(262 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 Advair® Diskus® 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 used to provide a medication reminder and usage recording function as an accessory to the inhalers specified on the device label. Under the current 510(k), the Hailie™ sensor is indicated for use only with the Advair® Diskus® (100/50, 250/50, 500/50 mcg) and Flovent® Diskus® (50, 100, 250 mcg) inhalers.
The Hailie™ sensor is a clip-on device that attaches externally around the housing of the inhaler. Optical sensors are used to detect the presence and usage of the inhaler. The Hailie™ sensor contains an electronic clock and calendar that are used to log the date and time of inhaler usage.
The user interface consists of a three control buttons and three LED indicators to check device status, initiate communications functions, and provide reminder features. The Hailie™ sensor has a Bluetooth interface to wirelessly exchange medication usage and reminder setting data with a paired communications device and compatible mobile software applications.
The provided text describes a medical device called the "Hailie™ Sensor," which is an accessory for inhalers, primarily for medication reminders and recording usage. The document is a 510(k) summary from the FDA, indicating a premarket notification for a medical device.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functional Verification | Completed successfully; ensured correct functionality and compatibility with Diskus® inhaler. |
| Device Performance | Testing confirmed accurate logging of inhaler usage by the sensor system. |
| Usability of User Interface | Successfully evaluated. |
| Software Verification | Demonstrated that device functions are substantially equivalent to the predicate device. |
| Wireless Communications | Meets standard requirements (implied by compliance to ANSI C63.10:2013 / 47 CFR Part 15 FCC regulations). |
| Electrical Safety | Meets standard requirements (demonstrated by compliance to ANSI/AAMI ES60601-1:2005 +A1:2012, C1:2009, A2:2010 and IEC 60601-1-11:2015). |
| Electromagnetic Compatibility (EMC) | Meets standard requirements (demonstrated by compliance to IEC 60601-1-2:2014). |
| Biocompatibility | Meets standard requirements (demonstrated by compliance to ANSI/AAMI/ISO 10993-1:2009, -5:2009, -10:2010, -12:2012). |
| Environmental Performance | Meets standard requirements. |
2. Sample Size Used for the Test Set and Data Provenance:
The document states that clinical testing was not required for a determination of substantial equivalence. The device's functionality was "adequately assessed by bench testing" and "non-clinical testing." Therefore, there isn't a "test set" in the traditional sense of patient data. The provenance of any underlying data for the non-clinical tests is not specified, but it would have been generated in a laboratory setting as part of the device's verification and validation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Since no clinical data or patient test set was used, there were no experts used to establish ground truth in this context. The "ground truth" for the non-clinical tests would have been established by engineering specifications and expected performance outcomes derived from the predicate device and regulatory standards.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set requiring expert adjudication was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No MRMC study was conducted. The Hailie™ sensor is not an AI-powered diagnostic device, but rather a data capture and reminder accessory. 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 bench testing as above."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The Hailie™ sensor itself is a standalone device in that it captures data independently. However, "standalone performance" in the context of AI often refers to an algorithm's diagnostic accuracy without human intervention. This device's primary function is not diagnostic, but rather data logging and reminders. Its "standalone performance" would refer to its ability to accurately detect and log inhaler usage, which was confirmed through non-clinical testing.
7. The Type of Ground Truth Used:
The ground truth used was based on engineering specifications, regulatory standards, and expected performance derived from the predicate device. For instance, the "accurate logging of inhaler usage" was verified against a known or simulated usage event. Biocompatibility was assessed against established ISO and AAMI standards.
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/ML device that requires a training set of data in the sense of supervised or unsupervised learning for making predictions or classifications. Its functionality is based on optical sensors and embedded logic.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there was no training set for an AI/ML model.
§ 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).