(161 days)
The Smartinhaler™ 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 Smartinhaler™ is compatible only with the following MDIs: Ventolin® HFA, Flovent® HFA, ProAir® HFA, and QVAR® HFA. The intended MDI is specified on the product labeling. The Smartinhaler™ is not intended to indicate remaining quantity of medication in an MDI and does not include a dose counting function.
Smartinhaler™ 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. Smartinhaler™ is a clip-on device that attaches externally around the housing of an MDI. The Smartinhaler™ comes in rechargeable and non-rechargeable models. Each Smartinhaler™ is compatible only with one of the following MDIs: Ventolin® HFA (90 mcg), Advair® HFA (45/21, 115/21, 230/21 mcg), Flovent® HFA (44, 110, 220 mcg), ProAir® HFA (90 mcg), QVAR® HFA (40, 80 mcg). The intended MDI is indicated on the device labeling. Optical and pressure sensors are used to detect MDI presence and actuation, and the device logs the usage history of the MDI. The Smartinhaler™ contains an electronic clock and calendar that is used to log the date and time of MDI actuation. The Smartinhaler™ user interface consists of one LED indicator and one control button to check device status, initiate communications functions, and cancel medication reminders. The Smartinhaler™ has a Bluetooth interface to wirelessly exchange medication and reminder setting data with a paired communications device and compatible mobile software applications.
The provided text describes the 510(k) summary for the Smartinhaler™ device. This is a premarket notification for a medical device and typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than extensive clinical efficacy studies in the same way a new drug would.
Based on the provided text, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of quantitative acceptance criteria for performance with corresponding results for accuracy, sensitivity, or specificity in detecting MDI actuations. Instead, it refers to a broader set of tests to establish functional equivalence and safety.
However, it does state the following objectives and general outcomes:
| Acceptance Criteria (Stated Objectives/Requirements) | Reported Device Performance (Summary of Findings) |
|---|---|
| Functional verification of device | Established correct functionality |
| Device performance (MDI presence & actuation sensing) | Ensured data is logged accurately for usage with each compatible MDI |
| Usability of the user interface | Successfully evaluated |
| Correct functionality and compatibility with specified MDIs (Ventolin® HFA, Advair® HFA, Flovent® HFA, ProAir® HFA, QVAR® HFA) | Confirmed according to requirements |
| Compliance with wireless communications standards | Meets standard requirements |
| Compliance with electrical safety standards | Meets standard requirements |
| Compliance with electromagnetic compatibility standards | Meets standard requirements |
| Compliance with environmental performance standards | Meets standard requirements |
| Meet requirements for Over-The-Counter (OTC) use | Review of product life cycle, labeling, and risk analysis conducted to ensure device meets requirements for OTC use |
| Equivalent performance to predicate device for minor design changes (medication reminders, spurious actuation log prevention improvements, enclosure modifications, non-rechargeable model) | Verified by non-clinical testing to establish equivalent performance |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "Non-clinical testing of the Smartinhaler™ 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 usage with each of the compatible MDIs."
It also mentions that the testing "established correct functionality and compatibility of the Smartinhaler™ with the Ventolin® HFA, Advair® HFA, Flovent® HFA, ProAir® HFA, QVAR® HFA according to requirements."
However, the document does not provide specific sample sizes (e.g., number of actuations, number of devices, duration of testing) for the non-clinical tests. It generalizes the testing as encompassing "functional verification, device performance, and usability."
Data Provenance: The testing was described as "Non-clinical testing" and conducted by "external laboratories." The specific country of origin for the data or whether it was retrospective or prospective is not detailed, beyond being verification and performance testing. Given it's pre-market, it would inherently be prospective testing for the device's functionality.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
The document states that the testing was "non-clinical" and describes it as "functional verification, device performance, and usability." This suggests the ground truth for these tests would likely be established by technical specifications, engineering benchmarks, and instrumental measurements, rather than human expert interpretation of medical images or data. Therefore, the concept of "experts" in the context of clinical ground truth (e.g., radiologists) is not applicable here.
4. Adjudication Method for the Test Set
As the testing was non-clinical and focused on device functionality and engineering performance, there's no mention or indication of a human-based adjudication method (like 2+1 or 3+1 consensus) for the test set. The results would be based on instrument readings and meeting defined performance specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. The document explicitly states: "Clinical testing was not required for a determination of substantial equivalence of the Smartinhaler™. The product functionality has been adequately assessed by bench testing as above." Therefore, an MRMC study comparing human readers with and without AI assistance was not conducted. The device is an accessory for recording MDI actuations, not an AI for image interpretation that would typically require an MRMC study for clinical effectiveness.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
The device itself is a standalone electronic device that records MDI actuations. The "performance testing of the MDI presence and actuation sensor system to ensure data is logged accurately" effectively acts as a standalone performance evaluation of the device's core function. It doesn't rely on human input for its primary function of detection and logging.
7. The Type of Ground Truth Used
The ground truth for the non-clinical tests would have been established through defined engineering specifications, simulated actuation events (e.g., automated MDI actuations), and comparison against known correct values or behaviors. For instance, knowing when an MDI was actuated (based on a test rig or direct observation by engineers) and comparing that to the device's logged data. The document implies that the ground truth was inherent to the bench testing environment.
8. The Sample Size for the Training Set
The concept of a "training set" is typically associated with machine learning or AI models. The Smartinhaler™ is described as using optical and pressure sensors to detect MDI presence and actuation. While there might be internal algorithms for processing sensor data, the document does not suggest a deep learning or complex AI model that would require a large, distinct "training set" in the conventional sense. The "software verification procedures" mentioned would relate to traditional software engineering and testing, not AI model training. Therefore, no specific training set sample size is mentioned or implied.
9. How the Ground Truth for the Training Set Was Established
As no "training set" for an AI or machine learning model is indicated, this question is not directly applicable. If there were any internal algorithms that required calibration or parameter tuning, their "ground truth" would likely have been established through controlled bench testing and validation against known physical events (e.g., verified MDI actuations in a laboratory setting).
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July 25, 2018
Adherium (NZ) Ltd Chris Mander Head of Regulatory & Quality Level 2, 204 Ouay Street Auckland, 1010 NZ
Re: K180407
Trade/Device Name: SmartinhalerTM Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: June 22, 2018 Received: June 25, 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Actinclude 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
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 comprehensive regulatory information about medical devices and radiation-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,
James J. Lee -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) K180407
Device Name Smartinhaler™
Indications for Use (Describe)
The Smartinhaler™ 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 Smartinhaler™ is compatible only with the following MDIs: Ventolin® HFA, Flovent® HFA,
ProAir® HFA, and QVAR® HFA. The intended MDI is specified on the product labeling. The Smartinhaler™ 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
20 July 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) LtdLevel 2, 204 Quay Street, Auckland 1010, New ZealandPO Box 106-612, Auckland 1143, New ZealandPhone +64 9 307 2771 |
|---|---|
| Contact Person: | Chris Mander, Head of Regulatory & Quality |
(a)(2) Name of the Device
| Model Number / Name: | Smartinhaler™ |
|---|---|
| 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 to which substantial equivalence is claimed is: K133951, SmartTouch™, manufactured by Nexus6 Limited. The reference device which supports a substantial equivalence determination is: K173310, SmartTouch™, manufactured by Adherium (NZ) Limited.
(a)(4) Description of the Device
Smartinhaler™ 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.
Smartinhaler™ is a clip-on device that attaches externally around the housing of an MDI. The Smartinhaler™ comes in rechargeable and non-rechargeable models. Each Smartinhaler™ is compatible only with one of the following MDIs: Ventolin® HFA (90 mcg), Advair® HFA (45/21, 115/21, 230/21 mcg), Flovent® HFA (44, 110, 220 mcg), ProAir® HFA (90 mcg), QVAR® HFA (40, 80 mcg). The intended MDI is indicated on the device labeling. Optical and pressure sensors are used to detect MDI presence and actuation, and the device logs the usage history of the MDI. The Smartinhaler™ contains an electronic clock and calendar that is used to log the date and time of MDI actuation.
The Smartinhaler™ user interface consists of one LED indicator and one control button to check device status, initiate communications functions, and cancel medication reminders. The
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Smartinhaler™ has a Bluetooth interface to wirelessly exchange medication and reminder setting data with a paired communications device and compatible mobile software applications.
(a)(5) Statement of the Intended Use
The Smartinhaler™ 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 Smartinhaler™ is compatible only with the following MDIs: Ventolin® HFA, Flovent® HFA, ProAir® HFA, and QVAR® HFA. The intended MDI is specified on the product label. The Smartinhaler™ 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 Smartinhaler™ are equivalent to the predicate device listed above. Equivalent 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; 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 Smartinhaler™ 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 the difference does not affect substantial equivalence. Minor design changes include addition of medication reminders, spurious actuation log prevention improvements, enclosure modifications for MDI compatibility, and a non-rechargeable model, and were verified by non-clinical testing to establish equivalent performance to the predicate device.
(b)(1) Discussion of the Non-Clinical Tests
Non-clinical testing of the Smartinhaler™ 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 usage with each of the compatible MDIs. This established correct functionality and compatibility of the Smartinhaler™ with the Ventolin® HFA, Advair® HFA, Flovent® HFA, ProAir® HFA, QVAR® HFA according to requirements.
Review and testing of the Smartinhaler™ for compliance to the following standards and regulations has been completed by external laboratories: ANSI/AAMI ES60601-1:2005 +A1:2012, C1:2009, A2:2010 (general safety), ANSI/AAMI HA60601-1-11:2015 (home-use safety), ANSI/AAMI/IEC 60601-1-2:2014 (electromagnetic compatibility); ANSI/AAMI/ISO 10993-1:2009, ANSI/AAMI/ISO 10993-5:2009, ANSI/AAMI/ISO 10993-10:2010, ANSI/AAMI/ISO 10993-12:2012 (biocompatibility); and ANSI C63.10:2013 / 47 CFR Part 15 FCC regulations for RF devices.
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(b)(2) Discussion of the Clinical Tests
Clinical testing was not required for a determination of substantial equivalence of the Smartinhaler™. The product functionality has been adequately assessed by bench testing as above.
(b)(3) Conclusions Drawn from Non-Clinical and Clinical Tests
Finished device testing carried out for the Smartinhaler™ indicates it meets design and performance functional requirements. Software verification demonstrates that the device functions are substantially equivalent to the predicate device. The device meets standard requirements for wireless communications, electrical safety, electromagnetic compatibility, and environmental performance.
This information indicates that the Smartinhaler™ 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).