(400 days)
The LiteAire is a collapsible, disposable dual-valved holding chamber designed to aid in the delivery of aerosolized medications delivered via a pressurized metered dose inhaler (MDI).
The LiteAire features a standard port designed for compatibility with standard MDI mouthpieces. It is a non-sterile device for single-patient use.
The LiteAire is intended to be used by adults, adolescents and children ages 5 and up who are able to use a holding chamber without the aid of a mask and who are under the care or treatment of a physician or licensed healtheare professional.
The LiteAire® BASIC Dual Valved, Collapsible MDI Holding Chamber (also referred to as the LiteAire® BASIC) and the modified LiteAire® Dual Valved, Collapsible MDI Holding Chamber (also referred to as the modified LiteAire®), are intended for use in the inhalation of medications delivered via a pressurized metered dose inhaler (pMDI). The subject devices feature a universal port designed for compatibility with most MDI medications. The subject devices are intended for use by a single patient and, when properly cared for, are reusable for up to one week. The devices consist of a collapsible paperboard housing and two one-way valves to control the direction of air flow when the patient inhales and exhales through the devices are popped-up by the user prior to use by pressing against the sides of the devices, can be collapsed flat between uses, and are anti-static. The intended environments of use include the home, hospitals and clinics. Note that the only differences between the modified LiteAire® and LiteAire® BASIC configurations is the removal of the window.
The provided text describes modifications to an existing medical device, the LiteAire Dual-Valved, Collapsible MDI Holding Chamber, and presents testing to demonstrate its substantial equivalence to the predicate device. It does not describe an AI/ML powered device, therefore the response below is based on the available information and identifies when specific AI/ML related questions are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
The core acceptance criterion for the modified devices (LiteAire BASIC and Modified LiteAire) is to demonstrate substantial equivalence to the predicate device (LiteAire K160109) in terms of aerosol characterization (particle size distributions) and other performance aspects. The tables below summarize the key aerosol characterization data.
Table 1: Acceptance Criteria and Reported Device Performance (Aerosol Characterization at Adult Flow Rates - 28.3 L/min)
| Parameter (MDI Medication) | Acceptance Criteria (Implicit: No statistically significant difference from Predicate) | Predicate LiteAire (N=9) Mean ± SD, 95% CI | LiteAire BASIC (N=9) Mean ± SD, 95% CI | Modified LiteAire (N=9) Mean ± SD, 95% CI | Test Result/Conclusion |
|---|---|---|---|---|---|
| Albuterol Sulfate | |||||
| Total Emitted Dose (µg) | Statistically similar to predicate | 56.06 ± 6.94, 50.73–61.40 | 54.75 ± 4.96, 50.94–58.45 | 53.85 ± 2.66, 51.81–55.90 | Deemed substantially equivalent |
| Fine Particle Dose (µg) | Statistically similar to predicate | 56.06 ± 6.94, 50.73–61.40 | 54.66 ± 4.99, 50.83–58.50 | 53.85 ± 2.57, 51.72–55.67 | Deemed substantially equivalent |
| MMAD (µm) | Statistically similar to predicate | 2.15 ± 0.05, 2.12–2.19 | 2.17 ± 0.05, 2.14–2.21 | 2.24 ± 0.06, 2.19–2.28 | Deemed substantially equivalent |
| GSD (µm) | Statistically similar to predicate | 1.44 ± 0.07, 1.39–1.49 | 1.43 ± 0.08, 1.37–1.49 | 1.41 ± 0.02, 1.39–1.43 | Deemed substantially equivalent |
| Ipratropium Bromide | |||||
| Total Emitted Dose (µg) | Statistically similar to predicate | 7.39 ± 0.55, 6.96–7.81 | 7.46 ± 0.61, 6.99–7.92 | 7.71 ± 0.62, 7.10–8.25 | Deemed substantially equivalent |
| Fine Particle Dose (µg) | Statistically similar to predicate | 7.39 ± 0.55, 6.96–7.81 | 7.46 ± 0.61, 6.99–7.92 | 7.71 ± 0.62, 7.10–8.25 | Deemed substantially equivalent |
| MMAD (µm) | Statistically similar to predicate | 0.51 ± 0.06, 0.46–0.55 | 0.57 ± 0.14, 0.46–0.67 | 0.60 ± 0.09, 0.53–0.66 | Deemed substantially equivalent |
| GSD (µm) | Statistically similar to predicate | 4.79 ± 0.70, 4.26–5.33 | 3.90 ± 1.81, 2.51–5.29 | 3.44 ± 0.95, 2.71–4.17 | Deemed substantially equivalent |
| Fluticasone Propionate | |||||
| Total Emitted Dose (µg) | Statistically similar to predicate | 40.96 ± 5.23, 36.94–44.98 | 41.27 ± 6.33, 36.41–46.14 | 38.43 ± 11.26, 28.72–44.55 | Deemed substantially equivalent |
| Fine Particle Dose (µg) | Statistically similar to predicate | 40.96 ± 5.23, 36.94–44.98 | 41.27 ± 6.33, 36.41–46.14 | 38.43 ± 11.26, 29.78–47.09 | Deemed substantially equivalent |
| MMAD (µm) | Statistically similar to predicate | 2.49 ± 0.17, 2.358–2.619 | 2.52 ± 0.03, 2.50–2.54 | 2.54 ± 0.06, 2.50–2.59 | Deemed substantially equivalent |
| GSD (µm) | Statistically similar to predicate | 1.39 ± 0.02, 1.38–1.41 | 1.41 ± 0.03, 1.39–1.43 | 1.46 ± 0.05, 1.426–1.499 | Deemed substantially equivalent |
(Note: "Deemed substantially equivalent" is concluded from the 510(k) summary statement that "the modification in design of the subject devices does not negatively impact the device performance and the modified (subject) devices continues to perform with substantial equivalence to the cleared (predicate) device." Statistical methods for "statistically similar" are not explicitly detailed but are implied by the comparison of means and confidence intervals.)
Table 2: Other Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Test Result/Conclusion |
|---|---|---|
| Biocompatibility (per ISO 10993-1) | Confirmed using FDA guidance document, no new risks identified due to material or process changes. Materials, manufacturing processes, finished device geometry, and body/fluid contact characterization are the same as the predicate (K160109). | Met |
| Visual Inspection | All tests passed | Passed |
| First Article Inspection | All tests passed | Passed |
| Accelerated Aging | All tests passed | Passed |
| Pop/Collapse functionality | All tests passed | Passed |
| Functional Equivalence (purpose, function, scientific technology, method of operation) | "The subject devices are substantially equivalent to the predicate device (K160109) in purpose, function, scientific technology and method of operation." | Met |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Aerosol Characterization: N=9 for each device (Predicate LiteAire, LiteAire BASIC, Modified LiteAire) for each MDI medication and flow rate tested (adult and pediatric). This means 9 units of each device type were tested for each specific drug and inhalation profile combination.
- Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. Given that it's a bench performance test for a medical device's physical properties, the concept of "retrospective or prospective" as applied to clinical studies is not directly applicable. These are laboratory-based, controlled experiments.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is Not Applicable as the device is a medical device (MDI Holding Chamber), not an Artificial Intelligence/Machine Learning (AI/ML) powered device that relies on expert interpretation for ground truth establishment. The performance is measured through objective physical and chemical tests (e.g., aerosol particle size, emitted dose).
4. Adjudication Method for the Test Set
This section is Not Applicable as adjudication methods (like 2+1, 3+1) are typically used in clinical studies or for establishing ground truth in AI/ML performance evaluations involving human readers. The tests performed here are objective bench tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
This section is Not Applicable as the device is a medical device (MDI Holding Chamber), not an AI/ML powered device, and no human-in-the-loop performance or reader studies were conducted or described.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is Not Applicable as the device is a physical medical device, not an algorithm or AI/ML product.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established through objective physical and chemical measurements obtained from standardized laboratory tests, specifically:
- Aerosol Characterization: Particle size distributions (MMAD, GSD), Total Emitted Dose, and Fine Particle Dose measured using an Andersen Cascade Impactor (ACI) as per FDA guidance.
- Biocompatibility: Conformance to ISO 10993-1, confirmed by material composition and manufacturing process identical to a previously cleared device.
- Bench Performance: Visual inspection, first article inspection, accelerated aging, and pop/collapse functionality.
The performance values obtained from the predicate device served as the reference for establishing substantial equivalence.
8. The Sample Size for the Training Set
This section is Not Applicable as the device is a traditional medical device, not an AI/ML powered device that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This section is Not Applicable for the reasons stated above.
§ 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).