Hailie Sensor NF0107 & NF0108

K221994 · Adherium (Nz), Ltd. · CAF · Oct 4, 2022 · Anesthesiology

Device Facts

• Record ID: K221994
• Device Name: Hailie Sensor NF0107 & NF0108
• Applicant: Adherium (Nz), Ltd.
• Product Code: CAF · Anesthesiology
• Decision Date: Oct 4, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2

Intended Use

Toe Hailie@ sensor is intended for single-patient multiple use in the home environment as an electronic data capture accessory for monitoring and recording actuation, 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 Ventolin, Advair, Flovent 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.

Device Story

Hailie Sensor is an electronic data capture accessory for specific inhalers (Ventolin, Advair, Flovent). It monitors and records inhaler actuation, inspiratory flow, and shake technique. Used in home environments by patients for self-management and medication reminders, or in clinical settings by healthcare providers (specialists, GPs, nurses, educators) to assess adherence and inhaler technique. The device does not count doses, indicate remaining medication, or perform spirometry. It provides data to assist clinical decision-making regarding patient medication usage and technique.

Clinical Evidence

No clinical data provided.

Technological Characteristics

Electronic data capture accessory for inhalers. Monitors actuation, inspiratory flow, and shake. Compatible with Ventolin, Advair, and Flovent inhalers. Single-patient multiple-use device.

Indications for Use

Indicated for patients using prescribed Ventolin, Advair, or Flovent inhalers. Used for monitoring and recording inhaler actuation, inspiratory flow, and shake technique in home environments or clinical settings for medication adherence and technique assessment.

Regulatory Classification

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.

Submission Summary (Full Text)

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October 4, 2022

Adherium (NZ) Ltd Tara Creaven-Capasso Vice President Quality, Regulatory and Clinical Affairs Level 11, 16 Kingston Street Auckland, 1010 New Zealand

Re: K221994

Trade/Device Name: Hailie Sensor NF0107 & NF0108 Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: June 28, 2022 Received: July 6, 2022

Dear Tara Creaven-Capasso:

We have reviewed vour 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

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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) 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 medical devices and radiation-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 [phone] or 301-796-7100).

Sincerely,

James J. Lee, Ph.D. Division 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 Ouality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K221994

Device Name Hailie® Sensor

## Indications for Use (Describe)

Toe Hailie@ sensor is intended for single-patient multiple use in the home environment as an electronic data capture accessory for monitoring and recording actuation, 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 Ventolin, Advair, Flovent 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.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| <label><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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