(92 days)
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No
The device description focuses on mechanical gas manifold design and safety features, with no mention of AI or ML capabilities.
No.
The device is a gas selection panel used with hyperbaric oxygen treatment gas systems to select between two available gases for hyperbaric chamber pressurization/ventilation and patient breathing gas systems; it does not directly provide therapy.
No
The document describes a gas selection manifold used in hyperbaric oxygen therapy systems to switch between two gases for ventilation and patient breathing. It does not mention any diagnostic function.
No
The device description clearly outlines a physical gas manifold with valves, gauges, and a "block and bleed" gas circuit, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to select between two available gases for hyperbaric oxygen (HBO) treatment systems. This involves delivering gases to a patient or a hyperbaric chamber, which is a therapeutic application, not a diagnostic one.
- Device Description: The device is a gas manifold designed to accept and supply breathing gases. It focuses on the safe and controlled delivery of gases for treatment.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for 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.
Product codes
73CBF
Device 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 qas.
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 GSPI 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 868.5470 Hyperbaric chamber.
(a)
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).(b)
Classification. Class II (performance standards).
0
REIMERS SYSTEMS, INC. 7668 FULLERTON ROAD SPRINGFIELD, VIRGINIA 22153
S. D. REIMERS PRESIDENT
TELEPHONE (703) 866-5490
510(k) SUMMARY - GSP1 GAS SELECTION PANEL
TELECOPIER (703) 866-9066
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 qas.
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 GSPI 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.
1
COMPARISON TO EXISTING EQUIPMENT:
The GSP1 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 | GSP1- 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 GSP1 gas circuit is manually operated by moving a quarter-turn valve, whereas the air/oxygen switch-over circuit is operated by a pneumatic The control system for a multiplace chamber automatically switches actuator. 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 GSP1 Gas Selection Panel is substantial equivalent to existing, legally marketed devices.