(51 days)
The Propeller System includes the Propeller MDI Model 2 Sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed MDI 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 MDI sensor, and review symploms 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 MDI and its use, to caplure 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 MDI, the system can report on information caplured during the normal course of use, such as the lime between actualions that can be helpful in assessing MDI technique. When used under the care of a physician will a prescribed MDI, the system can be used to reduce the frequency of respiratory health symploms and exacerbations by increasing adherence to MDI 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 ouldoors; 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 MDI medication(s) by a participant. The Propeller System is not inlended to diagnose or replace a diaonosis provided by a licensed physician. The Propeller System is not intended for use as an MDI dose counter, nor is it intended to indicate the quantity of medication remaining in an MDI.
Electronic MDI Accessory
Here's an analysis of the Propeller System based on the provided 510(k) summary, structured to address your specific questions.
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary for the Propeller System (K140638) does not explicitly present a table of "acceptance criteria" with quantitative targets or thresholds for its performance. Instead, it focuses on demonstrating that the device functions as intended and is substantially equivalent to a predicate device (Asthmapolis, K121609) through various verification and validation tests. The reported device performance is largely described in terms of successful completion of these tests and compliance with relevant standards.
| Acceptance Criterion (Implicit/Derived) | Reported Device Performance |
|---|---|
| Functional Verification & Data Logging Accuracy | "MDI actuation sensor system to ensure data is logged accurately for MDI usage." "established correct functionality of the Propeller System according to the requirements." |
| Software Verification & Validation | "complies with its predetermined specifications." |
| Electrical Safety (Compliance with IEC 60601-1) | "successfully completed patient safety testing according to IEC 60601-1." |
| Electromagnetic Compatibility (EMC) (Compliance with IEC 60601-1-2) | "successfully completed EMC testing according to IEC 60601-1-2." |
| Biocompatibility (Compliance with ISO 10993 series) | "completed by accredited laboratories prior to this submission." (Implies successful completion) |
| Wireless/Bluetooth Technology Performance | "successful performance testing that was completed for wireless/Bluetooth technology in accordance with specifications and also with, 'FDA's Guidance on Radio-Frequency Wireless Technology in Medical Devices'." "tests required for FCC licensing were successful." |
| Cleaning Instructions Validation | "validated by an accredited lab." |
| Equivalence in Features (e.g., display of time between actuations) | "These aspects of the device have been verified and validated in order to establish equivalent performance to the equivalent device." (Referring to expanded indications that include displaying time between actuations and focusing on symptom/exacerbation reduction through data review.) |
2. Sample Size Used for the Test Set and Data Provenance
The summary does not specify a sample size for a "test set" or data provenance in the context of clinical performance data comparing human readers with and without the device, or studies involving a test set of patient data. The testing described is primarily non-clinical, focusing on device functionality, safety, and compliance with standards. It mentions "functional verification and device performance" and "performance testing of the MDI actuation sensor system to ensure data is logged accurately for MDI usage," but these are general descriptions of bench testing rather than studies involving patient data or a defined test set with associated sample size and provenance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the 510(k) summary. Given that the testing detailed is primarily non-clinical and focused on device functionality, there is no mention of "experts" establishing ground truth for a test set in a medical diagnostic or interpretive context.
4. Adjudication Method for the Test Set
This information is not provided in the 510(k) summary. As there's no mention of a test set involving medical interpretations, there's no adjudication method described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human performance with and without AI (or device) assistance in the provided 510(k) summary. The device's purpose is to record and monitor MDI usage, provide feedback, and aid in adherence and self-management, not to assist human readers in interpreting medical images or data diagnostically.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The summary describes the core functionality of the device as standalone in its data collection and transmission aspects: "The Propeller Mobile Application records, stores, and transmits usage events from Propeller Sensors..." and the "MDI actuation sensor system to ensure data is logged accurately for MDI usage." This implies that the sensor and associated software perform their function (recording actuations) without direct human intervention in the moment of data capture. However, the system's intended use is described as assisting physicians and patients, and empowering users to review and share information, implying a human-in-the-loop for interpretation and action based on the data. The testing primarily verifies the accuracy of this standalone data collection.
7. The Type of Ground Truth Used
For the functional verification of the MDI actuation sensor system, the ground truth would have been established through known, controlled MDI actuations performed during bench testing. For example, actuating an MDI a specific number of times and then verifying that the Propeller System accurately recorded that exact number. For compliance with standards (IEC, ISO, FCC), the "ground truth" is adherence to the technical specifications and requirements defined by those standards.
8. The Sample Size for the Training Set
The summary does not specify a sample size for a training set. The Propeller System is primarily a data capture and feedback system, not a device that relies on complex machine learning models trained on large datasets in the way an AI diagnostic tool would. Its functionality is based on sensors and software logic.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set for a machine learning model, the concept of establishing ground truth for a training set is not applicable in the context of the information provided for this device. The "training" for such a system would involve software development and engineering processes, with verification against design specifications and functional requirements.
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MAY 0 2 2014
510(k) Summary
| Submission Date: | April 16, 2014 | |
|---|---|---|
| Submitter: | Reciprocal Labs Corporation634 W. Main Street, Ste. 201Madison, WI 53703 | |
| Submitter andOfficial Contact: | Ms. Inger L. CoutureChief Regulatory & Privacy OfficerReciprocal Labs634 W. Main Street, Ste. 102Madison, WI 53703+1 (608) 251-0470+1 (608) 338-0883 (fax)Inger.Couture@propellerhealth.com | |
| Manufacturing Site: | Reciprocal Labs Corporation634 W. Main Street, Ste. 102Madison, WI 53703 | |
| Trade Name: | Propeller System | |
| Common Name: | Nebulizer | |
| ClassificationName: | NEBULIZER (DIRECT PATIENT INTERFACE) | |
| ClassificationRegulation: | 21 CFR §868.5630 | |
| Product Code: | CAF | |
| Device Description: | Electronic MDI Accessory | |
| SubstantiallyEquivalent Devices: | Asthmapolis | K121609 |
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Intended Use:
0
The Propeller System includes the Propeller MDI Model 2 Sensor. The sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed MDI 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 MDI 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 MDI and its use, to capture other patientreported 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 MDI, 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 MDI technique.
When used under the care of a physician with a prescribed MDI, the system can be used to reduce the frequency of respiratory health symptoms and exacerbations by increasing adherence to MDI 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 MDI 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 MDI dose counter. nor is it intended to indicate the quantity of medication remaining in an MDI.
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Technology Comparison: Technological characteristics of the Propeller System and the Asthmapolis System are largely equivalent. Similarities include the indications for use, basic principle of operation, data collection information, time of data recording via internal clock, utilization of software for varying types of data review and modification, dose counting characteristics and internal power source type.
The Propeller System employs these technological characteristics in a similar way as the predicate device.
Differences include power management: the Model 2 Sensor is not rechargeable; the method used to send the usage data from the sensor to the mobile device is Bluetooth, low energy. Expanded indications for use include software feature additions such as display of time between individual actuations of the MDI Propeller Sensor that can be used to assess technique (defined as the time between inhalations, or "puffs"). This was recorded previously, but not displayed, and a greater focus than previously labeled to include use of the system to reduce the frequency of symptoms and exacerbations through review of data recorded by the patient, and the data recorded by the patient's Propeller Sensor. By reviewing the recorded data displayed by the Propeller System, the physician or care provider can identify that a patient's state is worsening, and as a result, may choose to take action, such as contacting their patient. These aspects of the device have been verified and validated in order to establish equivalent performance to the equivalent device. This information indicates that the Propeller System is equivalent to the predicate device in terms of device safety and effectiveness.
Based upon this comparison of the predicate, and the accompanying testing results for the Propeller System, the Propeller System is substantially equivalent to the predicate device.
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| PerformanceTesting Summary: | Non-clinical testing has been carried out to cover functional verificationand device performance. This included completion of softwareverification and validation procedures, with performance testing of theMDI actuation sensor system to ensure data is logged accurately forMDI usage. This established correct functionality of the Propeller .System according to the requirements.Third party testing of the Propeller System for compliance to IEC60601 series standards for general safety and electromagneticcompatibility and ISO 10993 series standards for biocompatibility wascompleted by accredited laboratories prior to this submission. Cleaninginstructions were validated by an accredited lab and testing in theapplicable environments for wireless interference were completed.Complete, detailed reports are included in the application forclearance; summary information is included below where differencesbetween the two devices use non-clinical test data to support equalsafety and efficacy. |
|---|---|
| Software: | Software and Firmware for the Propeller System was designed anddeveloped according to a robust software development processaligned with "Design Control Guidance for Medical DeviceManufacturers", "The Guidance for the Content of PremarketSubmissions for Software Contained in Medical Devices", "Guidancefor Off the Shelf Software Use in Medical Devices", and verified andvalidated using guidance from the "General Principles of SoftwareValidation" as recommended by FDA.Test results indicate that the Propeller System complies with itspredetermined specifications. |
| Electrical Safety: | The Propeller Sensor has successfully completed patient safety testingaccording to IEC 60601-1. |
| ElectromagneticCompatibilityTesting: | The Propeller Sensor has successfully completed EMC testingaccording to IEC 60601-1-2. |
| PerformanceTesting - Bench: | The Propeller System has successfully completed performance testingaccording to applicable standards and internal testing. Important tohighlight in this summary, is the successful performance testing thatwas completed for wireless/Bluetooth technology in accordance withspecifications and also with, "FDA's Guidance on Radio-FrequencyWireless Technology in Medical Devices". In addition, tests required forFCC licensing were successful. |
:
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Conclusion:
Hardware testing carried out for the Propeller System indicates it meets design and performance functional requirements. Software verification demonstrates that device features are effective, and that the system configuration functions equivalently to the predicate device. The Propeller System also meets standard requirements for electrical safety, electromagnetic compatibility, biocompatibility, cleaning validation, and wireless technology in medical devices.
Based upon this comparison of the predicate, and the accompanying testing results for the Propeller System, the Propeller System is substantially equivalent to the predicate device.
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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a person embracing or protecting another person, with flowing lines suggesting movement or support.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 2, 2014
Reciprocal Labs Corporation c/o Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th St. NW Buffalo, MN 55313
Re: K140638
Trade/Device Name: Propeller System Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer (Direct Patient Interface) Regulatory Class: Class II Product Code: CAF Dated: April 17, 2014 Received: April 18, 2014
Dear Mr. Job:
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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Page 2 - Mr. Job
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); 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 (800) 638-2041 or (301) 796-7100 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" (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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Tokskri Purchit-Shath, Sh.O Cinical Denuty Director DAGRID/ODE/CDRII
Erin I. Keith, M.S. Acting 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K140638
Device Name Propeller System
Indications for Use (Describe)
The Propeller System includes the Propeller MDI Model 2 Sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed MDI 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 MDI sensor, and review symploms 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 MDI and its use, to caplure 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 MDI, the system can report on information caplured during the normal course of use, such as the lime between actualions that can be helpful in assessing MDI technique. When used under the care of a physician will a prescribed MDI, the system can be used to reduce the frequency of respiratory health symploms and exacerbations by increasing adherence to MDI 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 ouldoors; 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 MDI medication(s) by a participant. The Propeller System is not inlended to diagnose or replace a diaonosis provided by a licensed physician. The Propeller System is not intended for use as an MDI dose counter, nor is it intended to indicate the quantity of medication remaining in an MDI.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ | Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
| FOR FDA USE ONLY |
|---|
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) |
| Anya C. Harry -S | |
|---|---|
| 2014.05.02 | |
| 14:29:36 -04'00' |
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§ 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).