Propeller Sensor Model 2015-E

K161454 · Reciprocal Labs Corporation · CAF · Nov 1, 2016 · Anesthesiology

Device Facts

• Record ID: K161454
• Device Name: Propeller Sensor Model 2015-E
• Applicant: Reciprocal Labs Corporation
• Product Code: CAF · Anesthesiology
• Decision Date: Nov 1, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Propeller System includes the Propeller Sensor is an accessory device intended for singlepatient use to assist physicians and patients in recording and monitoring the actuations of prescribed DPI usage for the Ellipta devices. 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 DPI sensor, 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 DPI and its use, to capture other patient-reported information and outcomes, and to allow that information to be shared with their caregivers, physicians, and health care providers. When used with a prescribed DPI, 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 DPI technique. The Propeller System is intended to be used in populations from Child (>2 years) to Adult. The Propeller System can be used both indoors 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 DPI medication(s) by a participant. The output of the Propeller System is not intended to diagnosis provided by a licensed physician. The Propeller System is not intended for use as an DPI dose counter, nor is it intended to indicate the quantity of medication remaining in an DPI.

Device Story

Propeller Sensor Model 2015-E is a portable, polycarbonate accessory that clips onto Ellipta DPI mouthpiece covers. It uses infra-red (IR) sensors to passively detect and record inhalation events. Data is transmitted via Bluetooth to a mobile application or wireless gateway, then to a remote storage system. The system includes mobile and web applications for users to review usage history, symptoms, and disease management data, which can be shared with caregivers and physicians. Used in home, work, clinical, and aircraft settings. It does not diagnose, count doses, or indicate remaining medication quantity. It aids clinicians in assessing DPI technique and supports clinical trial data collection.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including software verification and validation, biocompatibility (ISO 10993), EMC (IEC 60601-1-2), electrical safety (IEC 60601-1), and wireless coexistence testing. Battery performance and particle size distribution (PSD) testing were also performed.

Technological Characteristics

Polycarbonate (Lexan) construction. Sensing via infra-red (IR) for actuation detection. Bluetooth connectivity. Powered by a single 3V DC Li-ion battery. Form factor: clip-on accessory for Ellipta DPI. Software: Moderate Concern. Standards: IEC 60601-1:2012, IEC 60601-1-2:2007, IEC 60601-1-6:2010, IEC 60601-1-11:2015, ISO 10993:2010.

Indications for Use

Indicated for patients (Child >2 years to Adult) using prescribed Ellipta dry powder inhalers (DPI) to assist in recording and monitoring medication usage.

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 Sensor Model 2014-D (K152882)

Submission Summary (Full Text)

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

November 1, 2016

Reciprocal Labs Corporation Taylor Mahan-Rudolph Regulatory & Ouality Affairs Lead 634 W. Main Street, Suite 102 Madison, Wisconsin 53703

Re: K161454

Trade/Device Name: Propeller Sensor Model 2015-E Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: September 30, 2016 Received: October 3, 2016

Dear Ms. Mahan-Rudolph:

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.

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 devicerelated 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.

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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" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

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Sincerely yours,

**Tejashri Purohit-Sheth, M.D.**

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Tina Kiang, Ph.D. 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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#### Indications for Use

510(k) Number (if known) K161454

Device Name Propeller Sensor Model 2015-E

#### Indications for Use (Describe)

The Propeller System includes the Propeller Sensor is an accessory device intended for singlepatient use to assist physicians and patients in recording and monitoring the actuations of prescribed DPI usage for the Ellipta devices.

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 DPI sensor, 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 DPI and its use, to capture other patient-reported information and outcomes, and to allow that information to be shared with their caregivers, physicians, and health care providers.

When used with a prescribed DPI, 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 DPI technique.

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

The Propeller System can be used both indoors 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 DPI medication(s) by a participant.

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

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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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### 510(k) Summary

| | Submission Date: | October 27, 2016 |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| Submitter: | Reciprocal Labs Corporation<br>634 W. Main Street, Ste. 102<br>Madison, WI 53703 | |
| Submitter and<br>Official Contact: | Taylor Mahan-Rudolph<br>Regulatory & Quality Affairs Lead<br>Reciprocal Labs<br>634 W. Main Street, Ste. 102<br>Madison, WI 53703<br>[phone]<br>[phone] (fax)<br>[e-mail] | |
| Manufacturing<br>Site: | Reciprocal Labs Corporation | |
| | 634 W. Main Street, Ste. 102<br>Madison, WI 53703 | |
| Trade Name: | Propeller System | |
| Model Name: | Propeller Sensor Model 2015-E | |
| Common Name: | Nebulizer | |
| Classification<br>Name: | NEBULIZER (DIRECT PATIENT INTERFACE) | |
| Classification<br>Regulation: | 21 CFR §868.5630 | |
| Product Code: | CAF | |
| Substantially<br>Equivalent<br>Devices | K152882 Propeller Sensor Model 2014-D | |
| Indications for<br>Use: | The Propeller System includes the Propeller Sensor Model<br>2015-E. The sensor is an accessory device intended for<br>single-patient use to assist physicians and patients in recording<br>and monitoring the actuations of prescribed DPI usage for the<br>Ellipta devices. | |

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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 DPI 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 DPI and its use, to capture other patient-reported information and outcomes, and to allow that information to be shared with their caregivers, physicians, and health care providers.

When used with a prescribed DPI, 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 DPI technique.

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 DPI 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 DPI dose counter, nor is it intended to indicate the quantity of medication remaining in an DPI.

Device Description:

Dry Power Inhaler (DPI) / Ellipta Accessory that monitors a patient's inhaler usage. The portable, polycarbonate sensor clips on top of a DPI mouthpiece cover and passively records inhalation events when the inhaler is used using infra-red (IR) sensors. The sensor then sends the event information via Bluetooth to the mobile phone or wireless gateway.

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The Propeller Sensor Model 2015-E keeps track of medication Technology Comparison: use, with a record of when the dry-powder inhaler is used. The sensor is a small device that attaches to the existing inhaler. Both the subject device and the predicate devices use technology that includes bluetooth wireless connectivity which connects to the previously cleared Propeller Health software system together with a mobile phone or wireless gateway.

> The Propeller Sensor Model 2015-E and the predicate (K152882) have similar technological characteristics. Both devices are bluetooth enabled sensors fixed to dry powder inhalers designed to detect medication use. The indications for use are similar for both devices, the only difference is the word "Diskus" which is replaced with"Ellipta". No other changes were made to the indications for use.

> Two primary differences are outlined in the technology comparison in the table below: battery and patient contact. The predicate device had two Li-ion batteries and the subject device has a single Li-ion battery. As this change for the subject device involves a lower voltage and fewer batteries, no new issues of safety and effectiveness of the device are found. The predicate device also had potential contact with breached skin (e.g. chapped lips) which is not possible with the subject device due to the location on the medication cover.

> An additional minor difference is supported mobile versions. For the Propeller system, the supported mobile versions have changed to correspond with the versions supported by the operating systems.

All other listed characteristics are identical between the subject and predicate. These changes do not impact the safety and effectiveness of the device.

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| | K152882 | |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Design -<br>Attachment to<br>Medication<br>Dispenser | Physically attaches<br>to DPI without<br>inhibiting patient<br>use | Same |
| Principle of<br>Operation | The Propeller<br>Health<br>Sensor attaches to<br>the medication<br>canister and<br>performs<br>wireless uploading<br>of<br>usage history of the<br>DPI | Same |
| Output port and<br>Computer<br>Interface | Wireless uploading<br>to<br>database; viewed by<br>PC or other<br>Internet-capable<br>device. | Same |
| Data Collection<br>Technology | Records date and<br>time of DPI usage by<br>monitoring<br>actuation<br>of the DPI via<br>sensors | Same |
| Mobile Platforms | • iOS versions 7 or<br>higher<br>• Android<br>operating system | • iOS versions 8 or<br>higher<br>• Android<br>operating system |
| Required Off the<br>Shelf Hardware | • Apple<br>smartphones or<br>devices with<br>Bluetooth, iOS 7<br>or higher<br>• Android<br>smartphones or<br>devices with | • Apple<br>smartphones or<br>devices with<br>Bluetooth, iOS 8<br>or higher<br>• Android<br>smartphones or<br>devices with |

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| | Bluetooth and<br>operating system<br>version of 4.3<br>and up for app<br>• Internet capable<br>device; no<br>processor or<br>memory<br>requirements<br>(see Required<br>Browser) | Bluetooth and<br>operating system<br>version of 4.3<br>and up for app<br>• Internet capable<br>device; no<br>processor or<br>memory<br>requirements<br>(see Required<br>Browser) |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Required<br>Browser | Firefox, Chrome,<br>Safari , Internet<br>Explorer | Same |
| Mobile<br>Application | The Propeller<br>Health<br>Mobile Application<br>records, stores, and<br>transmits usage<br>events from the<br>Propeller Health<br>Sensor via a smart<br>phone. In<br>addition, the mobile<br>application can be<br>used to review the<br>information<br>captured<br>when using a smart<br>phone | Same |
| Software | The Propeller<br>Health<br>Web Application is<br>software intended<br>to<br>allow users to<br>review<br>the collected<br>information and<br>characteristics of<br>DPI<br>use, to add detail | Same |

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| | associated with a<br>recorded usage<br>event, and to share<br>that information<br>with<br>their physician in<br>order to provide<br>additional<br>information<br>associated with the<br>condition for which<br>their DPI<br>medication(s) are<br>prescribed. | |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| Dose Counter | No | Same |
| Records Usage | Yes | Same |
| Records<br>Location of<br>Usage (GPS<br>Coordinates) | Geographic<br>coordinates can be<br>captured by the<br>wireless device if<br>paired with a<br>sensor. | Same |
| Keyboard/Input<br>Interface | Single button<br>interface | Same |
| Digital Display | No | Same |
| Power Source | 2 internal 3V DC<br>Li-ion Batteries | 1 internal 3V DC<br>Li-lon battery |
| Battery Life | 1 year | Same |
| Low Battery<br>Indicator | Yes, light<br>combination;<br>software display of<br>battery life. | Same |
| Environment | The Propeller<br>System can be used<br>both indoors and<br>outdoors;<br>home, work, and | Same |

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| | clinical settings, as<br>well as on aircraft.<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 DPI<br>medication(s) by a<br>participant. | |
|------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Patient<br>Reminder | Yes | Same |
| Support | Yes | Same |
| Patient Data<br>Storage with<br>Software | Yes | Same |
| Patient Data<br>Report<br>Generation with<br>Software | Yes | Same |
| Patient Data<br>Graphs<br>Generation | Yes | Same |
| Data Retrieval<br>from Device<br>w/Software | Yes | Same |
| Case Material -<br>Patient Contact<br>by intact skin<br>(hands) | Lexan<br>Polycarbonate | Same |
| Case Material -<br>Patient Contact<br>by breached skin<br>(lips) | Lexan<br>Polycarbonate | None |

Test Summary: Test results indicate that the Propeller Sensor Model 2015-E

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and its predicate Propeller Sensor Model 2014-D complies with predetermined specifications. Software verification and validation testing confirms this result. Software is listed as Moderate Concern, which is identical to the predicate device. Documentation was provided as recommended by the FDA's Guidance for Industry and FDA staff, "Guidance for Content of Premarket Submissions for Software Contained in Medical Devices."

Compliance to IEC 60601-1:2012, IEC 60601-1-2:2007, IEC 60601-1-6:2010, IEC 60601-1-11:2015, ISO 10993:2010 Biocompatibility (Primary Skin Irritation, Patch Dermal Sensitization, Cytotoxicity) was confirmed. EMC testing was completed with test levels applicable to home use environment as recommended in the FDA guidance "Design Considerations for Devices Intended for Home Use". Wireless coexistence testing was performed with passing results.

Bench testing included battery performance testing and particle size distribution (PSD) testing.

The above testing confirms that the device is substantially equivalent to the predicate device as the minor differences between the predicate and the subject device were shown by the above testing that the subject device meets the predetermined performance specifications as was the case with the predicate device.

- Clinical Testing No clinical testing was required
- Conclusion: The technology differences are minor between the candidate and predicate device. The overall testing confirms that the Propeller Sensor Model 2015-E is as safe and as effective as the predicate device.