(155 days)
The Invacare TPOC Portable Oxygen Concentrator is intended to be used by patients with respiratory disorders who require supplemental oxygen. It supplies a high concentration of supplemental oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Invacare TPOC Portable Oxygen Concentrator can be used in a home, institution, vehicle, and various mobile environments. The Invacare TPOC Portable Oxygen Concentrator does not nor is it intended to sustain or support life.
The Invacare TPOC is to be used by patients with respiratory disorders who require supplemental oxygen. The device can be used in the home, an institution, vehicle and various mobile and outdoor environments. The device is not intended to sustain or support life. The device is typically used with a nasal cannula to direct oxygen from the device to the patient.
When set for Continuous Flow Mode, the TPOC can deliver up to 3 LPM continuous flow in 0.5 LPM increments. While in Pulse Delivery Mode, when the demand for oxygen is detected, the oxygen is delivered through pulsed flow with pulse flow settings of 1 through 5. The oxygen concentration level of the output gas ranges from 87% to 95.6% in all modes.
The modified TPOC contains an integrated oxygen sensor to provide added monitoring of the output gas purity, as well as additional patient warnings and alarms based on those levels. The oxygen sensor process uses a heated Zirconia element as the method of measurement. This is the exact same sensor process used in previously cleared oxygen concentrators such as the Invacare Platinum 5 Oxygen Concentrator, K020386.
With the addition of continuous flow, the TPOC is now capable of supporting two features commonly with the addition of ocultified no ne nextrators; usc with a humidification and use in conjunction with PAP, Bi-Level and other such devices as an oxygen bleed-in. The use of this equipment is only during continuous flow mode, as indicated in the User's Manual. odulphileit is only aaning othium battery pack, standard power options include switching power Anong with a rents from AC power outlet (120 VAC/ 60 Hertz nominal) and from accessory DC outlets typically found in a mobile vehicle type environment (12 VDC nominal).
The Invacare TPOC uses a molecular sieve and pressure swing adsorption methodology to produce the The in theater Tr C abber a nair enters the device, is filtered and then compressed. This compressed air is then directed toward one of two nitrogen adsorbing sieve beds. Concentrated oxygen exits the opposite end of the active sieve bed and is directed into an oxygen reservoir where it is delivered to the patient in specific volumes during the inhalation portion of a detected breath in pulse mode. In continuous flow mode, the operation is the same with the exception that the oxygen is delivered continuously, without the need for breath detection.
The basic technology of the Invacare TPOC is equivalent to its predicate device.
This document describes the Invacare Transportable Oxygen Concentrator (TPOC, Model TPOC100) and its 510(k) summary, which essentially acts as a claim for substantial equivalence to a predicate device, the Invacare Flyer Oxygen Concentrator (K0719028).
There is no detailed study provided within the given text that explicitly describes acceptance criteria and then presents study results to prove those criteria were met for the Invacare TPOC.
The document states: "Performance Testing: The performance testing conducted as a result of the modifications to the Invacare Flyer, as required by the risk analysis, was performed and the results demonstrated that the predetermined acceptance criteria were met." However, it does not provide the specifics of these acceptance criteria or the study details.
Based only on the provided text, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Parameter | Acceptance Criteria (Inferred/Missing Details) | Reported Device Performance (Invacare TPOC100) |
|---|---|---|
| Intended Use | Matches predicate device. | Matches predicate device (Invacare Flyer). |
| Oxygen Purity | "87% minimum at all flow rates" | "87% minimum at all flow rates" |
| Flow Rates | Continuous: 0.5 - 3.0 LPM (0.5 LPM resolution) | Continuous: 0.5 - 3.0 LPM (0.5 LPM resolution) |
| Pulse Flow: 1, 2, 3, 4, 5 | Pulse Flow: 1, 2, 3, 4, 5 | |
| Method of Oxygen Release | Molecular sieve (mechanical) | Molecular sieve (mechanical) |
| Process of Oxygen Release | Pressure swing adsorption | Pressure swing adsorption |
| Sieve Bed Material | Synthetic zeolite | Synthetic zeolite |
| Software/Hardware | Analog and digital electronics with microprocessor | Analog and digital electronics with microprocessor |
| Flow Control | Microprocessor controlled valves | Microprocessor controlled valves |
| Oxygen Sensor | Yes (integrated for added monitoring) | Yes (integrated) |
| Weight | ≤ 18.0 lbs. (without battery module or cart) | ≤ 18.0 lbs. (without battery module or cart) |
| Power Options | AC (100-240 V, 50/60 Hz), DC (11-16 V) | AC (100-240 V, 50/60 Hz), DC (11-16 V) |
| Battery | Li-ion, 16.8 Volt, 15.6 Ah | Li-ion, 16.8 Volt, 15.6 Ah |
Explanation: The "acceptance criteria" are implied by the performance characteristics listed for the device itself and against its predicate. The text explicitly states that "Performance Testing... was performed and the results demonstrated that the predetermined acceptance criteria were met," but it does not list those specific criteria or the detailed results of the tests. The table above largely compares the TPOC's specifications to the predicate and notes its own specifications as the "reported device performance."
Regarding the study proving the device meets the acceptance criteria:
The provided text only makes a general statement about performance testing, rather than describing a specific study with detailed methodology. Therefore, most of the following information is missing from the input text:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Missing. The document does not specify any sample size for a test set or the provenance of data. The "performance testing" mentioned is generic.
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)
- Not applicable / Missing. This device is an oxygen concentrator, not an imaging or diagnostic device that would typically rely on expert human interpretation for ground truth establishment. Therefore, there would not be "experts" establishing ground truth in this context, but rather engineering/technical verification against specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Missing. As above, this concept typically applies to studies where human reviewers are assessing data (e.g., medical images) and their agreement is critical for ground truth. It's not relevant to the performance testing of a physical medical device like an oxygen concentrator against its specifications.
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
- No. This is not an AI-assisted diagnostic or interpretive device. An MRMC study would not be applicable to an oxygen concentrator.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This isn't an algorithm; it's a hardware device with embedded software. Its performance would inherently be "standalone" in terms of its mechanical and electronic functions. The "standalone" concept typically applies to pure AI/algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Inferred: The "ground truth" for oxygen concentrators meeting performance criteria is based on direct physical measurements against engineering specifications and validated test methods (e.g., oxygen concentration using a sensor, flow rate measurement, weight measurement, battery life tests, safety tests). The document mentions an integrated oxygen sensor and "predetermined acceptance criteria" from risk analysis, which implies such direct measurements.
8. The sample size for the training set
- Not applicable/Missing. This device does not use a "training set" in the context of machine learning or AI. Performance testing involves demonstrating the device meets its specifications, not training an algorithm.
9. How the ground truth for the training set was established
- Not applicable/Missing. No training set is involved for this type of 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).