(159 days)
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 DPI usage for the Ellipta 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 Power Inhaler (DPI) / Ellipta Accessory that monitors a patient's inhaler usage. The portable, polycarbonate sensor clips on top of a DPI mouthpiece cover and passively records inhalation events when the inhaler is used using infra-red (IR) sensors. The sensor then sends the event information via Bluetooth to the mobile phone or wireless gateway.
The provided text does not contain detailed acceptance criteria or a study proving that the device meets those criteria with specific performance metrics. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing intricate details of performance studies against defined acceptance criteria.
However, based on the information available, I can infer some aspects and present the information as requested, using placeholders where specific data is absent.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document mentions that "Test results indicate that the Propeller Sensor Model 2015-E... complies with predetermined specifications." However, the specific predetermined specifications (acceptance criteria) and the corresponding reported device performance values are not detailed in this summary.
| Acceptance Criteria (Inferred from text) | Reported Device Performance |
|---|---|
| Software Verification & Validation (Moderate Concern) | Complies with predetermined specifications (Identical to predicate) |
| Compliance to IEC 60601-1:2012 (Medical Electrical Equipment) | Confirmed |
| Compliance to IEC 60601-1-2:2007 (Electromagnetic Compatibility) | Confirmed |
| Compliance to IEC 60601-1-6:2010 (Usability) | Confirmed |
| Compliance to IEC 60601-1-11:2015 (Home Healthcare Environment) | Confirmed |
| Compliance to ISO 10993:2010 Biocompatibility (Primary Skin Irritation, Patch Dermal Sensitization, Cytotoxicity) | Confirmed |
| EMC testing (Home use environment levels) | Completed with passing results |
| Wireless coexistence testing | Performed with passing results |
| Battery performance | Tested (Specific results not detailed) |
| Particle size distribution (PSD) | Tested (Specific results not detailed) |
| Actuation detection (implicit, as it monitors DPI usage) | Complies with predetermined specifications (Implied) |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "Bench testing included battery performance testing and particle size distribution (PSD) testing." It also references "Software verification and validation testing." However, no specific sample sizes for these test sets are provided, nor is the data provenance (e.g., country of origin, retrospective or prospective) mentioned.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided. The testing mentioned (software, electrical safety, biocompatibility, battery, PSD) does not typically involve expert review for ground truth establishment in the same way as performance studies for diagnostic algorithms.
4. Adjudication Method
This information is not applicable and therefore not provided. The testing described does not involve an adjudication process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done or reported. The device is a sensor for monitoring inhaler usage, not a diagnostic tool requiring human reader interpretation in comparison to AI assistance. The document explicitly states: "Clinical Testing No clinical testing was required."
6. Standalone (Algorithm Only) Performance Study
The device is a hardware sensor that passively records inhalation events and transmits data. Its "performance" is primarily about accurately detecting these events and transmitting them reliably. While software verification and validation were performed, no standalone "algorithm-only" performance study in the context of, for example, diagnostic image analysis, is described. The core function is sensing and data transmission, for which specific accuracy metrics are implied to be part of the "predetermined specifications" but are not detailed.
7. Type of Ground Truth Used
For the various tests mentioned:
- Software verification and validation: Ground truth would be defined by the software requirements and specifications.
- Compliance to standards (IEC, ISO): Ground truth is the adherence to the requirements outlined in those standards.
- EMC, Wireless Coexistence: Ground truth is defined by the technical limits and requirements of relevant standards and regulations.
- Battery performance, PSD: Ground truth would be the expected physical or electrical characteristics defined by the manufacturer's specifications.
8. Sample Size for the Training Set
This information is not provided and likely not relevant in the conventional sense of machine learning training data for this type of device. The device is a hardware sensor primarily. While there is a "Propeller System" that includes mobile and web applications, the document focuses on the sensor itself. Any "training" for the sensor would be during its design and calibration, not typically described as a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not provided given the nature of the device and the absence of a distinct "training set" as understood in AI/ML performance studies.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 1, 2016
Reciprocal Labs Corporation Taylor Mahan-Rudolph Regulatory & Ouality Affairs Lead 634 W. Main Street, Suite 102 Madison, Wisconsin 53703
Re: K161454
Trade/Device Name: Propeller Sensor Model 2015-E Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: September 30, 2016 Received: October 3, 2016
Dear Ms. 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. 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
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) K161454
Device Name Propeller Sensor Model 2015-E
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 DPI usage for the Ellipta 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: | October 27, 2016 | |
|---|---|---|
| Submitter: | Reciprocal Labs Corporation634 W. Main Street, Ste. 102Madison, WI 53703 | |
| Submitter andOfficial Contact: | Taylor Mahan-RudolphRegulatory & Quality Affairs LeadReciprocal Labs634 W. Main Street, Ste. 102Madison, WI 53703+1 (608) 251-0470+1 (608) 338-0883 (fax)taylor@propellerhealth.com | |
| ManufacturingSite: | Reciprocal Labs Corporation | |
| 634 W. Main Street, Ste. 102Madison, WI 53703 | ||
| Trade Name: | Propeller System | |
| Model Name: | Propeller Sensor Model 2015-E | |
| Common Name: | Nebulizer | |
| ClassificationName: | NEBULIZER (DIRECT PATIENT INTERFACE) | |
| ClassificationRegulation: | 21 CFR §868.5630 | |
| Product Code: | CAF | |
| SubstantiallyEquivalentDevices | K152882 Propeller Sensor Model 2014-D | |
| Indications forUse: | The Propeller System includes the Propeller Sensor Model2015-E. The sensor is an accessory device intended forsingle-patient use to assist physicians and patients in recordingand monitoring the actuations of prescribed DPI usage for theEllipta devices. |
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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.
Device Description:
Dry Power Inhaler (DPI) / Ellipta Accessory that monitors a patient's inhaler usage. The portable, polycarbonate sensor clips on top of a DPI mouthpiece cover and passively records inhalation events when the inhaler is used using infra-red (IR) sensors. The sensor then sends the event information via Bluetooth to the mobile phone or wireless gateway.
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The Propeller Sensor Model 2015-E keeps track of medication Technology 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 2015-E and the predicate (K152882) have similar technological characteristics. Both devices are bluetooth enabled sensors fixed to dry powder inhalers designed to detect medication use. The indications for use are similar for both devices, the only difference is the word "Diskus" which is replaced with"Ellipta". No other changes were made to the indications for use.
Two primary differences are outlined in the technology comparison in the table below: battery and patient contact. The predicate device had two Li-ion batteries and the subject device has a single Li-ion battery. As this change for the subject device involves a lower voltage and fewer batteries, no new issues of safety and effectiveness of the device are found. The predicate device also had potential contact with breached skin (e.g. chapped lips) which is not possible with the subject device due to the location on the medication cover.
An additional minor difference is supported mobile versions. For the Propeller system, the supported mobile versions have changed to correspond with the versions supported by the operating systems.
All other listed characteristics are identical between the subject and predicate. These changes do not impact the safety and effectiveness of the device.
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| K152882 | ||
|---|---|---|
| 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 otherInternet-capabledevice. | Same |
| Data CollectionTechnology | Records date andtime of DPI usage bymonitoringactuationof the DPI viasensors | Same |
| Mobile Platforms | • iOS versions 7 orhigher• Androidoperating system | • iOS versions 8 orhigher• Androidoperating system |
| Required Off theShelf Hardware | • Applesmartphones ordevices withBluetooth, iOS 7or higher• Androidsmartphones ordevices with | • Applesmartphones ordevices withBluetooth, iOS 8or higher• Androidsmartphones ordevices with |
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| Bluetooth andoperating systemversion of 4.3and up for app• Internet capabledevice; noprocessor ormemoryrequirements(see RequiredBrowser) | Bluetooth andoperating systemversion of 4.3and up for app• Internet capabledevice; noprocessor ormemoryrequirements(see RequiredBrowser) | |
|---|---|---|
| RequiredBrowser | Firefox, Chrome,Safari , InternetExplorer | Same |
| MobileApplication | The PropellerHealthMobile Applicationrecords, stores, andtransmits usageevents from thePropeller HealthSensor via a smartphone. Inaddition, the mobileapplication can beused to review theinformationcapturedwhen using a smartphone | Same |
| Software | The PropellerHealthWeb Application issoftware intendedtoallow users toreviewthe collectedinformation andcharacteristics ofDPIuse, to add detail | Same |
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| associated with arecorded usageevent, and to sharethat informationwiththeir physician inorder to provideadditionalinformationassociated with thecondition for whichtheir DPImedication(s) areprescribed. | ||
|---|---|---|
| Dose Counter | No | Same |
| Records Usage | Yes | Same |
| RecordsLocation 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 | 1 internal 3V DCLi-lon battery |
| Battery Life | 1 year | Same |
| Low BatteryIndicator | Yes, lightcombination;software display ofbattery life. | Same |
| Environment | The PropellerSystem can be usedboth indoors andoutdoors;home, work, and | Same |
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| clinical settings, aswell as on aircraft.The PropellerSystem may also beused in clinicaltrials whereresearchers need toknow informationabout the use of DPImedication(s) by aparticipant. | ||
|---|---|---|
| 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) | LexanPolycarbonate | Same |
| Case Material -Patient Contactby breached skin(lips) | LexanPolycarbonate | None |
Test Summary: Test results indicate that the Propeller Sensor Model 2015-E
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and its predicate Propeller Sensor Model 2014-D complies with predetermined specifications. Software verification and validation testing confirms this result. Software is listed as Moderate Concern, which is identical to the predicate device. Documentation was provided as recommended by the FDA's Guidance for Industry and FDA staff, "Guidance for Content of Premarket Submissions for Software Contained in Medical Devices."
Compliance to IEC 60601-1:2012, IEC 60601-1-2:2007, IEC 60601-1-6:2010, IEC 60601-1-11:2015, ISO 10993:2010 Biocompatibility (Primary Skin Irritation, Patch Dermal Sensitization, Cytotoxicity) was confirmed. EMC testing was completed with test levels applicable to home use environment as recommended in the FDA guidance "Design Considerations for Devices Intended for Home Use". Wireless coexistence testing was performed with passing results.
Bench testing included battery performance testing and particle size distribution (PSD) testing.
The above testing confirms that the device is substantially equivalent to the predicate device as the minor differences between the predicate and the subject device were shown by the above testing that the subject device meets the predetermined performance specifications as was the case with the predicate device.
- 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 2015-E is as safe and as effective as 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).