(164 days)
The Invacare® Platinum® 5NXG Oxygen Concentrator is indicated for patients with respiratory disorders requiring supplemental oxygen at flow rates of 1 to 5 liters per minute. For flow rates below 1 liter per minute use with Invacare Pediatric Flowmeter accessory. It is not intended to sustain or support life.
The subject Invacare® Platinum® 5NXG Oxygen Concentrator device is used by patients who require supplemental oxygen. The device is not intended to sustain or support life. The oxygen concentration level of the output gas ranges from 87% to 96% at an output flow rate range of 1 to 5 liters per minute (LPM). The oxygen is delivered to the user through the use of a nasal cannula. The concentrator provides supplemental oxygen to patients with respiratory disorders, in the home, long term care facility or other non-acute patient care facilities. It is not intended to sustain or support life. It is to be used indoors and is intended to support the patient's lifestyle within the home or care facility. The device operates at a nominal 120VAC/60 Hertz supply.
The provided document is a 510(k) Pre-Market Notification for the Invacare Platinum 5NXG Oxygen Concentrator. It describes the device, its intended use, and compares it to a predicate device (Invacare Perfecto2™V Oxygen Concentrator K200890) to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a "table of acceptance criteria and reported device performance" in the format of pass/fail measurements against specific numerical criteria for all aspects. Instead, it describes general performance categories and states that the device "met the performance requirements" or "demonstrates that the subject device meets performance specifications and requirements."
However, we can infer some criteria and reported performance from the "Design Characteristics Comparison" table on page 6 and the "Performance Testing – Bench" section on page 9.
| Acceptance Criteria (Inferred from Predicate/Standards) | Reported Device Performance (Invacare Platinum 5NXG Oxygen Concentrator) |
|---|---|
| Oxygen Output Concentration Levels | 87% to 96% at all flow rates |
| (Predicate was 95.6% to 87% at all flow rates) | |
| Maximum Flow Rate | 5.0 L/min |
| (Same as predicate) | |
| Adjustable Flow Range | 1 to 5 L/min in 0.5 L/min increments |
| (Same as predicate) | |
| Oxygen Purity Fault Indication | If oxygen purity falls below 82% but above 50% |
| (Predicate was if oxygen purity falls below 85% (±2%) but above 73% (±3%)) | |
| Rated Current Input | 3.0 A |
| (Predicate was 3.2 A) | |
| Electrical Requirements | 120 VAC ±10%, 60 Hz |
| (Same as predicate) | |
| Weight | 33 ± 2 lbs. |
| (Predicate was 40 lbs.) | |
| Height | 24 ± 3/8" |
| (Predicate was 23 ± 3/8") | |
| Width | 16 ± 3/8" |
| (Predicate was 15 ± 3/8") | |
| Depth | 12 ± 3/8" |
| (Same as predicate) | |
| Basic Safety and Essential Performance | Device meets performance specifications and requirements |
| (Assessed against ISO 80601-2-69, AAMI ES60601-1, IEC 60601-1 etc.) | |
| Risk Management | Risk profile unchanged, no significant impact on safety/effectiveness. |
| (In accordance with ISO 14971:2012) | |
| Software Functionality (including alarms and indicators) | Evaluated and verified |
| (In accordance with FDA guidance and IEC 62304:2006, ISO 80601-2-69) | |
| Electrical Safety and EMC | Confirmed post-change functionality, demonstrated equivalence |
| (Against various IEC and AAMI standards) | |
| Biocompatibility | Performed on components; met requirements for inorganic gases (CO, CO2, O2) and odor. |
| (In accordance with ISO 18562 series and USP monograph) | |
| Power and Oxygen Output Performance | Met performance specifications and requirements |
| Transportation Testing (ISTA 2A) | Successfully performed |
| Sound Testing | Successfully performed |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to "design verification testing data" and "bench performance testing." These are laboratory or engineering tests performed on the device itself (or its components) rather than clinical data from a human population. Therefore, the concept of a "sample size" in the clinical sense (e.g., number of patients) is not applicable here. The testing involves physical devices.
The provenance of the data is internal to the manufacturer (Invacare Corporation) as it describes their internal verification testing. The document does not specify the country of origin of the test data (e.g., if the tests were performed in the US, or elsewhere) nor does it explicitly state whether the testing was prospective (done specifically for this submission) or retrospective (using existing data), though the context of "design verification testing" implies it was specifically conducted for the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This product is an oxygen concentrator, a medical device for delivering oxygen. It is not an AI/imaging device requiring expert interpretation for ground truth. Therefore, the concept of "experts establishing ground truth for a test set" with qualifications such as radiologists is not applicable to this submission. The ground truth for performance is established by objective measurements and adherence to recognized consensus standards by qualified testing engineers and laboratories.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, this device does not involve human interpretation requiring adjudication for establishing ground truth. Performance is measured objectively.
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. The device is an oxygen concentrator, not an AI-assisted diagnostic tool. No MRMC study was performed, nor is it relevant to the device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The device is an oxygen concentrator, not an algorithm or software-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is established by objective measurements against defined engineering specifications and recognized consensus standards. This includes:
- Measurements of oxygen concentration, flow rates, electrical characteristics, weight, dimensions, and sound levels.
- Adherence to specific clauses and requirements within international standards like ISO 80601-2-69 (specific for oxygen concentrators), AAMI ES60601-1, IEC 60601-1 (general medical electrical equipment safety), IEC 62304 (software life cycle), ISO 14971 (risk management), and ISO 18562 series (biocompatibility).
8. The sample size for the training set
Not applicable. This is a hardware medical device, not an AI/machine learning model that requires a "training set" of data.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of medical device.
§ 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).