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510(k) Data Aggregation
(230 days)
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 | <45°C Maximum | <45°C Maximum (Met and passed criteria) |
| Outlet gas temperature | <40°C Maximum | <40°C Maximum (Met and passed criteria) |
| Single use, disposable | Yes | Yes |
| OTC designation | Yes | Yes |
| Indications for Use | To produce oxygen for emergency use | Intended to produce oxygen for emergency use at 6 lpm flow rate for at least 15 minutes (90 liters). Identical to predicate. |
| Environment of Use | Home, emergency locations | Home, emergency locations. Identical to predicate. |
| Patient Population | Any individual | Any individual requiring oxygen in an emergency setting. Identical to predicate. |
| Contraindications | None | None |
| Method for oxygen generation | Chemical reaction | Chemical reaction (solid chemicals ignited to generate oxygen). Identical technology to predicate. |
| Patient interface | Standard oxygen mask or nasal cannula | Standard oxygen mask or nasal cannula. |
| Materials | Tested for VOC and PM2.5 | Materials in gas pathway tested via VOC and PM2; similar to predicate, demonstrating no unwanted particulate matter or undesirable gases. |
| Dimensions | 35 cm x 10 cm (Predicate) | 28.5 cm x 11.5 cm |
| Gross weight | 1.8 kg (Predicate) | 1.5 kg |
| Accessories | Mask or Oxygen cannula | Mask or Oxygen cannula |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state a specific "sample size" for a test set in the traditional statistical sense for device performance. Instead, it mentions "Performance testing was performed" and lists various tests, implying that units of the ROGS device were tested against the specified parameters. The provenance of the data is retrospective, as the testing was performed and then summarized for the 510(k) submission. The country of origin for the device's manufacturer is the United Kingdom.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. This device is a portable oxygen generator, not a diagnostic or AI-driven decision support system that would require expert-established ground truth for a test set. The "ground truth" here is objective physical and chemical measurements (e.g., % oxygen purity, flow rate, temperature).
4. Adjudication Method for the Test Set:
Not applicable. Given the nature of the device (physical oxygen generator), the performance evaluation relies on direct measurement against predefined specifications, not expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
Not applicable. An MRMC study is relevant for AI-assisted diagnostic or interpretive tasks involving multiple human readers and imaging cases. The ROGS is a standalone physical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No, this is not an algorithm-only device. It is a physical device where its performance is inherently "standalone" in the sense that its oxygen generation function operates independently of human intervention during its use, once activated. The performance testing described (flow rate, purity, temperature, etc.) represents the intrinsic performance of the device itself.
7. The Type of Ground Truth Used:
The ground truth used for evaluating the ROGS device is objective physical and chemical measurements against engineering specifications and regulatory requirements. This includes metrics such as:
- Percent oxygen generated
- Flow rate (liters per minute)
- Duration of flow
- Temperature measurements (external container, outlet gas)
- Presence of VOCs, PM2.5, and Ozone.
- Resistance to environmental conditions (temperature, vibration).
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
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