PRESSURE VALVE

K963250 · Respironics, Inc. · BZD · Nov 14, 1996 · Anesthesiology

Device Facts

• Record ID: K963250
• Device Name: PRESSURE VALVE
• Applicant: Respironics, Inc.
• Product Code: BZD · Anesthesiology
• Decision Date: Nov 14, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2

Intended Use

To prevent backflow of oxygen or water from patient circuit into Respironics CPAP or BiPAP device when the unit is not functioning

Device Story

The Pressure Valve is an in-line one-way valve for Respironics CPAP and bi-level systems. It consists of a housing, valve disc, and spring. When the CPAP/BiPAP unit pressure drops below 0.5 cm H₂O, the valve vents backflow of oxygen or water to the atmosphere, protecting the device from fluid ingress. It is used in hospital and home settings. The device features standard 22 mm fittings for integration into patient breathing circuits. It is a reusable component designed to be cleaned between uses.

Clinical Evidence

Bench testing only. The device was evaluated for minimal resistance to flow while in-line and for meeting design requirements after cleaning.

Technological Characteristics

Materials: Polycarbonate body and valve, phosphor bronze spring. Form factor: In-line valve with standard 22 mm fittings. Principle: Mechanical one-way valve with atmospheric venting when pressure drops below 0.5 cm H₂O. Reusable; cleanable.

Indications for Use

Indicated for use in hospital and home environments with Respironics CPAP and bi-level systems that utilize supplemental oxygen and/or humidifiers to prevent backflow of oxygen or water into the device during non-functioning states.

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

• Instrumentation Industries, Inc. - Reusable One-Way Valve (Preamendment)

Submission Summary (Full Text)

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K963250

NOV 14 1996

# RESPIRONICS INC.

## Non-Confidential Summary of Safety and Effectiveness

page 1 of 3
August 16, 1996

Respironics, Inc.
1001 Murry Ridge Drive
Murrysville, PA
Tel - [phone]
Fax - [phone]

| Official Contact: | Francis X. Dobscha, Manager, Regulatory Affairs |
| --- | --- |
| Proprietary or Trade Name: | Pressure Valve |
| Common/Usual Name: | One-way valve |
| Classification Name: | Accessory for Ventilator, Passive Exhaust Port, Critical Care |
| Device: | Respironics Pressure Valve |
| Predicate Devices: | Instrumentation Industries, Inc. - Reusable One-Way Valve (Preamendment) |

### Device Description:

The Pressure Valve is an in-line one-way valve which prevents oxygen or water in the patient circuit from backflowing into the Respironics CPAP or bi-level device when the unit is not functioning. The Pressure Valve incorporates a valve disc, spring, and housing. The device vents any backflow to the atmosphere when the pressure output of the Respironics CPAP or BiPAP unit drops below 0.5 cm H₂O.

### Intended Use:

| Indicated Use -- | To prevent backflow of oxygen or water from patient circuit into Respironics CPAP or BiPAP device when the unit is not functioning |
| --- | --- |
| Environment of Use -- | Hospital and Home |
| Equipment -- | Respironics CPAP and bi-level systems indicated for use with supplemental oxygen and/or humidifiers. |

page 3 of 54

1001 Murry Ridge Drive, Murrysville, PA 15668-8550
412/733-0200 Fax: [phone]

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page 2 of 3
August 16, 1996

# Non-Confidential Summary of Safety and Effectiveness (continued)

## Comparison to Predicate Devices:

| Attribute | Intended device: Respironics, Inc. Pressure Valve | Instrumentation Industries, Inc. One-Way Valve |
| --- | --- | --- |
| Use | | |
| Intended Use -- placed in-line in patient circuits | Yes | Yes |
| Intended equipment - to be used only with Respironics, Inc. CPAP and bi-level systems | Yes | No |
| Indicated - to establish directional flow in a patient circuit and thus prevent backflow | Yes | Yes |
| Indicated - prevents backflow of oxygen or water into CPAP or bi-level device when the unit is not functioning. | Yes | No |
| Intended environment - Hospital and Home | Yes | Yes |
| Design | | |
| Placed in-line in patient breathing circuit | Yes | Yes |
| Has standard 22 mm fittings | Yes | Yes |
| Vents backflow to atmosphere | Yes | No |
| Reusable - multiple use, can be cleaned | Yes | Yes |
| Materials - Body Valve Spring | Polycarbonate
Polycarbonate
Phosphor Bronze | Polycarbonate
Silicone Rubber
N/A |
| Performance Standards/Specifications | | |
| Has minimal resistance to flow while in-line | Yes | Yes |
| Meets design requirements after cleaning | Yes | Yes |

page 4 of 54

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page 5 of 54
# Non-Confidential Summary of Safety and Effectiveness (continued)

page 3 of 3
August 16, 1996

## Differences Compared To Other Legally Marketed Predicate Device

The differences between the intended device and the Instrumentation Industries, Inc., One-Way Valve are -

* The intended device is designed to be used only with the Respironics, Inc., CPAP and bi-level systems.

* The intended device vents any backflow of oxygen or water to the atmosphere, whereas the predicate device is generally placed in a circle type of circuit and is not required to vent to atmosphere.

There are no other significant differences in design, intended use, safety and effectiveness between the Pressure Valve and the predicate device.