(77 days)
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.
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.
Here's an analysis of the provided text regarding the Orion Nasal CPAP System's acceptance criteria and studies, organized according to your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Functional Performance | All functions operate as designed and intended. | Verified; all functions operated as designed and intended. |
| Measured parameters meet required ranges and accuracies. | Verified; measured parameters met required ranges and accuracies. | |
| Electrical Safety | Compliance with internationally accepted standards. | Complied with the requirements of internationally accepted standards for electrical safety (tested by NRTL). |
| Electro-Magnetic Compatibility (EMC) | Compliance with internationally accepted standards. | Complied with the requirements of internationally accepted standards for electro-magnetic compatibility (tested by NRTL). |
| Substantial Equivalence (General) | Not significantly different from a predicate device. | Determined to be substantially equivalent to the Bird Products Corporation Softaire/Alura Nasal CPAP System (K990856). |
| Intended Use | For treatment of Obstructive Sleep Apnea (OSA) in adults. | System is intended for this use. |
| Applies to spontaneously breathing patients. | System is intended for this type of patient. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify a sample size or data provenance (e.g., country of origin, retrospective/prospective) for any test set involving patients or clinical data. The performance testing described is limited to laboratory verification of device functions and compliance with engineering and safety standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Given that the performance testing was laboratory-based and focused on engineering specifications and safety standards, there is no mention of experts establishing a "ground truth" in a clinical sense for a test set. The "ground truth" here would be the engineering specifications and international standards, which are evaluated through direct measurement and compliance testing.
4. Adjudication Method for the Test Set
As the testing was primarily laboratory-based and focused on objective measurements against engineering specifications and international standards, an adjudication method is not applicable in the context of clinical evaluation or expert consensus. Compliance was determined by direct measurement and verification.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or reported. The provided information solely pertains to the device's functional performance, electrical safety, and EMC in a laboratory setting, and its substantial equivalence to a predicate device. There is no mention of human readers or AI assistance in the context of this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
No, a standalone study describing the performance of an algorithm without human-in-the-loop interaction was not done or reported. The Orion Nasal CPAP System is a hardware device, not an AI or algorithmic diagnostic tool.
7. The Type of Ground Truth Used
The "ground truth" used for the reported performance testing was primarily engineering specifications and internationally accepted standards for electrical safety and electromagnetic compatibility. This is demonstrated by statements like "all functions were verified to operate as designed and intended, and measured parameters met required ranges and accuracies" and "the Orion complied with the requirements of these standards."
8. The Sample Size for the Training Set
The provided text does not mention a training set sample size. This is because the device described is a physical medical device (CPAP machine) and not an AI or machine learning model that would require a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set, the question of how its ground truth was established is not applicable to this device submission.
{0}------------------------------------------------
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: 714-283-2228
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.
{1}------------------------------------------------
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.
{2}------------------------------------------------
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.
{3}------------------------------------------------
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 (301) 594-4646. 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" (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 (800) 638-2041 or (301) 443-6597 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
{4}------------------------------------------------
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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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).
§ 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).