(128 days)
The Innosan Travelair® "S" Plus Portable Oxygen Concentrator is a mobile oxygen concentrator for use in an automobile, with power from the automobile's battery or for use with a power supply accessory (off of a mains current - 110 VAC, 60 Hz or 220 VAC, 50 Hz) when the patient is away from their primary home oxygen source, intended to provide a patient with supplemental oxygen. This device delivers oxygen to patients by physical means, using a molecular sieve bed oxygen concentrator and is designed to conserve the use of oxygen during such delivery.
The Innosan Travelair® "S" Plus Portable Oxygen Concentrator is a mobile oxygen concentrator intended for use in an automobile, with power from the automobile's battery and, for use with an AC power supply accessory. The Travelair® uses two molecular sieves to extract oxygen from ambient air; this is similar to most domestic oxygen concentrators. The unit provides two switch-selectable operating modes, continuous and demand, with a nonadjustable flow of approximately 1.2 L/min continuous and approximately 2.6 L/min in the demand mode. The unit has two large wheels, one small caster, and an adjustable handle to provide maneuverability. It has a hinged cover across the top panel to protect against the entry of fluids. An alarm warns of low oxygen concentration, excessive internal temperature and blocked air inlet filter.
The provided text is a 510(k) summary for the Innosan Travelair® "S" Plus Portable Oxygen Concentrator. It describes the device, its intended use, and its comparison to a predicate device. The core of the submission revolves around demonstrating substantial equivalence to a previously cleared device, rather than proving performance against specific acceptance criteria in a study with a defined test set, ground truth, or expert review process, as would be typical for a novel device or AI/ML-based system.
Therefore, many of the requested categories are not applicable or cannot be extracted directly from this document.
Here's an attempt to answer the questions based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) submission does not present "acceptance criteria" in the traditional sense of measurable performance thresholds for a novel device. Instead, it refers to compliance with existing guidance documents and standards to demonstrate safety and effectiveness. The "reported device performance" is implicitly that the device met all relevant requirements of the cited tests and guidelines, thus demonstrating substantial equivalence.
| Acceptance Criterion (Referenced Standard/Guidance/Requirement) | Reported Device Performance |
|---|---|
| For Concentrator Unit (Innosan Travelair® "S" Plus Portable Oxygen Concentrator): | |
| FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions" (Electrical, Mechanical & Environmental) | All testing performed. None demonstrated design characteristics that violated requirements or resulted in safety hazards. CITECH concluded the Travelair® sample met all relevant requirements. |
| IEC-601-1 (1988) - Mechanical Vibration and Shock Resistance | Met all relevant requirements. |
| IEC-601-1 (1988), Clause 44.6 - Fluid Spill Resistance | Met all relevant requirements. |
| ASTM F1464-93, "Standard Specification for Oxygen Concentrators for Domiciliary Use" | All testing performed. Met all relevant requirements. |
| DCRND Reviewer's Guideline, November 1993 - Radiated and Conducted Electromagnetic Energy and Magnetic Field Testing | All testing performed. Met all relevant requirements. |
| For AC Power Supply Accessory: | |
| FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions" (active operating conditions) | All testing performed. None demonstrated design characteristics that violated requirements or resulted in safety hazards. CITECH concluded the AC Power Supply sample met all relevant requirements. |
| DCRND Reviewer's Guideline, November 1993 - Radiated and Conducted Electromagnetic Energy and Magnetic Field Testing | All testing performed. Met all relevant requirements. |
| UL and TÜV Certification | Certified by UL and TÜV. |
2. Sample Size Used for the Test Set and Data Provenance
The document refers to "the Travelair® sample tested" for the concentrator and "the AC Power Supply sample tested" for the accessory. This implies a small sample size, likely one unit of each, which is common for testing physical medical devices against engineering specifications.
- Sample Size: Likely 1 unit for the concentrator, 1 unit for the AC power supply accessory.
- Data Provenance: Not explicitly stated, but the testing was conducted by CITECH, an independent testing laboratory. The document is a 510(k) submission from Sim Italia s.r.l. (Italy), but the testing itself seems to be standard regulatory compliance testing, not a clinical data collection from patients or specific regions. It is retrospective in the sense that the testing was completed before the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The "ground truth" here is compliance with engineering standards and regulatory guidance, which is determined by objective measurements and testing protocols, not by expert interpretation of patient data or images. The "experts" would be the engineers and technicians at CITECH performing the tests, qualified in electrical, mechanical, and environmental testing.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for reconciling discordant expert opinions in clinical studies (e.g., image interpretation). This submission deals with objective engineering compliance testing, where results are typically binary (pass/fail against a specification).
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 device is an oxygen concentrator, not an AI/ML-based diagnostic or therapeutic aid that would involve human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" used for demonstrating substantial equivalence is compliance with established engineering standards and regulatory guidance documents. This includes:
- FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions" (Electrical, Mechanical & Environmental Performance Requirements).
- IEC-601-1 (1988) for specific tests like mechanical vibration/shock and fluid spill resistance.
- ASTM F1464-93, "Standard Specification for Oxygen Concentrators for Domiciliary Use".
- DCRND Reviewer's Guideline, November 1993 for electromagnetic compatibility.
- UL and TÜV certification requirements for the AC power supply.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no "training set" as this is not an AI/ML device.
Summary of the Study:
The "study" or testing performed for this 510(k) submission was a series of non-clinical bench tests conducted by CITECH. These tests evaluated the electrical, mechanical, and environmental performance of the Innosan Travelair® "S" Plus Portable Oxygen Concentrator (and its AC power supply accessory) against recognized industry standards and FDA guidance documents. The purpose was to demonstrate that the expanded capabilities of the "Plus" model (namely, the AC power supply) did not introduce any new safety or effectiveness concerns compared to the predicate device and that the combined system met all relevant safety and performance requirements for oxygen concentrators. The conclusion of these tests was that the device met all relevant requirements and therefore was substantially equivalent to the predicate 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).