(92 days)
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.
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.
This K962869 submission for the REIMERS SYSTEMS, INC. GSP1 Gas Selection Panel describes a medical device, but it does not include any acceptance criteria or a study demonstrating device performance in the way typically expected for clinical or diagnostic devices.
The submission focuses primarily on demonstrating substantial equivalence to a predicate device (RSI T-Class air/oxygen switch-over circuit) based on design, materials, and intended use. This is a common approach for 510(k) clearances when a new device is very similar to an already marketed one.
Therefore, I cannot populate the requested table and information as there isn't a study proving the device meets performance criteria in the usual sense (e.g., sensitivity, specificity, accuracy against a clinical gold standard).
Here's a breakdown of why and what information can be extracted:
Why the requested information is not available in this 510(k) summary:
- Device Type: The GSP1 is a gas manifold, essentially a mechanical system for routing breathing gases. It's not a diagnostic tool or a treatment device where typical performance metrics like sensitivity, specificity, or outcomes are relevant.
- Regulatory Pathway: The 510(k) pathway relies on demonstrating substantial equivalence to a predicate device. This often involves comparing design specifications, materials, and intended use, rather than conducting new clinical performance studies.
- Focus on Safety and Equivalence: The key "proof" in this submission is that the GSP1 uses the same "block-and-bleed" gas isolation method as the predicate, which is a safety requirement of the ASME PVHO-1 code to prevent gas contamination. Its effectiveness is thus presumed by its adherence to this established, safe design principle already used in a legally marketed device.
Information that can be inferred or directly stated from the document, but does not fit the requested format for acceptance criteria/performance study:
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"Acceptance Criteria" (Implicit): The implicit acceptance criteria are that the device:
- Accepts two breathing gases.
- Employs a "block-and-bleed" gas isolation method.
- Is intended for breathing gases (air, oxygen).
- Uses specified wetted materials (Copper, Brass, Stainless-steel).
- Uses 100% oxygen compatible soft goods.
- Can be manually operated.
- Adheres to ASME PVHO-1 code for gas isolation.
- Is substantially equivalent to the predicate in function and safety.
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"Device Performance" (Implicit): The device is reported to perform "the same" as the predicate device's air/oxygen switch-over circuit in terms of gas selection and isolation. The "block-and-bleed" design "insures that the device supplied receives only the gas selected even if there is a leak in any of the other piping components," which is the core performance claim related to safety.
Therefore, the table and subsequent questions cannot be populated meaningfully as a clinical performance study was not conducted or reported.
Explanation for missing fields:
- A table of acceptance criteria and the reported device performance: Not applicable as performance is demonstrated by substantial equivalence to an existing device and adherence to a safety standard (ASME PVHO-1) for its safety mechanism. There are no measurable performance metrics like accuracy, sensitivity, or specificity.
- Sample size used for the test set and the data provenance: Not applicable. No test set in the conventional sense was used for performance evaluation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth in a clinical sense was established.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a mechanical gas manifold, not an AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device does not have an algorithm.
- The type of ground truth used: Not applicable. The "ground truth" here is the established safety and functional equivalence of the "block-and-bleed" design, as validated by ASME PVHO-1 code and its prior use in a legally marketed device.
- The sample size for the training set: Not applicable. No training set for an algorithm.
- How the ground truth for the training set was established: Not applicable.
In summary, this 510(k) focuses on demonstrating safety and functional equivalence through design comparison rather than presenting results from a performance study with specific acceptance criteria.
§ 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).