(90 days)
No
The description mentions a "microprocessor-controlled feedback system" for pressure control, which is a standard control mechanism and does not indicate the use of AI or ML. There are no mentions of AI, ML, or related terms like DNN, or descriptions of training/test sets.
Yes
The device delivers CPAP and bi-level positive airway pressure therapies for the treatment of adult OSA, which are medical treatments.
No
The device is described as a therapy delivery system (CPAP and bi-level positive airway pressure therapies), not for diagnostic purposes. While it mentions being used in settings where patients are 'diagnosed and treated', and the Maestro CRC provides 'data monitoring capabilities' and 'recording capabilities', the primary function of the BiPAP Duet System itself is therapeutic pressure delivery.
No
The device description explicitly states the system consists of the "BiPAP Duet device" which includes a "blower motor assembly" and a "microprocessor control system," indicating it is a hardware device with integrated software, 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 BiPAP Duet System is a medical device that delivers positive airway pressure therapy to treat Obstructive Sleep Apnea (OSA). It works by providing air pressure to the patient's airway, not by analyzing biological samples.
- Intended Use: The intended use clearly states it's for delivering therapy for OSA, not for diagnostic testing of biological samples.
- Device Description: The description focuses on the mechanical and electronic components that generate and control air pressure, not on components for sample analysis.
Therefore, the BiPAP Duet System falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The BiPAP Duet System delivers CPAP and bi-level positive airway pressure therapies for the treatment of adult OSA. The BiPAP Duet System is intended for use in the home and by a qualified clinician (any individual trained to perform sleep study diagnoses) in clinical (hospital or sleep laboratory) settings where adult patients suffering from OSA are diagnosed and treated. When used in clinical settings, the BiPAP Duet System can be used with or without the Respironics Maestro Clinical Remote Control. The BiPAP Duet System is used in conjunction with masks, headgear, and various combinations of patient circuit accessories.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The BiPAP Duet System is intended to apply CPAP and bi-level positive airway pressure therapies to adult patients who suffer from OSA. The device can operate on either 115 - 120 Volts AC or 230 - 240 Volts AC. The System consists of the BiPAP Duet device and the recommended patient circuit that is used to direct the air to the patient. The tubing, exhalation port, humidifier (if needed), and mask are referred to as the patient circuit. Also, the Maestro CRC can be used in clinical settings to provide control from a remote location. The Maestro CRC also provides data monitoring capabilities, alphanumeric and graphical representations of patient data, and recording capabilities via DC outputs that optionally connect to a polysomnograph for data recording.
The primary components of the BiPAP Duet device are a blower motor assembly and a microprocessor control system. The blower motor is capable of generating positive airway pressures from 4 to 20 cm H2O. The level of pressure is dependent on motor speed and a pressure control valve, which are controlled by a microprocessor-controlled feedback system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult
Intended User / Care Setting
Home and by a qualified clinician (any individual trained to perform sleep study diagnoses) in clinical (hospital or sleep laboratory) settings.
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 BiPAP Duet System in its intended environment is as safe and effective as that of the legally marketed predicate device. The safety and effectiveness of the BiPAP Duet System was verified through performance related testing that consisted of Electrical Safety, Electromagnetic Compatibility, Mechanical, and Environmental Testing. The BiPAP Duet System was found compliant and has been certified to the standards referenced in the "FDA Reviewer Guidance for Premarket Notifications."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Respironics BiPAP S-D System (K883825 and K905540)
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
§ 868.5905 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
Premarket Notification Section 510(k) Section 12 - Summary of Safety and Effectiveness JAN 3 0 1997
K96436 3
BiPAP Duet System
Image /page/0/Picture/3 description: The image shows the title of a section of a document. The section is titled "SECTION 12 SUMMARY OF SAFETY & EFFECTIVENESS". The text is in a sans-serif font and is black on a white background. The text is aligned to the left.
Image /page/0/Picture/4 description: The image shows the logo for RESPIRONICS INC. The logo consists of a stylized figure inside of a triangle above the company name. The figure appears to be a person with a large head and small body. The text "RESPIRONICS INC." is in all capital letters.
1001 Murry Ridge Drive, Murrysville, PA 15668
October 30, 1996
| Official Contact | Francis X. Dobscha
Manager, Regulatory Affairs
Respironics, Inc.
1001 Murry Ridge Drive
Murrysville, PA 15668 |
|---------------------|---------------------------------------------------------------------------------------------------------------------------|
| Classification Name | 21 CFR 868.5905, 73 BZD |
| Common/Usual Name | Ventilator, Noncontinuous |
| Proprietary Name | BiPAP Duet System |
| Predicate Device | Respironics BiPAP S-D System
(K883825 & K905540) |
'
1
Reason for Submission
The BiPAP Duet System is a new device.
Substantial Equivalence
The BiPAP Duet System is substantially equivalent to the Respironics BiPAP S-D System (K883825 and K905540), a bi-level positive airway pressure system with remote control capabilities. Both devices provide CPAP and bi-level positive airway pressure therapies for the treatment of adult OSA.
Testing was performed to demonstrate that the performance of the BiPAP Duet System in its intended environment is as safe and effective as that of the legally marketed predicate device. The safety and effectiveness of the BiPAP Duet System was verified through performance related testing that consisted of Electrical Safety, Electromagnetic Compatibility, Mechanical, and Environmental Testing. The BiPAP Duet System 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 BiPAP Duet System delivers CPAP and bi-level positive airway pressure therapies for the treatment of adult OSA. The BiPAP Duet System is intended for use in the home and by a qualified clinician (any individual trained to perform sleep study diagnoses) in clinical (hospital or sleep laboratory) settings where adult patients suffering from OSA are diagnosed and treated. When used in clinical settings, the BiPAP Duet System can be used with or without the Respironics Maestro Clinical Remote Control. The BiPAP Duet System is used in conjunction with masks, headgear, and various combinations of patient circuit accessories.
October 30, 1996
2
Contraindications
The BiPAP Duet System is contraindicated for the following medical conditions:
- . Bullous lung disease
- . Pneumothorax
- . Pneumomediastinum
- Pathologically low blood pressure .
- Severe cardiac arrhythmias .
- Susceptible patients with CSF leaks, abnormalities of the cribriform . plate, prior history of head trauma, and/or Pneumocephalus
- Sinus or middle ear infection may be temporarily contraindicated .
- . Coronary Artery Disease
Device Description
Technical Description
The BiPAP Duet System is intended to apply CPAP and bi-level positive airway pressure therapies to adult patients who suffer from OSA. The device can operate on either 115 - 120 Volts AC or 230 - 240 Volts AC. The System consists of the BiPAP Duet device and the recommended patient circuit that is used to direct the air to the patient. The tubing, exhalation port, humidifier (if needed), and mask are referred to as the patient circuit. Also, the Maestro CRC can be used in clinical settings to provide control from a remote location. The Maestro CRC also provides data monitoring capabilities, alphanumeric and graphical representations of patient data, and recording capabilities via DC outputs that optionally connect to a polysomnograph for data recording.
The primary components of the BiPAP Duet device are a blower motor assembly and a microprocessor control system. The blower motor is capable of generating positive airway pressures from 4 to 20 cm H2O. The level of pressure is dependent on motor speed and a pressure control valve, which are controlled by a microprocessor-controlled feedback system.
© 1996 Respironics, Inc.
October 30, 1996
3
BiPAP Duet Device Hardware
The BiPAP Duet device is approximately 5.45" high by 15.25" long by 8.75" wide. The device is made up of the following components:
- Top, bottom, and rear enclosure sections .
- . Control panel
- I/O board with LCD screen .
- . Air outlet, blower motor
- . Valve assembly
- . Flow transducer
- . Air inlet
- . Filter (with or without optional fine filter)
- . Filter cap
- Transformer .
- . BiPAP Duet main printed circuit board
- Power entry module .
- Communications connector ●
System Accessories
Maestro Clinical Remote Control
Accessories for the BiPAP Duet System include the Maestro CRC and patient circuit accessories. Please refer to K954572 for complete information about the Maestro CRC.
Patient Circuit Accessories
The patient circuit accessories intended for use with the Solo CPAP System (K961626) are also intended for use with the BiPAP Duet System. The accessories have not been modified since the Solo was determined substantially equivalent. Consequently, the labeling for the accessories used with the BiPAP Duet system will contain the same information as that provided for the accessories in the Solo submission. Please refer to K961626 for complete accessory information.
October 30, 1996
4
An additional accessory intended for use with the BiPAP Duet System is the Spectrum™ Reusable Full Face Mask (K961915). Please refer to that cleared 510(k) for complete information.
The patient circuit accessories that are available for use with the BiPAP Duet System and the manufacturer of each accessory are listed below.
- Respironics Contour Nasal Mask and headgear ●
- Respironics Spectrum™ Disposable Full Face Mask and headgear .
- Respironics Spectrum Reusable Full Face Mask and headgear ●
- Respironics Comfort Flap® Mask Accessory .
- . Respironics Whisper Swivel® Exhalation Port
- Respironics 6' Reusable Flexible Tubing Assembly .
- Respironics 6' Disposable Flexible Tubing Assembly .
- Respironics 18" Reusable Flexible Tubing Assembly
- Respironics 18" Disposable Flexible Tubing Assembly .
- . Respironics Plateau™ Exhalation Valve
- Respironics GEL™ Mask and headgear .
- Respironics Monarch™ Mini Mask and headgear .
- . King Bacteria Filter
- . Respironics Passover Humidifier
- Fisher & Paykel Heated Humidifier
October 30, 1996
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A typical patient circuit for the BiPAP Duet System is shown below.
Image /page/5/Figure/3 description: This image shows a diagram of a nasal mask connected to a BiPAP Duet device. The nasal mask has an optional comfort flap and pressure ports for pressure measurement. The mask is connected to the BiPAP device via flexible tubing and an exhalation port, also known as a whisper swivel.
Figure 12-1. Typical Patient Circuit for the BiPAP Duet System
General Principles of Operation
Air Pressure Delivery of the BiPAP Duet Device
When the BiPAP Duet device is in operation, its blower is driven by a high-speed DC motor to supply pressurized air through a patient circuit to the patient. Figure 12-1 shows the BiPAP Duet device and the patient circuit (six-foot, 3/4 inch I.D. flexible tubing, exhalation port, and nasal mask).
Image /page/5/Picture/8 description: The image shows a line drawing of a medical device, possibly a CPAP machine. The device is rectangular with a control panel on top that includes a digital display and several buttons. A corrugated tube connects to the side of the machine and extends to a humidifier chamber on the left side of the device. The drawing is detailed, showing the texture of the corrugated tube and the various components of the machine.
Figure 12-1. The BiPAP Duet Device and Patient Circuit
© 1996 Respironics, Inc.
October 30, 1996
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Pressure Control
The valve is the main control for pressure for the BiPAP Duet device. The energized blower motor draws ambient air through an air filter, pressurizes it, and provides airflow to the patient. The motor speed is fixed based on the inspiratory (IPAP) pressure setting. The airflow path from the blower to the patient circuit flows through a valve assembly that incorporates a valve driver circuit, which employs FET (field effect transmission) circuitry capable of switching the valve control voltage at very fast rates. Valve position is based on IPAP and EPAP settings. The microprocessor controls the valve's position by pulse width modulation (PWM) of one of its I/O lines, which is connected to the FET circuitry.
Pressure is regulated through a combination of valve opening and motor speed to assure that desired pressure is applied to the patient. Closing the valve increases the pressure and opening the valve lowers pressure. When the valve is closed, the majority of the airflow travels from the blower through the valve enclosure to the patient circuit. As the valve is opened, airflow is dumped out the valve to the atmosphere, thereby lowering the pressure delivered to the patient. The amount of airflow dumped out the valve depends on the actual position of the valve. The actual pressure is still sensed by the pressure transducer.
The BiPAP Duet System can sense the patient's breathing efforts by monitoring airflow in the patient circuit. Bi-level therapy is provided by the administration of two (e.g., inspiratory and expiratory) levels of positive pressure. During exhalation the pressure is variably positive or near ambient. The inspiratory level is variably positive and always higher than or equal to the expiratory level.
The airflow path from the blower flows through an enclosed valve and pneumotach to the patient circuit. The BiPAP Duet System monitors the flow and pressure to determine when the patient is inhaling or exhaling. The unit switches between inspiratory and expiratory states and delivers the desired IPAP and EPAP pressure accordingly. Flow and pressure are monitored in order to determine whether the patient is inhaling or exhaling and/or if there are any leaks in the patient circuit. The Inhalation/Exhalation State (IE State), Leak and Estimated Patient Flow are computed based on the flow and pressure signals obtained from the Sensor Module. IE State toggles between the constant values
© 1996 Respironics, Inc.
October 30, 1996
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for Inhalation and Exhalation. Estimated Patient Flow has a range of -120 to 120 L/min with an accuracy of ± 10% at standard temperature and pressure. Leak has a range of 0 to 120 L/min with an accuracy of ± 10% or ± 10 L/min (whichever is greater) at standard temperature and pressure. The Leak value contains both the intentional (exhalation port) and the unintentional (mask) leak values.
Set-Up of the BiPAP Duet System
Once the BiPAP Duet device is plugged into an electrical source, it will perform a self-diagnostic test, test sound the annunciator, and display readiness status via the signal lights. A green light indicates that the system is ready for use; a yellow light indicates a leak detected in the circuit or a System Error. If the system is ready for use, the display screen then shows the System Setup Menu, which allows settings for the leak alert, date, and time. The BiPAP Duet device control buttons, comprising the Pressure On/Off, Ramp, and two user buttons, can be operated within the System Setup Menu to set date and time, and to optionally turn off the audible portion of the leak alert.
© 1996 Respironics, Inc.
October 30, 1996
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Control of the BiPAP Duet System
The clinician can adjust the following parameters for the BiPAP Duet device:
- . IPAP
- EPAP .
- . Minimum Ramp Pressure
- . Ramp Time
When IPAP and EPAP are set to different levels (Bi-level mode), the device delivers bi-level therapy. Figure 12-3 shows the applied bi-level pressure settings versus time with Ramp activated when in the Bi-level mode.
Image /page/8/Figure/15 description: The image shows a graph with a square wave pattern. The graph is divided into two sections by a vertical break labeled "Elapsed Time". The section on the right is shaded gray and labeled "Ramp".
Figure 12-3. Bi-level Mode
The BiPAP Duet device can be set to operate in CPAP mode by setting IPAP equal to EPAP. Figure 12-4 shows the applied Therapeutic Pressure versus time with Ramp activated for the BiPAP Duet System when in the CPAP mode.
© 1996 Respironics, Inc.
October 30, 1996
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Premarket Notification Section 510(k) Section 12 - Summary of Safety and Effectiveness
Image /page/9/Figure/2 description: The image shows a graph with pressure on the y-axis and time on the x-axis. The graph shows the therapeutic pressure over time, with a ramp time in between. The pressure increases linearly during the ramp time. The graph also shows the minimum ramp pressure.
Image /page/9/Figure/3 description: The image shows the text "Figure 12-4. CPAP Mode". The text is written in a clear, sans-serif font and is likely a caption or title for a diagram or illustration. The text suggests that the figure is related to CPAP (Continuous Positive Airway Pressure) mode, which is a type of respiratory therapy.
Therapeutic Pressure
Therapeutic Pressure levels are set for both IPAP and EPAP by the clinician. The clinician can increase or decrease Therapeutic Pressure using the user buttons. Pressure adjustments can be made any time during therapy with a range of 4.0 to 20.0 cm H2O in Bi-level mode.
- Although the stated pressure range for IPAP and EPAP pressures is 4.0 NOTE: to 20.0 cm H2O, the system will allow a 3.0 cm setting. At some elevations 3.0 cm of delivered presure may not be obtainable. The BiPAP Duet User Instructions notes that a 3.0 cm pressure setting should be verified with a manometer.
Ramp, Minimum Ramp Pressure, Ramp Time
The Ramp parameter applies to both the CPAP and Bi-level modes. When activated, the Ramp feature initially reduces the pressure to the prescribed Minimum Ramp Pressure setting. Minimum Ramp Pressure is the pressure setting to which the device initially drops when Ramp is activated. Ramp incrementally increases to the set Therapeutic IPAP and EPAP Pressures allowing the patient to fall asleep more comfortably. The time period required for the pressure to increase from Minimum Ramp Pressure to the set Therapeutic IPAP and EPAP Pressures is referred to as the Ramp Time.
The clinician can activate the Ramp and set both the Minimum Ramp Pressure and the Ramp Time by pressing the Ramp Function button as indicated by the main screen. Using the user buttons, the Minimum Ramp Pressure can be set
© 1996 Respironics, Inc.
October 30, 1996
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from 4.0 cm H2O to the EPAP level, and the Ramp Time can be set from 0 to 45 minutes.
Data Monitoring and Recording
When used with the BiPAP Duet System, the Maestro CRC provides data monitoring capabilities, presents alphanumeric and graphical representations of patient data, and provides recording capabilities via DC outputs that connect to a polysomnograph for data recording. The data recording function is optional. The Maestro CRC can control the BiPAP Duet device whether or not it is connected to a polysomnograph.
The following data groups can be monitored and recorded when using the Maestro CRC with the BiPAP Duet System: Event Predictor, VT (Estimated Tidal Volume), Vest (Estimated Patient Flow), and P (Pressure).
Description of Signals
- Pressure (P) This signal permits continuous recording of the . pressure measured at the mask.
- Estimated Tidal Volume (VT) Determines the amount of air inhaled . and exhaled during the breathing cycle. The tidal volume signal should be viewed in conjunction with the estimated patient flow signal to help identify abnormal breathing events and hypoventilation.
- Estimated Patient Flow (Vest) Determines the flow rate in the patient . circuit. This output signal can eliminate the need for a thermistor, thermocouples, or pneumotach within the positive pressure circuit.
- Estimated Leak (Vleak) Monitors changes in the unintentional leak . in the patient circuit.
Software Control System - BiPAP Duet System
Both the BiPAP Duet device and the Maestro CRC are software-controlled. This section contains a summarized functional description of the Software Control System for both devices.
© 1996 Respironics, Inc.
October 30, 1996
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BiPAP Duet Device Software
The BiPAP Duet device software addresses functions relating to the operation of the valve, pressure and flow sensors, and control of the blower motor that generates pressure. The following are some of the high-level software functions that are performed by the BiPAP Duet device:
- . Bi-level Pressure Control
- Blower Time Logger .
- . Pressure Control
- . Pressure Error Calculation
- Pressure Mediator .
- . Sensor Module
- Flow Sensor Function
- Motor Speed Voltage & Valve Voltage
- Pressure Sensor Function
- Stored Parameters o
- . Therapy Menu
- . User Interface
- User Menu .
- . Watchdog Timer
Maestro Clinical Remote Control Software
The purpose of the Maestro CRC software is to control the monochrome LCD, the DC outputs to the recording device, and the serial communications port when the CRC is attached for use with the BiPAP Duet device. The Maestro CRC software also controls the audible annunciator and processes information from the setting and function buttons, which signal changes to the Maestro CRC and the BiPAP Duet device. The Maestro CRC will receive data via the serial communications port from the BiPAP Duet device.
The Maestro CRC software is described in K954572. Please refer to that previously cleared 510(k) for complete information about the Maestro CRC.
© 1996 Respironics, Inc.
October 30, 1996