PROPELLER SYSTEM - MODEL 2

K140638 · Reciprocal Labs Corporation · CAF · May 2, 2014 · Anesthesiology

Device Facts

• Record ID: K140638
• Device Name: PROPELLER SYSTEM - MODEL 2
• Applicant: Reciprocal Labs Corporation
• Product Code: CAF · Anesthesiology
• Decision Date: May 2, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The Propeller System includes the Propeller MDI Model 2 Sensor. The sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed MDI usage. The Propeller Mobile Application records, stores, and transmits usage events from Propeller Sensors, or via manual user entry, to a remote storage system. With the Propeller Mobile Application the user can review information collected from the MDI sensor, 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, physician and healthcare providers. The Propeller Web Application is software that, like the Propeller Mobile Application, is intended to allow users to review the collected information and characteristics of their MDI and its use, to capture other patientreported information and outcomes, and to allow that information to be shared with their caregivers, physicians and health care providers. When used under the care of a physician with a prescribed MDI, 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 be used to reduce the frequency of respiratory health symptoms and exacerbations by increasing adherence to MDI medications through the use of feedback such as reminders and notifications, and self-management education. The Propeller System is intended to be used in populations from Child (>2 years) to adult. The Propeller system can be used both indoors and outdoors: home. work and clinical settings, as well as on aircraft. The Propeller System may also be used in clinical trials where researchers need to know information about the use of MDI medication(s) by a participant. The output of the Propeller System is not intended to diagnose or replace a diagnosis provided by a licensed physician. The Propeller System is not intended for use as an MDI dose counter. nor is it intended to indicate the quantity of medication remaining in an MDI.

Device Story

Propeller System consists of MDI Model 2 Sensor, mobile app, and web app; sensor attaches to MDI to detect/log actuation events; data transmitted via Bluetooth Low Energy to mobile app; app syncs data to remote storage; users/physicians review usage patterns, symptoms, and technique (time between puffs) via web/mobile interfaces; system provides reminders/notifications to improve medication adherence; used in home, work, clinical, or aircraft settings; intended to assist in disease management; output supports clinical decision-making regarding patient status; not for diagnosis or dose counting.

Clinical Evidence

Bench testing only. Included software verification/validation, MDI actuation sensor logging accuracy, wireless/Bluetooth performance per FDA guidance, FCC licensing, and electrical safety/EMC per IEC 60601 series. Biocompatibility testing performed per ISO 10993 series. No clinical trial data presented.

Technological Characteristics

Electronic MDI accessory; Bluetooth Low Energy connectivity; internal power source (non-rechargeable); software-based data logging and analysis; compliant with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), and ISO 10993 (biocompatibility).

Indications for Use

Indicated for patients aged >2 years to adult using prescribed MDI for respiratory conditions. Used to record/monitor MDI actuations, assess technique, and improve adherence to reduce symptoms/exacerbations. Not for use as a dose counter or to indicate remaining medication quantity.

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

• Asthmapolis (K121609)

Submission Summary (Full Text)

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**MAY 0 2 2014**

K140638

# 510(k) Summary

| Submission Date: | April 16, 2014 | |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Submitter: | Reciprocal Labs Corporation<br>634 W. Main Street, Ste. 201<br>Madison, WI 53703 | |
| Submitter and<br>Official Contact: | Ms. Inger L. Couture<br>Chief Regulatory & Privacy Officer<br>Reciprocal Labs<br>634 W. Main Street, Ste. 102<br>Madison, WI 53703<br>[phone]<br>[phone] (fax)<br>[e-mail] | |
| Manufacturing Site: | Reciprocal Labs Corporation<br>634 W. Main Street, Ste. 102<br>Madison, WI 53703 | |
| Trade Name: | Propeller System | |
| Common Name: | Nebulizer | |
| Classification<br>Name: | NEBULIZER (DIRECT PATIENT INTERFACE) | |
| Classification<br>Regulation: | 21 CFR §868.5630 | |
| Product Code: | CAF | |
| Device Description: | Electronic MDI Accessory | |
| Substantially<br>Equivalent Devices: | Asthmapolis | K121609 |

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Intended Use:

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The Propeller System includes the Propeller MDI Model 2 Sensor. The sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed MDI usage.

The Propeller Mobile Application records, stores, and transmits usage events from Propeller Sensors, or via manual user entry, to a remote storage system. With the Propeller Mobile Application the user can review information collected from the MDI sensor, 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, physician and healthcare providers.

The Propeller Web Application is software that, like the Propeller Mobile Application, is intended to allow users to review the collected information and characteristics of their MDI and its use, to capture other patientreported information and outcomes, and to allow that information to be shared with their caregivers, physicians and health care providers.

When used under the care of a physician with a prescribed MDI, 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 be used to reduce the frequency of respiratory health symptoms and exacerbations by increasing adherence to MDI medications through the use of feedback such as reminders and notifications, and self-management education.

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

The Propeller system can be used both indoors and outdoors: home. work and clinical settings, as well as on aircraft.

The Propeller System may also be used in clinical trials where researchers need to know information about the use of MDI medication(s) by a participant. The output of the Propeller System is not intended to diagnose or replace a diagnosis provided by a licensed physician.

The Propeller System is not intended for use as an MDI dose counter. nor is it intended to indicate the quantity of medication remaining in an MDI.

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Technology Comparison: Technological characteristics of the Propeller System and the Asthmapolis System are largely equivalent. Similarities include the indications for use, basic principle of operation, data collection information, time of data recording via internal clock, utilization of software for varying types of data review and modification, dose counting characteristics and internal power source type.

The Propeller System employs these technological characteristics in a similar way as the predicate device.

Differences include power management: the Model 2 Sensor is not rechargeable; the method used to send the usage data from the sensor to the mobile device is Bluetooth, low energy. Expanded indications for use include software feature additions such as display of time between individual actuations of the MDI Propeller Sensor that can be used to assess technique (defined as the time between inhalations, or "puffs"). This was recorded previously, but not displayed, and a greater focus than previously labeled to include use of the system to reduce the frequency of symptoms and exacerbations through review of data recorded by the patient, and the data recorded by the patient's Propeller Sensor. By reviewing the recorded data displayed by the Propeller System, the physician or care provider can identify that a patient's state is worsening, and as a result, may choose to take action, such as contacting their patient. These aspects of the device have been verified and validated in order to establish equivalent performance to the equivalent device. This information indicates that the Propeller System is equivalent to the predicate device in terms of device safety and effectiveness.

Based upon this comparison of the predicate, and the accompanying testing results for the Propeller System, the Propeller System is substantially equivalent to the predicate device.

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| Performance<br>Testing Summary: | Non-clinical testing has been carried out to cover functional verification<br>and device performance. This included completion of software<br>verification and validation procedures, with performance testing of the<br>MDI actuation sensor system to ensure data is logged accurately for<br>MDI usage. This established correct functionality of the Propeller .<br>System according to the requirements.<br><br>Third party testing of the Propeller System for compliance to IEC<br>60601 series standards for general safety and electromagnetic<br>compatibility and ISO 10993 series standards for biocompatibility was<br>completed by accredited laboratories prior to this submission. Cleaning<br>instructions were validated by an accredited lab and testing in the<br>applicable environments for wireless interference were completed.<br>Complete, detailed reports are included in the application for<br>clearance; summary information is included below where differences<br>between the two devices use non-clinical test data to support equal<br>safety and efficacy. |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Software: | Software and Firmware for the Propeller System was designed and<br>developed according to a robust software development process<br>aligned with "Design Control Guidance for Medical Device<br>Manufacturers", "The Guidance for the Content of Premarket<br>Submissions for Software Contained in Medical Devices", "Guidance<br>for Off the Shelf Software Use in Medical Devices", and verified and<br>validated using guidance from the "General Principles of Software<br>Validation" as recommended by FDA.<br><br>Test results indicate that the Propeller System complies with its<br>predetermined specifications. |
| Electrical Safety: | The Propeller Sensor has successfully completed patient safety testing<br>according to IEC 60601-1. |
| Electromagnetic<br>Compatibility<br>Testing: | The Propeller Sensor has successfully completed EMC testing<br>according to IEC 60601-1-2. |
| Performance<br>Testing - Bench: | The Propeller System has successfully completed performance testing<br>according to applicable standards and internal testing. Important to<br>highlight in this summary, is the successful performance testing that<br>was completed for wireless/Bluetooth technology in accordance with<br>specifications and also with, "FDA's Guidance on Radio-Frequency<br>Wireless Technology in Medical Devices". In addition, tests required for<br>FCC licensing were successful. |

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Conclusion:

Hardware testing carried out for the Propeller System indicates it meets design and performance functional requirements. Software verification demonstrates that device features are effective, and that the system configuration functions equivalently to the predicate device. The Propeller System also meets standard requirements for electrical safety, electromagnetic compatibility, biocompatibility, cleaning validation, and wireless technology in medical devices.

Based upon this comparison of the predicate, and the accompanying testing results for the Propeller System, the Propeller System is substantially equivalent to the predicate device.

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a person embracing or protecting another person, with flowing lines suggesting movement or support.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 2, 2014

Reciprocal Labs Corporation c/o Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th St. NW Buffalo, MN 55313

Re: K140638

Trade/Device Name: Propeller System Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer (Direct Patient Interface) Regulatory Class: Class II Product Code: CAF Dated: April 17, 2014 Received: April 18, 2014

Dear Mr. Job:

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. 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.

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### Page 2 - Mr. Job

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Tokskri Purchit-Shath, Sh.O Cinical Denuty Director DAGRID/ODE/CDRII

Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

#### 510(k) Number (if known) K140638

#### Device Name Propeller System

Indications for Use (Describe)

The Propeller System includes the Propeller MDI Model 2 Sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed MDI usage.

The Propeller Mobile Application records, stores, and transmits usage events from Propeller Sensors, or via manual user entry, to a remote storage system. With the Propeller Mobile Application the user can review information collected from the MDI sensor, and review symploms and other information about their disease management and its impact. The user may also share their information with their caregivers, physician and healthcare providers.

The Propeller Web Application is software that, like the Propeller Mobile Application, is intended to allow users to review the collected information and characteristics of their MDI and its use, to caplure other patient-reported information and outcomes, and to allow that information to be shared with their caregivers, physicians and health care providers.

When used under the care of a physician with a prescribed MDI, the system can report on information caplured during the normal course of use, such as the lime between actualions that can be helpful in assessing MDI technique. When used under the care of a physician will a prescribed MDI, the system can be used to reduce the frequency of respiratory health symploms and exacerbations by increasing adherence to MDI medications through the use of feedback such as reminders and notifications, and self-management education.

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

The Propeller system can be used both indoors and ouldoors; home, work and clinical settings, as well as on aircraft.

The Propeller System may also be used in clinical trials where researchers need to know information about the use of MDI medication(s) by a participant. The Propeller System is not inlended to diagnose or replace a diaonosis provided by a licensed physician. The Propeller System is not intended for use as an MDI dose counter, nor is it intended to indicate the quantity of medication remaining in an MDI.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ | Over-The-Counter Use (21 CFR 801 Subpart C)

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

| FOR FDA USE ONLY |
|------------------------------------------------------------------------------|
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) |

| | Anya C. Harry -S |
|--|------------------|
| | 2014.05.02 |
| | 14:29:36 -04'00' |

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