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510(k) Data Aggregation
(432 days)
PORTABLE OXYGEN UNIT SCA900
The Portable Oxygen Unit SCA900 is an integrated portable oxygen delivery system intended to provide supplemental oxygen to adults; a pressure regulator, flow meter and oxygen cylinder fully integrated into single unit. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only. Compressed gas cylinders in service or in storage shall be stabilized or otherwise secured to prevent falling and rolling.
The Portable Oxygen Unit SCA900 is a portable oxygen delivery system, consisting of a fully integrated cylinder, valve, regulator, nasal cannula and mask. The oxygen is delivered through the mask or nasal cannula with a range of user-selectable flow settings. This unit is suitable for use in all healthcare settings. including hospital and home healthcare.
This submission is for a Class I medical device, a Portable Oxygen Unit, which typically does not require extensive clinical studies to demonstrate effectiveness or safety. The FDA filing indicates a "substantial equivalence" determination to existing predicate devices based on design, materials, indications, intended use, packaging, labeling, and performance. Therefore, a formal study with defined acceptance criteria and detailed performance reporting as one might expect for a higher-risk device with novel technology is not present in this document.
The documentation provided does not contain specific acceptance criteria or a study designed to prove the device meets those criteria in the way a clinical trial would. Instead, the submission relies on demonstrating substantial equivalence to already legally marketed predicate devices.
Here's an analysis based on the provided text, addressing the requested points where possible, and noting where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission for a substantially equivalent device of Class I, specific, quantifiable acceptance criteria and corresponding performance metrics from a formal study are not explicitly stated or provided in the document. The acceptance is based on demonstrating equivalence in general aspects.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied from "Substantially Equivalent") |
|---|---|
| Equivalent Design | Design is comparable to predicate devices. |
| Equivalent Materials | Materials are comparable to predicate devices. |
| Equivalent Indications | Indications for Use are comparable to predicate devices. |
| Equivalent Intended Use | Intended Use is comparable to predicate devices. |
| Equivalent Packaging | Packaging is comparable to predicate devices. |
| Equivalent Labeling | Labeling is comparable to predicate devices. |
| Equivalent Performance | Performance is comparable to predicate devices (e.g., oxygen delivery, safety features). |
The phrase "Testing and other comparisons have established that the subject of Portable Oxygen Unit SCA900 is substantially equivalent in design, materials, indications and intended use, packaging, labeling, and performance to other predicate devices of the type currently marketed in the U.S." (page 2) is the primary "proof" of meeting the (implied) acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable/not provided. This type of submission does not detail a "test set" in the context of clinical or diagnostic performance assessment.
- Data Provenance: Not applicable/not provided. The comparison is against predicate devices and likely relies on design specifications and engineering bench testing, rather than patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable/not provided. Ground truth in the context of expert review of images or clinical outcomes is not relevant for this type of device submission.
- Qualifications of Experts: Not applicable/not provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/not provided. There is no mention of a "test set" requiring adjudication in the provided documentation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices to assess human reader performance with and without AI assistance. It is not relevant for a portable oxygen unit.
- Effect Size: Not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: No, a standalone performance assessment (in the context of an algorithm) was not done. This device is a mechanical system, not an AI or algorithmic device.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not applicable in the traditional sense of clinical or diagnostic studies. The "ground truth" for this submission is based on the established safety and effectiveness of the predicate devices and the demonstration that the SCA900 is functionally equivalent to them. This would primarily involve engineering specifications, performance testing (e.g., flow rate accuracy, pressure regulation, durability), and compliance with relevant standards, rather than expert consensus on medical images or patient outcomes.
8. The Sample Size for the Training Set
- Sample Size: Not applicable/not provided. This device relies on established engineering principles and materials, not a "training set" for a machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable/not provided. As there is no training set, there is no ground truth establishment for it.
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