GSP1 - GAS SELECTION PANEL

K962869 · Reimers Systems, Inc. · CBF · Oct 23, 1996 · Anesthesiology

Device Facts

• Record ID: K962869
• Device Name: GSP1 - GAS SELECTION PANEL
• Applicant: Reimers Systems, Inc.
• Product Code: CBF · Anesthesiology
• Decision Date: Oct 23, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The RSI GSP1 Gas Selection Panel is intended for use with hyperbaric oxygen (HBO) treatment gas systems whenever there is a need to select between two available gases. This typically includes support for monoplace chamber pressurization/ventilation systems and patient breathing gas systems supporting masks and hoods.

Device Story

GSP1 Gas Selection Panel is a wall-mounted gas manifold designed to accept two breathing gas inputs (e.g., air and oxygen) and distribute them to up to four downstream devices, such as monoplace hyperbaric chambers or patient breathing stations (e.g., RSI ODS1 Hood Driver). The device utilizes a 'block and bleed' gas circuit to ensure gas isolation and prevent cross-contamination, meeting ASME PVHO-1 safety requirements. Operation is manual via quarter-turn valves. The panel includes service shut-off valves and pressure gauges for monitoring. It is used in clinical hyperbaric treatment settings by medical staff to manage patient breathing gas delivery, including the administration of 'air breaks' during treatment protocols.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Wall-mounted gas manifold. Materials: Copper, brass, stainless steel. Gas isolation: 'Block-and-bleed' circuit. Energy source: Pneumatic (gas pressure). Compatibility: 100% oxygen compatible. Operation: Manual quarter-turn valves. Standards: ASME PVHO-1.

Indications for Use

Indicated for use in hyperbaric oxygen (HBO) treatment environments requiring selection between two breathing gases for monoplace chamber pressurization, ventilation, or patient breathing systems (masks/hoods).

Regulatory Classification

Identification

A hyperbaric chamber is a device that is intended to increase the environmental oxygen pressure to promote the movement of oxygen from the environment to a patient's tissue by means of pressurization that is greater than atmospheric pressure. This device does not include topical oxygen chambers for extremities (§ 878.5650).

Predicate Devices

• RSI T-Class Hyperbaric Facilities (K954387)

Submission Summary (Full Text)

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OCT 23 1996
X962869

# REIMERS SYSTEMS, INC.
7668 FULLERTON ROAD
SPRINGFIELD, VIRGINIA 22153

S. D. REIMERS
PRESIDENT

# 510(k) SUMMARY - GSP1 GAS SELECTION PANEL

TELEPHONE
[phone]

TELECOPIER
[phone]

DATE: July 12, 1996

SUBMITTER: Stephen D. Reimers, PE
President

CONTACT: Carlyle H. Smith, PE
Staff Engineer

# DEVICE INFORMATION:

Trade name: GSP1 - Gas Selection Panel
Common name: Gas Selection Panel
Classification name: Chambers, Hyperbaric 73CBF

# DESCRIPTION:

The RSI gas selection panels (GSP1) are gas manifolds designed to accept two breathing gases. (Usually, air and oxygen will be specified; however, the device will work with any breathing gas.) Depending on the options selected, it will then supply one to four other devices. These other devices may be hyperbaric, monoplace chambers (up to two) or patient breathing stations such as the RSI ODS1 Hood Driver (up to four). The GSP1 allows each device supplied to receive either gas.

The GSP1 incorporates a "block and bleed" gas circuit (like those used to supply mask breathing systems on larger, multiplace hyperbaric chambers) that insures that the device supplied receives only the gas selected even if there is a leak in any of the other piping components. A positive means, such as the "block and bleed" design, is required to prevent contamination of one gas with another and is a safety requirement of the ASME PVHO-1 code.

The GSP1 is designed to be surface mounted on a wall. It also has two service shut-off valves, one for each gas supply, and gauges to indicate supply pressures.

# INTENDED USE:

The RSI GSP1 Gas Selection Panel is intended for use with hyperbaric oxygen (HBO) treatment gas systems whenever there is a need to select between two available gases. This typically includes support for monoplace chamber pressurization/ventilation systems and patient breathing gas systems supporting masks and hoods.

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# COMPARISON TO EXISTING EQUIPMENT:

The GSPI is substantially equivalent to the air/oxygen switch-over circuit found in larger hyperbaric chamber systems, such as the RSI T-Class Hyperbaric Facilities (K954387) as the following table indicates:

| Parameter | RSI T-Class air/oxygen switch-over circuit | GSPI- Gas Selection Panel |
| --- | --- | --- |
| Number of gas sources | Two (2) | Same |
| Gas isolation method | "Block-and-bleed" | Same |
| Intended fluids | Breathing gases; air, oxygen, etc. | Same |
| Switch over is.. | Automatic and/or manual | Manual |
| Wetted materials | Copper, Brass, Stainless-steel | Same |
| Soft goods | 100% oxygen compatible | 100% oxygen compatible |
| Gas isolation method | Block-and-bleed | Same |
| Packaging | No special packaging. Unit is integrally incorporated in system. | Panel mounted, ready for wall mounting. |

# DISCUSSION:

The significant differences between the gas selection panel and the T-class air/oxygen switch-over circuit are as follows:

a) The GSPI gas circuit is housed in an esthetically pleasing panel which is designed for wall mounting in a treatment room. The air/oxygen switch-over circuit is designed integrally as part of a breathing gas system feeding multiple patient breathing stations in a T-class facility. The functional circuit; however, is the same for each.

b) The GSPI gas circuit is manually operated by moving a quarter-turn valve, whereas the air/oxygen switch-over circuit is operated by a pneumatic actuator. The control system for a multiplace chamber automatically switches the breathing gas to air when the fire system is activated or (optionally) can be toggled by the operator from the control console. Switching from oxygen to air is desired to provide "air breaks" for the patients when required by some treatment protocols.

Neither of these differences affect the safety or effectiveness of the GSPI which is inherent in the "block and bleed" design. The differences are only related to the packaging of the circuit.

# CONCLUSION:

The GSPI Gas Selection Panel is substantial equivalent to existing, legally marketed devices.