(86 days)
No
The description focuses on the mechanical and acoustical design of the humidifier, with no mention of AI or ML algorithms for control or analysis.
No.
The device is described as an accessory to CPAP and BiPAP systems, providing moisture to the patient circuit. It does not directly treat a medical condition.
No
The device is a humidifier designed to provide moisture to a patient's breathing circuit for CPAP/BiPAP systems. Its function is to moisturize air, not to diagnose a medical condition.
No
The device description clearly outlines physical components (lid, reservoir, gasket, tubing, latches, ports) and their materials (plastic), indicating it is a hardware device.
Based on the provided text, the Oasis Humidifier is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to provide moisture to a patient circuit for CPAP and BiPAP systems. This is a therapeutic function related to respiratory support, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a humidifier with a reservoir, tubing, and ports for connecting to a pressure-generating unit and patient circuit. This aligns with a device used for delivering humidified air, not for analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is clearly described as an accessory for respiratory therapy devices.
N/A
Intended Use / Indications for Use
The Oasis Humidifier is an accessory for Respironics CPAP and BiPAP systems to provide moisture to the patient circuit. The Oasis is the only humidifier with the acoustical design that enables effective operation of Respironics' Auto-CPAP mode. As such, it is the only humidifier that can be used with Respironics' Auto-CPAP products (i.e., Virtuoso Smart CPAP System (K953930) and Quartet Clinical System (K963761, currently under review)). The Oasis can also be used with standard CPAP devices from other manufacturers which have maximum operating pressures of 20 cm H2O, and do not have bi-level or automatic pressure titration capabilities. Performance of non-Respironics CPAP systems with the Oasis humidifier should be verified before use.
Product codes (comma separated list FDA assigned to the subject device)
73BTT
Device Description
The Oasis Humidifier (Figure 12-1) consists of a top ("lid"), bottom ("reservoir"), gasket, and a 24" reusable flexible tube that connects the Oasis to the pressuregenerating unit (Respironics CPAP or BiPAP unit). The lid and reservoir are held together by four release latches. The latches are connected to the reservoir.
The Oasis has an inlet port and an outlet port on its lid. The inlet port is on the top of the lid. The inlet port is where water is poured into the reservoir and where flexible tube connects the Oasis to the pressure-generating unit. The outlet port is on the front of the lid. (The six-foot patient circuit tubing is attached to the Oasis outlet port.) A J-shaped tube molded in the top of this lid is an acousticallytuned passage. This passage gives the Oasis the acoustical characteristics that enable effective operation of Respironics' Auto-CPAP mode. As such, it allows the Oasis to be used as an accessory for Respironics' Auto-CPAP devices.
The inlet port's 26 mm outside diameter corresponds with the larger end of the 24" flexible tubing (26 mm inside diameter). The smaller end of the tubing -- 22 mm inside diameter -- connects to the outlet port of the pressure-generating unit. Refer to K945782 for complete information on the 24" flexible tubing.
The Oasis (excluding the gasket) is made of dishwasher-safe plastic.
Mentions image processing
No
Mentions AI, DNN, or ML
No
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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)
Testing was performed to demonstrate that the performance of the Oasis Humidifier in its intended environment is as safe and effective as that of the legally marketed predicate device. The safety and effectiveness of the Oasis Humidifier was verified through performance related Environmental Testing. The Oasis Humidifier was found compliant and has been certified to the standards referenced in the "FDA Reviewer Guidance for Premarket Notifications."
The unit conditions dry (5% RH at 40° C) inspiratory air at 85 L/min to a minimum of 25%RH, using distilled water, when subjected to pressure range of 3 to 20 cm H2O. A full reservoir (2 cups, or 440 ml) will give approximately ten hours of humidification at those environmental conditions.
The Oasis was tested, in part, with the Respironics REMstar CPAP System, which is representative of most currently marketed standard CPAP devices. The pressure drop performance characteristic, resulting from additional flow resistance through the humidifier, is the only humidifier performance characteristic that would affect the performance of a standard CPAP device. The Oasis humidifier pressure drop is approximately 0.5 cmH2O @ 60 LPM, which is negligible relative to the performance of any currently marketed standard CPAP device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Ambient Operating Temperature: 5° to 40° C
- Storage Temperature: -20° to +60°
- Ambient Operating Relative Humidity Range: 5% to 95%
- Reservoir Capacity: 440 ml
- Relative Humidity Output: >25%
- Pressure Drop (humidifier and 24" tubing): .17 cm H2O on-condensing at flow of 30 L/min; .5 cm H2O at flow of 60 L/min.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
RI Humidifier (K945782)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.5450 Respiratory gas humidifier.
(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(b)
Classification. Class II (performance standards).
0
Premarket Notification Section 510(k) Section 12 - Summary of Safety and Effectiveness Oasis Humidifier
Image /page/0/Picture/4 description: The image shows the logo for RESPIRONICS INC. The logo consists of a triangle with a stylized figure inside, above the text "RESPIRONICS INC". The text is in a bold, sans-serif font.
FEB 1 4 1997
1001 Murry Ridge Drive, Murrysville, PA 15668
November 19, 1996
| Official Contact | Francis X. Dobscha
Manager, Regulatory Affairs
Respironics, Inc.
1001 Murry Ridge Drive
Murrysville, PA 15668 |
|---------------------|---------------------------------------------------------------------------------------------------------------------------|
| Classification Name | 21 CFR 868.5450 73BTT |
| Common/Usual Name | Respiratory Gas Humidifier |
| Proprietary Name | Oasis Humidifier |
RI Humidifier (K945782) Predicate Device
1
Reason for Submission
The Oasis Humidifier is a new device.
Substantial Equivalence
The Oasis Humidifier is substantially equivalent to the RI Humidifier (K945782). Both devices provide moisture to the patient circuit when used as an accessory to CPAP and BiPAP devices.
Testing was performed to demonstrate that the performance of the Oasis Humidifier in its intended environment is as safe and effective as that of the legally marketed predicate device. The safety and effectiveness of the Oasis Humidifier was verified through performance related Environmental Testing. The Oasis Humidifier was found compliant and has been certified to the standards referenced in the "FDA Reviewer Guidance for Premarket Notifications."
General Technical Description
Intended Use
The Oasis Humidifier is an accessory for Respironics CPAP and BiPAP systems to provide moisture to the patient circuit. The Oasis is the only humidifier with the acoustical design that enables effective operation of Respironics' Auto-CPAP mode. As such, it is the only humidifier that can be used with Respironics' Auto-CPAP products (i.e., Virtuoso Smart CPAP System (K953930) and Quartet Clinical System (K963761, currently under review)). The Oasis can also be used with standard CPAP devices from other manufacturers which have maximum operating pressures of 20 cm H2O, and do not have bi-level or automatic pressure titration capabilities. Performance of non-Respironics CPAP systems with the Oasis humidifier should be verified before use.
Device Description
The Oasis Humidifier (Figure 12-1) consists of a top ("lid"), bottom ("reservoir"), gasket, and a 24" reusable flexible tube that connects the Oasis to the pressuregenerating unit (Respironics CPAP or BiPAP unit). The lid and reservoir are held together by four release latches. The latches are connected to the reservoir.
2
Image /page/2/Figure/2 description: The image is a black and white line drawing of a rectangular device with two ports labeled. The "Inlet Port" is a small, cylindrical opening located on the top right side of the device. A pipe runs across the top of the device, connecting the inlet and outlet ports. The "Outlet Port" is a larger, cylindrical opening located on the bottom left side of the device.
Figure 12-1. The Oasis Humidifier
The Oasis has an inlet port and an outlet port on its lid. The inlet port is on the top of the lid. The inlet port is where water is poured into the reservoir and where flexible tube connects the Oasis to the pressure-generating unit. The outlet port is on the front of the lid. (The six-foot patient circuit tubing is attached to the Oasis outlet port.) A J-shaped tube molded in the top of this lid is an acousticallytuned passage. This passage gives the Oasis the acoustical characteristics that enable effective operation of Respironics' Auto-CPAP mode. As such, it allows the Oasis to be used as an accessory for Respironics' Auto-CPAP devices.
The inlet port's 26 mm outside diameter corresponds with the larger end of the 24" flexible tubing (26 mm inside diameter). The smaller end of the tubing -- 22 mm inside diameter -- connects to the outlet port of the pressure-generating unit. Refer to K945782 for complete information on the 24" flexible tubing.
The Oasis (excluding the gasket) is made of dishwasher-safe plastic.
Specifications:
| Ambient Operating Temperature | 5° to 40° C |
|---|---|
| Storage Temperature: | -20° to +60° |
| Ambient Operating Relative Humidity Range | 5% to 95% |
| Reservoir Capacity | 440 ml |
| Relative Humidity Output | >25% |
| Pressure Drop (humidifier and 24" tubing) | .17 cm H2O |
( ) on-condensing at flow of 30 L/min; .5 cm H2O at flow of 60 L/min.
3
Principles of Operation
Air passes through a container partially filled with water and absorbs vapor by evaporation. No heating is used to vaporize the water. The humidified air is conveyed to the patient through the patient circuit.
The unit conditions dry (5% RH at 40° C) inspiratory air at 85 L/min to a minimum of 25%RH, using distilled water, when subjected to pressure range of 3 to 20 cm H2O. A full reservoir (2 cups, or 440 ml) will give approximately ten hours of humidification at those environmental conditions.
The Oasis is to be filled only when it is disconnected from the pressuregenerating unit. It is filled by pouring 2 cups (440 ml) distilled or sterile water into the inlet port. To verify the correct amount of water has been added, the humidifier is tilted up vertically, so that the water line can be seen against the fill line. By design, bulk liquid in the reservoir will not enter any other part of the patient circuit when the device is tilted up to 20°.
The Oasis is positioned below the circuit connection at the mask and the air outlet on the CPAP or BiPAP unit.
The Oasis can support a CPAP or BiPAP unit placed directly on top of it. An optional shelf placed around the Oasis is recommended if the user chooses to place a BiPAP Ventilatory Support System or the Great Performers' BiPAP Duet System or Quartet Clinical System on top of the Oasis.
The humidifier has the same acoustical impedance as the RI Virtuoso CPAP unit so that it can be used as an accessory for Respironics' 'Auto-CPAP devices (i.e., Virtuoso and Quartet).
The Oasis can be used with standard CPAP devices from other manufacturers which have maximum operating pressures of 20 cm H2O, and do not have bi-level or automatic pressure titration capabilities. The Oasis was tested, in part, with the Respironics REMstar CPAP System, which is representative of most currently marketed standard CPAP devices. The pressure drop performance characteristic, resulting from additional flow resistance through the humidifier, is the only humidifier performance characteristic that would affect the performance of a standard CPAP device. The Oasis humidifier pressure drop is
4
approximately 0.5 cmH2O @ 60 LPM, which is negligible relative to the performance of any currently marketed standard CPAP device.
Cleaning/Disinfection/Sterilization
The performance of the Oasis has been validated for the following methods:
Cleaning
- . Hand washing in a solution of warm water and mild dish washing liquid.
- . Dishwasher cleaning (The gasket and tubing are not dishwasher safe and must be removed when dishwasher cleaning).
Disinfection
- . Pasteurization.
Sterilization
- . Ethylene Oxide (EtO) Sterilization.