Ochsner Connected Inhaler Sensor

K223367 · Ochsner Clinic Foundation · CAF · Aug 30, 2023 · Anesthesiology

Device Facts

• Record ID: K223367
• Device Name: Ochsner Connected Inhaler Sensor
• Applicant: Ochsner Clinic Foundation
• Product Code: CAF · Anesthesiology
• Decision Date: Aug 30, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended Use

The Ochsner Connected Inhaler Sensor System includes the Ochsner Connected Inhaler Sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring actuations of prescribed MDI usage. The Ochsner Connected Inhaler Sensor Mobile Application records, stores, and transmits usage events from the Sensors to a remote storage system. With the Mobile Application, the user can review information collected from the Sensors and report and review symptoms and other information about their disease management and its impact. The user may also share their information with their caregivers, physicians, and health care providers. When used with a prescribed MDL, the System can report on information captured during the normal course of use, such as the time between actuations, that can be helpful in assessing MDI technique. When used under the care of a physician with a prescribed MDI, the System can assist in the management of respiratory health symptoms and exacerbations by providing feedback through reminders, notifications, and self-management education. The System is intended to be used in populations from Child (>2 years) to adult. The System can be used both indoors and outdoors; home, work, and clinical settings, as well as on aircraft. The System may also be used in clinical trials where researchers need to know information about the use of MDI medications by a participant. The output of the System is not intended to diagnose or replace a diagnosis provided by a licensed physician. The System is not intended for use as an MDI or inhaled medication dose counter, nor is it intended to indicate the quantity of medication remaining in an MDI or inhaled medication.

Device Story

Electronic MDI accessory; attaches to inhaler canister; uses button press to detect/record MDI actuation date/time. Bluetooth Low Energy transmits data to mobile application; app stores/displays usage history, symptoms, and disease management info. Used by patients (home/work/travel) and clinicians (clinical settings/trials). Provides feedback/reminders to improve adherence/technique. Physician reviews data to assess patient status/worsening symptoms. Benefits include improved disease management and adherence.

Clinical Evidence

No clinical data. Bench testing only. Includes software verification/validation, performance testing of MDI actuation sensor, wireless/Bluetooth technology testing per FDA guidance, FCC licensing, electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and biocompatibility (ISO 10993).

Technological Characteristics

Silicon rubber enclosure; single-button interface; 3V DC Li-ion battery (1-year life). Bluetooth Low Energy connectivity. Non-sterile. Software-based data logging/transmission. Complies with IEC 60601 (safety/EMC) and ISO 10993 (biocompatibility).

Indications for Use

Indicated for patients (child >2 years to adult) using prescribed MDI to record/monitor actuation events, assist in respiratory symptom/exacerbation management via feedback/reminders, and assess MDI technique. Not for diagnosis, dose counting, or medication quantity tracking.

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.

Predicate Devices

• Propeller System Model 2 OTC (K142516)

Submission Summary (Full Text)

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August 30, 2023

Ochsner Clinic Foundation Hakm Murad Bioengineer 1514 Jefferson Hwy New Orleans, Louisiana 70121

Re: K223367

Trade/Device Name: Ochsner Connected Inhaler Sensor Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: July 10, 2023 Received: July 25, 2023

Dear Hakm Murad:

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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Ethan L. Nyberg -S

Ethan Nyberg, Ph.D. 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) K223367

Device Name Ochsner Connected Inhaler Sensor

#### Indications for Use (Describe)

The Ochsner Connected Inhaler Sensor System includes the Ochsner Connected Inhaler Sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring actuations of prescribed MDI usage.

The Ochsner Connected Inhaler Sensor Mobile Application records, stores, and transmits usage events from the Sensors to a remote storage system. With the Mobile Application, the user can review information collected from the Sensors and report and review symptoms and other information about their disease management and its impact. The user may also share their information with their caregivers, physicians, and health care providers.

When used with a prescribed MDL, the System can report on information captured during the normal course of use, such as the time between actuations, that can be helpful in assessing MDI technique.

When used under the care of a physician with a prescribed MDI, the System can assist in the management of respiratory health symptoms and exacerbations by providing feedback through reminders, notifications, and self-management education.

The System is intended to be used in populations from Child (>2 years) to adult.

The System can be used both indoors and outdoors; home, work, and clinical settings, as well as on aircraft.

The System may also be used in clinical trials where researchers need to know information about the use of MDI medications by a participant.

The output of the System is not intended to diagnose or replace a diagnosis provided by a licensed physician. The System is not intended for use as an MDI or inhaled medication dose counter, nor is it intended to indicate the quantity of medication remaining in an MDI or inhaled medication.

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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## 510(k) Summary

| Prepared Date: | 8/28/23 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Ochsner Clinic Foundation<br>1514 Jefferson Highway<br>New Orleans, LA 70121 |
| Official Contact: | Hakm Murad, Ph.D.<br>Biomedical Engineering Mgr.<br>Ochsner Clinic Foundation<br>1514 Jefferson Highway<br>New Orleans, LA 70121<br>5048427785<br>[e-mail] |
| Trade Name:<br>Common Name:<br>Classification Name:<br>Classification Regulation:<br>Product Code:<br>Device Description:<br>Predicate Device:<br>Intended Use: | Ochsner Connected Inhaler Sensor<br>Nebulizer Accessory<br>Nebulizer<br>21 CFR §868.5630<br>CAF<br>Electronic MDI Accessory<br>Propeller System Model 2 OTC K142516<br>The Ochsner Connected Inhaler Sensor System includes the Ochsner<br>Connected Inhaler Sensor. The Sensor is an accessory device intended for<br>single-patient use to assist physicians and patients in recording and<br>monitoring actuations of prescribed MDI usage.<br>The Ochsner Connected Inhaler Sensor Mobile Application records,<br>stores, and transmits usage events from the Sensors to a remote storage<br>system. With the Mobile Application, the user can review information<br>collected from the Sensors and report and review symptoms and other<br>information about their disease management and its impact. The user may<br>also share their information with their caregivers, physicians, and health<br>care providers.<br>When used with a prescribed MDI, the System can report on information<br>captured during the normal course of use, such as the time between |
| | actuations, that can be helpful in assessing MDI technique.<br>When used under the care of a physician with a prescribed MDI, the<br>System can assist in the management of respiratory health symptoms and<br>exacerbations by providing feedback through reminders, notifications,<br>and self-management education. |
| | The System is intended to be used in populations from Child (>2 years)<br>to adult. |
| | The System can be used both indoors and outdoors; home, work, and<br>clinical settings, as well as on aircraft. |
| | The System may also be used in clinical trials where researchers need to<br>know information about the use of MDI medications by a participant. |
| | The output of the System is not intended to diagnose or replace a<br>diagnosis provided by a licensed physician. The System is not intended<br>for use as an MDI or inhaled medication dose counter, nor is it intended<br>to indicate the quantity of medication remaining in an MDI or inhaled<br>medication. |
| Technology Comparison<br>and Device Description: | The subject device uses technology similar to the predicate device,<br>Propeller System Model 2 OTC, including Bluetooth wireless<br>connectivity which connects to a similar mobile application. Like the<br>predicate device, the Ochsner Connected Inhaler Sensor has an enclosure<br>to fit to inhalers and a button for detecting use. |
| | Technological characteristics of the Ochsner System and the Comparison<br>Propeller System are largely equivalent. Similarities include the<br>indications for use, basic principle of operation, data collection<br>information, time of data recording via internal clock, utilization of<br>software for varying types of data review and modification,<br>nonrechargable batteries, and the use of Bluetooth, low energy. The<br>Ochsner System employs these technological characteristics in a similar<br>way to the predicate device. |
| | By reviewing the recorded data displayed by the Ochsner System, the<br>physician or care provider can identify that a patient's state is worsening,<br>and as a result, may choose to take action, such as contacting their<br>patient. These aspects of the device have been verified and validated in<br>order to establish equivalent performance to the equivalent device. This<br>information indicates that the Ochsner System is equivalent to the<br>predicate device in terms of device safety and effectiveness. |

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# Comparison Table

| Technology Characteristics | Predicate Device: | Candidate Device: | Comparison |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| | Propeller System,<br>Propeller Sensor<br>Model 2 OTC | Ochsner Connected<br>Inhaler Sensor | N/A |
| | 510(k) Number: | 510(k) Number: | |
| | K142516 | K223367 | |
| | Prescription/OTC | OTC | |
| Indications for Use | The Propeller<br>System includes the | The Ochsner<br>Connected Inhaler | Similar: The<br>Ochsner |
| Propeller MDI | Sensor System | Connected | |
| Model 2 Sensor. The<br>sensor is an<br>accessory device<br>intended for single-<br>patient use to assist<br>physicians and<br>patients in<br>recording and<br>monitoring the<br>actuations of<br>prescribed MDI<br>usage. | includes the Ochsner<br>Connected Inhaler<br>Sensor. The Sensor<br>is an accessory<br>device intended for<br>single-patient use to<br>assist physicians and<br>patients in recording<br>and monitoring<br>actuations of<br>prescribed MDI<br>usage. | Inhaler | |
| | | System does<br>not include a<br>Web<br>Application.<br>The<br>functionalities<br>of the web<br>application<br>are contained<br>entirely within<br>the Ochsner | |
| | | Connected | |
| The Propeller<br>Mobile Application<br>records, stores, and<br>transmits usage | The Ochsner<br>Connected Inhaler<br>Sensor Mobile<br>Application records,<br>stores, and transmits | Inhaler | |
| | | Mobile | |
| events from<br>Propeller Sensors,<br>or via manual user<br>entry, to a remote<br>storage system.<br>With the Propeller<br>Mobile Application<br>the user can review<br>information<br>collected from the<br>MDI sensor, and<br>report and review<br>symptoms and<br>other information<br>about their disease<br>management and its<br>impact. The user<br>may also share their<br>information with<br>their caregivers,<br>physician, and<br>healthcare<br>providers. | usage events from<br>the Sensors to a<br>remote storage<br>system. With the<br>Mobile Application,<br>the user can review<br>information<br>collected from the<br>Sensors and report<br>and review<br>symptoms and other<br>information about<br>their disease<br>management and its<br>impact. The user<br>may also share their<br>information with<br>their caregivers,<br>physicians, and<br>health care<br>providers.<br>When used with a<br>prescribed MDI, the<br>System can report on<br>information captured | Application<br>since mobile<br>application is<br>necessary for<br>device use. It<br>was<br>determined<br>that there<br>would be no<br>increase in<br>risk for users<br>from this<br>change.<br>Otherwise the<br>IFUs for both<br>products<br>contain the<br>same purpose<br>for the<br>devices,<br>patient<br>populations,<br>and use<br>environments. | |
| The Propeller Web<br>Application is<br>software that, like | during the normal | | |

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| the Propeller<br>Mobile Application,<br>is intended to allow<br>users to review the<br>collected<br>information and<br>characteristics of<br>their MDI and its<br>use, to capture<br>other patient-<br>reported<br>information and<br>outcomes, and to<br>allow that<br>information to be<br>shared with their<br>caregivers,<br>physicians, and<br>health care<br>providers. | course of use, such<br>as the time between<br>actuations, that can<br>be helpful in<br>assessing MDI<br>technique.<br><br>When used under the<br>care of a physician<br>with a prescribed<br>MDI, the System can<br>assist in the<br>management of<br>respiratory health<br>symptoms and<br>exacerbations by<br>providing feedback<br>through reminders,<br>notifications, and<br>self-management<br>education. |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| When together with<br>a prescribed MDI,<br>the system can<br>report on<br>information<br>captured during the<br>normal course of<br>use, such as the<br>time between<br>actuations that can<br>be helpful in<br>assessing MDI<br>technique. | The System is<br>intended to be used<br>in populations from<br>Child (>2 years) to<br>adult.<br><br>The System can be<br>used both indoors<br>and outdoors; home,<br>work, and clinical<br>settings, as well as<br>on aircraft. |
| When together with<br>a prescribed MDI,<br>the system can be<br>used to reduce the<br>frequency of<br>respiratory health<br>symptoms and<br>exacerbations by<br>increasing<br>adherence to MDI | The System may<br>also be used in<br>clinical trials where<br>researchers need to<br>know information<br>about the use of MDI<br>medications by a<br>participant.<br><br>The output of the<br>System is not |
| medications<br>through the use of<br>feedback such as<br>reminders and<br>notifications, and<br>self-management<br>education.<br><br>The Propeller<br>System is intended<br>to be used in<br>populations from<br>Child (>2 years) to<br>Adult.<br><br>The Propeller<br>System can be used<br>both indoors and<br>outdoors; home,<br>work, and clinical<br>settings, as well as<br>on aircraft.<br><br>The Propeller<br>System may also be<br>used in clinical<br>trials where<br>researchers need to<br>know information<br>about the use of<br>MDI medication(s)<br>by a participant.<br><br>The output of the<br>Propeller System is<br>not intended to<br>diagnose or replace<br>a diagnosis<br>provided by a<br>licensed physician.<br>The Propeller<br>System is not<br>intended for use as<br>an MDI dose<br>counter, nor is it<br>intended to indicate | intended to diagnose<br>or replace a<br>diagnosis provided<br>by a licensed<br>physician. The<br>System is not<br>intended for use as<br>an MDI or inhaled<br>medication dose<br>counter, nor is it<br>intended to indicate<br>the quantity of<br>medication<br>remaining in an MDI<br>or inhaled<br>medication. |

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| | the quantity of<br>medication<br>remaining in an<br>MDI or inhaled<br>medication. | | |
|--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | |
| Design - Attachment to<br>Medication Dispenser | Physically attached<br>to dispenser without<br>inhibiting patient use | Physically attached<br>to dispenser without<br>inhibiting patient use | Equivalent |
| Principle of Operation | Attaches to the top of<br>the medication<br>canister and performs<br>wireless uploading of<br>usage history of the<br>inhaler | Attaches to the top<br>of the medication<br>canister and<br>performs wireless<br>uploading of usage<br>history of the inhaler | Equivalent |
| Output Port and Computer<br>Interface | Wireless uploading<br>to database; viewed<br>by PC or other<br>internet-capable<br>devices | N/A | Different: The<br>candidate<br>device is not<br>web-based |
| Data Collection Technology | Records date and<br>time of MDI usage<br>with button press<br>switch | Records date and<br>time of MDI usage<br>with button press<br>switch | Equivalent |
| Mobile Platforms | iOS version 7 or<br>higher<br>Android operating<br>system version 4.3 or<br>higher | iOS version 14 or<br>higher<br>Android operating<br>system version 11 or<br>higher | Different: The<br>candidate<br>device<br>supports more<br>recent<br>versions of<br>mobile<br>platforms |
| Required Off-the-Shelf<br>Hardware | Apple smartphones<br>or devices with<br>Bluetooth, iOS 7 or<br>higher<br>Android smartphones<br>or devices with<br>Bluetooth<br>Internet capable<br>device; no processor<br>or memory | Apple smartphones<br>or devices with<br>Bluetooth, iOS 14 or<br>higher<br>Android<br>smartphones or<br>devices with<br>Bluetooth, version<br>11 or higher | Similar: The<br>candidate<br>device only<br>works on<br>mobile and<br>thus only<br>requires apple<br>and android<br>hardware. |
| | requirements (see Required Browser) | | |
| Required Browser | Firefox, Chrome, Safari, Internet Explorer | N/A | Different: The candidate device is not web-based |
| Mobile Application | Propeller Health Mobile Application records, stores, and transmits usage events from the Propeller Health Sensor via a feature or smartphone and can be used to review the information captured when using a smartphone | Ochsner Connected Inhaler Sensor Mobile Application records, stores, and transmits usage events from the Ochsner Connected Inhaler Sensor via a feature or smartphone and can be used to review the information captured when using a smartphone | Equivalent |
| Software | The Propeller Health Web Application is software intended to allow users to review the collected information and characteristics of MDI use, to add detail associated with a recorded usage event, and to share that information with their physician in order to provide additional information associated with the condition for which their MDI medication(s) are prescribed. | N/A, not web based. But the mobile application allows the user to share information with their provider and add other details related to their condition for which their MDI medication(s) are prescribed. | Different: The candidate device is not web based. But its mobile application allows the user to share information with their provider and add other details related to their condition for which their MDI medication(s) are prescribed. |
| Dose Counter | No | No | Equivalent |
| Records Usage | Yes | Yes | Equivalent |
| Records Location of Usage (GPS Coordinates) | Geographic coordinates can be | Geographic coordinates can be | Equivalent |
| | wireless device if<br>paired with a Sensor | wireless device if<br>paired with a Sensor | |
| | | | |
| Keyboard/Input Interface | Dual button<br>interface: primary<br>button and secondary<br>button | Single button<br>interface | Similar: The<br>candidate<br>device also<br>uses buttons<br>as input, but<br>only 1. |
| Digital Display | No | No | Equivalent |
| Power Source | Single 3V DC Li-ion<br>battery | Single 3V DC Li-ion<br>battery | Equivalent |
| Battery Life | 1.5 years | 1 year | Similar |
| Low Battery Indicator | Yes, light<br>combination;<br>software display of<br>battery life | Software displays<br>battery life, no on<br>device indicator | Similar:<br>Candidate<br>device only<br>uses software<br>to display<br>battery, while<br>the predicate<br>also has a<br>light-based<br>indicator |
| Patient Reminder | Yes | Yes | Equivalent |
| Support | Yes | Yes | Equivalent |
| Patient Data Storage with<br>Software | Yes | Yes | Equivalent |
| Patient Data Report<br>Generation with Software | Yes | Yes | Equivalent |
| Patient Data Graphs<br>Generation | Yes | Yes | Equivalent |
| Data Retrieval from Device<br>with Software | Yes | Yes | Equivalent |
| Case Material - Patient<br>Contact by Intact Skin<br>(Hands) | Lexan polycarbonate | Silicon Rubber | Different: The<br>candidate<br>device uses a<br>different but<br>also<br>biocompatible<br>case material |
| Electrical Safety | IEC 60601 | IEC 60601 | Equivalent |
| Biocompatibility | ISO 10993 | ISO 10993 | Equivalent |
| Sterility | Non sterile | Non sterile…