(302 days)
Not Found
No
The device description and performance summary focus on basic CPAP functionality, clinician-adjustable settings, and compliance with standards. There is no mention of AI, ML, or any features that would suggest adaptive algorithms or data-driven decision making beyond simple timed pressure rise.
Yes.
The device is intended for the treatment of adult Obstructive Sleep Apnea (OSA) by providing continuous positive airway pressure (CPAP), which is a therapeutic intervention.
No
The device is a CPAP unit intended for treatment of Obstructive Sleep Apnea (OSA) by providing positive airway pressure, not for diagnosing the condition. Diagnosis of OSA is stated to be done via a sleep study.
No
The device description clearly outlines physical components such as a nasal CPAP unit, a 22 millimeter tube air delivery system, a nasal mask, an AC to DC adapter, and a 12 VDC connector. These are hardware components, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The SoftAire Nasal CPAP System is a device that provides continuous positive airway pressure to treat Obstructive Sleep Apnea. It works by physically delivering air pressure to the patient's airway.
- Lack of Sample Analysis: The description does not mention the device analyzing any biological samples from the patient. Its function is purely mechanical/pneumatic.
Therefore, the device's purpose and mechanism of action clearly fall outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The nasal CPAP unit 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 by a sleep study. The study obtains the optimum level of pressure required to maintain an unobstructed airway, the positive pressure allows the is ve or prosuropen. The nasal CPAP unit is intended only for spontaneously breathing adult patients.
Product codes
73 BZD
Device Description
The SoftAire 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 designated operating range and a clinician adjustable timer will allow timed rise to pressure ("Ramp" mode). The user controls will be limited to an on/off switch and option of using the timed pressure rise. This product is designed to be used with a 22 millimeter (smooth bore) tube air delivery system and user selected nasal mask. This mask is not marketed by Bird.
Power will be provided by AC to DC adapter s which accommodate a variety of input voltages and frequencies. This adapter will plug into a 12 VDC connector on the side of the unit.
The SoftAire Nasal CPAP System does not utilize an actively controlled exhalation valve. The patient circuit consists of two essential parts: a large-bore tube from the ventilator to the patient and a required exhaust port. The exhaust is an orifice which may be part of the adapter between the tubing an the patient mask, or may be an orifice which is part of the patient mask.
Flow to the patient is provided via 12 VDC Brushless Motor driving an impeller. Air intake passes through a filter and muffler into the motor, which operates at a preset speed established by the (clinical) operator. Patient tubing pressure is verified by an independent pressure measurement.
An external 12-Volt power source supplies a 5-Volt regulator, which provides power to all interval components. The CPU runs at 4 MHz. There are 5 switches underneath the unit for Mode, Plus, Minus, "Ramp Mode On" and "Ramp Mode Off",
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
Not Found
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 operation compliance to the device specifications. Testing to Environmental, EMI/RFI and Electrical Safety Standards were performed by certified test facilities. All functions were verified to operate as designed and intended.
Key results:
Adjustable Therapeutic Pressure Range: 4-18 cmH2O.
Adjustable Beginning Pressure Range: 4 and 18 cmH2O and below therapeutic range.
Pressure Accuracy: +/- 10% to the nearest displayed digit (claibrated at 500ft elevation)
Timer: 0, 5, 10, 15, 20 minutes, +/- 2 minutes
Input Voltage: 12 +/- 10% VDC, 2A
Noise Level:
§ 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
510(K) SUMMARY
SoftAire Nasal CPAP System
Bird Products Corporation
Tom Gutierrez P.E. Regulatory Compliance Engineer Bird Products Corporation 1100 Bird Center Drive Palm Springs, CA 92262-6267
760.778.7341 (voice) 760.778.7274 (fax)
June 18, 1999
1
510(k) Summary for the tem, page 2 of 4
General Information
. . .
Device Trade Name: SoftAire Nasal CPAP System
Device Common/Classification Name:
The SoftAire Nasal CPAP System is Bird Products Corporation ventilator classified under 73 BZD "Non-Continuous Ventilator"
- · 868.5905 Non-Continuous Ventilator, 73 BZD
| Predicate Device: | ResMed Sullivan III Nasal CPAP System
FDA 510(k) No: 930656 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Year 2000 Compatibility: | The SoftAire Nasal CPAP System does not perform any date
calculation or processing and is therefore year-2000 compliant. |
Device Description
The SoftAire 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 designated operating range and a clinician adjustable timer will allow timed rise to pressure ("Ramp" mode). The user controls will be limited to an on/off switch and option of using the timed pressure rise. This product is
designed to be used with a 22 millimeter (smooth bore) tube air delivery system and user selected nasal mask. This mask is not marketed by Bird.
Power will be provided by AC to DC adapter s which accommodate a variety of input voltages and frequencies. This adapter will plug into a 12 VDC connector on the side of the unit.
Image /page/1/Picture/12 description: The image shows a close-up of a black electrical box with a label on it. The label contains the model number 15682 and serial number KJTC00313. It also includes electrical requirements of 12VDC 2 amps and several warnings and cautions. The label also has several certification logos.
Bottom View of SoftAire Nasal CPAP System
2
Image /page/2/Picture/1 description: The image shows a close-up of a gas mask. The mask is black and has a boxy shape. Two corrugated tubes extend from the mask, one on each side. The tubes are also black and appear to be made of a flexible material.
SoftAire Nasal CPAP System with tube and nasal mask.
The SoftAire Nasal CPAP System does not utilize an actively controlled exhalation valve. The patient circuit consists of two essential parts: a large-bore tube from the ventilator to the patient and a required exhaust port. The exhaust is an orifice which may be part of the adapter between the tubing an the patient mask, or may be an orifice which is part of the patient mask.
Electrical/Pneumatic System
Image /page/2/Figure/5 description: This image is a block diagram of a system. The system includes a 100 PPI filter, a muffler, and a 12 VDC blower with a 22 MM outlet. The system also includes a power supply that can accept either 110 VAC or 220 VAC, a connector that is 2.5MM x 5.5MM, an electronic module, a user input, and a temp fuse.
Flow to the patient is provided via 12 VDC Brushless Motor driving an impeller. Air intake passes through a filter and muffler into the motor, which operates at a preset speed established by the (clinical) operator. Patient tubing pressure is verified by an independent pressure measurement.
An external 12-Volt power source supplies a 5-Volt regulator, which provides power to all interval components. The CPU runs at 4 MHz. There are 5 switches underneath the unit for Mode, Plus, Minus, "Ramp Mode On" and "Ramp Mode Off",
3
Comparison to Predicate Device
The SoftAire Nasal CPAP System is not significantly different from the predicate device, the ResMed Sullivan III Nasal CPAP, first cleared for market under 510(k) K930656. Both devices utilize Blower type flow generators with the Bird SoftAire Nasal CPAP having a maximum working pressure of 22cmH,O.
Summary of Performance Testing
Performance testing was conducted in the laboratory to confirm operation compliance to the device specifications. Testing to Environmental, EMI/RFI and Electrical Safety Standards were performed by certified test facilities. The following table specifies all SoftAire Nasal CPAP functions. All functions were verified to operate as designed and intended, as denoted by the checkmark.
| Specification | Requirement | |
|---|---|---|
| Adjustable Therapeutic | ||
| Pressure Range | 4-18 cmH2O. | ☑ |
| Adjustable Beginning | ||
| Pressure Range | 4 and 18 cmH2O and below therapeutic range. | ☑ |
| Pressure Accuracy | $\pm$ 10% to the nearest displayed digit (claibrated at 500ft elevation) | ☑ |
| Timer | 0, 5, 10, 15, 20 minutes, $\pm$ 2 minutes | ☑ |
| Input Voltage | 12 $\pm$ 10% VDC, 2A | ☑ |
| Noise Level |