(167 days)
The Oxygen Concentrators with the Oxygen Filling accessory are indicated to provide supplemental oxygen to patients in the home and to supply pressurized oxygen to fill gas cylinders for the patient's personal ambulatory use. The device is not intended for life support nor does it provide any patient monitoring capabilities.
The Profill Q601 series home oxygen filling machines are prescription devices designed for use in home by patients that require supplemental oxygen. It is intended to pressurize oxygen from an oxygen concentrator to fill gas cylinders for the patient's personal ambulatory use. It is not intended for life support nor does it provide any patient monitoring capabilities.
The device consists of a compressor module and a portable oxygen cylinder with a specially adapted cylinder fitting. It is compatible with available standard oxygen concentrators as the source of oxygen. The oxygen generated by the oxygen concentrator is inducted into a buffer tank. Then it is split into two streams. The first stream flows to the outlet on the control panel. The patients can use this as their source of supplemental oxygen while they are filling their cylinders. The second stream flows to the compressor where the oxygen is pressurized and filled into the cylinder. The devices are not sold or labeled as sterile
This is a 510(k) premarket notification for an oxygen concentrator accessory, not a study evaluating the performance of an AI/ML device. Therefore, many of the requested categories, such as acceptance criteria, sample size, ground truth, and MRMC studies, are not applicable.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not provide specific acceptance criteria or quantitative device performance data in a format applicable to evaluating an AI/ML device or a medical imaging system. The performance is summarized qualitatively.
| Criterion | Reported Performance |
|---|---|
| Device Functionality | "Verification testing has confirmed the product meets its specifications." |
| Safety and Effectiveness | "Based on the design, performance specifications, testing and intended use, the Oxygen Filling Accessories are substantially equivalent to the currently marketed devices." |
2. Sample size used for the test set and the data provenance:
Not applicable. This is a premarket notification for a physical medical device, not a study involving a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth establishment with experts is not relevant for this type of device submission.
4. Adjudication method for the test set:
Not applicable.
5. 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 not an AI/ML device or an imaging device that would typically undergo such a study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable.
7. The type of ground truth used:
Not applicable. The "ground truth" for this device would be its ability to perform its intended function (pressurize oxygen and fill cylinders) according to its engineering specifications, not expert consensus or pathology on medical data.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established:
Not applicable.
Additional Information from the Document:
- Device Name: Merits Health Products Oxygen Tank Filling Accessory (for Merits Health Products Oxygen Concentrators)
- Manufacturer: Merits Health Products Co., LTD.
- Intended Use: To provide supplemental oxygen to patients in the home and to supply pressurized oxygen to fill gas cylinders for the patient's personal ambulatory use. Not intended for life support nor does it provide any patient monitoring capabilities.
- Comparison to Predicate Device: Substantially equivalent to the Invacare Corporation Model HomeFill II Complete Home Oxygen System (K003939).
- K Number: K050430
- Date: Submitted April 26, 2005 (FDA approval letter dated August 4, 2005)
- Regulatory Classification: Class II, Portable Oxygen Generator (21 CFR 868.5440), Product Code CAW.
- Performance Data: "Verification testing has confirmed the product meets its specifications." This generally refers to engineering and functional tests to ensure the device operates as designed.
§ 868.5440 Portable oxygen generator.
(a)
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).(b)
Classification. Class II (performance standards).