(159 days)
The Smart Touch is intended for single-patient use in the home environment as a medication reminder and electronic data capture accessory for recording actuations of prescribed MDI usage. This may be used in the following applications:
· In clinical trials, where researchers need to know when a patient has actuated their trial MDI medication:
· In clinical practice, where specialists, general practitioners, nurses, and educators need to know if a patient has actuated their prescribed MDI medication.
· In self-management, where patients need to track their medication use as part of their management plan.
The SmartTouch is compatible only with the Symbicort MDI. The SmartTouch is not intended to indicate remaining quantity of medication in an MDI and does not include a dose counting function.
SmartTouch is used to provide a medication reminder and actuation recording function for use as an accessory with a Metered Dose Inhaler (MDI) as part of normal daily use of the MDI.
SmartTouch is a clip-on device that attaches externally around the housing of an MDI. SmartTouch is compatible only with the Symbicort MDI. Optical and mechanical sensors are used to detect MDI presence and actuation, and the device logs the usage history of the MDI. The SmartTouch contains an electronic clock and calendar that is used to log the date and time of MDI actuation.
The SmartTouch user interface consists of two LED indicators and three control buttons to check device status, initiate communications functions, and provide reminder features. The SmartTouch has a Bluetooth interface to wirelessly exchange medication and reminder setting data with a paired communications device and compatible mobile software applications.
The document does not contain acceptance criteria or a study that proves a device meets specific performance criteria. Instead, it is an FDA 510(k) summary for the "SmartTouch" device.
Here's a breakdown of the information that can be extracted from the document, and what is missing:
Information extracted from the document:
- Device Name: SmartTouch
- Intended Use: Medication reminder and electronic data capture accessory for recording actuations of prescribed MDI usage. Compatible only with Symbicort MDI. Not intended to indicate remaining medication quantity or for dose counting.
- Operating Principle: Clip-on device that attaches externally to an MDI. Uses optical and mechanical sensors to detect MDI presence and actuation. Logs date and time of MDI actuation using an internal clock. Has LED indicators, control buttons, and Bluetooth interface for data exchange.
- Predicate Device: K163485, SmartTouch, Adherium (NZ) Limited. The current device is stated to have "identical features" in technological characteristics to the predicate, with minor software-only change for "spurious actuation log prevention improvements."
- Test Type: Non-clinical (bench testing) was performed. Clinical testing was not required.
- Tests Performed: Functional verification, device performance, usability of the user interface. Specifically, "performance testing of the MDI presence and actuation sensor system to ensure data is logged accurately for MDI usage."
- Standards/Regulations Complied with (external lab testing):
- AAMI/ANSI ES60601-1:2005 +A1:2012, C1:2010 (general safety)
- AAMI/ANSI HA60601-1-11:2015 (home-use safety)
- AAMI/ANSI/IEC 60601-1-2:2014 (electromagnetic compatibility)
- AAMI/ANSI/ISO 10993-1:2009, AAMI/ANSI/ISO 10993-5:2009, AAMI/ANSI/ISO 10993-10:2010, AAMI/ANSI/ISO 10993-12:2012 (biocompatibility)
- ANSI C63.10:2013 / 47 CFR Part 15 FCC regulations for RF devices.
Missing Information (and why it's missing from this type of document):
This document is a 510(k) summary submitted to the FDA to demonstrate substantial equivalence, not a detailed study report. Therefore, it does not contain:
- A table of acceptance criteria and the reported device performance: The document states that "performance testing of the MDI presence and actuation sensor system to ensure data is logged accurately for MDI usage" was done but does not provide specific metrics, acceptance criteria, or quantitative results (e.g., accuracy percentage, false positive/negative rates).
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this was non-clinical bench testing.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not done, as clinical testing was not required.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself is standalone in its function as a recorder, but the performance metrics of its accuracy are not provided.
- The type of ground truth used: For the bench testing, the ground truth would likely be based on controlled, known MDI actuations verified by direct observation or automated mechanical means. However, the document does not specify this.
- The sample size for the training set: Not applicable, as this is hardware/firmware, not a machine learning algorithm requiring a "training set" in the typical sense. The "spurious actuation log prevention improvements" are a software change, but the data used to develop this improvement is not detailed.
- How the ground truth for the training set was established: Not applicable.
Summary regarding acceptance criteria and study:
The 510(k) summary indicates that the device underwent non-clinical bench testing including "performance testing of the MDI presence and actuation sensor system to ensure data is logged accurately for MDI usage." It states that this testing "established correct functionality and compatibility of the SmartTouch with the Symbicort MDI according to requirements." However, it does not provide the specific numerical acceptance criteria (e.g., 99% accuracy for actuation detection) or the quantitative results of these performance tests. The basis for declaring "equivalent performance" to the predicate for "minor design changes" was also non-clinical testing.
The document primarily focuses on demonstrating substantial equivalence to a predicate device through shared technological characteristics and compliance with recognized safety and performance standards for medical devices, rather than presenting a detailed performance study against specific acceptance criteria for a novel functionality.
§ 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).