(186 days)
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.
Electronic Soft-Mist Inhaler (SMI) Accessory. The Propeller Sensor Model 2014-R keeps track of medication use, with a record when a soft mist inhaler 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 provided document is a 510(k) summary for the Propeller Sensor Model 2014-R, focusing on its reclassification for Over-The-Counter (OTC) use. It does not describe an AI/ML-based medical device. Therefore, the questions related to AI/ML model performance, such as acceptance criteria based on AI metrics, sample sizes for test and training sets, expert ground truth establishment, adjudication methods, or MRMC studies, are not applicable.
The document primarily addresses the substantial equivalence of the Propeller Sensor Model 2014-R for OTC use to its previously cleared prescription-use version (K142960) and another OTC predicate (K142516).
Here's a breakdown of the relevant information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document focuses on compliance with established medical device standards and the device's functional equivalence to its predicate. There isn't a table presenting specific acceptance criteria and reported device performance in the context of an AI/ML device (e.g., sensitivity, specificity, or AUC). Instead, the "performance" is demonstrated by adherence to safety and functional standards.
| Acceptance Criteria (Implied from testing) | Reported Device Performance (Summary) |
|---|---|
| Compliance to medical device standards | Complies with IEC 60601-1, IEC60601-2, IEC60601-6, IEC60601-11, ISO 10993 Biocompatibility (primary skin irritation, dermal sensitization, cytotoxicity). Additional testing to ESD levels of 10V/m was performed. |
| Functional equivalence to predicate | Validation testing (EMC, electrical, safety, mechanical durability, functional) confirms the device continues to meet specified requirements for OTC status. |
| Safety for OTC use | Hazard Analysis for OTC was identical to predicate (K142516); no new safety concerns with the proposed OTC indication were found. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. The testing described is primarily focused on engineering validation, safety, and functional equivalence, not on a data-driven performance evaluation with a "test set" in the context of AI/ML.
- Data Provenance: Not applicable for AI/ML. The device's functionality involves recording SMI usage events, but the testing described is not based on patient data in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The ground truth concept for an AI/ML test set is not relevant here as this is not an AI/ML device.
4. Adjudication method for the test set:
Not applicable. There is no mention of an adjudication method, as it doesn't apply to the type of testing described (engineering, safety, functional equivalence).
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 done. This is not an AI/ML device, and its purpose is not to assist human readers in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, a standalone algorithm performance study was not done. This is not an AI/ML device. The device itself is a physical sensor and associated software for tracking inhaler use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. Ground truth for AI/ML models is not relevant here. The "ground truth" for the device's function is simply the actual actuation of the SMI, which the sensor is designed to detect and record. The testing confirmed the sensor's ability to accurately record these events and its compliance with safety and electrical standards.
8. The sample size for the training set:
Not applicable. There is no AI/ML model described that would require a training set.
9. How the ground truth for the training set was established:
Not applicable. There is no AI/ML model described that would require a ground truth for a training set.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.
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 (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" (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 (800) 638-2041 or (301) 796-7100 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 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 Corporation634 W. Main Street, Ste. 102Madison, WI 53703 |
| Submitter andOfficial Contact: | David HubanksVP OperationsReciprocal Labs634 W. Main Street, Ste. 102Madison, WI 53703+1 (608) 251-0470+1 (608) 338-0883 (fax)david.hubanks@propellerhealth.com |
| Manufacturing Site: | Reciprocal Labs Corporation634 W. Main Street, Ste. 102Madison, WI 53703 |
| Trade Name: | Propeller Sensor Model 2014-R |
| Common Name: | Nebulizer |
| Classification Name: | NEBULIZER (DIRECT PATIENT INTERFACE) |
| ClassificationRegulation: | 21 CFR §868.5630 |
| Product Code: | CAF |
| DeviceDescription: | Electronic Soft-Mist Inhaler (SMI) Accessory |
| SubstantiallyEquivalent Devices: | K14 2960, Propeller Sensor Model 2014-R (Rx)K142516, Propeller Sensor Model 2 (OTC) |
| Intended Use: | The Propeller System includes the Propeller SensorModel 2014-R. The sensor is an accessory deviceintended for single-patient use to assist physicians andpatients in recording and monitoring the actuations ofprescribed SMI usage. |
| The Propeller Mobile Application records, stores, andtransmits usage events from Propeller Sensors, or viamanual user entry, to a remote storage system. Withthe 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 theover-the-counter indication to the previously clearedPropeller 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.
| TechnologyComparison | Predicate Device:Propeller System,Propeller SensorModel 2014-R510k Number:K142960 | Candidate Device:Propeller System,Propeller SensorModel 2014-R (OTC) |
|---|---|---|
| Design - Attachmentto MedicationDispenser | Physically attachesto SMI withoutinhibiting patientuse | Same |
| Principle ofOperation | The PropellerHealth Sensorattaches to the topof the medicationcanister andperforms wirelessuploading of usagehistory of the SMI. | Same |
| Output port andComputer Interface | Wireless uploadingto database; viewedby PC or otherInternet-capabledevice. | Same |
| Data CollectionTechnology | Records date andtime of SMI usageby monitoringactuation of the SMIvia sensors | Same |
| Mobile Platforms | • iOS versions 7or higher• Androidoperatingsystem | Same |
| Required Off theShelf Hardware | • Applesmartphones ordevices withBluetooth, iOS7 or higher• Androidsmartphones ordevices withBluetooth andoperatingsystem versionof 4.3 and upfor app• Internetcapable device;no processor ormemoryrequirements(see RequiredBrowser) | Same |
| Required Browser | Firefox, Chrome,Safari , InternetExplorer | Same |
| Mobile Application | The PropellerHealth MobileApplication records,stores, andtransmits usageevents from thePropeller HealthSensor via a featureor smart phone. Inaddition, themobile application | Same |
| can be used toreview theinformationcaptured whenusing a smartphone. | ||
| Software | The PropellerHealth WebApplication issoftware intendedto allow users toreview thecollectedinformation andcharacteristics ofSMI use, to adddetail associatedwith a recordedusage event, and toshare thatinformation withtheir physician inorder to provideadditionalinformationassociated with thecondition for whichtheir SMImedication(s) areprescribed. | Same |
| Dose Counter | No | Same |
| Records Usage | Yes | Same |
| Records Location ofUsage (GPSCoordinates) | Geographiccoordinates can becaptured by thewireless device ifpaired with asensor. | Same |
| Keyboard/InputInterface | Single buttoninterface | Same |
| Digital Display | No | Same |
| Power Source | 2 internal 3V DCLi-ion Batteries | Same |
| Battery Life | 1 Years | Same |
| Low battery indicator | Yes, lightcombination;software display ofbattery life. | Same |
| Patient Reminder | Yes | Enhanced audioremindercomponent which islouder than thepredicate. |
| Support | Yes | Same |
| Patient DataStorage withSoftware | Yes | Same |
| Patient Data ReportGeneration withSoftware | Yes | Same |
| Patient Data GraphsGeneration | Yes | Same |
| Data Retrieval fromDevice w/ Software | Yes | Same |
| Case Material -Patient Contact byIntact Skin (hands) | LexanPolycarbonate | 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 Analysisfor OTC | Hazard Analysis for OTC was identical to the predicate(K142516) included a review of existing hazards as wellas how the patient obtains and learns about the system,registers for the system, installs the sensor, uses thePropeller System to track SMI medication use, sharesdata with their physician/care team and obtains help &support with SMI labeling. No new concerns of safetywith the proposed OTC indication were found. |
|---|---|
| Clinical Testing | No clinical testing was required |
| Conclusion: | There are no new safety or effectiveness issues withclassification as an over-the-counter medical 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).