(203 days)
Not Found
No
The device description and summary of performance studies do not mention any AI or ML components or capabilities. The device appears to be a standard CPAP system with basic controls and a microprocessor for regulating pressure.
Yes
Explanation: The device is intended for the treatment of Adult Obstructive Sleep Apnea (OSA) by providing continuous positive airway pressure, which directly addresses a medical condition to alleviate symptoms or improve health.
No
Explanation: The device is intended for the treatment of Obstructive Sleep Apnea (OSA) by providing continuous positive airway pressure, not for diagnosing the condition.
No
The device description explicitly states that the Pegasus™ consists of a plastic enclosure surrounding hardware components such as a power supply, impeller, motor, microprocessor, motor controller, display, and switch inputs. This indicates it is a physical device with integrated software, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Pegasus™ Nasal CPAP System Function: The Pegasus™ Nasal CPAP System is a therapeutic device. It delivers continuous positive airway pressure to treat Obstructive Sleep Apnea (OSA). It does not analyze any samples from the patient's body.
- Intended Use: The intended use clearly states "treatment of Adult Obstructive Sleep Apnea (OSA)". This is a therapeutic purpose, not a diagnostic one.
- Device Description: The description details the components involved in generating and delivering air pressure, not in analyzing biological samples.
Therefore, based on the provided information, the Pegasus™ Nasal CPAP System is a therapeutic device, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
BZD
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.
- 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway
Indicated Patient Age Range
Adult
Intended User / Care Setting
Clinician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
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.(b)
Classification. Class II (performance standards).
0
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: 714-283-2228
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.
A3-1
1
- 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.
2
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.
3
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 (301) 594-4646. 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,
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
4
Page __ 1_ of of 1 __
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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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)