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510(k) Data Aggregation
(281 days)
Molecular Products Ltd.
Intended to produce oxygen for emergency use at 6 LPM flow rate for at least 15 minutes (90 liters) for individuals 17 years and older requiring emergency or supplemental oxygen.
The Rugged Oxygen Generator (ROG) is intended for environment such as emergency use, home use, and commercial use and is OTC. The ROG is designed to provide supplemental oxygen and is a single use product. The ROG is a chemical oxygen generator that produces a minimum of 90 liters of oxygen at ≥96% purity for minimum of 15 minutes with an average flow rate of 6 liters per minute or greater. There is a need for oxygen in a variety of applications/locations where compressed oxygen cylinders are not suitable.
Principle of Operation: The subject device is initiated though a friction interaction between an integrated phosphorous match and the candle block. To initiate, open the lid and turn the dial clockwise 2-3 times. The turning of the dial will rotate the match and screw the match down into the candle block. This will start the chemical reaction, which will produce oxygen. Once oxygen is flowing, close the lid and place the face mask onto patient.
Here's a summary of the acceptance criteria and study information for the Rugged Oxygen Generator (ROG) based on the provided document:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| % Oxygen | 96% (Predicate: 99%. Note: USP defines medical oxygen purity as > 93%) |
| Flow rate minimum | 6 LPM |
| Duration | At least 15 minutes |
| Initiation of oxygen flow | 5 seconds |
| Housing temperature |
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(230 days)
MOLECULAR PRODUCTS LTD.
Intended to produce oxygen for emergency use at 6 lpm flow rate for at least 15 minutes (90 liters).
The ROGS is a chemical based portable oxygen generator which generates 99% oxygen for at least 15 minutes at a flow rate of at least 6 lpm. It is a self-contained device with the oxygen delivered via standard oxygen face mask or nasal cannula.
The provided text describes the ROGS portable oxygen generator, a chemical-based device intended for emergency oxygen production. The acceptance criteria and the study proving it meets these criteria are outlined through a comparison to a predicate device (Molecular Products - POGS - K062153) and performance testing.
Here's an organized breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature | Acceptance Criteria (Predicate/Proposed Device) | Reported Device Performance (ROGS) |
|---|---|---|
| % Oxygen | 99% | >99% generated |
| Flow Rate minimum | 6 lpm | > 6 lpm |
| Duration of flow | At least 15 minutes | At least 15 minutes |
| Total Oxygen generated | 90 liters (implied from 6 lpm for 15 minutes) | At least 90 liters (6 lpm for at least 15 minutes) |
| Time to start of gas flow | 60 seconds (Predicate) | 5 seconds |
| VOC / PM2.5 / Ozone | Yes (tested) | Met and passed criteria; does not generate unwanted particulate matter or undesirable gases |
| Environmental testing | High and low temperature conditions | Met and passed criteria (Storage: -20° to +40°C; Operating: 0° to +40°C) |
| Mechanical testing | Vibration | Met and passed criteria |
| External container temperature |
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(117 days)
MOLECULAR PRODUCTS LTD.
The Portable Oxygen Generator (POG) is intended to produce oxygen for emergency use at 6 lpm for at least 15 minutes.
The Molecular Products' POG is a chemical based portable oxygen generator which generates 99% oxygen for 15 minutes at a flow rate of 6 lpm. It is a self-contained device with the oxygen delivered via a standard oxygen face mask or nasal cannula.
The document describes the acceptance criteria and performance of the POG (Portable Oxygen Generator) device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Test flow rate | 6 Lpm |
| Duration | At least 15 minutes |
| % Oxygen | 99% |
| External canister temperature |
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