(181 days)
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.
Pressurized Metered Dose Inhaler (pMDI) / Symbicort Accessory that monitors inhaler usage. The portable sensor mounts to the back of the pMDI and records inhalation events when the inhaler is used.
This document is a 510(k) Premarket Notification from the FDA regarding the "Propeller Sensor for Symbicort" (Model 2018-S). It asserts that the device is substantially equivalent to a previously cleared predicate device (Propeller Sensor Model 2017-B).
Based on the provided text, the device in question is a sensor that attaches to a Pressurized Metered Dose Inhaler (pMDI) to record and monitor its usage. The main purpose of the testing described here is to demonstrate that the new model (2018-S) is substantially equivalent to the previous model (2017-B), especially regarding its ability to detect and record inhaler actuations, and its safety.
Here's an analysis based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or a direct performance table for features like accuracy of actuation detection. Instead, it relies on demonstrating substantial equivalence to a predicate device. The "Test Summary" statement, "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," acts as the overall conclusion of meeting the implicit criteria of functioning similarly and safely to the predicate.
The primary comparison is regarding technological characteristics and their sameness between the new device and the predicate. The table on page 6-7 serves as the direct "comparison" showing where the devices are similar or identical.
Here's how we can infer the "acceptance criteria" and "performance" from this document:
| Feature/Criterion (Inferred) | Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|---|
| Functionality | Device effectively records and monitors actuations of prescribed pMDI usage, similar to the predicate. | "Records date and time of pMDI usage by monitoring actuation of the pMDI via sensors." Functionally "Same" as predicate. |
| Attachment Mechanism | Physically attaches to pMDI without inhibiting patient use, similar to how the predicate attached to DPI. | "Physically attaches to pMDI without inhibiting patient use." |
| Principle of Operation | Uses wireless uploading of usage history, similar to the predicate. | "Performs wireless uploading of usage history of the pMDI." Functionally "Same" as predicate. |
| Output Port/Interface | Wireless uploading to database; viewed by PC or other Internet-capable device, similar to the predicate. | "Wireless uploading to database; viewed by PC or other Internet-capable device." "Same" as predicate. |
| Software Functionality | Mobile and Web applications allow review of collected information and characteristics of pMDI use, consistent with the predicate's software. | Mobile Application: "records, stores, and transmits usage events." Web Application: "allows users to review collected information." Both are "Same" as predicate's software functionality. |
| Safety - Electrical | Compliance with IEC 60601-1, IEC 60601-2, IEC 60601-6, IEC 60601-11. | "Compliance to IEC 60601-1, IEC 60601-2, IEC 60601-6, IEC 60601-11, ISO 10993-5, and ISO 10993-10 was confirmed." |
| Safety - Biocompatibility | Compliance with ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation/sensitization). | "Compliance to... ISO 10993-5, and ISO 10993-10 was confirmed." |
| Safety - Mechanical/Use | Usability testing successful; device does not affect particle size distribution of medication. | "Usability testing" and "electrostatic discharge testing (to verify the device does not affect particle size distribution of the medication)" were performed. Results implicit in "complies with predetermined specifications." |
| Battery Performance | Battery life and low battery indicator function as expected. | "Battery performance testing" was performed. Results implicit in "complies with predetermined specifications." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a sample size for any specific "test set" or the number of devices or uses tested. It generally refers to "bench testing."
- Data Provenance: Not explicitly stated, but given it's a submission to the FDA for a medical device company in Madison, WI, the testing would typically be conducted by the manufacturer, which is usually in the U.S. or through their contract labs. The document does not indicate if data was retrospective or prospective in the sense of clinical study data, as no clinical testing was required or performed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This submission focuses on engineering and performance testing to demonstrate substantial equivalence, not on establishing a "medical ground truth" from experts interpreting diagnostic data (like radiology images). The device's function is to record actuation events, not to interpret complex medical data.
4. Adjudication Method for the Test Set
- Not applicable. As there's no interpretation of complex data by multiple readers necessitating adjudication, this method is not relevant to the type of testing described (bench testing, software verification/validation, electrical safety).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. An MRMC study was not conducted. The document explicitly states: "Clinical Testing: No clinical testing was required." The device is intended as an accessory to record pMDI usage, not to provide diagnostic interpretations that would assist human readers in an MRMC setting.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, in essence. The testing described (bench testing, software verification/validation) is a form of standalone performance evaluation of the device's ability to detect and record inhaler actuations, and its software's ability to process and display that data accurately. The core function of the device (detecting actuation) is an algorithmic function performed by the sensor. The reported "Test Summary" and "Conclusion" indicate this standalone performance meets "predetermined specifications" and is "substantially equivalent" to the predicate.
7. The Type of Ground Truth Used
- For the core function of detecting pMDI actuations: The "ground truth" would be the actual physical actuation events of the pMDI during bench testing. This would be established by direct observation or synchronized, validated measurement techniques during the testing process. The device's recorded actuation event would be compared against the actual event occurring.
- For compliance with standards (IEC, ISO): The ground truth is the specified requirements within those engineering and safety standards. The device's performance is measured against these established quantitative and qualitative criteria.
8. The Sample Size for the Training Set
- Not applicable. This device is a sensor that records physical events and transmits data. It's not described as an AI/ML algorithm that requires a "training set" in the conventional sense of machine learning for classification or prediction tasks based on complex data (e.g., image analysis). The "algorithms" would be embedded logic for event detection and data processing, which are validated through standard software V&V and bench testing.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. (See point 8).
In summary, this 510(k) submission establishes substantial equivalence primarily through comparing the new device's engineering specifications and performance (demonstrated through bench testing and compliance with recognized standards) to a previously cleared predicate device. It avoids significant clinical studies or complex AI/ML "training/ground truth" methodologies because its function is a relatively straightforward data acquisition task rather than a diagnostic interpretation or predictive AI model.
{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) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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 Corporation1 S. Pinckney St., Ste. 610Madison, WI 53703 |
| Submitter andOfficial Contact: | Greg DunkelbergerRegulatory Affairs Project ManagerReciprocal Labs Corporation1 S. Pinckney St., Ste. 610Madison, WI 53703+1 (608) 251-0470+1 (844) 411-7475 (fax)greg.dunkelberger@propellerhealth.com |
| ManufacturingSite: | Reciprocal Labs Corporation1 S. Pinckney St., Ste. 610Madison, WI 53703 |
| Trade Name: | Propeller System |
| Model Name: | Propeller Sensor Model 2018-S |
| Common Name: | Nebulizer |
| ClassificationName: | NEBULIZER (DIRECT PATIENT INTERFACE) |
| ClassificationRegulation: | 21 CFR §868.5630 |
| Product Code: | CAF |
| DeviceDescription: | Pressurized Metered Dose Inhaler (pMDI) / Symbicort Accessorythat monitors inhaler usage. The portable sensor mounts to theback of the pMDI and records inhalation events when the inhaleris 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.
| TechnologyCharacteristic | Predicate Device:Propeller System,Propeller SensorModel 2017-B510k Number:K180770 | Candidate Device:Propeller System,Propeller SensorModel 2018-S510k Number:K192724 |
|---|---|---|
| Design -Attachment toMedicationDispenser | Physically attachesto DPI withoutinhibiting patientuse | Physically attachesto pMDI withoutinhibiting patientuse |
| Principle ofOperation | The Propeller HealthSensor attaches tothe medicationcanister andperforms wirelessuploading of usagehistory of the DPI | The Propeller Health Sensorattaches tothe medicationcanister andperforms wirelessuploading of usagehistory of the pMDI |
| Output port andComputerInterface | Wireless uploadingtodatabase; viewed byPC or otherInternet-capabledevice. | Same |
| Data CollectionTechnology | Records date andtime of DPI usage bymonitoringactuationof the DPI viasensors | Records date andtime of pMDI usageby monitoringactuation of thepMDI via sensors |
| Mobile Platforms | • iOS versions 10or higher• Androidoperating system | • iOS versions 11or higher• Androidoperating system |
| Required Off theShelf Hardware | • Applesmartphones ordevices withBluetooth, iOS 10or higher• Androidsmartphones ordevices withBluetooth andoperating systemversion of 4.4and up for app• Internet capabledevice; noprocessor ormemoryrequirements(see RequiredBrowser) | • Applesmartphones ordevices withBluetooth, iOS 11or higher• Androidsmartphones ordevices withBluetooth andoperating systemversion of 5.0and up for app• Internet capabledevice; noprocessor ormemoryrequirements(see RequiredBrowser) |
| Required | Firefox, Chrome, | Same |
| Browser | Safari , InternetExplorer | |
| MobileApplication | The Propeller HealthMobile Applicationrecords, stores, andtransmits usageevents from thePropeller HealthSensor via a featureor smartphone. Inaddition, the mobileapplication can beused to review theInformationcaptured when usinga smartphone | Same |
| Software | The Propeller HealthWeb Application issoftware intendedto allow users toreview the collectedinformation andcharacteristics ofDPI use, to adddetail associatedwith a recordedusage event, and toshare thatinformation withtheir physician inorder to provideadditionalinformationassociated with thecondition for whichtheir DPImedication(s) areprescribed. | The PropellerHealth WebApplication issoftware intendedto allow users toreview thecollectedinformation andcharacteristics ofpMDI use, to adddetail associatedwith a recordedusage event, and toshare thatinformation withtheir physician inorder to provideadditionalinformationassociated with thecondition for whichtheir pMDImedication(s) areprescribed. |
| Dose Counter | No | Same |
| Records Usage | Yes | Same |
| Records Locationof Usage (GPSCoordinates) | Geographiccoordinates can becaptured by thewireless device ifpaired with asensor. | Same |
| Keyboard/InputInterface | Single buttoninterface | Same |
| Digital Display | No | Same |
| Power Source | 1 internal 3V DCLi-ion Battery | Same |
| Battery Life | 1 year | Same |
| Low BatteryIndicator | Yes, lightcombination;software display ofbattery life. | Same |
| PatientReminder | Yes | Same |
| Support | Yes | Same |
| Patient DataStorage withSoftware | Yes | Same |
| Patient DataReportGeneration withSoftware | Yes | Same |
| Patient DataGraphsGeneration | 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 Retrievalfrom Devicew/Software | Yes | Same |
|---|---|---|
| Case Material -Patient Contactby intact skin(hands) | Lexan Polycarbonate | MakrolonPolycarbonate |
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.
§ 868.5630 Nebulizer.
(a)
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.(b)
Classification. Class II (performance standards).