Propeller Model 2014-D Sensor

K143671 · Reciprocal Labs · CAF · Jun 19, 2015 · Anesthesiology

Device Facts

• Record ID: K143671
• Device Name: Propeller Model 2014-D Sensor
• Applicant: Reciprocal Labs
• Product Code: CAF · Anesthesiology
• Decision Date: Jun 19, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Propeller System includes the Propeller Model 2014-D 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 Diskus 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 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 under the care of a physician 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. When used under the care of a physician with a prescribed DPI, the system can be used to reduce the frequency of respiratory health symptoms and exacerbations by increasing adherence to DPI 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; 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 Story

Propeller Model 2014-D Sensor is a wearable accessory for Diskus Dry Powder Inhalers (DPI). Device encases medication canister; uses internal sensors to detect and record date/time of DPI actuations. Data transmitted via Bluetooth to mobile/web applications for storage and review by patients, caregivers, and physicians. System provides reminders, notifications, and self-management education to improve medication adherence and reduce respiratory symptoms. Used in home, work, clinical settings, or aircraft. Healthcare providers use output to assess DPI technique and disease management. Does not diagnose; not a dose counter.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including ISO 10993 biocompatibility, IEC 60601 electrical safety, wireless coexistence, and mechanical performance testing (insertion/removal force).

Technological Characteristics

Lexan Polycarbonate construction; Bluetooth wireless connectivity; 2 internal 3V DC Li-ion batteries; sensor-based actuation detection; mobile/web application interface. Complies with IEC 60601-1, 60601-2, 60601-6, 60601-11, and ISO 10993.

Indications for Use

Indicated for patients (Child >2 years to Adult) prescribed a Diskus Dry Powder Inhaler (DPI) to assist in recording/monitoring medication actuations, improving adherence, and managing respiratory symptoms/exacerbations.

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 (K140638)

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

June 19, 2015

Reciprocal Labs Corporation David Hubanks VP Operations 634 W. Main Street, Suite 102 Madison, WI 53703

Re: K143671

Trade/Device Name: Propeller Sensor Model 2014-D Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: May 20, 2015 Received: May 21, 2015

Dear Mr. Hubanks:

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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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 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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

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

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

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#### Indications for Use

510(k) Number (if known) K143671

Device Name Propeller Model 2014-D Sensor

#### Indications for Use (Describe)

The Propeller System includes the Propeller Model 2014-D 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 Diskus 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 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 under the care of a physician 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.

When used under the care of a physician with a prescribed DPI, the system can be used to reduce the frequency of respiratory health symptoms and exacerbations by increasing adherence to DPI 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; 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.

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.

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# 510(k) Summary

| Submission Date: | June 17, 2015 |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Reciprocal Labs Corporation<br>634 W. Main Street, Ste. 102<br>Madison, WI 53703 |
| Submitter and<br>Official Contact: | David Hubanks<br>VP Operations<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 Model 2014-D Sensor |
| Model Name: | Propeller Model 2014-D Sensor |
| Common Name: | Nebulizer |
| Classification<br>Name: | NEBULIZER (DIRECT PATIENT INTERFACE) |
| Classification<br>Regulation: | 21 CFR §868.5630 |
| Product Code: | CAF |
| Device<br>Description: | Dry Powder Inhaler (DPI) / Diskus Accessory |
| Substantially<br>Equivalent<br>Devices: | Propeller System K140638 |
| Intended Use: | The Propeller System includes the Propeller Model 2014-D<br>Sensor. The sensor is an accessory device intended for<br>single-patient use to assist physicians and patients in recording |
| | K143671 Section 5.1 Page 1 of 7 |

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and monitoring the actuations of prescribed DPI usage for the Diskus 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 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 under the care of a physician 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.

When used under the care of a physician with a prescribed DPI, the system can be used to reduce the frequency of respiratory health symptoms and exacerbations by increasing adherence to DPI 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 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.

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Technology Comparison and Device Description:

The subject device uses technology similar to the predicate device including Bluetooth wireless connectivity which connects to the same previously cleared Propeller Health software system together with a mobile phone or wireless gateway. The Sensor Model 2014-D is different from the Sensor Model 2 in that it contains enclosure size differences required to install on the DPI inhaler and electronic sensors to detect Propeller Sensor 2014-D use rather than a button which was used in the predicate device.

| Technology<br>Comparison | Predicate Device:<br>Propeller System,<br>Propeller Sensor<br>Model 2<br>510k Number:<br>K140638 | Candidate Device:<br>Propeller System,<br>Propeller Sensor<br>Model 2014-D |
|---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design - Attachment<br>to Medication<br>Dispenser | Same | Physically attaches<br>to dispenser<br>without inhibiting<br>patient use |
| Principle of<br>Operation | The Propeller Health<br>Sensor attaches to<br>the top of the<br>medication canister<br>and performs wireless<br>uploading of usage<br>history of the MDI. | The Propeller<br>Health Sensor<br>securely encases<br>the medication<br>canister and<br>performs wireless<br>uploading of Diskus<br>usage history. |
| Output port and<br>Computer Interface | Wireless uploading 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 MDI usage<br>with button press<br>switch. | Records date and<br>time of DPI usage<br>by monitoring<br>actuation of the DPI<br>via sensors |
| Mobile Platforms | ● iOS versions 7<br>or higher | Same |
| | | |
| | Android operating system | |
| Required Off the<br>Shelf Hardware | Apple smartphones or devices with Bluetooth, iOS 7 or higher Android smartphones or devices with Bluetooth and operating system version of 4.3 and up for app Internet capable device; no processor or memory requirements (see Required Browser) | Same |
| Required Browser | Firefox, Chrome,<br>Safari , Internet<br>Explorer | Same |
| Mobile Application | The Propeller Health<br>Mobile Application<br>records, stores, and<br>transmits usage<br>events from the<br>Propeller Health<br>Sensor via a feature<br>or smart phone. In<br>addition, the mobile<br>application can be<br>used to review the<br>information captured | Same |
| | when using a smart<br>phone. | |
| Software | The Propeller Health<br>Web Application is<br>software intended to<br>allow users to review<br>the collected<br>information and<br>characteristics of MDI<br>use, to add detail<br>associated with a<br>recorded usage<br>event, and to share<br>that information with<br>their physician in<br>order to provide<br>additional<br>information<br>associated with the<br>condition for which<br>their MDI<br>medication(s) are<br>prescribed. | The Propeller<br>Health Web<br>Application is<br>software intended<br>to allow users to<br>review the<br>collected<br>information and<br>characteristics of<br>Diskus use, to add<br>detail associated<br>with a recorded<br>usage event, and to<br>share that<br>information with<br>their physician in<br>order to provide<br>additional<br>information<br>associated with the<br>condition for which<br>their Diskus<br>medication(s) are<br>prescribed. |
| Dose Counter | No | Same |
| Records Usage | Yes | Same |
| Records Location of<br>Usage (GPS<br>Coordinates) | Geographic<br>coordinates can be<br>captured by the<br>wireless device if<br>paired with a sensor. | Same |
| Keyboard/Input<br>Interface | Dual button<br>Interface: Primary<br>button and secondary<br>button. | Single button<br>interface |
| Digital Display | No | Same |
| Power Source | Single 3V DC Li-ion<br>Battery | 2 internal 3V DC<br>Li-ion Batteries |
| Battery Life | 1.5 Years | 1 year |
| Low battery indicator | Yes, light combination;<br>software display of<br>battery life. | Same |
| Patient Reminder | Yes | Same |
| Support | Yes | Same |
| Patient Data Storage with Software | Yes | Same |
| Patient Data Report Generation with Software | Yes | Same |
| Patient Data Graphs Generation | Yes | Same |
| Data Retrieval from Device w/ Software | Yes | Same |
| Case Material - Patient Contact by Intact Skin (hands) | Lexan Polycarbonate | Same |
| Case Material - Patient Contact by breached skin (lips) | N/A | Lexan<br>Polycarbonate |

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Test Summary: Test results indicate that the Propeller Sensor Model 2014-D and its predicate Propeller System Model 2 complies with predetermined specifications. Software verification and validation testing confirms this result.

> Compliance to IEC 60601-1, IEC60601-2, IEC60601-6, IEC60601-11, ISO 10993 Biocompatibility (primary skin irritation, dermal sensitization, ISO Agarose Overlay, ISO Guinea Pig Maximization Sensitization, ISO MEM Elution, ISO Intracutaneous Irritation, ISO MEM Elutiion Post-Cleaning ) was confirmed.

> Bench testing included air-flow and PSD Safety Assessment using Electrostatic Measurements and analysis of Electric Fields from the sensor on the Diskus medication. Insertion-removal measurements were performed to insure the device meets the performance specification for insertion and removal force and

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does not damage the Diskus device or label. Co-existence testing to confirm in-home wireless compatibility.

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 and validation through testing has demonstrated no impact to safety or effectiveness. The overall testing confirms that the Propeller Sensor Model 2014-D is as safe and effective and performs as well as the predicate device.