SOLO CPAP SYSTEM

K961626 · Respironics, Inc. · BZD · Jul 18, 1996 · Anesthesiology

Device Facts

• Record ID: K961626
• Device Name: SOLO CPAP SYSTEM
• Applicant: Respironics, Inc.
• Product Code: BZD · Anesthesiology
• Decision Date: Jul 18, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Electromechanical CPAP device; delivers continuous positive airway pressure (4-15 cm H2O) to treat adult OSA. Input: AC/DC power; user-selected settings via control panel. Operation: Microprocessor-controlled blower assembly regulates motor speed to maintain pressure. Output: Pressurized air delivered via flexible tubing, exhalation port, and mask. Used in clinical settings or home; operated by patient or clinician. Features: Ramp function (starts at 4 cm H2O, increases over 20 mins); elevation compensation; lockout mechanism for therapeutic pressure settings. Benefits: Provides non-invasive respiratory therapy for OSA; portable via DC power option.

Clinical Evidence

Bench testing only. Performance verified through electrical safety, electromagnetic compatibility, and mechanical/environmental testing in accordance with FDA Reviewer Guidance for Premarket Notifications (November 1993). No clinical data presented.

Technological Characteristics

Electromechanical CPAP device; microprocessor-controlled blower assembly. Pressure range: 4-15 cm H2O. Power: 115/230V AC or 12V DC. Connectivity: Standalone. User interface: Two-button control panel (Pressure ON/OFF, Ramp) with LED status indicator. Software: Embedded assembly language routines. Patient circuit: 22 mm flexible tubing, exhalation port, mask.

Indications for Use

Indicated for adult patients with Obstructive Sleep Apnea (OSA). Contraindicated for patients with bullous lung disease, pathologically low blood pressure, severe cardiac arrhythmias, coronary artery disease, pneumothorax, or pneumomediastinum. Use caution in patients with CSF leaks, cribriform plate abnormalities, prior head trauma, or pneumocephalus. Temporarily contraindicated if patient exhibits signs of sinus or middle ear infection.

Regulatory Classification

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.

Predicate Devices

• Aria CPAP System (K953341)
• Companion 314 Nasal CPAP System (K952292)

Reference Devices

• Respironics GEL Mask (K954207)
• Monarch Mini-Mask (K945938)
• Respironics Contour Nasal Mask (K851396)
• Respironics Spectrum Disposable Full Face Mask (K936047)
• REMstar Choice Nasal CPAP System (K900113)
• BiPAP System (K883825)
• Respironics Plateau Exhalation Valve (K925587)
• Respironics Passover Humidifier (K945782)
• Fisher & Paykel Heated Humidifier (K915460C)
• King ViroBac Bacteria Filter (K880681)

Submission Summary (Full Text)

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SolopPAP System
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1001 Murry Ridge Drive, Murrysville, PA 15668

SECTION 12

JUL 18 1996

REP

1001 Murry Ridge Drive, Murrysville, PA 15668

April 23, 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 | 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 |

© 1996 Respironics, Inc.

April 23, 1996

Section 12, Page 1

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Premarket Notification Section 510(k)
Section 12 - Summary of Safety & Effectiveness
Solo CPAP System

## Reason for Submission

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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April 23, 1996
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Solo CPAP System

## 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 Solo CPAP System contraindications by deleting "seizures" from the list. This is in keeping with the labeling of other CPAP devices.

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April 23, 1996
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Solo CPAP System

# 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.

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 microprocessor-controlled 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

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Solo CPAP System

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.

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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Solo CPAP System

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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April 23, 1996
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Solo CPAP System

# 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.

Table 12-1. Solo CPAP System Accessories

| Accessory | Reference 510(k) |
| --- | --- |
| Respironics Contour Nasal Mask and headgear | K851396 |
| Respironics Spectrum™ Disposable Full Face Mask and headgear | K936047 |
| Respironics Comfort Flap® Mask Accessory | K953341
(Aria CPAP System) |
| Respironics 6' Reusable Flexible Tubing Assembly | K900113
(REMstar Choice®
Nasal CPAP System) |
| Respironics 6' Disposable Flexible Tubing Assembly | |
| Respironics 18" Reusable Flexible Tubing Assembly | |
| Respironics 18" Disposable Flexible Tubing Assembly | |
| 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 Cord
Battery Adapter Cable | K953341
(Aria CPAP System) |

© 1996 Respironics, Inc.
April 23, 1996
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