(86 days)
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.
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.
The provided document describes the Oasis Humidifier (K964653), which is a medical device accessory for CPAP and BiPAP systems. This submission is a Premarket Notification (510(k)), indicating that the company is demonstrating substantial equivalence to a predicate device, not necessarily a new clinical study to establish novel performance criteria.
Therefore, many of the requested criteria for a clinical study on device performance (such as sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable (N/A) in this context, as this is a submission demonstrating equivalence through verification and validation (V&V) engineering tests against established standards and predicate device performance, not a clinical effectiveness trial for a new AI/imaging device.
Here's the information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Specification) | Reported Device Performance (Oasis Humidifier) |
|---|---|
| Ambient Operating Temperature: 5° to 40° C | Met (implied by "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.") |
| Storage Temperature: -20° to +60° C | Met (implied) |
| Ambient Operating Relative Humidity Range: 5% to 95% | Met (implied) |
| Reservoir Capacity: 440 ml | 440 ml (2 cups) |
| Relative Humidity Output: >25% (at 85 L/min flow, 3-20 cm H2O pressure, 5% RH at 40° C dry inspiratory air, distilled water) | Minimum of 25% RH |
| Humidification Duration (full reservoir): Approximately 10 hours (at specified environmental conditions) | Approximately 10 hours |
| Pressure Drop (humidifier and 24" tubing): 0.17 cm H2O (on-condensing at 30 L/min); 0.5 cm H2O (at 60 L/min) | 0.5 cm H2O @ 60 LPM (reported as negligible) |
| Acoustic characteristics for Auto-CPAP mode: Acoustically-tuned passage | Has acoustically-tuned passage for effective operation with Respironics' Auto-CPAP devices |
| Ability to operate with standard CPAP devices (non-Respironics, max 20 cm H2O, no bi-level/auto titration) | Can be used with compatible standard CPAP devices; tested with Respironics REMstar CPAP System (representative) |
| Cleaning validation: Hand washing, Dishwasher cleaning (reservoir/lid only) | Validated |
| Disinfection validation: Pasteurization | Validated |
| Sterilization validation: Ethylene Oxide (EtO) Sterilization | Validated |
| Bulk liquid not entering patient circuit when tilted up to 20° | By design, bulk liquid will not enter any other part of the patient circuit when device is tilted up to 20°. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of human data. The "test set" here refers to engineering verification and validation (V&V) testing performed on the Oasis Humidifier physical units. The document does not specify the number of units tested, but rather the performance parameters.
- Data Provenance: Not applicable as this relates to engineering and performance testing of the device itself, rather than human data. The testing was carried out by Respironics, Inc. in the United States. The data is prospective in the sense that the testing was performed specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. Ground truth, in the sense of expert review for diagnostic accuracy or clinical outcomes, is not established for this type of device submission. The "ground truth" for the engineering tests would be the established scientific and engineering principles, and the specifications of the predicate device and relevant standards. The testing itself is conducted by qualified engineers and technicians.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods (e.g., 2+1) are common in clinical studies where expert consensus on controversial findings is needed. This is an engineering V&V process, where test results are compared directly against predefined acceptance criteria from specifications or standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is a physical medical device (humidifier), not an AI-powered diagnostic or imaging device. Therefore, MRMC studies and AI assistance comparisons are irrelevant.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm, so "standalone" performance in the AI context does not apply. The device's performance characteristics (e.g., humidity output, pressure drop) are inherent to its design and functional operation without human intervention during its humidifying function.
7. The Type of Ground Truth Used
- Engineering Specifications and Standardized Test Methods: The "ground truth" is defined by the device's technical specifications (e.g., reservoir capacity, temperature ranges, humidity output targets), relevant medical device standards (implied by "certified to the standards referenced in the 'FDA Reviewer Guidance for Premarket Notifications'"), and the performance characteristics of the legally marketed predicate device (RI Humidifier, K945782). For example, for pressure drop, the "ground truth" is the scientifically measurable resistance to flow that determines if it's within acceptable limits and comparable to the predicate.
8. The Sample Size for the Training Set
- Not Applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no "training set," there is no ground truth established for it.
{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. DobschaManager, Regulatory AffairsRespironics, Inc.1001 Murry Ridge DriveMurrysville, 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.
§ 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).