HTS is intended for single-patient multiple use in the home environment as an electronic data capture accessory for monitoring and recording actuation, inhaler shake, inhaler orientation, inhalation coordination, and inspiratory strength and duration for prescribed inhaler usage.

HTS 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 inhaler technique.

HTS is designed to work only with the MDI and medication indicated on the HTS label.

HTS is not intended to indicate the remaining quantity of medication in an inhaler and does not include a dose counting function.

HTS is not intended to provide spirometry measurements.

HTS is intended to be used by Metered Dose Inhaler (MDI) users aged 12 years and over.

Device Description

The HeroTracker Sense (HTS) is a nebulizer accessory. It is an add-on device which is attached by patients on a metered dose inhaler (MDI) and is used to record and analyze data related to medication actuation and technique of use for prescribed inhaler usage. Data is transferred to a mobile application with appropriate settings and is displayed to end users.

AI/ML Overview

The provided FDA 510(k) Clearance Letter for HeroTracker Sense (HTS) does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and a study proving the device meets those criteria. The document primarily focuses on demonstrating substantial equivalence to a predicate device based on non-clinical performance data.

Here's a breakdown of what can be gleaned from the document and what information is missing:

Missing Information: The document explicitly states "No clinical data was necessary to determine the substantial equivalence of this device." This means there was likely no "performance study" in the traditional sense, with a clinical test set, ground truth experts, adjudication, or MRMC studies. The acceptance criteria for performance would have been established and demonstrated through non-clinical testing.

Therefore, many of the sections you requested (e.g., sample size for test set, number of experts, adjudication, MRMC, specific effect sizes, ground truth type for test set the training set) cannot be answered from the provided text.

Inference from Document's Purpose: The 510(k) process for this device relies heavily on demonstrating that the HeroTracker Sense (HTS) functions similarly to its predicate device (Hailie® Sensor NF0110) and that any differences do not raise new questions of safety or effectiveness. The performance validation would have been against defined specifications for each function, likely derived from the predicate device's capabilities and internal design requirements.

Acceptance Criteria and Device Performance (Based on available non-clinical data)

Since clinical data was not required, the "acceptance criteria" for the device would be met by passing the non-clinical performance and safety tests. The "reported device performance" is essentially that it "passed" these tests and met its internal specifications.

Table of Acceptance Criteria and Reported Device Performance (Inferred from Non-Clinical Testing):

Acceptance Criteria Category	Specific Criteria (Inferred from testing)	Reported Device Performance
Biocompatibility	Materials are biocompatible (ISO 10993-1)	Passed - "Materials can be considered as biocompatible."
Electrical Safety	Compliance with IEC 60601-1, IEC 60601-1-11, IEC 60601-1-6	Passed
Electromagnetic Disturbance (EMD)	Compliance with IEC 60601-1-2	Passed
Software Functionality	Correct functionality of HTS software, modules, and mobile app association (IEC 62304/FDA Guidance)	Passed - "verified"
Breathing Gas Pathway Biological Safety	Risk-based evaluation adequacy (ISO 18562-1)	Passed - "considered adequately addressed."
Core Performance (Data Recording Accuracy)	Device meets specifications for recording actuation, inhaler shake, inhaler orientation, inhalation coordination, inspiratory strength and duration	Passed - "Device was verified to meet specifications and the correct functionality and compatibility for the HTS with the concerned MDI inhalers was verified"
Service Life	At least 1 year service life	Passed - "Supports 1 year service life"
Shelf-Life	At least 2 years shelf life	Passed - "Supports 2 years shelf life"
Transportation Impact	Transport has no impact on device (ASTM 4169)	Passed - "confirmed the transport has no impact on device."

Study Details (Based on available information and limitations)

Given the explicit statement that "No clinical data was necessary to determine the substantial equivalence of this device," the following sections reflect this limitation. The "study" refers to the non-clinical verification and validation activities.

A table of acceptance criteria and the reported device performance:
- (Provided above, based on non-clinical testing outcomes).
Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of a clinical test set. For non-clinical performance testing (e.g., electrical safety, software validation, sensor accuracy), the sample sizes would refer to the number of devices or test iterations used. This specific detail is not provided in the document.
- Data Provenance: Not applicable in the sense of patient data. The tests were performed in a lab or testing facility environment.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No clinical ground truth experts were used as no clinical data was required. Ground truth for non-clinical performance (e.g., whether a sensor accurately detects an actuation) would be established by validated test methods and reference standards, not human expert consensus.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There was no human expert adjudication as no clinical test set with subjective interpretations was used.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. The document explicitly states "No clinical data was necessary." Therefore, no MRMC study comparing human readers with and without AI assistance was performed.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The "Performance Testing" section confirms that the device was "verified to meet specifications" and its "correct functionality and compatibility" was verified. This implies standalone performance testing of the device's ability to record and analyze data from the MDI. The "algorithm" itself (which processes sensor data to identify events like actuation, shake, etc.) would have been validated against controlled physical actions.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Instrumental/Physical Ground Truth: For the non-clinical performance tests, the "ground truth" would be established by controlled physical inputs and reference measurements. For example:
  - For "actuation," the ground truth would be a definitively measured actuation event.
  - For "inhaler shake," the ground truth would be a quantitatively measured shaking motion.
  - For software functionality, the ground truth would be predefined correct outputs for given inputs.
The sample size for the training set:
- Not applicable / Not specified. This device is an electronic data capture accessory. While it uses sensors and potentially algorithms to interpret movements, the document doesn't indicate that it employs machine learning or AI that would require a "training set" in the typical sense (e.g., for image classification or complex pattern recognition). Its function seems to be based on pre-defined thresholds and sensor data processing rather than adaptive learning from a large training dataset. If any "calibration" or initial parameter setting was done, the size of that dataset is not provided.
How the ground truth for the training set was established:
- Not applicable. As no training set is indicated.

Summary

FDA 510(k) Clearance Letter - HeroTracker Sense

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

June 30, 2025

Voluntis
℅ Rachel Paul
Lead Quality and Regulatory Affairs Consultant
Emergo Global Consulting
LLC 2500 Bee Cave Road Building 1
Austin, Texas 78746

Re: K250022
Trade/Device Name: HeroTracker Sense
Regulation Number: 21 CFR 868.5630
Regulation Name: Nebulizer
Regulatory Class: Class II
Product Code: CAF
Dated: January 3, 2025
Received: January 3, 2025

Dear Rachel Paul:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

Page 2

K250022 - Rachel Paul
Page 2

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).

Page 3

K250022 - Rachel Paul
Page 3

Sincerely,

John S. Bender -S
2025.06.30 12:39:13 -04'00'

for Ethan Nyberg, Ph.D.
Assistant Director
DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices
OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Submission Number (if known): K250022
Device Name: HeroTracker Sense

Indications for Use (Describe)

The HeroTracker Sense Device (HTS) is an add-on device which is attached by patients on a metered-dose inhaler (MDI).

HTS is designed to work only with the MDI and medication indicated on the HTS label.

HTS is not intended to indicate the remaining quantity of medication in an inhaler and does not include a dose counting function.

HTS is not intended to provide spirometry measurements.

HTS is intended to be used by Metered Dose Inhaler (MDI) users aged 12 years and over.

Compatible Medication - Strength and Dose Account

Ventolin 90 mcg HFA (60 count)
Advair 45 mcg / 21 mcg (120 count)
Advair 115 mcg / 21 mcg (120 count)
Advair 230 mcg / 21 mcg (120 count)
Albuterol Sulfate (Prasco) 90 mcg (200 count)
Fluticasone Propionate & Salmeterol 45 mcg / 21 mcg (120 count)
Fluticasone Propionate & Salmeterol 115 mcg / 21 mcg (120 count)
Fluticasone Propionate & Salmeterol 230 mcg / 21 mcg (120 count)
Albuterol Sulfate (Lupin) 90 mcg (200 count)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

Page 5

510(k) Summary

HeroTracker Sense (HTS)

K250022
Page 1 of 7

1. Submission Sponsor

Voluntis
58 avenue de Wagram
75017 Paris
France
Sana Charnine, Regulatory Affairs and Quality Manager, Aptar Digital Health

2. Submission Correspondent

Emergo by UL
2500 Bee Cave Road
Building 1, Suite 300
Austin, TX 78746
Office Phone: (512) 327-9997
Email: LST.US.EmergoFDASubmissions@ul.com
Contact: Rachel Paul
Title: Lead Quality and Regulatory Affairs Consultant

3. Date Prepared

30 June 2025

4. Device Identification

Trade/Proprietary Name: HeroTracker® Sense
Common/Usual Name: Nebulizer Accessory
Regulation Number(s): 868.5630
Product Code(s): CAF, Nebulizer (Direct Patient Interface)
Class: Class 2
Classification Panel: Anesthesiology

5. Legally Marketed Predicate Device(s)

Device name: Hailie® Sensor NF0110
510(k) number: K222247
Manufacturer: Adherium (NZ) Ltd

Page 6

K250022
Page 2 of 7

6. Device Description

7. Indication for Use Statement

The HeroTracker Sense Device (HTS) is an add-on device which is attached by patients on a metered-dose inhaler (MDI).

HTS is designed to work only with the MDI and medication indicated on the HTS label.

HTS is not intended to indicate the remaining quantity of medication in an inhaler and does not include a dose counting function.

HTS is not intended to provide spirometry measurements.

HTS is intended to be used by Metered Dose Inhaler (MDI) users aged 12 years and over.

Compatible Medication Strength and Dose Account

Ventolin 90 mcg HFA (60 count)
Advair 45 mcg / 21 mcg (120 count)
Advair 115 mcg / 21 mcg (120 count)
Advair 230 mcg / 21 mcg (120 count)
Albuterol Sulfate (Prasco) 90 mcg (200 count)
Fluticasone Propionate & Salmeterol 45 mcg / 21 mcg (120 count)
Fluticasone Propionate & Salmeterol 115 mcg / 21 mcg (120 count)
Fluticasone Propionate & Salmeterol 230 mcg / 21 mcg (120 count)
Albuterol Sulfate (Lupin) 90 mcg (200 count)

8. Substantial Equivalence Discussion

The following table compares the HTS to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance, and forms the basis for

Page 7

K250022
Page 3 of 7

the determination of substantial equivalence. The subject device does not raise any new questions of safety or effectiveness as compared to the predicate device.

Page 8

K250022
Page 4 of 7

Comparison of Characteristics

Attribute	Subject: HeroTracker Sense® v1.2	Predicate: Hailie® Sensor NF0110 K222247	Comparison
Product Code	CAF	CAF	Same
Regulation Number	868.5630	868.5630	Same
Intended for Use	Nebulizer accessory for recording nebulizer use and technique	Nebulizer accessory for recording nebulizer use and technique	Same
Indications for Use	The HeroTracker Sense Device (HTS) is an add-on device which is attached by patients on a metered-dose inhaler (MDI). HTS is intended for single-patient multiple use in the home environment as an electronic data capture accessory for monitoring and recording actuation, inhaler shake, inhaler orientation, inhalation coordination, and inspiratory strength and duration for prescribed inhaler usage. HTS 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 inhaler technique. HTS is designed to work only with the MDI and medication indicated on the HTS label. HTS is not intended to indicate the remaining quantity of medication in an inhaler and does not include a dose counting function. HTS is not intended to provide spirometry measurements. HTS is intended to be used by Metered Dose Inhaler (MDI) users aged 12 years and over. Compatible Medication Strength and Dose Account Ventolin 90 mcg HFA (60 count)	The 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 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 self-management. The Hailie sensor is compatible only with the following TEVA MDI inhalers: ProAir® HFA & Albuterol Sulphate HFA. The Hailie sensor is not intended to indicate the 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.	Similar; the differences do not constitute a new intended for use or bring up new questions related to safety or effectiveness.

Compatible Medication	Strength and Dose Account
Ventolin	90 mcg HFA (60 count)

Page 9

K250022
Page 5 of 7

Attribute	Subject: HeroTracker Sense® v1.2	Predicate: Hailie® Sensor NF0110 K222247	Comparison
	Advair 45 mcg / 21 mcg (120 count)
	Advair 115 mcg / 21 mcg (120 count)
	Advair 230 mcg / 21 mcg (120 count)
	Albuterol Sulfate (Prasco) 90 mcg (200 count)
	Fluticasone Propionate & Salmeterol 45 mcg / 21 mcg (120 count)
	Fluticasone Propionate & Salmeterol 115 mcg / 21 mcg (120 count)
	Fluticasone Propionate & Salmeterol 230 mcg / 21 mcg (120 count)
	Albuterol Sulfate (Lupin) 90 mcg (200 count)
Design – Attachment to Medication Dispenser	Physically attached to dispenser without inhibiting patient use	Physically attached to dispenser without inhibiting patient use	Same
Principle of Operation	Attaches to the top of the medication canister and performs wireless uploading of usage history of the inhaler	Attaches to the top of the medication canister and performs wireless uploading of usage history of the inhaler	Same
Data Collection Technology	Records date and time of MDI usage and inhaler usage technique through sensors (force, acceleration, and airflow sensors).	Records date and time of MDI usage and inhaler usage technique through sensors (optical, induction coil, motion and flow sensors).	Similar; although the kind of sensors are not fully the same, the principle of operation is still the same.
Records Usage	Yes	Yes	Same
Dose Counter	No	No	Same
Patient Data Storage with Software	Yes	Yes	Same
Patient Data Report	Yes	Yes	Same

Page 10

K250022
Page 6 of 7

Attribute	Subject: HeroTracker Sense® v1.2	Predicate: Hailie® Sensor NF0110 K222247	Comparison
Generation with Software Mobile Platforms	iOS 13 and higher version (13, 14, 15) Android 8 and higher version (8, 9, 10 11, 12).	iOS 9 and above Android 5.1 and above	Similar; both devices are available with recent versions of iOS and Android.
Required Off-the Shelf Hardware	Apple smartphones or devices with Bluetooth	Apple smartphones or devices with Bluetooth	Same
Wireless Technology Bluetooth	Bluetooth® 4.0: 2.40 - 2.48 GHz, 1.0 mW Low Energy	Bluetooth® 4.0: 2.40 - 2.48 GHz, 1.0 mW Low Energy	Same
Power Source	Lithium coin cell CR2032 non-rechargeable battery	Lithium Coin Cells Non-rechargeable Battery	Same
Battery Life / Service Life	1 year	1 year	Same
Case Material – Patient Contact by Intact Skin (Hands)	Cover: ABS Light diffuser: PC	Plastic cover	Similar; both devices are presented as a plastic external enclosure.
Electrical Safety	IEC 60601	IEC 60601	Same
Biocompatibility	ISO 10993-1	ISO 10993-1	Same
Sterility	Non-sterile	Non-sterile	Same

Page 11

K250022
Page 7 of 7

9. Non-Clinical Performance Data

To demonstrate safety and effectiveness of HTS and to show substantial equivalence to the predicate device, Voluntis completed the following non-clinical tests. Results confirm that the design inputs and performance specifications for the device are met. The HTS passed the testing in accordance with internal requirements, national standards, and international standards shown below, supporting its safety and effectiveness, and its substantial equivalence to the predicate device:

Biocompatibility evaluation per ISO 10993-1 - Materials can be considered as biocompatible.
Electrical safety testing per IEC 60601-1, IEC 60601-1-11, IEC 60601-1-6 – Passed
Electromagnetic Disturbance (EMD) testing per IEC 60601-1-2 – Passed
Software verification and validation per IEC 62304/FDA Guidance – The correct functionality for the HTS software release, for all software modules and for association with the compatible mobile app. to display the data was verified
Biocompatibility evaluation of breathing gas pathways in healthcare applications per ISO 18562-1: The biological safety of the gas pathway is supported by a risk-based evaluation and is considered adequately addressed.
Performance Testing – Device was verified to meet specifications and the correct functionality and compatibility for the HTS with the concerned MDI inhalers was verified
Service Life – Supports 1 year service life
Shelf-Life Testing – Supports 2 years shelf life
Transportation testing per ASTM 4169 – confirmed the transport has no impact on device.

10. Clinical Performance Data

No clinical data was necessary to determine the substantial equivalence of this device.

11. Statement of Substantial Equivalence

The HTS has the same intended use as the predicate device and similar technological characteristics. The differences in technological characteristics do not raise new or different questions of safety and effectiveness. Based on the results of the risk assessment and all applicable testing, the HTS is determined to perform as intended during normal anticipated usage and is at least as safe, as effective, and performs as well as or better than the legally marketed predicate device and therefore can be determined to be 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).