(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.
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March 26, 2018
Adherium (NZ) Ltd Chris Mander Head of Regulatory & Quality Level 2, 204 Quay Street Auckland, 1010 NZ
Re: K173310
Trade/Device Name: SmartTouch Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: February 21, 2018 Received: February 22, 2018
Dear Chris Mander:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K173310
Device Name SmartTouch
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
_ | Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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Adherium (NZ) Limited Level 2, 204 Quay Street, Auckland 1010, New Zealand PO Box 106-612, Auckland 1143, New Zealand Phone +64 9 307 2771 contact@smartinhaler.com www.smartinhaler.com
24 March 2018
510(k) SUMMARY
This summary of 510(k) information is submitted in accordance with requirements of 21 CFR 807.92:
(a)(1) Submitter Information
| Company Details: | Adherium (NZ) Ltd |
|---|---|
| Level 2, 204 Quay Street, Auckland 1010, New Zealand | |
| PO Box 106-612, Auckland 1143, New Zealand | |
| Phone +64 9 307 2771 | |
| Contact Person: | Chris Mander, Head of Regulatory & Quality |
(a)(2) Name of the Device
| Model Number / Name: | SmartTouch |
|---|---|
| Classification Name: | Nebulizer (Direct Patient Interface) |
| Anesthesiology Devices, 21 CFR 868.5630, Class II, CAF |
(a)(3) Identification of Legally Marketed Devices
The predicate device that equivalence is claimed to is: K163485, SmartTouch, Adherium (NZ) Limited.
(a)(4) Description of the Device
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.
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(a)(5) Statement of the Intended Use
The SmartTouch 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.
(a)(6) Technological Characteristics Summary
Technological characteristics of the SmartTouch are equivalent to the predicate device listed above. ldentical features between the devices include: configuration in attaching to the outside of an MDI housing; microprocessor control and use of an internal clock to log date and time of MDI actuation; power supply from an internal battery; sensor technology used to detect MDI actuation; user interface design; provision of reminder features; Bluetooth communications technology; interface to a communications device to upload MDI usage data; and capability to provide MDI usage data for further analysis using remote review software.
The SmartTouch is intended for OTC use, which is a change from the predicate. A review of the product life cycle, labeling, and risk analysis was conducted to ensure the device meets requirements for OTC use and to confirm this difference does not affect substantial equivalence. Minor design changes include a software-only change to make spurious actuation log prevention improvements. The minor design changes were verified by non-clinical testing to establish equivalent performance to the predicate.
(b)(1) Discussion of the Non-Clinical Tests
Non-clinical testing of the SmartTouch has been carried out to cover functional verification, device performance, and usability of the user interface. This included completion of software and device verification procedures, with performance testing of the MDI presence and actuation sensor system to ensure data is logged accurately for MDI usage. This established correct functionality and compatibility of the SmartTouch with the Symbicort MDI according to requirements.
Review and testing of the SmartTouch for compliance to the following standards and regulations has been completed by external laboratories: 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); and ANSI C63.10:2013 / 47 CFR Part 15 FCC regulations for RF devices.
(b)(2) Discussion of the Clinical Tests
Clinical testing was not required for a determination of substantial equivalence of the SmartTouch. The product functionality has been adequately assessed by bench testing as above.
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(b)(3) Conclusions Drawn from Non-Clinical and Clinical Tests
Finished device testing carried out for the SmartTouch indicates it meets design and performance functional requirements. Software verification demonstrates that the device functions equivalently to the predicate device. The device meets standard requirements for wireless communications, electrical safety, electromagnetic compatibility, and environmental performance.
This information indicates that the SmartTouch is substantially equivalent to the predicate device.
§ 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).