(148 days)
The LiteTouch medium mask for ages 1-5 is to be used with OptiChamber Advantage Valved Holding Chambers. The mask is intended to be used to help administer aerosolized medication from most pressurized metered dose inhalers used with valved holding chambers as prescribed by a physician or health care professional. The intended environments for use include homes, hospitals, and clinics.
The LiteTouch mask is a Class II device. It is a mask for use with Respironics' OptiChamber Valved Holding Chamber (K962822). The LiteTouch mask is a mask that utilizes the same operating principles as the AeroChamber Max Valved Holding Chamber Small and Medium Mask (K032972). The difference between the LiteTouch mask and the AeroChamber Max Valved Holding Chamber Small and Medium Mask is that, the LiteTouch mask does not come assembled to the chamber and the exhalation valve is located in different positions and is not of the same shape. The LiteTouch mask comprises of a Flap Valve and a Cushion plate.
Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" with numerical thresholds. Instead, it frames the evaluation as a comparison to a predicate device to demonstrate "substantial equivalence." The performance is reported in terms of Fine Particle Dose and Leak Test results.
| Study Type | Unstated Acceptance Criteria (Implied) | Reported LiteTouch Mask Performance (with OptiChamber) | Predicate Device (AeroChamber Max) Performance (or baseline) |
|---|---|---|---|
| Fine Particle Dose (0.4-4.7 µg) | Maintain comparable Fine Particle Dose to predicate device, ensuring effective drug delivery. | Ventolin: 21.1 µg | |
| Flovent: 18.5 µg | |||
| Atrovent: 3.7 µg | Ventolin: 29.5 µg | ||
| Flovent: 27.1 µg | |||
| Atrovent: 5.4 µg | |||
| Fine Particle Dose Percentage (Drug mass recovered) | Maintain a high percentage of drug mass recovered compared to the chamber without the mask. (No explicit threshold, but values in the 70% range are considered acceptable to support substantial equivalence) | Ventolin: 71.5% | |
| Flovent: 68.3% | |||
| Atrovent: 68.5% | (OptiChamber without LiteTouch is the baseline for this percentage) | ||
| Leak Test Results (with Tilt Angles and Applied Force) | Achieve comparable or superior seal effectiveness (lower leaks) to other facemasks, including the predicate device, under various conditions (tilt angles and applied force). (Implicitly, the lower the leak percentage, the better the seal.) | See Table below for specific angles and forces. (The LiteTouch mask generally shows comparable or lower leak percentages compared to other masks at various conditions, indicating an effective seal.) | See Table below for specific angles and forces of predicate and other masks. |
Detailed Leak Test Results (approximated from the image, as text parsing was difficult)
| Device | 0°/0.4lb | 0°/1lb | 10°/0.4lb | 10°/1lb | 5°/0.4lb | 5°/1lb |
|---|---|---|---|---|---|---|
| LiteTouch | 13.8% | 6.1% | 79.6% | 7.7% | 75.7% | 7.9% |
| AeroChamber Plus | 14.2% | 2.8% | 89.5% | 7.6% | 74.2% | 6.5% |
| OptiChamber | 49.8% | 7.7% | 66.8% | 4.8% | 67.8% | 6.1% |
| AeroChamber Max | 4.4% | 7.3% | 93.3% | 7.7% | 73.6% | 8.4% |
| PocketChamber | 0.8% | 9.9% | 97.0% | 9.8% | 97.0% | 7.1% |
Note: The leak test results in the provided text are difficult to parse accurately due to formatting issues and seemingly non-English characters. The table above is an interpretation based on the discernible numbers and column headers. The document's conclusion states that the LiteTouch mask demonstrates substantial equivalence in terms of seal, dead space volume, and resistance to inhalation.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for either the Fine Particle Dose or the Leak Test. The tables present aggregated results (e.g., average values) rather than individual sample measurements.
- Data Provenance: Not explicitly stated (e.g., country of origin). The testing would be considered retrospective as it was conducted to support the 510(k) submission for an already developed device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is a medical device accessory (mask) for drug delivery. The "ground truth" is established through engineering and performance testing (Fine Particle Dose, Leak Tests) against measurable physical parameters and comparison with predicate devices, not through expert consensus on diagnostic images or clinical outcomes.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this is an objective performance study rather than an evaluation requiring human adjudication (like in a diagnostic image study).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human readers interpret medical images or data, and the AI's impact on their performance is being evaluated. The LiteTouch mask is a physical accessory for drug delivery, not an AI-powered diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the studies conducted (Fine Particle Dose and Leak Tests) represent "standalone" performance in the context of device function. The device's physical properties and interaction with the OptiChamber were tested without direct human interaction as part of the primary measurement, other than technicians operating the testing equipment. The goal was to assess the mask's functional efficacy and integrity.
7. The Type of Ground Truth Used
The ground truth used for these tests is based on measurable physical performance characteristics and comparison to established predicate devices.
- Fine Particle Dose: Measured efficacy of drug delivery, quantified in micrograms (µg) and percentages. This is an objective, quantitative measure.
- Leak Test Results: Measured seal effectiveness under controlled conditions (tilt angles, applied force), quantified as a percentage of leak. This is also an objective, quantitative measure.
- The overall "ground truth" for submission is demonstrating substantial equivalence to an already marketed predicate device based on these engineering and performance tests.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical device accessory, not an AI or machine learning algorithm that requires a "training set." The design and manufacturing processes are validated, but there isn't a data-driven training phase in the context of artificial intelligence.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).