(203 days)
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.
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.
Acceptance Criteria and Device Performance Study
The provided document describes the Pegasus™ Nasal CPAP System and its safety and effectiveness summary for 510(k) clearance.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a table format. However, it implicitly defines acceptance based on compliance with device specifications and internationally accepted standards.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Compliance to device specifications | "all functions were verified to operate as designed and intended, and measured parameters met required ranges and accuracies." |
| Electrical safety standards compliance | "The Pegasus complied with the requirements of these standards." (Internationally accepted standards for electrical safety) |
| Electro-magnetic compatibility (EMC) standards compliance | "The Pegasus complied with the requirements of these standards." (Internationally accepted standards for electro-magnetic compatibility) |
2. Sample Size and Data Provenance
The document states "Performance testing was conducted in the laboratory." It does not specify a distinct "test set" in terms of subject or patient data. The testing appears to be based on evaluating the device's functional performance against its specifications and relevant standards.
- Sample Size for Test Set: Not applicable as the testing described is functional and compliance-based, not involving a patient test set.
- Data Provenance: Not applicable. The testing was laboratory-based.
3. Number and Qualifications of Experts for Ground Truth
- Number of Experts: Not applicable. The ground truth for this type of device (functional performance, electrical safety, EMC) is established through engineering and regulatory standards, not expert clinical consensus on patient data.
- Qualifications of Experts: The testing was performed by a "Nationally Recognized Testing Laboratory (NRTL)," implying qualified engineers and technicians experienced in electrical safety and EMC testing conducted the evaluation.
4. Adjudication Method
- Adjudication Method: Not applicable. The nature of the performance testing (functional compliance, electrical/EMC standards) does not involve adjudication of expert opinions.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a multi-reader multi-case comparative effectiveness study was not done. This device is a therapeutic device (CPAP system), not an diagnostic imaging or AI-driven interpretive system that would typically involve human readers.
6. Standalone (Algorithm Only) Performance
- Standalone Performance: Not applicable. The Pegasus™ Nasal CPAP System is a hardware device with embedded software for control, not a standalone algorithm/AI system in the sense of predictive or interpretive software. Its "performance" refers to its physical functioning and adherence to engineering specifications.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth used was based on device specifications and internationally accepted standards for electrical safety and electro-magnetic compatibility.
8. Sample Size for Training Set
The document does not mention a "training set" as it is typically understood in the context of machine learning or AI models. This device is a hardware-based medical device.
- Sample Size for Training Set: Not applicable.
9. How Ground Truth for Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable.
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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: 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.
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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 (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
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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.
(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)
§ 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).