, selecting the physician-enabled bar graph, viewing the real-time clock and setting of the real-time clock. The Pegasus™ is designed to be used with a 22-millimeter, smooth-bore air delivery hose and user- or physician-selected nasal or face mask. The Pegasus™ consists of a plastic enclosure that surrounds a power supply, impeller and motor, microprocessor, motor controller, display and switch inputs.

Input Power Supply: 90-260 VAC, 50-6- Hz

Motor & Impeller: Papst 24-VDC brushless motor

- Microprocessor: 16-bit Microchip microcontroller with 16K of program space, 1536 bytes of RAM, 256 bytes of eeprom and running at 4.0 mHz.
- Motor Controller: Motorola MC33035 controller for brushless D.C. motor. operating from 10 to 30 Vdc.
- Pressure Readout Display: 4-digit, 7-segment display controlled by the microprocessor. The digits are multiplexed so that only one digit is on at a time. The 4-digits provide a quantitative, numerical readout of the delivered pressure, and their vertical seqments provide and indicatortype bar graph display of the delivered pressure.

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- Switch Inputs: There are 6 membrane push-button switches used for input of Mode. Plus and Minus pressure, Rise to Pressure On, Rise to Pressure Off And Real-time Clock for compliance.
Titration: Remote access via RS-232 port for setting or changing Titration.

Comparison to Predicate Devices: The Pegasus™ Nasal CPAP System is primarily similar to the Bird Orion Nasal CPAP System [510(k) No. K020730], but incorporates improved requlation of the delivered pressure as in two other devices, the Resprionics Remstar Pro [current version of the Aria LX, 510(k) No. K993307] and the Resmed S6 Elite [current version of the Sullivan III, 510(k) No. K930656].

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 Pegasus complied with the requirements of these standards.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized symbol resembling a bird or abstract human figure, composed of three curved lines. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 4 2003

Mr. Paul Kittinger Manager, Regulatory Affairs SenorMedics Corporation 22705 Savi Ranch Parkway Yorba Linda, California 92887

Re: K022192

Trade/Device Name: Pegasus™ Nasal CPAP System Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator Regulatory Class: II Product Code: BZD Dated: October 28, 2002 Received: October 29, 2002

Dear Mr. Kittinger:

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. Kittinger

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 (OS) 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 vour 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,

Susan-Ramirez

Susan Runner, DDS, MA Interim 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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## 510(k) Number (if known): K022192

Device Name: Pegasus™ Nasal CPAP System

Indications For Use:

The Pegasus™ Nasal CPAP System is intended for treatment of Adult Obstructive Sleep Apnea (OSA). The Pegasus™ Nasal CPAP System is intended only for spontaneously breathing patients.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental De

510(k) Number: K071912

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)