(83 days)
The Respironics Solo CPAP System is intended to deliver Continuous Positive Airway Pressure (CPAP) therapy for the treatment of adult Obstructive Sleep Apnea (OSA) only. The Solo CPAP System may be used in clinical settings (hospitals & sleep labs) and in home environments, and must be prescribed by a physician. It is not intended for life support or life sustaining applications. The device is used in conjunction with a mask (various styles and sizes available), headgear, and a combination of breathing circuit accessories.
The Solo CPAP System is an electromechanical device that produces Continuous Positive Airway Pressure (CPAP) and delivers it to a patient. As shown in Figure 12-1, the system consists of the Solo CPAP device and a patient circuit that is used to direct the air to the patient. The Solo CPAP device consists of a blower assembly and a microprocessor control system. The blower assembly generates positive airway pressures from 4 to 15 cm H2O. The level of pressure is dependent on motor speed. Two control buttons (Pressure ON/OFF and Ramp) and an LED are located on the control panel at the top of the unit. Motor speed is controlled by a microprocessorcontrolled feedback system. The device can operate on either 115 or 230 Volts AC, or 12 volts DC using the DC accessories included with the system. The Solo CPAP System offers DC power as an alternative power source; it is not intended to be used as a battery back-up source. The Solo CPAP System is not intended to be used in a mobile environment. Pressurized air travels from the Solo CPAP device to the patient via 22 mm flexible tubing. The flexible tubing connects with an exhalation port to exhaust carbon dioxide from the circuit, which in turn connects to a mask. The tubing, exhalation port, and mask are referred to as the patient circuit.
The provided document is a 510(k) premarket notification for the Solo CPAP System. It states that the submission demonstrates the system's substantial equivalence to predicate devices (Respironics Aria CPAP System and Nellcor Puritan-Bennett Companion 314 Nasal CPAP System) through performance-related testing.
Here's an analysis based on your request, highlighting the limitations of the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a specific table of acceptance criteria with corresponding performance metrics for the Solo CPAP System in terms of diagnostic accuracy or clinical outcomes. Instead, it broadly states:
"Testing was performed to demonstrate that the performance of the Solo CPAP System in its intended environment is as safe and effective as that of the legally marketed predicate devices. The safety and effectiveness of the Solo CPAP System were verified through performance-related testing that consisted of Electrical Safety, Electromagnetic Compatibility, Mechanical and Environmental Testing. The Solo CPAP System was tested and found compliant with the standards referenced in the "Draft FDA Reviewer Guidance for Premarket Notifications," November 1993."
This indicates that the "acceptance criteria" were compliance with established safety and performance standards for these types of electromechanical devices, rather than clinical efficacy metrics.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Electrical Safety | Compliant with standards |
| Electromagnetic Compatibility | Compliant with standards |
| Mechanical Testing | Compliant with standards |
| Environmental Testing | Compliant with standards |
| Overall Safety & Effectiveness | As safe and effective as predicate devices |
2. Sample Size Used for the Test Set and Data Provenance
The document does not mention any clinical test set involving patients or human subjects. The testing described is focused on the device's engineering performance (electrical, EMC, mechanical, environmental). Therefore, there is no sample size for a "test set" in the context of clinical data, nor is there information about data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Since there was no clinical study described with a test set requiring ground truth established by experts, this information is not applicable and not present in the document.
4. Adjudication Method for the Test Set
As no clinical test set is described, there is no adjudication method mentioned.
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 described in this document. The submission focuses on demonstrating substantial equivalence through technical performance testing, not direct comparison of human reader performance with or without AI assistance. The device is a CPAP machine, not an AI diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The Solo CPAP System is an electromechanical device with an embedded software control system that regulates pressure. It's not an "algorithm" in the sense of an AI model making diagnostic or prescriptive decisions that would require a "standalone" performance evaluation against human performance. The software controls motor speed and monitors functions, which are integral to the device's operation. Its performance is assessed as part of the overall device's electrical, mechanical, and safety testing. Therefore, this question is not applicable in the context of this device.
7. The Type of Ground Truth Used
The "ground truth" for the testing described is primarily engineering specifications and regulatory standards for electrical safety, electromagnetic compatibility, mechanical integrity, and environmental performance. For example, a "ground truth" for electrical safety would be meeting specific current leakage limits or insulation resistance values.
8. The Sample Size for the Training Set
The document discusses an "embedded software control system" and assembly language routines. This software controls motor speed and monitors various conditions. There is no mention of a training set in the context of machine learning or AI models. The software is likely developed using traditional programming and control systems engineering, not a data-driven training approach.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set mentioned in the context of machine learning, there is no information on how ground truth for a training set was established. The software's "ground truth" would be its functional specifications and correct execution of control logic, verified through software testing and validation processes. The document states: "Its software has been designed and developed in accordance with the FDA Reviewer's Guidance for Computer Controlled Medical Devices." This implies adherence to established software development and verification principles, rather than a data-driven ground truth for a training set.
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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 figure appears to be a person with a circular head and a circular object at the bottom.
1001 Murry Ridge Drive, Murrysville, PA 15668
JUL 18 1996
April 23, 1996
Official Contact
Francis X. Dobscha Manager, Regulatory Affairs Respironics, Inc. 1001 Murry Ridge Drive Murrysville, PA 15668
- 21 CFR 868.5905, 73 BZD Classification Name
- Ventilator, Noncontinuous Common/Usual Name
Proprietary Name Solo CPAP System
Predicate Devices
Aria CPAP System - K953341 Respironics, Inc. 1001 Murry Ridge Drive Murrysville, PA 15668
Companion 314 Nasal CPAP System - K952292 Nellcor Puritan-Bennett 10800 Pflumm Road Lenexa, KS 66215
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Reason for Submission 11 11
The Solo CPAP System is a new device
Substantial Equivalence
This premarket notification section 510(k) submission demonstrates that the Solo CPAP System is substantially equivalent to the Respironics Aria CPAP System (K953341) and the Nellcor Puritan-Bennett Companion 314 Nasal CPAP System (K952292), both of which are used to treat adult Obstructive Sleep Apnea.
Testing was performed to demonstrate that the performance of the Solo CPAP System in its intended environment is as safe and effective as that of the legally marketed predicate devices. The safety and effectiveness of the Solo CPAP System were verified through performance-related testing that consisted of Electrical Safety, Electromagnetic Compatibility, Mechanical and Environmental Testing. The Solo CPAP System was tested and found compliant with the standards referenced in the "Draft FDA Reviewer Guidance for Premarket Notifications," November 1993.
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General Technical Description
Intended Use
The Respironics Solo CPAP System is intended to deliver Continuous Positive Airway Pressure (CPAP) therapy for the treatment of adult Obstructive Sleep Apnea (OSA) only. The Solo CPAP System may be used in clinical settings (hospitals & sleep labs) and in home environments, and must be prescribed by a physician. It is not intended for life support or life sustaining applications. The device is used in conjunction with a mask (various styles and sizes available), headgear, and a combination of breathing circuit accessories.
Contraindications
Studies have shown that the following pre-existing conditions may contraindicate the use of CPAP therapy for some patients:
- Bullous Lung Disease .
- . Pathologically Low Blood Pressure
- . Severe Cardiac Arrhythmias
- . Coronary Artery Disease
- . Pneumothorax
- . Pneumomediastinum
- Pneumocephalus has been reported in a patient using nasal . Continuous Positive Airway Pressure. Caution should be used when prescribing CPAP for susceptible patients such as those with: cerebral spinal fluid (CSF) leaks, abnormalities of the cribriform plate, prior history of head trauma, and/or pneumocephalus.
The use of positive airway pressure therapy may be temporarily contraindicated if you exhibit signs of a sinus or middle ear infection. Contact your physician if you have any questions concerning your therapy.
Note:
"Seizures" have been inaccurately listed as contraindicated for Respironics CPAP therapy products (refer to the Aria CPAP System labeling, for example). There is no clinical basis for this claim. Consequently, Respironics has corrected the Sclos CPAP System contraindications by deleting "seizures" from the list. This is in keeping with the labeling of other CPAP devices.
() 1996 Respirenics, Inc.
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Summary of the Device Description
The Solo CPAP System is an electromechanical device that produces Continuous Positive Airway Pressure (CPAP) and delivers it to a patient. As shown in Figure 12-1, the system consists of the Solo CPAP device and a patient circuit that is used to direct the air to the patient.
Image /page/3/Figure/4 description: The image shows a Solo CPAP device with its different parts labeled. The CPAP device is connected to a flexible tubing assembly. The other end of the tubing is connected to a patient interface, which is a nasal mask, and an exhalation port.
Figure 12-1. Solo CPAP System
The Solo CPAP device consists of a blower assembly and a microprocessor control system. The blower assembly generates positive airway pressures from 4 to 15 cm H2O. The level of pressure is dependent on motor speed. Two control buttons (Pressure ON/OFF and Ramp) and an LED are located on the control panel at the top of the unit. Motor speed is controlled by a microprocessorcontrolled feedback system. (The control panel and software control system are each detailed separately later in this section.) The device can operate on either 115 or 230 Volts AC, or 12 volts DC using the DC accessories included with the system. The Solo CPAP device incorporates DC operation to provide portability for patient use of the device when away from home where AC voltage is not accessible. The Solo CPAP System offers DC power as an alternative power source; it is not intended to be used as a battery back-up source. The Solo CPAP System is not intended to be used in a mobile environment.
Pressurized air travels from the Solo CPAP device to the patient via 22 mm flexible tubing. The flexible tubing connects with an exhalation port to exhaust
O 1996 Respironics, Inc.
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carbon dioxide from the circuit, which in turn connects to a mask. The tubing, exhalation port, and mask are referred to as the patient circuit.
Principles of Operation
Control Panel
The control panel located on top of the Solo CPAP device shown in Figure 12-2 consists of two control buttons (Pressure ON/OFF and Ramp) and an LED. The control panel is the user interface, which allows the therapist or patient to operate, monitor, and control the Solo CPAP System. The Pressure ON/OFF button activates the blower to start delivering pressure and the Ramp button activates the Ramp feature (explained below). The LED provides operational status and will indicate when the Solo CPAP System is energized and/or if a system fault is recognized.
Image /page/4/Figure/6 description: This image shows a close-up of a medical device with several labeled components. The labels indicate the presence of a signal light, a pressure on/off button, a ramp button, and an air outlet. The device appears to be a portable or compact unit, possibly related to respiratory therapy or air pressure regulation.
Figure 12-2. The Solo CPAP System Control Panel
Alternate Function of Controls
In addition to their specifically labeled functions, the Pressure ON/OFF and Ramp buttons allow for adjustment of Therapeutic Pressure and Elevation Compensation. The Therapeutic Pressure can only be set by the therapist or home care dealer and the design incorporates a lockout mechanism (detailed in Solo CPAP Software Control System) to prevent patient tampering. The
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Elevation Compensation is a feature of the device that allows the patient to adjust the blower speed to compensate for elevation changes.
When Ramp is activated, it first decreases the pressure to a lower level (4 cm) so that patients can fall asleep more comfortably. It then incrementally increases the pressure over a specified time (Ramp time is approximately 20 minutes) until the Therapeutic Pressure is reached.
Solo CPAP Software Control System
The Solo CPAP System has an embedded software control system. Its software has been designed and developed in accordance with the FDA Reviewer's Guidance for Computer Controlled Medical Devices.
The software consists of several assembly language routines that provide the necessary functions for operation of the Solo CPAP System. A brief discussion of the software is described below.
- The software controls and regulates the patient pressure, via an . algorithm that monitors and controls motor speed.
- . The software monitors the specifically labeled functions of the Pressure ON/OFF and Ramp buttons, as well as their alternate functions (Therapeutic Pressure adjustment and Elevation Compensation).
- . Built-in self tests verify various hardware and software conditions. These checks include monitoring a watch-dog timer, locked rotor checking, checksum memory errors, motor speed, and power loss.
- . The Patient Mode allows the patient to change specified parameters. These parameters are Pressure ON/OFF, Ramp and Elevation Compensation.
- . The Therapy Mode allows the home care dealer, therapist, or sleep lab technician to change specified parameters. The Therapy Mode is initiated by holding down the user Pressure ON/OFF and Ramp buttons while simultaneously plugging in the unit. This combination of actions constitutes the Therapy Mode's lockout feature. The only operating parameter that can be adjusted in this mode is the Therapeutic Pressure setting.
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Solo CPAP System Accessories
The accessories intended for use with the Aria CPAP System are also intended for use with the Solo CPAP System. The accessories have not been modified since the Aria was determined substantially equivalent. Please refer to K953341 for complete accessory information.
Two additional accessories intended for use with the Solo CPAP System are the Respironics GEL™ Mask (K954207) and Monarch™ Mini-Mask (K945938). Please refer to those cleared 510(k)s for complete information.
The following table lists the accessories that are available for use with the Solo CPAP System, the manufacturer, and the reference number under which each accessory received 510(k) clearance.
| Accessory | Reference 510(k) |
|---|---|
| Respironics Contour Nasal Mask and headgear | K851396 |
| Respironics Spectrum™ Disposable Full Face Mask andheadgear | K936047 |
| Respironics Comfort Flap® Mask Accessory | K953341(Aria CPAP System) |
| Respironics 6' Reusable Flexible Tubing AssemblyRespironics 6' Disposable Flexible Tubing AssemblyRespironics 18" Reusable Flexible Tubing AssemblyRespironics 18" Disposable Flexible Tubing Assembly | K900113(REMstar Choice®Nasal CPAP System) |
| Respironics Whisper Swivel® Exhalation Port | K883825(BiPAP® System) |
| Respironics Plateau™ Exhalation Valve | K925587 |
| Respironics Passover Humidifier | K945782 |
| Fisher & Paykel Heated Humidifier | K915460C |
| King ViroBac Bacteria Filter | K880681 |
| Respironics GEL™ Mask and headgear | K954207 |
| Respironics Monarch™ Mini Mask and headgear | K945938 |
| DC Accessories:DC Power CordBattery Adapter Cable | K953341(Aria CPAP System) |
| Table 12-1. Solo CPAP System Accessories | ||
|---|---|---|
| -- | ------------------------------------------ | -- |
§ 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).