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510(k) Data Aggregation
(400 days)
LiteAire Basic Dual-Valved, Collapsible MDI Holding Chamber
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.
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(486 days)
Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber
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 healthcare professional.
The Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber is intended for use in the inhalation of medications delivered via a pressurized metered dose inhaler (pMDI). The device consists of a collapsible paperboard housing and 2 one-way valves to control the direction of air flow when the patient inhales and exhales through the device. The LiteAire is not sterile, but clean and ready to use right out of the package. The LiteAire can be assembled by gently pushing in the edges of the device. The holding chamber can also be collapsed flat between uses and is anti-static.
The provided text describes modifications to a medical device (LiteAire Dual-Valved, Collapsible MDI Holding Chamber) and evaluates its substantial equivalence to a predicate device. The information presented focuses on non-clinical performance testing rather than a clinical study involving human readers or AI.
Here's an analysis of the provided text in the context of your questions:
1. A table of acceptance criteria and the reported device performance.
The document discusses performance in the context of non-clinical testing, specifically regarding the aerosolization efficiency of the device with different MDI products. The "acceptance criteria" are implied by the comparison to the predicate and the general expectation for an MDI holding chamber to deliver appropriate doses. The "reported device performance" is given in tables for Total Delivered Dose, Coarse Particle Dose, Fine Particle Dose, MMAD, and GSD.
Acceptance Criteria (Implied / Functional Requirements):
- Aerosol Delivery Performance: The ability to effectively deliver the prescribed dose from an MDI, with appropriate particle size distribution, comparable to or better than predicate devices. This is assessed via "Total Emitted Dose, Course Particle Dose or Fine Particle Dose."
- Mechanical Integrity: Maintain structural integrity and functionality (pop-ability, collapsibility, valve resistance) over expected shelf-life and under environmental stresses.
- Biocompatibility: No adverse biological reactions when in contact with lung tissue, skin, and mucosal membranes.
- Anti-static Properties: Exhibit anti-static properties to minimize drug adherence to the chamber walls.
Reported Device Performance:
The document provides specific data in Tables 2 and 3 for the subject device (K160109) with three different MDI products (Proventil HFA, Atrovent HFA, QVAR 80 mcg) at adult (28 L/min) and pediatric (12 L/min) flow rates. The values reported are 95% confidence intervals.
Table 1: Device Performance (Excerpts from Tables 2 & 3 Combined)
| Performance Metric | MDI Product Tested (Example Range) | Flow Rate |
|---|---|---|
| Total Delivered Dose (µg/actuation) | 39.77 – 77.62 | Adult/Pediatric |
| Coarse Particle Dose (>4.7 µm) (µg/actuation) | 0 – 3.42 | Adult/Pediatric |
| Fine Particle Dose ( |
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(406 days)
LITEAIRE
The LiteAire is a collapsible, disposable accessory device for use with a metered dose inhaler (MDI) canister and nozzle/mouthpiece provided by the MDI drug manufacturer. It is designed to be used with virtually all MDI nozzles/mouthpieces. The LiteAire is a dual-valved holding chamber designed to serve three major functions:
- To reduce the amount of MDI medication deposited in the patient's mouth and . throat, thus reducing the potential for unwanted local or systemic side effects.
- To ease the problems that many patients have in synchronizing actuation of the . MDI canister with the start of inhalation.
- To retain a significant portion of the MDI drug plume until the patient's next . inhalation, in cases where actuation and inhalation are asynchronous. The LiteAire is a non-sterile device for single-patient use.
The LiteAire is a collapsible, disposable accessory device for use with a metered dose inhaler (MDI) canister and nozzle/mouthpiece provided by the MDI drug manufacturer. It is designed to be used with virtually all MDI nozzles/mouthpieces. The LiteAire is a dual-valved holding chamber.
This document is a 510(k) premarket notification approval letter from the FDA to Thayer Medical Corporation for a device called "LiteAire," which is a collapsible, disposable accessory device for use with metered dose inhalers (MDIs). The document does not contain information about acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot fulfill the request for information regarding acceptance criteria and study details.
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