(486 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 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 ( |
§ 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).