Propeller Sensor for Symbicort

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. March 26, 2020 Reciprocal Labs Corporation Greg Dunkelberger Regulatory Affairs Project Manager 1 S. Pinckney St. Suite 610 Madison, Wisconsin 53703 Re: K192724 Trade/Device Name: Propeller Sensor for Symbicort Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: February 27, 2020 Received: February 28, 2020 #### Dear Greg Dunkelberger: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, James J. Lee Ph.D. Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K192724 Device Name Propeller Sensor Model 2018-S #### Indications for Use (Describe) The Propeller System includes the Propeller Sensor Model 2018-S. The sensor is an accessory device intended for singlepatient use to assist physicians and patients in recording and monitoring the actuations of prescribed pMDI usage for the Symbicort device. 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 pMDI 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 pMDI 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 pMDI, 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 pMDI 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 pMDI 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 pMDI dose counter, nor is it intended to indicate the quantity of medication remaining in an pMDI. Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> | |----------------------------------------------|----------------------------| | Over-The-Counter Use (21 CFR 801 Subpart C) | <div> <span></span> </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. {3}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ #### 510(k) Summary | Submission Date: | February 24, 2020 | |------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | Reciprocal Labs Corporation<br>1 S. Pinckney St., Ste. 610<br>Madison, WI 53703 | | Submitter and<br>Official Contact: | Greg Dunkelberger<br>Regulatory Affairs Project Manager<br>Reciprocal Labs Corporation<br>1 S. Pinckney St., Ste. 610<br>Madison, WI 53703<br>+1 (608) 251-0470<br>+1 (844) 411-7475 (fax)<br>greg.dunkelberger@propellerhealth.com | | Manufacturing<br>Site: | Reciprocal Labs Corporation<br>1 S. Pinckney St., Ste. 610<br>Madison, WI 53703 | | Trade Name: | Propeller System | | Model Name: | Propeller Sensor Model 2018-S | | Common Name: | Nebulizer | | Classification<br>Name: | NEBULIZER (DIRECT PATIENT INTERFACE) | | Classification<br>Regulation: | 21 CFR §868.5630 | | Product Code: | CAF | | Device<br>Description: | Pressurized Metered Dose Inhaler (pMDI) / Symbicort Accessory<br>that monitors inhaler usage. The portable sensor mounts to the<br>back of the pMDI and records inhalation events when the inhaler<br>is used. | Section 5.1 Page 1 of 7 {5}------------------------------------------------ | Substantially Equivalent Devices: | K180770 Propeller Sensor Model 2017-B | |-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications For Use: | The Propeller System includes the Propeller Sensor Model 2018-S. The sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed pMDI usage for the Symbicort device. | | | 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 pMDI 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 pMDI 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 pMDI, 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 pMDI 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 pMDI 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 pMDI dose | Section 5.1 Page {6}------------------------------------------------ counter, nor is it intended to indicate the quantity of medication remaining in an pMDI. Technology The Propeller Sensor Model 2018-S keeps track of medication Comparison: use, with a record of when the pressurized metered dose 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 2018-S and the predicate (K180770) have the same technological characteristics, both devices are bluetooth enabled sensors fixed to inhalers designed to detect medication use. The changes below only reflect a change to support the Symbicort form factor. | Technology<br>Characteristic | Predicate Device:<br>Propeller System,<br>Propeller Sensor<br>Model 2017-B<br>510k Number:<br>K180770 | Candidate Device:<br>Propeller System,<br>Propeller Sensor<br>Model 2018-S<br>510k Number:<br>K192724 | |-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Design -<br>Attachment to<br>Medication<br>Dispenser | Physically attaches<br>to DPI without<br>inhibiting patient<br>use | Physically attaches<br>to pMDI without<br>inhibiting patient<br>use | | Principle of<br>Operation | The Propeller Health<br>Sensor attaches to<br>the medication<br>canister and<br>performs wireless<br>uploading of usage<br>history of the DPI | The Propeller Health Sensor<br>attaches to<br>the medication<br>canister and<br>performs wireless<br>uploading of usage<br>history of the pMDI | | 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 | Records date and<br>time of pMDI usage<br>by monitoring<br>actuation of the<br>pMDI via sensors | | Mobile Platforms | • iOS versions 10<br>or higher<br>• Android<br>operating system | • iOS versions 11<br>or higher<br>• Android<br>operating system | | Required Off the<br>Shelf Hardware | • Apple<br>smartphones or<br>devices with<br>Bluetooth, iOS 10<br>or higher<br>• Android<br>smartphones or<br>devices with<br>Bluetooth and<br>operating system<br>version of 4.4<br>and up for app<br>• Internet capable<br>device; no<br>processor or<br>memory<br>requirements<br>(see Required<br>Browser) | • Apple<br>smartphones or<br>devices with<br>Bluetooth, iOS 11<br>or higher<br>• Android<br>smartphones or<br>devices with<br>Bluetooth and<br>operating system<br>version of 5.0<br>and up for app<br>• Internet capable<br>device; no<br>processor or<br>memory<br>requirements<br>(see Required<br>Browser) | | Required | Firefox, Chrome, | Same | | Browser | Safari , Internet<br>Explorer | | | Mobile<br>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 smartphone. In<br>addition, the mobile<br>application can be<br>used to review the<br>Information<br>captured when using<br>a smartphone | Same | | Software | The Propeller Health<br>Web Application is<br>software intended<br>to allow users to<br>review the collected<br>information and<br>characteristics of<br>DPI 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 DPI<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>pMDI 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 pMDI<br>medication(s) are<br>prescribed. | | Dose Counter | No | Same | | Records Usage | Yes | Same | | Records Location<br>of 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 | 1 internal 3V DC<br>Li-ion Battery | Same | | Battery Life | 1 year | Same | | Low Battery<br>Indicator | Yes, light<br>combination;<br>software display of<br>battery life. | Same | | 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 | Section 5.1 Page 3 of 7 {7}------------------------------------------------ {8}------------------------------------------------ Section 5.1 Page 5 of 7 {9}------------------------------------------------ Section 5.1 Page 6 of 7 {10}------------------------------------------------ | Data Retrieval<br>from Device<br>w/Software | Yes | Same | |-----------------------------------------------------------------|---------------------|---------------------------| | Case Material -<br>Patient Contact<br>by intact skin<br>(hands) | Lexan Polycarbonate | Makrolon<br>Polycarbonate | Test Summary: Test results indicate that the Propeller Sensor Model 2018-S and its predicate Propeller Sensor Model 2017-B complies with predetermined specifications. Software verification and validation testing confirms this result. > Compliance to IEC 60601-1, IEC 60601-2, IEC 60601-6, IEC 60601-11, ISO 10993-5, and ISO 10993-10 was confirmed. Bench testing included battery performance testing, usability testing, and electrostatic discharge testing (to verify the device does not affect particle size distribution of the medication). - 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 2018-S is substantially equivalent to the predicate device.