Propeller Sensor Model 2014-R

K152482 · Reciprocal Labs · CAF · Mar 4, 2016 · Anesthesiology

Device Facts

• Record ID: K152482
• Device Name: Propeller Sensor Model 2014-R
• Applicant: Reciprocal Labs
• Product Code: CAF · Anesthesiology
• Decision Date: Mar 4, 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 Model 2014-R. The sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed SMI 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 SMI 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 SMI 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 SMI, 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 SMI 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 SMI 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 SMI dose counter, nor is it intended to indicate the quantity of medication remaining in an SMI.

Device Story

Propeller Sensor Model 2014-R is an electronic accessory for Soft-Mist Inhalers (SMI). Device attaches to the top of an SMI canister; records date/time of inhaler actuations via internal sensors. Data is transmitted via Bluetooth to a mobile application or wireless gateway, then to a remote storage system. Users review usage history, symptoms, and disease management data via mobile or web applications; information can be shared with caregivers and physicians. Used in home, work, clinical, and aircraft settings by patients or clinical trial participants. Provides insights into SMI technique (e.g., time between actuations) to support clinical decision-making. Does not count doses or measure remaining medication. Powered by two 3V Li-ion batteries.

Clinical Evidence

No clinical data. Bench testing only. Compliance confirmed for IEC 60601-1, IEC 60601-2, IEC 60601-6, IEC 60601-11, and ISO 10993 (biocompatibility). ESD testing performed to 10V/m.

Technological Characteristics

Lexan Polycarbonate case; Bluetooth wireless connectivity; 2 internal 3V Li-ion batteries (1-year life). Dimensions/form factor: attaches to SMI top. Standards: IEC 60601-1, IEC 60601-2, IEC 60601-6, IEC 60601-11, ISO 10993. Connectivity: Bluetooth to mobile/gateway, then cloud/web. Software: Mobile/Web application for data review/reporting.

Indications for Use

Indicated for patients from Child (>2 years) to Adult to assist in recording and monitoring actuations of prescribed Soft-Mist Inhaler (SMI) usage. Not intended to diagnose, replace physician diagnosis, act as a dose counter, or 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

• Propeller Sensor Model 2014-R (K142960)
• Propeller Sensor Model 2 (K142516)

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

March 4, 2016

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

Re: k152482

Trade/Device Name: Propeller Sensor Model 2014-R Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: February 2, 2016 Received: February 3, 2016

Dear David 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.

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

Erin I. Keith M.S. 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) K152482

Device Name Propeller Sensor Model 2014-R

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

| 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: | November 10, 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 Site: | Reciprocal Labs Corporation<br>634 W. Main Street, Ste. 102<br>Madison, WI 53703 |
| Trade Name: | Propeller Sensor Model 2014-R |
| Common Name: | Nebulizer |
| Classification Name: | NEBULIZER (DIRECT PATIENT INTERFACE) |
| Classification<br>Regulation: | 21 CFR §868.5630 |
| Product Code: | CAF |
| Device<br>Description: | Electronic Soft-Mist Inhaler (SMI) Accessory |
| Substantially<br>Equivalent Devices: | K14 2960, Propeller Sensor Model 2014-R (Rx)<br>K142516, Propeller Sensor Model 2 (OTC) |
| Intended Use: | The Propeller System includes the Propeller Sensor<br>Model 2014-R. The sensor is an accessory device<br>intended for single-patient use to assist physicians and<br>patients in recording and monitoring the actuations of<br>prescribed SMI usage. |
| | The Propeller Mobile Application records, stores, and<br>transmits usage events from Propeller Sensors, or via<br>manual user entry, to a remote storage system. With<br>the Propeller Mobile Application the user can review |

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information collected from the SMI 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 SMI 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 SMI, 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 SMI 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 SMI 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 SMI dose counter, nor is it intended to indicate the quantity of medication remaining in an SMI.

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| Note: | This 510k is for expanded indications for use adding the<br>over-the-counter indication to the previously cleared<br>Propeller Sensor Model 2014-R (K142960). |
|-------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|

Technology The Propeller Sensor Model 2014-R keeps track of Comparison and medication use, with a record when a soft mist inhaler Device Description: is used. The sensor is a small device that attaches to the top an existing inhaler. Both the subject device and the predicate device use technology that includes bluetooth wireless connectivity which connects to the same previously cleared Propeller Health software system together with a mobile phone or wireless gateway.

> The Propeller Sensor Model 2014-R is identical to the predicate (K142960), and therefore there are no technology differences.

| Technology<br>Comparison | Predicate Device:<br>Propeller System,<br>Propeller Sensor<br>Model 2014-R<br>510k Number:<br>K142960 | Candidate Device:<br>Propeller System,<br>Propeller Sensor<br>Model 2014-R (OTC) |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Design - Attachment<br>to Medication<br>Dispenser | Physically attaches<br>to SMI without<br>inhibiting patient<br>use | Same |
| Principle of<br>Operation | The Propeller<br>Health Sensor<br>attaches to the top<br>of the medication<br>canister and<br>performs wireless<br>uploading of usage<br>history of the SMI. | Same |
| Output port and<br>Computer Interface | Wireless uploading<br>to database; viewed<br>by PC or other<br>Internet-capable<br>device. | Same |
| Data Collection<br>Technology | Records date and<br>time of SMI usage<br>by monitoring<br>actuation of the SMI<br>via sensors | Same |
| Mobile Platforms | • iOS versions 7<br>or higher<br>• Android<br>operating<br>system | Same |
| Required Off the<br>Shelf Hardware | • Apple<br>smartphones or<br>devices with<br>Bluetooth, iOS<br>7 or higher<br>• Android<br>smartphones or<br>devices with<br>Bluetooth and<br>operating<br>system version<br>of 4.3 and up<br>for app<br>• Internet<br>capable device;<br>no processor or<br>memory<br>requirements<br>(see Required<br>Browser) | Same |
| Required Browser | Firefox, Chrome,<br>Safari , Internet<br>Explorer | Same |
| Mobile Application | The Propeller<br>Health Mobile<br>Application records,<br>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<br>mobile application | Same |
| | can be used to<br>review the<br>information<br>captured when<br>using a smart<br>phone. | |
| Software | 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>SMI 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 SMI<br>medication(s) are<br>prescribed. | Same |
| 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<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 | Same |
| | | |
| Battery Life | 1 Years | Same |
| Low battery indicator | Yes, light<br>combination;<br>software display of<br>battery life. | Same |
| Patient Reminder | Yes | Enhanced audio<br>reminder<br>component which is<br>louder than the<br>predicate. |
| Support | Yes | Same |
| Patient Data<br>Storage with<br>Software | Yes | Same |
| Patient Data Report<br>Generation with<br>Software | Yes | Same |
| Patient Data Graphs<br>Generation | Yes | Same |
| Data Retrieval from<br>Device w/ Software | Yes | Same |
| Case Material -<br>Patient Contact by<br>Intact Skin (hands) | Lexan<br>Polycarbonate | Same |

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Test Summary: Test results indicate that the Propeller Sensor Model 2014-R and its predicate Propeller Sensor Model 2014-R complies with predetermined specifications.

> Compliance to IEC 60601-1, IEC60601-2, IEC60601-6, IEC60601-11, ISO 10993 Biocompatibility (primary skin irritation, dermal sensitization, cytotoxicity) was confirmed. Additional testing to ESD levels of 10V/m was performed to ensure safety in a home health environment.

- Validation testing including EMC, electrical, safety, Validation Testing mechanical durability, and functional testing has been for OTC completed and confirms that the device continues to meet the specified requirements for the change from "Prescription Use" to "OTC" status.

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| Hazard Analysis<br>for OTC | Hazard Analysis for OTC was identical to the predicate<br>(K142516) included a review of existing hazards as well<br>as how the patient obtains and learns about the system,<br>registers for the system, installs the sensor, uses the<br>Propeller System to track SMI medication use, shares<br>data with their physician/care team and obtains help &<br>support with SMI labeling. No new concerns of safety<br>with the proposed OTC indication were found. |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical Testing | No clinical testing was required |
| Conclusion: | There are no new safety or effectiveness issues with<br>classification as an over-the-counter medical device. |