(131 days)
The Propeller System includes the Propeller Sensor Model 2017-B. The sensor is an accessory device intended for singlepatient use to assist physicians and patients in recording and monitoring the actuations of prescribed DPI usage for the Neohaler and Breezhaler devices.
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 DPI sensor, 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 DPI 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 DPI, 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 DPI 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 DPI 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 DPI dose counter, nor is it intended to indicate the quantity of medication remaining in an DPI.
Dry Powder Inhaler (DPI) / Neohaler Accessory that monitors inhaler usage. The portable sensor mounts on top of a DPI and records inhalation events when the inhaler is used.
The provided text describes the Propeller Sensor Model 2017-B, an accessory device for Dry Powder Inhalers (DPIs), and its substantial equivalence to a predicate device (Propeller Sensor Model 2015-E). However, the document does NOT contain information regarding acceptance criteria and a study that proves the device meets those criteria in the context of diagnostic performance metrics (e.g., sensitivity, specificity, accuracy).
Instead, the document focuses on:
- Regulatory clearance (510(k) summary): Demonstrating "substantial equivalence" to a previously cleared device.
- Technological comparison: Highlighting the similarities between the new device and the predicate.
- Bench testing: Confirming compliance with various standards and specifications (e.g., electrical safety, biocompatibility, battery performance).
Therefore, I cannot provide the requested information about acceptance criteria and performance metrics for diagnostic purposes. The device described here is a sensor for monitoring inhaler usage, not a diagnostic tool requiring such performance studies.
Here's what can be extracted from the document regarding the type of testing and its conclusion:
1. A table of acceptance criteria and the reported device performance:
Since the device is an accessory for monitoring inhaler usage and not a diagnostic device, the acceptance criteria are not in terms of diagnostic performance metrics (e.g., sensitivity, specificity). Instead, they relate to compliance with regulatory standards and functional specifications.
| Acceptance Criteria (Implied from text) | Reported Device Performance |
|---|---|
| Compliance with predetermined specifications (functional performance of the sensor, software verification/validation) | Test results indicate that the Propeller Sensor Model 2017-B complies with predetermined specifications. Software verification and validation testing confirms this result. |
| Compliance with IEC 60601-1 (medical electrical equipment - General requirements for basic safety and essential performance) | Confirmed |
| Compliance with IEC 60601-2 (particular requirements for basic safety and essential performance of specific medical electrical equipment) | Confirmed |
| Compliance with IEC 60601-6 (particular requirements for basic safety and essential performance of medical electrical equipment in the home healthcare environment) | Confirmed |
| Compliance with IEC 60601-11 (particular requirements for basic safety and essential performance of medical electrical equipment for use by lay operators) | Confirmed |
| Compliance with ISO 10993 Biocompatibility (Primary Skin Irritation, Patch Dermal Sensitization, Cytotoxicity) | Confirmed |
| Battery performance | Bench testing included battery performance testing (Implicitly met based on conclusion of compliance with specifications). The technical characteristics table mentions a 1-year battery life, which should have been verified. |
| Particle Size Distribution (PSD) testing (implying no adverse effect on DPI functionality) | Bench testing included particle size distribution (PSD) testing (Implicitly met based on conclusion of substantial equivalence and safety). The device itself is an accessory that attaches to a DPI, so PSD testing would likely ensure it doesn't negatively impact the DPI's ability to deliver medication, rather than being a performance metric of the sensor itself. |
2. Sample size used for the test set and the data provenance:
Not applicable as no diagnostic performance study involving test sets from patients was conducted. The testing focused on engineering, software verification, and biocompatibility.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No ground truth establishment by experts for diagnostic performance was required as it's not a diagnostic device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.
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:
Not applicable. This device is a sensor for inhaler usage, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. While the device does have an "algorithm" to detect inhaler actuations, the document does not describe it in terms of standalone "performance" in the way a diagnostic algorithm would be evaluated (e.g., sensitivity/specificity for a disease). The testing confirms its functional operation (e.g., compliance with specifications) rather than diagnostic accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable in the context of diagnostic performance. The "ground truth" for the device's functionality would likely be physical measurements and observations during bench testing to confirm accurate detection of inhaler actuations.
8. The sample size for the training set:
Not applicable. As a non-AI diagnostic device, there is no mention of a "training set" in the context of machine learning. The device's operation is based on physical principles (sensors detecting actuation) rather than learned patterns from a training dataset.
9. How the ground truth for the training set was established:
Not applicable.
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August 1, 2018
Reciprocal Labs Corporation Taylor Mahan-Rudolph Regulatory & Quality Affairs Lead 634 West Main St. Madison, Wisconsin 53703
Re: K180770
Trade/Device Name: Propeller Sensor Model 2017-B Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: May 2, 2018 Received: May 3, 2018
Dear Taylor Mahan-Rudolph:
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/cdrl/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
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 -S
for Tina Kiang, Ph.D. 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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Indications for Use
510(k) Number (if known) K180770
Device Name Propeller Sensor Model 2017-B
Indications for Use (Describe)
The Propeller System includes the Propeller Sensor Model 2017-B. The sensor is an accessory device intended for singlepatient use to assist physicians and patients in recording and monitoring the actuations of prescribed DPI usage for the Neohaler and Breezhaler devices.
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 DPI sensor, 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 DPI 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 DPI, 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 DPI 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 DPI 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 DPI dose counter, nor is it intended to indicate the quantity of medication remaining in an DPI.
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: | March 9, 2018 |
|---|---|
| Submitter: | Reciprocal Labs Corporation634 W. Main Street, Ste. 102Madison, WI 53703 |
| Submitter andOfficial Contact: | Taylor Mahan-RudolphRegulatory & Quality Affairs LeadReciprocal Labs Corporation634 W. Main Street, Ste. 102Madison, WI 53703+1 (608) 251-0470+1 (608) 338-0883 (fax)taylor@propellerhealth.com |
| ManufacturingSite: | Reciprocal Labs Corporation634 W. Main Street, Ste. 102Madison, WI 53703 |
| Trade Name: | Propeller System |
| Model Name: | Propeller Sensor Model 2017-B |
| Common Name: | Nebulizer |
| ClassificationName: | NEBULIZER (DIRECT PATIENT INTERFACE) |
| ClassificationRegulation: | 21 CFR §868.5630 |
| Product Code: | CAF |
| DeviceDescription: | Dry Powder Inhaler (DPI) / Neohaler Accessory that monitorsinhaler usage. The portable sensor mounts on top of a DPI andrecords inhalation events when the inhaler is used. |
| SubstantiallyEquivalentDevices: | K161454 Propeller Sensor Model 2015-E |
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Intended Use: The Propeller System includes the Propeller Sensor Model 2017-B. The sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed DPI usage for the Neohaler devices.
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 DPI 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 DPI 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 DPI, 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 DPI 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 DPI 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 DPI dose counter, nor is it intended to indicate the quantity of medication remaining in an DPI.
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Technology The Propeller Sensor Model 2017-B keeps track of medication Comparison: use, with a record of when the dry-powder 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 2017-B and the predicate (K161454) 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 Neohaler form factor.
| TechnologyCharacteristic | Predicate Device:Propeller System,Propeller SensorModel 2015-E510k Number:K161454 | Candidate Device:Propeller System,Propeller SensorModel 2017-B |
|---|---|---|
| Design -Attachment toMedicationDispenser | Physically attachesto DPI withoutinhibiting patientuse | Same |
| Principle ofOperation | The PropellerHealthSensor attaches tothe medicationcanister andperformswireless uploadingofusage history of theDPI | Same |
| Output port andComputerInterface | Wireless uploadingtodatabase; viewed byPC or other | Same |
| Data CollectionTechnology | Records date andtime of DPI usage bymonitoringactuationof the DPI viasensors | Same |
| Mobile Platforms | • iOS versions 8 orhigher• Androidoperating system | • iOS versions 10or higher• Androidoperating system |
| Required Off theShelf Hardware | • Applesmartphones ordevices withBluetooth, iOS 8or higher• Androidsmartphones ordevices withBluetooth andoperating systemversion of 4.3and up for app• Internet capabledevice; noprocessor ormemoryrequirements(see RequiredBrowser) | • Applesmartphones ordevices withBluetooth, iOS 10or higher• Androidsmartphones ordevices withBluetooth andoperating systemversion of 4.4and up for app• Internet capabledevice; noprocessor ormemoryrequirements(see RequiredBrowser) |
| RequiredBrowser | Firefox, Chrome,Safari , InternetExplorer | Same |
| MobileApplication | The Propeller HealthMobile Applicationrecords, stores, andtransmits usageevents from the | Same |
| Propeller HealthSensor via a featureor smartphone. Inaddition, the mobileapplication can beused to review theinformationcapturedwhen using asmartphone | ||
| Software | The Propeller HealthWeb Application issoftware intendedtoallow users toreviewthe collectedinformation andcharacteristics ofDPIuse, to add detailassociated with arecorded usageevent, and to sharethat informationwiththeir physician inorder to provideadditionalinformationassociated with thecondition for whichtheir DPImedication(s) areprescribed. | Same |
| Dose Counter | No | Same |
| Records Usage | Yes | Same |
| Records Locationof Usage (GPSCoordinates) | Geographiccoordinates can becaptured by the | Same |
| wireless device ifpaired with asensor. | ||
| 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 |
| Data Retrievalfrom Devicew/Software | Yes | Same |
| Case Material -Patient Contactby intact skin(hands) | Lexan Polycarbonate | Same |
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| Test Summary: | Test results indicate that the Propeller Sensor Model 2017-Band its predicate Propeller Sensor Model 2015-E complies withpredetermined specifications. Software verification andvalidation testing confirms this result. |
|---|---|
| Compliance to IEC 60601-1, IEC 60601-2, IEC 60601-6, IEC60601-11, ISO 10993 Biocompatibility (Primary Skin Irritation,Patch Dermal Sensitization, Cytotoxicity) was confirmed. | |
| Bench testing included battery performance testing and particlesize distribution (PSD) testing. | |
| The above testing confirms that the device is substantiallyequivalent to the predicate device as the minor differencesbetween the predicate and the subject device were shown bythe above testing that the subject device meets thepredetermined performance specifications as was the case withthe predicate device. | |
| Clinical Testing | No clinical testing was required |
| Conclusion: | The technology differences are minor between the candidateand predicate device. The overall testing confirms that thePropeller Sensor Model 2017-B is as safe and as effective as thepredicate 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).