(197 days)
The Hailie® sensor is intended for single-patient multiple use in the home environment as an electronic data capture accessory for monitoring and recording actuation, inspiratory flow and inhaler shake for prescribed inhaler usage.
The Hailie® sensor may be used in the following applications: in clinical trials, where specialists, general practitioners, nurses, and educators need to know if a patient has used their prescribed medication, or assess inspiratory flow and inhaler technique; and in patient self-management.
The Hailie® sensor is compatible only with the Teva HFA MDIs like ProAir, Albuerol Sulphate inhalers. The Hailie® sensor is not intended to indicate remaining quantity of medication in an inhaler and does not include a dose counting function. The Hailie® sensor is not intended to provide spirometry measurements.
The subject device Hailie® Sensor (Hailie® sensor) NF0110 model, is a modification to the Hailie® sensor NF0109 model (the predicate device) and is used to provide medication actuation monitoring, shake and airflow recording functions, for use as an accessory to the inhaler specified on the device label. The Hailie® sensor is indicated for use only with the following TEVA MDIs: ProAir® HFA & Albuterol Sulphate HFA.
The Hailie sensor NF0110 is a clip-on device that attaches externally around the housing of the inhaler. The optical sensor and induction coil sensor are used to detect the inhaler presence and monitor actuation. Motion and flow sensors are used to record inhaler usage technique parameters. The Haile sensor contains an electronic clock and calendar that are used to log the date and time of inhaler usage events.
The user interface consists of a single Status Button and a multi-color LED indicator to check device status and initiate communications functions. The Hailie sensor has a Bluetooth interface to wirelessly exchange medication usage data with a paired communications device and compatible mobile software applications.
The Adherium Hailie Sensor (model NF0110) is an electronic data capture accessory that records actuation, inspiratory flow, and inhaler shake for prescribed inhaler usage in the home environment. It is compatible with Teva HFA MDIs like ProAir and Albuterol Sulphate inhalers.
Here's an analysis of its acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly define specific numerical acceptance criteria for performance metrics (e.g., a specific percentage for accuracy of actuation detection). Instead, the performance testing section generally states that tests were conducted to "establish correct functionality and compatibility" and "confirmed performance." The conclusions state that the device "meets design, safety, and performance requirements" and that "inhaler usage parameters are measured with sufficient accuracy for monitoring inhaler use equivalent to reference device."
Therefore, the table below will summarize the areas of performance evaluated and the reported outcome in terms of meeting requirements or confirming functionality, rather than specific numerical criteria and results.
| Acceptance Criteria Area | Reported Device Performance |
|---|---|
| Biocompatibility | Evaluated in accordance with FDA guidance and ISO 10993 standards (1, 5, 10, 12). Materials meet requirements for surface device contacting intact skin for limited duration (≤ 24 hours). |
| Electrical Safety (ANSI/AAMI ES60601-1:2005 +A1:2012, C1:2009, A2:2020, IEC 60601-1-11:2020) | Device complies with general safety and home-use safety standards. |
| Electromagnetic Compatibility (IEC 60601-1-2:2020) | Device complies with EMC standards for an internally powered, non-patient coupled, Bluetooth radio device. Information provided per FDA guidance. |
| Software Verification & Validation | Testing ensured correct functionality for all software modules. Documentation provided per FDA guidance (software content, OTS software, cybersecurity). Software performs as intended and equivalently to predicate for common software functions. |
| Optical Inhaler Presence Detection | Correct functionality established; determined optical calibration limits and confirmed accurate detection of installed Teva MDI inhalers. |
| Airflow Detection Sensor | Confirmed performance of flow detection during inhaler usage. |
| Airflow Verification (Effect on Airflow Path) | Confirmed the device does not adversely affect the airflow path. |
| Motion Detection Sensor | Confirmed performance of shake detection before inhaler use. |
| General Performance (Shelf Life, Bluetooth Range) | Confirmed acceptable performance over the specified shelf life and specified Bluetooth communications range. |
| User Interface (LED, Piezo Buzzer) | Confirmed visibility of device LED display and audibility of device Piezo buzzer. |
| Usability Evaluation | Evaluation conducted to assess impact on critical tasks as per usability risk analysis for the updated design. Established validity of results in accordance with FDA guidance. No issues for successful use with compatible inhalers. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not detail the specific sample sizes for tests related to optical detection, airflow, motion, or general performance. It mentions "non-clinical testing" and "finished device testing" but does not provide numbers of devices tested or iterations.
The and data provenance is not specified in terms of country of origin or whether it was retrospective or prospective. Given it's non-clinical performance testing of a device, it would typically be conducted in a laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. The study is primarily non-clinical device performance testing. Ground truth for device functionality would be established by validated test equipment and measurement standards, not typically by human experts in this context.
4. Adjudication Method for the Test Set
This is not applicable as the performance testing described is objective measurement against specified standards/functionality, not subjective assessment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A MRMC comparative effectiveness study was not done. The Hailie sensor is a data capture accessory, not an AI diagnostic tool that would typically involve human readers. Clinical testing was explicitly stated as "not required for a determination of substantial equivalence."
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, in essence, the performance testing described is a standalone evaluation of the device's functionality. The device's ability to detect inhaler use parameters (actuation, flow, shake) and its general functionality (shelf life, Bluetooth range, UI) were assessed independently of a human user's interpretation or interaction beyond basic usability. The device itself is designed to operate autonomously in recording data, which is then accessed by users/clinicians.
7. Type of Ground Truth Used
For the non-clinical performance tests, the "ground truth" would be established by:
- Validated measurement equipment and sensors: For parameters like inspiratory flow, shake detection, and actuation.
- Engineering specifications and design requirements: To confirm optical detection limits, Bluetooth range, battery life, etc.
- Industry standards: For biocompatibility (ISO 10993), electrical safety (ANSI/AAMI ES60601-1, IEC 60601-1-11), and EMC (IEC 60601-1-2).
- Known device behavior/calibration: For confirming the effect on the airflow path.
8. Sample Size for the Training Set
This information is not applicable. The Hailie sensor is a hardware device with embedded software designed for data capture, not a machine learning or AI model that requires a separate training set in the conventional sense. The "software verification and validation testing" refers to ensuring the embedded software functions correctly, not training a predictive algorithm from a dataset.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no mention of a training set for an AI/ML algorithm within the provided document. The software validation is against expected functional requirements, not through a training process with ground truth data.
§ 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).