The Hailie® sensor is intended for single-patient use in the home environment as an electronic data capture accessory for monitoring and recording actuations, inspiratory flow, and inhaler shake, for prescribed inhaler usage.

The Hailie® sensor may be used in the following applications: in clinical trials, where specialists, general practitioners, nurses, and educators need to know if a patient has used their prescribed medication, or assess inspiratory flow and inhaler technique; and in patient self-management including medication reminders.

The Hailie® sensor is compatible only with the Symbicort™ MDI inhaler. The Haile® sensor is not intended to indicate remaining quantity of medication in an inhaler and does not include a dose counting function. The Hallie® sensor is not intended to provide spirometry measurements.

Device Description

The Hailie® sensor is a modification to the SmartTouch sensor, and is used to provide medication reminder, actuation monitoring, and shake and airflow recording for use as an accessory to the inhaler specified on the device label. The Hailie® sensor is indicated for use only with the Symbicort™ MDI inhaler.

The Hailie® sensor is a clip-on device that attaches externally around the housing of the inhaler. Mechanical and optical sensors are used to detect the inhaler presence and monitor actuation. Motion and flow sensors are used to record inhaler usage technique parameters. The Hailie® sensor contains an electronic clock and calendar that are used to log the date and time of inhaler usage events.

The user interface consists of a single Status Button and a multi-color LED indicator to check device status, initiate communications functions, and provide reminder features. The Hailie® sensor has a Bluetooth interface to wirelessly exchange medication usage data and reminder setting data with a paired communications device and compatible mobile software applications.

AI/ML Overview

The provided text describes information related to the 510(k) premarket notification for the Hailie® Sensor, but it does not contain a table of acceptance criteria or a detailed study proving the device meets those criteria with specific performance metrics (e.g., sensitivity, specificity, accuracy).

The document primarily focuses on demonstrating substantial equivalence to a predicate device (SmartTouch) and reference devices (K183586 CapMedic, K181405 Hailie® Sensor) through non-clinical testing. It highlights the technological characteristics of the Hailie® sensor and its performance in various non-clinical tests.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them from the given text.

However, I can extract and summarize other relevant information you asked for:

Information Extracted from the Document:

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- The document states "Clinical testing was not required for a determination of substantial equivalence of the Hailie® sensor." This implies that no clinical test set with patient data was used for performance evaluation against ground truth in the way typically seen for AI/ML device validations for diagnostic or prognostic purposes. The performance assessment was based on non-clinical testing (e.g., mechanical, electrical, software functionality) in a lab setting.
- Data provenance for these non-clinical tests is not specified in terms of country of origin or retrospective/prospective nature, as it relates to device functionality testing rather than patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no clinical test set using expert-established ground truth was presented for the device's core functionality of monitoring actuations, inspiratory flow, and inhaler shake. The ground truth for performance testing would have been established by engineering specifications and known physical principles.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable, as there was no expert review/adjudication of a clinical test set.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. The device is an electronic data capture accessory, not an AI assisting human readers in diagnostic interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The "performance testing" described (optical inhaler presence detection, airflow detection sensor, motion detection sensor, general performance testing, user interface testing) essentially represents standalone testing of the device's core functions. However, these are functional tests, not "algorithm only" performance in the context of an AI/ML diagnostic or predictive algorithm. The device itself is an "algorithm" in the sense of executing programmed functions, and these tests verify its standalone performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the performance tests appears to be based on:
  - Engineering specifications and expected device behavior: e.g., accurate detection within defined calibration limits for optical detection.
  - Physical measurements: e.g., flow rate measurements, duration of shake.
  - Requirements from the inhaler manufacturer: for shake detection.
  - Regulatory standards: for biocompatibility, electrical safety, EMC.
The sample size for the training set:
- The document does not describe a "training set" in the context of machine learning. The device's functionality appears to be rule-based or engineered, rather than learned from a large dataset.
How the ground truth for the training set was established:
- Not applicable, as there is no mention of a machine learning training set.

Summary of what CANNOT be provided from the text:

A table of acceptance criteria and reported device performance related to diagnostic accuracy (e.g., sensitivity, specificity, AUC). The document focuses on functional performance and substantial equivalence based on non-clinical tests.
Detailed information on clinical test set sample size, provenance, expert qualifications, or adjudication methods. The document explicitly states clinical testing was not required for determining substantial equivalence for this device.
Specific effect sizes for human reader improvement with AI assistance. The device is not an AI diagnostic aid.

Summary

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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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 18, 2021

Adherium (NZ) Ltd Chris Mander Head of Regulatory & Ouality Level 11, 16 Kingston Street Auckland, 1010 New Zealand

Re: K211233

Trade/Device Name: Hailie Sensor NF0109 Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: July 15, 2021 Received: July 19, 2021

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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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,

Brandon Blakely, Ph.D. Acting Assistant Director DHT1C: Division of 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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Indications for Use

510(k) Number (if known) K211233

Device Name

Hailie® Sensor

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
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 sans-serif font, with the letters in a salmon color. To the right of the word is a stylized checkmark symbol, with one side in salmon and the other in light gray. The checkmark appears to be made of two rounded shapes that overlap slightly. The overall design is clean and modern.

Adherium (NZ) Limited Level 11, 16 Kingston Street, Auckland 1010, New Zealand PO Box 106-612, Auckland 1143, New Zealand Phone +64 9 307 2771 contact@hailie.com www.hailie.com

17 August 2021

510(k) SUMMARY

I. Submitter

Company Details:	Adherium (NZ) LtdLevel 11, 16 Kingston 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:	NF0109
Classification Name:	Nebulizer
	Anesthesiology Devices, 21 CFR 868.5630, Class II, CAF

III. Predicate Device

The predicate device to which substantial equivalence claimed is: K173310 SmartTouch, manufactured by Adherium (NZ) Limited. The reference devices which support a substantial equivalence determination are: K183586 CapMedic, manufactured by Cognita Labs LLC; and K181405 Hailie® Sensor, manufactured by Adherium (NZ) Ltd.

IV. Device Description

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Bluetooth interface to wirelessly exchange medication usage data and reminder setting data with a paired communications device and compatible mobile software applications.

V. Indications for Use

The Hailie® sensor is intended for single patient use in the home environment as an electronic data capture accessory for monitoring and recording actuations, inspiratory flow, and inhaler shake, for prescribed inhaler usage.

The Hailie® sensor may be used in the following applications: in clinical practice or clinical trials, where specialists, general practitioners, nurses, and educators need to know if a patient has used their prescribed medication or assess inspiratory flow and inhaler technique; and in patient selfmanagement including medication reminders.

The Hailie® sensor is compatible only with the Symbicort™ MDI inhaler. 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 not intended to provide spirometry measurements.

The Indications for Use statement differs from the predicate device, in that monitoring and recording and assessment of inhaler usage parameters for inspiratory flow and inhaler shake have been added. These features provide further information on inhaler use and technique and do not affect the safety or effectiveness of the device. The changes are within the scope of the cleared Indications for Use for the reference device K183586.

VI. Comparison of Technological Characteristics with the Predicate Device

Technological characteristics of the Hailie® sensor are equivalent to the predicate and reference devices 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.

The Hailie® sensor has equivalent technological characteristics to the predicate device in terms of:

Compatibility only with the Symbicort™ MDI inhaler to monitor medication usage. .
Clip-on attachment around the outside of an inhaler housing and secured by hinged door. .
Microprocessor control and use of an internal clock to log date and time of inhaler usage events. .
Provision of medication reminders. .
Sensor technology used to detect inhaler presence and actuation. .
No interference with inhaler operation, medication delivery, label visibility, or dose counter. .
Event storage capacity and memory management. .
Power supply from an internal non-rechargeable battery and shelf life / service life. .
Bluetooth communications technology for data upload. .
Interface to a communications device to upload inhaler usage data. .
Materials contacted by the user are the same as the Adherium reference device.
Capability to provide inhaler usage data for further analysis using remote review software. .

The Hailie® sensor has differing technological characteristics from the predicate device in terms of:

Additional motion and flow sensor technology to detect inhaler usage technique parameters. .
Housing shape modified to relocate actuation detection sensor. .
User interface simplified to single button and LED indicator format. .
USB port and battery pull-tab removed to simplify device design. .
Device electronics, processor and PCB updated to current technology and to accommodate . additional sensors.

These design changes were verified by non-clinical testing to establish equivalent performance to the predicate device.

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VII. Performance Data

Non-clinical testing and evaluation of the Hailie® sensor has been carried out to cover biocompatibility evaluation, electrical safety and electromagnetic compatibility testing, software verification and validation testing, performance testing, and usability evaluation.

Biocompatibility Evaluation

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: ISO 10993-1:2009 (biocompatibility), ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2010 (sensitization and intracutaneous irritation), and ISO 10993-12:2012 (sample preparation for biocompatibility testing). The materials used in the Hailie® sensor were evaluated according to requirements for a surface device contacting intact skin for limited duration ≤ 24 hours.

Electrical Safety and Electromagnetic Compatibility (EMC) Testing

Electrical safety and EMC testing was conducted by external laboratories on the Hailie® sensor. The device complies with the following standards: ANSI/AAMI ES60601-1:2005 +A1:2012, C1:2009, A2:2010 (general safety), IEC 60601-1-11:2015 (home-use safety), and IEC 60601-1-2:2014 (electromagnetic compatibility). General safety testing was conducted according to applicable requirements for a home use, battery-powered device. EMC testing was conducted according to applicable requirements for an internally powered, non-patient coupled, Bluetooth radio device. 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 (14 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. 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 (27 Sep 2019), 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 Symbicort™ MDI inhaler according to requirements, covering:

. Optical inhaler presence detection - determined optical calibration limits and confirmed accurate detection of an installed inhaler, with equivalent performance to the predicate.
. Airflow detection sensor - confirmed performance of flow detection during inhaler usage across potential inspiratory flow range, to record flow rate and duration related to inhaler actuation, and detect inhalation appropriately for the purpose of monitoring use of a medication inhaler.
Airflow verification testing confirmed the effect of the Hailie® sensor on flow impedance in the . airflow path is negligible with respect to required airflow through the inhaler.
. Motion detection sensor - confirmed performance of shake detection to monitor inhaler shake duration before use, according to requirements from the inhaler manufacturer, while not detecting normal handling of the inhaler.
General performance testing confirmed acceptable performance over the specified shelf life . and specified Bluetooth communications range, with equivalent performance to the predicate.
User interface testing confirmed visibility of device display and audibility of device buzzer, with . equivalent performance to the predicate.

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Usability Evaluation

Usability evaluation for the Hailie® sensor was carried out to evaluate impact on critical tasks indicated by the usability risk analysis for the updated design, and established validity of the results obtained from testing carried out 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, safety, and performance requirements. Inhaler detection, communications, shelf life, and user interface performance is equivalent to the predicate. Inhaler usage parameters are measured with sufficient accuracy for monitoring inhaler use, and the addition of the sensor does not adversely affect use of the inhaler. Software verification demonstrates that the device should perform as intended in the specified use conditions, and equivalently to the predicate for common software functions. The device meets standard requirements for biocompatibility, electrical safety, and electromagnetic compatibility. The usability evaluation indicates there are no issues for successful use with the compatible inhaler.

This information indicates that the Hailie® sensor is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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).