(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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 19, 2019
Adherium (NZ) Ltd Chris Mander Head of Regulatory & Quality Level 2, 204 Quay Street Auckland, 1010 NZ
Re: K182638
Trade/Device Name: Hailie Sensor Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: May 16, 2019 Received: May 20, 2019
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 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
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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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 Lee Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality 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) K182638
Device Name Hailie™ Sensor
Indications for Use (Describe)
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.
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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Image /page/3/Picture/1 description: The image shows the word "adherium" in a lowercase, sans-serif font. The word is colored in a light orange hue. To the right of the word, there is a stylized graphic that resembles two overlapping shapes, one in light gray and the other in the same light orange as the word. The shapes are positioned in a way that suggests movement or a dynamic interaction.
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@hailie.com www.hailie.com
20 June 2019
510(k) SUMMARY
I. Submitter
| 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 |
II. Device
| Device Name: | Hailie™ Sensor |
|---|---|
| Model Number: | NF0101 |
| Classification Name: | Nebulizer (Direct Patient Interface)Anesthesiology Devices, 21 CFR 868.5630, Class II, CAF |
III. Predicate Device
The predicate device to which substantial equivalence is: K180407, Smartinhaler™, manufactured by Adherium (NZ) Limited.
IV. Device Description
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.
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V. Indications for Use
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.
VI. Comparison of Technological Characteristics with the Predicate Device
Technological characteristics of the Hailie™ sensor are equivalent to the predicate device listed above. They are both microprocessor-controlled electronic devices that clip on to an inhaler, using a combination of sensors to detect inhaler use which is logged to compile a usage history.
| Device Feature | Proposed Device | Comparison to Predicate Device |
|---|---|---|
| Intended Use... | ||
| Purpose and function: | Remind and monitor medication usage | Same |
| Type of use: | Over-the-counter use | Same |
| User population: | HandiHaler® users | Substantially equivalent. User population appropriate for intended inhaler. |
| Device usage: | Single-patient use | Same |
| Environment of use: | Home use | Same |
| Dose counting: | No dose counting function | Same |
| Features... | ||
| Data collected: | Date and time for inhaler usage | Same |
| User notifications: | Audio/visual | Same |
| Medication reminders: | Configurable times | Same |
| Data transfer interface: | Automatic upload via Bluetooth | Same |
| User Interface... | ||
| Controls: | Status button | Same |
| Display: | LED lights | Substantially equivalent. Proposed device LEDs located for better visibility. |
| Audio: | Buzzer | Same |
| Hardware... | ||
| Size and weight: | Small and lightweight, suitable for use with inhaler | Substantially equivalent. Proposed device shape and attachment method modified to fit intended inhaler. |
| Configuration: | Attaches around outside of inhaler housing with clip-on fit | Same |
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| Device Feature | Proposed Device | Comparison to Predicate Device |
|---|---|---|
| Sensor technology: | • Optical sensor for inhaler presence• Mechanical and acoustic sensors forinhaler usage | SameSubstantially equivalent. Inhaler usagesensors appropriate to type of inhaler.Testing verifies functional performance. |
| Wireless technology: | Bluetooth | Same |
| Inhaler Interaction... | ||
| Inhaler compatibility | Attaches to inhaler without affectingmechanism or operation | Same |
| Inhaler access: | Inhaler readily removed from devicefor cleaning and label access | Substantially equivalent. Usability testingverifies users understand instructions forreview and removal of inhaler. |
| Electronics/Software | ||
| Internal clock: | Yes | Same |
| Event record resolution: | 1 second | Same |
| Event storage: | Non-volatile memory | Same |
| Limited event overwrite: | Yes | Same |
| Reject spurious events: | Yes | Same |
| Power source: | Rechargeable battery | Substantially equivalent. Proposed deviceonly has rechargeable model. |
| Battery life: | 2-3 months on full charge | Substantially equivalent. Proposed deviceonly has rechargeable model. Bothdevices meet intended battery life. |
| Battery level indicator: | LED light color | Same |
| Power save before use: | Deep-sleep mode | Same |
| Materials... | ||
| Device components: | Components tested to meet ISO 10993cytotoxicity, sensitization, irritation | Substantially equivalent. Proposed devicecolor matches intended inhaler. Allmaterials and colorants are safe forintended use and pass biocompatibilitytesting. |
The design changes described in the above table were verified by non-clinical testing to establish equivalent performance to the predicate device.
VII. Performance Data
Non-clinical testing of the Hailie™ sensor has been carried out to cover biocompatibility testing, electrical safety and electromagnetic compatibility, software verification and validation testing, performance testing, and usability evaluation.
Biocompatibility Testing
The biocompatibility evaluation for the Hailie™ sensor was conducted in accordance with the FDA guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (16 Jun 2016), to meet requirements from the following standards: ANSI/AAMI/ISO 10993-1:2009 (biocompatibility), ANSI/AAMI/ISO 10993-5:2009 (cytotoxicity), ANSI/AAMI/ISO 10993-10:2010 (sensitization and intracutaneous irritation), and ANSI/AAMI/ISO 10993-12:2012 (sample preparation for biocompatibility testing). The
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Hailie™ sensor was tested according to requirements for a surface device contacting intact skin for limited duration ≤ 24 hours.
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and EMC testing were conducted by external laboratories on the Hailie™ sensor. The device complies with the following standards and regulations: ANSI/AAMI ES60601-1:2005 +A1:2012, C1:2009, A2:2010 (general safety), IEC 60601-1-11:2015 (home-use safety), IEC 60601-1-2:2014 (electromagnetic compatibility), and ANSI C63.10:2013 / 47 CFR Part 15 (FCC regulations for radiofrequency (RF) devices). General safety testing was conducted according to applicable requirements for a home use, battery-powered device, that may be recharged via a USB connector. EMC testing was conducted according to applicable requirements for an internally powered, nonpatient coupled, Bluetooth radio device that may be recharged from an AC adaptor. Information was provided according to FDA guidance Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices (11 Jul 2016), and Radio-Frequency Wireless Technology in Medical Devices (13 Aug 2013).
Software Verification and Validation Testing
Software verification and validation testing were conducted to ensure correct functionality for the Hailie™ sensor software release, for all software modules (real-time clock, user interface, power management, event recording, Bluetooth communications, USB power, non-volatile parameters, medication reminders, medication, and user functionality). Documentation was provided as recommended by FDA guidance Content of Premarket Submissions for Software Contained in Medical Devices (11 May 2005), Off-The-Shelf Software Use in Medical Devices (9 Sep 1999), and Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (2 Oct 2014).
Performance Testing
Performance testing was conducted to establish correct functionality and compatibility of the Hailie™ sensor with the HandiHaler® according to requirements, covering:
- Optical inhaler presence detection determined optical calibration limits and confirmed . accurate detection of an installed inhaler.
- Mechanical inhaler usage detection sensor confirmed reliability of sensor over device lifetime. .
- Acoustic inhaler usage detection sensor confirmed accurate detection of inhaler usage and . prevention of detection from other inputs.
- Spurious log prevention testing determined circuit parameters and confirmed prevention of . erroneous medication usage logs.
- General performance testing confirmed acceptable performance over the specified shelf life . and specified Bluetooth communications range.
- . User interface testing - confirmed visibility of device display and audibility of device buzzer.
Usability Evaluation
Summative usability validation testing was carried out to evaluate critical tasks indicated by the usability risk analysis process. A description of the usability engineering process and the results obtained from the testing were provided in accordance with the FDA guidance Applying Human Factors and Usability Engineering to Medical Devices (3 Feb 2016).
Clinical Testing
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.
VIII. Conclusions
Finished device testing carried out for the Hailie™ sensor indicates it meets design and performance functional requirements. Software verification demonstrates that device functions are substantially equivalent to the predicate device meets standard requirements for biocompatibility,
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510(k) Summary continued - Hailie™ Sensor
electrical safety, electromagnetic compatibility, and wireless communications. The usability evaluation demonstrated that the Hailie™ sensor can be used successfully with the compatible inhaler.
This information indicates that the Hailie™ sensor 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).