(268 days)
The Hailie™ sensor is intended for single-patient use in the home environment as a medication reminder and electronic data capture accessory for recording usage of prescribed inhaler medication. This may be used in the following applications:
· In clinical trials, where researchers need to know when a patient has used their trial inhaler medication.
· In clinical practice, where specialists, general practitioners, nurses, and educators need to know if a patient has used their prescribed inhaler medication.
· In self-management, where patients need to track their medication use as part of their management plan.
The Hailie™ sensor is compatible only with the HandiHaler® inhaler and is for use by adults.
The Hailie™ sensor is used to provide a medication reminder and actuation recording function for use as an accessory to the inhaler specified on the device label. Under the current 510(k), the Hailie™ sensor is indicated for use only with the HandiHaler® inhaler.
The Hailie™ sensor is a clip-on device that attaches externally around the housing of the inhaler. Mechanical, optical and acoustic sensors are used to detect the presence and actuation of the inhaler. The Hailie™ sensor contains an electronic clock and calendar that are used to log the date and time of inhaler actuation.
The user interface consists of a single Status Button and dual multi-color LED indicators to check device status, initiate communications functions, and provide reminder features. The Hailie™ sensor has a Bluetooth interface to wirelessly exchange medication and reminder setting data with a paired communications device and compatible mobile software applications.
The medical device in question is the Hailie™ Sensor, which is intended "for single-patient use in the home environment as a medication reminder and electronic data capture accessory for recording usage of prescribed inhaler medication."
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present acceptance criteria in a tabular format with specific quantitative targets. Instead, it describes various tests and states that the device "meets design and performance functional requirements" and "meets standard requirements." Based on the provided text, the acceptance criteria are implicitly defined by the successful completion of the listed tests and adherence to relevant standards.
| Acceptance Criteria Category | Reported Device Performance/Met Standards |
|---|---|
| I. Non-Clinical Performance | |
| Biocompatibility | Meets ISO 10993 standards (cytotoxicity, sensitization, irritation) for surface device contacting intact skin for limited duration ≤ 24 hours. |
| Electrical Safety | Complies with ANSI/AAMI ES60601-1:2005 +A1:2012, C1:2009, A2:2010 (general safety) and IEC 60601-1-11:2015 (home-use safety). |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2:2014 (EMC) and ANSI C63.10:2013 / 47 CFR Part 15 (FCC regulations). |
| Software Verification & Validation | Ensures correct functionality for all software modules. Documentation provided as recommended by FDA guidance. |
| Optical Inhaler Presence Detection | Determined optical calibration limits and confirmed accurate detection of an installed inhaler. |
| Mechanical Inhaler Usage Detection | Confirmed reliability of sensor over device lifetime. |
| Acoustic Inhaler Usage Detection | Confirmed accurate detection of inhaler usage and prevention of detection from other inputs. |
| Spurious Log Prevention | Determined circuit parameters and confirmed prevention of erroneous medication usage logs. |
| General Performance (Shelf Life & Bluetooth) | Confirmed acceptable performance over the specified shelf life and specified Bluetooth communications range. |
| User Interface Visibility/Audibility | Confirmed visibility of device display and audibility of device buzzer. |
| Usability Evaluation | Summative usability validation testing carried out to evaluate critical tasks. Demonstrated that the Hailie™ sensor can be used successfully with the compatible inhaler. |
| II. Device Specifications | |
| Power Source | Rechargeable battery (meets intended battery life of 2-3 months on full charge). |
| Inhaler Interaction | Attaches to inhaler without affecting mechanism or operation. Inhaler readily removed for cleaning and label access (verified by usability testing). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size for any of the individual non-clinical tests (e.g., performance testing, usability evaluation). The provenance of the data is indicated as "non-clinical testing," performed by "external laboratories" for electrical safety and EMC. There is no mention of specific country of origin or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish a "ground truth" for the non-clinical test set in the same way clinical studies use experts for diagnosis. The testing primarily involved engineering and technical evaluations against defined standards and functional requirements. For the usability evaluation, it states "summative usability validation testing was carried out," implying user participants, but it does not specify the number or qualifications of experts for establishing ground truth related to the device's functional outputs.
4. Adjudication Method for the Test Set
No adjudication method (e.g., 2+1, 3+1) is mentioned or relevant for the described non-clinical performance and safety testing. The evaluation focused on compliance with technical standards and functional requirements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No MRMC comparative effectiveness study was done. The document explicitly states: "Clinical testing was not required for a determination of substantial equivalence of the Hailie™ sensor. The product functionality has been adequately assessed by non-clinical testing as above."
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device is a hardware sensor that captures data and provides reminders. Its core function is automated detection and recording of inhaler usage. Therefore, the "performance testing" described (optical, mechanical, acoustic sensor validation, spurious log prevention) inherently represents a standalone performance evaluation of the device's ability to accurately detect and log events without human intervention during the detection process. The usability evaluation, however, involves human interaction with the device for its intended purpose.
7. The Type of Ground Truth Used
The ground truth for the non-clinical performance tests was based on:
- Established Standards: For biocompatibility, electrical safety, and EMC.
- Defined Functional Requirements: Optical, mechanical, and acoustic sensor validation, spurious log prevention, general performance (shelf life, Bluetooth range), and user interface. These are likely based on engineering specifications and expected device behavior.
- Usability Risk Analysis: For the usability evaluation, focusing on "critical tasks."
8. The Sample Size for the Training Set
The document describes non-clinical testing for regulatory clearance (510(k)). This type of submission typically focuses on validation and verification of the final device, not on the training of machine learning models. There is no mention of a "training set" in the context of device development or performance evaluation. The device utilizes sensors and electronics, not a machine learning algorithm that would require a training set.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned or applicable to the device's stated technology (sensors and electronics rather than machine learning), there is no information on how a "ground truth for the training set" was established.
§ 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).