(192 days)
The Aerobika* Oscillating Positive Expiratory Pressure device is intended for use as a Positive Expiratory Pressure (PEP) device. The Aerobika* Oscillating PEP device may also be used simultaneously with nebulized aerosol drug delivery. The device is intended to be used by patients capable of generating an exhalation flow of 10 lpm for 3 – 4 seconds.
The Aerobika* Oscillating Positive Expiratory Pressure (PEP) device is indicated as a single patient use, hand held secretion clearance and lung expansion device that creates vibrating positive expiratory pressure when a patient exhales through the device. The Aerobika* device may be used simultaneously with aerosol drug delivery from a nebulizer.
The Aerobika* Oscillating Positive Expiratory Pressure (PEP) Device was found substantially equivalent to a predicate device (Acapella, K002768) based on mechanical testing and biocompatibility.
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Measure) | Reported Device Performance (Aerobika* PEP Device) |
|---|---|
| Mechanical Operating Parameters | |
| Oscillation Frequency | Ranges of data for oscillation frequency are similar to the predicate device, showing clear overlap. The mean frequency value is within 15% of the predicate device. The slightly lower minimum frequency observed for Aerobika* is considered clinically insignificant, citing therapeutic effectiveness of other devices down to 3Hz and 6Hz, and previous predicate evaluations showing 8.0 Hz. |
| Oscillation Amplitude | Ranges of data for oscillation amplitude are similar to the predicate device, showing clear overlap. The mean amplitude value is within 15% of the predicate device. |
| Biocompatibility | |
| Cytotoxicity | Patient-contacting components meet the requirements of ISO 10993-5. |
| Sensitization | Patient-contacting components meet the requirements of ISO 10993-10. |
| Irritation/Intracutaneous Reactivity | Patient-contacting components meet the requirements of ISO 10993-10. |
| Aerosol Drug Delivery (Cascade Impactor) | Performance comparable to the Acapella device when used with a nebulizer and three different drugs. No new safety or efficacy issues raised. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for mechanical testing. The submission mentions "ranges of data" and "mean Frequency and Amplitude values," implying multiple measurements were taken and statistically compared. For cascade impactor testing, three different drugs were used with the nebulizer.
- Data Provenance: Not explicitly stated, but assumed to be from laboratory testing conducted by Trudell Medical International. This is a pre-market submission, so the data would be prospective in the context of the device's clearance, but retrospective for the performed tests themselves (i.e., tests were concluded before submission). Country of origin is Canada (manufacturer).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This submission focuses on demonstrating substantial equivalence through mechanical and biocompatibility testing, not on diagnostic accuracy requiring expert interpretation of results. The "ground truth" here is the measured physical properties and biological reactions against established standards and the predicate device's performance.
4. Adjudication Method for the Test Set
- Not applicable. As the tests are objective mechanical and biological evaluations, there is no human adjudication of results in the traditional sense. The comparison is made against quantitative measurements from the predicate device and established ISO standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This was not a clinical performance study involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, in essence. The mechanical and biocompatibility testing can be considered standalone performance evaluations of the device's characteristics against a predicate device and predetermined standards, without human interaction influencing the measurement results themselves. The "algorithm" here is the device's inherent mechanical function.
7. The Type of Ground Truth Used
- Objective measurements against established standards and predicate device performance.
- For mechanical parameters (frequency, amplitude): The ground truth was the measured performance of the predicate device (Acapella) and the statistical comparison of the Aerobika* device's performance to it. Clinical insignificance was supported by literature (Volsko et al, 2003; Okeson and McGowen, 2007) indicating acceptable oscillation ranges for similar devices.
- For biocompatibility: The ground truth was compliance with ISO 10993-1, 10993-5, and 10993-10 standards.
- For aerosol drug delivery: The ground truth was the comparative performance against the predicate device in cascade impactor testing.
8. The Sample Size for the Training Set
- Not applicable. This device is a mechanical medical device, not an AI/machine learning model that typically requires a training set. The "training" for such a device would be its engineering design and manufacturing process.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As stated above, this is not an AI/ML device.
§ 868.5690 Incentive spirometer.
(a)
Identification. An incentive spirometer is a device that indicates a patient's breathing volume or flow and that provides an incentive to the patient to improve his or her ventilation.(b)
Classification. Class II (performance standards).