Propeller System 2014-R

K142960 · Reciprocal Labs · CAF · Mar 5, 2015 · Anesthesiology

Device Facts

• Record ID: K142960
• Device Name: Propeller System 2014-R
• Applicant: Reciprocal Labs
• Product Code: CAF · Anesthesiology
• Decision Date: Mar 5, 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 SMI Model 2014-R 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 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 under the care of a physician 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 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 System Model 2014-R is an electronic accessory for Soft-Mist Inhalers (SMI); attaches to inhaler to monitor usage. Device uses electronic sensors to detect SMI actuations; replaces button-based detection used in predicate. Data transmitted via Bluetooth to mobile application or wireless gateway; stored in remote system. Used by patients in home, work, clinical settings, or aircraft; also used in clinical trials. Mobile and web applications allow patients to review usage, report symptoms, and share data with caregivers/physicians. System provides insights on time between actuations to assist in assessing inhaler technique. Not intended for diagnosis, dose counting, or indicating remaining medication quantity.

Clinical Evidence

No clinical testing was required. Substantial equivalence supported by bench testing, including EMC, electrical, safety, mechanical durability, and software verification and validation.

Technological Characteristics

Electronic SMI accessory; uses electronic sensors for actuation detection; Bluetooth wireless connectivity; connects to mobile phone or wireless gateway; software-based data management; single-patient use.

Indications for Use

Indicated for patients aged >2 years to adult using prescribed Soft-Mist Inhalers (SMI) to assist in recording and monitoring medication usage events.

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

March 5, 2015

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

Re: K142960

Trade/Device Name: Propeller System Model 2014-R Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer (Direct Patient Interface) Regulatory Class: Class II Product Code: CAF Dated: February 10, 2015 Received: February 11, 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.

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

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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.

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

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

*Tejashri Purohit-Sheth, M.D.*

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

Erin 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) K142960

Device Name Propeller Sensor Model 2014-R

#### Indications for Use (Describe)

The Propeller System includes the Propeller SMI Model 2014-R 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 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 under the care of a physician 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 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)

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

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## 510(k) Premarket Notification Reciprocal Labs Corporation Propeller Sensor Model 2014-R

# 510(k) Summary

| Submission Date: | September 26, 2014 |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Reciprocal Labs Corporation<br>634 W. Main Street, Ste. 201<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 System |
| Model Name: | Sensor Model 2014-R |
| Common Name: | Nebulizer |
| Classification<br>Name: | NEBULIZER (DIRECT PATIENT INTERFACE) |
| Classification<br>Regulation: | 21 CFR §868.5630 |
| Product Code: | CAF |
| Device Description: | Electronic Soft-Mist Inhaler (SMI) Accessory |
| Substantially<br>Equivalent Devices: | Propeller System K140638 |
| Intended Use: | The Propeller System includes the Propeller SMI Model<br>2014-R Sensor. The sensor is an accessory device intended<br>for single-patient use to assist physicians and patients in<br>recording and monitoring the actuations of prescribed SMI<br>usage. |

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### 510(k) Premarket Notification Reciprocal Labs Corporation Propeller Sensor Model 2014-R

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 under the care of a physician 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.

Technology The subject device uses technology similar to the predicate Comparison: device including Bluetooth wireless connectivity which connects to the same previously cleared Propeller Health software system together with a mobile phone or wireless

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### 510(k) Premarket Notification Reciprocal Labs Corporation Propeller Sensor Model 2014-R

| | gateway. The Sensor Model 2014-R is different from the<br>Sensor Model 2 in that it contains enclosure size differences<br>required to install on the SMI inhaler and electronic sensors<br>to detect Propeller Sensor 2014-R use rather than a button<br>which was used in the predicate device. |
|------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Test Summary: | Test results indicate that the Propeller Sensor Model 2014-R<br>and its predicate Propeller System Model 2 complies with<br>predetermined specifications. Completed EMC, electrical,<br>safety, mechanical durability, software verification and<br>validation testing confirms this result. |
| Clinical Testing | No clinical testing was required |
| Conclusion: | The technology differences are minor and validation through<br>testing has demonstrated the subject device is as safe and<br>effective as the predicate device. |