(281 days)
The LeverHaler Spacer is a spacer device that is designed to effectively deliver respirable medical aerosols produced by most MDI's to a patient during inhalation. This product is intended for use in the treatment of lung disease. The device has been designed for use by all patients who have been prescribed MDI treatment by their physician. It is intended for use in both the hospital and homecare environments.
The LeverHaler Spacer (Spacer) is an injection molded polycarbonate spacer device intended for use with FDA approved metered dose inhalers (MDI's). The MDI canister fits through a slot in a lever located on the top of the spacer. Activation of the MDI canister can be done by manually pressing down on the MDI (typical activation), or the MDI may be actuated by depressing the Lever Actuator down towards the top of the spacer body. The device is made from polycarbonate injection molded plastic and is designed to be used with FDA approved MDI drugs for treatment of lung disease. When not in use, up to two MDI canisters can be stored inside of the LeverHaler Chamber. The product is sold non-sterile, and is a single-patient device intended to be used for up to one year. This device does not generate aerosols. Its purpose is to provide an effective mixing chamber for the aerosols produced by a metered dose inhaler to assure proper concentration for inhalation by the patient. This is a prescription device. The device has no detection capabilities. It is mechanical and has no alarm functions or capabilities. There is no software integrated or used in conjunction with this device.
The provided document describes a medical device, the Birdsong Medical LeverHaler Spacer, which is not an AI/ML device. Therefore, the questions regarding acceptance criteria and studies proving the device meets those criteria, as typically applied due to AI/ML devices, are not directly applicable in their entirety.
However, I can extract information related to the device's performance, testing, and basis for market clearance, reinterpreting the provided headings to fit the context of this traditional medical device.
1. Table of Acceptance Criteria and Reported Device Performance
For this medical device, "acceptance criteria" are implied by the performance characteristics of predicate devices and the regulatory guidance. The reported performance aimed for equivalence or superiority to the predicate devices.
| Characteristic | Acceptance Criteria (Implied by Predicate & Guidance) | Reported Device Performance (LeverHaler Spacer) |
|---|---|---|
| Particle size distribution | Comparable to predicate devices | Met design requirements; comparable or superior to predicate devices (OptiHaler, AeroChamber) |
| Dose output (quantity & total mass) | Comparable to predicate devices | Met design requirements; comparable or superior to predicate devices |
| Mean Median Aerodynamic Diameter (MMAD) | Comparable to predicate devices | Met design requirements; comparable or superior to predicate devices |
| Geometric Standard Deviation (GSD) | Comparable to predicate devices | Met design requirements; comparable or superior to predicate devices |
| Plume Analysis Testing | Comparable to predicate devices | Included; results used to support equivalence/superiority |
| Single patient use testing (life testing) | Up to one year (as per device description) | Passed validation and comparative product testing, ensuring functionality for up to one year single-patient use |
| Spacer Material | Clear Polycarbonate | Clear Polycarbonate (identical to a predicate device) |
| Mouthpiece and Valve Material | Biocompatible (e.g., Silicone, Polycarbonate) | Silicone |
| Single Patient Use | Yes | Yes |
| Sterility | Non-Sterile | Non-sterile |
| Ventilator Use | No | No |
| Maximum Length of Use | Up to 365 days | Up to 365 days (single patient) |
| Effective Size of Mixing Area | Effectively allows sufficient mixing and delivery | Approximately 170 ml (larger than OptiHaler, similar to AeroChamber) |
| Method of Operation | Mechanical | Mechanical |
| Prescription Device | Yes | Yes |
| Port Protection | Yes | Yes |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes (e.g., number of units tested, number of drug actuations) for each test. It states "All tests included comparative testing of the two predicate devices and the LeverHaler Spacer."
- Test Set Sample Size: Not explicitly quantified with numbers of units or repetitions. The tests involved "3 drugs" for particle size distribution and dose output testing.
- Data Provenance: The testing was conducted by an independent medical device manufacturer and test laboratory contracted by Birdsong Medical. This suggests the data is prospective as it was generated specifically for this premarket notification. The country of origin is not specified but is implicitly the US, given the FDA submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable for this type of mechanical medical device. The "ground truth" for its performance is established through objective physical and chemical measurements (e.g., particle size, drug quantity) as per recognized guidance documents, not expert consensus interpretation of data.
4. Adjudication Method for the Test Set
Not applicable. Testing involved objective measurements in a laboratory setting, not subjective human assessment requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of images or other data. The LeverHaler Spacer is a mechanical drug delivery aid.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. This is a non-software, mechanical device. Its performance is inherent to its design and how it functions with an MDI, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on in vitro measurements and established engineering/physical principles. This includes:
- Physicochemical measurements: Particle size distribution, overall dose output (drug quantity and total mass), mean median aerodynamic diameter (MMAD), and geometric standard deviation (GSD).
- Functional testing: Life testing to assess durability over time/use.
- Comparative data: Performance against established predicate devices, which serve as benchmarks for safety and effectiveness.
- Regulatory guidance: Compliance with the "Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators: Reviewer Guidance 10-01-93."
8. The Sample Size for the Training Set
Not applicable. This is a traditional mechanical device, not an AI/ML device that requires a training set.
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).