(178 days)
The Propeller System includes the Propeller Model 2014-D 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 Diskus 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 under the care of a physician 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.
When used under the care of a physician with a prescribed DPI, the system can be used to reduce the frequency of respiratory health symptoms and exacerbations by increasing adherence to DPI 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; 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.
Dry Powder Inhaler (DPI) / Diskus Accessory
The subject device uses technology similar to the predicate device including Bluetooth wireless connectivity which connects to the same previously cleared Propeller Health software system together with a mobile phone or wireless gateway. The Sensor Model 2014-D is different from the Sensor Model 2 in that it contains enclosure size differences required to install on the DPI inhaler and electronic sensors to detect Propeller Sensor 2014-D use rather than a button which was used in the predicate device.
The provided text describes the Propeller Sensor Model 2014-D, an accessory device for Dry Powder Inhalers (DPIs), and its comparison to a predicate device. However, the document does not contain specific acceptance criteria values or a detailed study explicitly proving the device meets these criteria in the format requested.
The text generally states that "Test results indicate that the Propeller Sensor Model 2014-D and its predicate Propeller System Model 2 complies with predetermined specifications. Software verification and validation testing confirms this result." and "the subject device meets the predetermined performance specifications as was the case with the predicate device." without providing the actual specifications or the detailed results of the tests in a quantitative manner.
Therefore, I cannot populate the table and answer all questions directly from the provided input. I will extract what information is present and indicate where the information is missing.
Here's the breakdown based on the provided document:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Specific Values/Metrics) | Reported Device Performance (Specific Values/Metrics) |
|---|---|
| Not explicitly stated with specific values in the document. The document generally refers to "predetermined specifications." | Not explicitly stated with specific values in the document. The document generally states compliance with "predetermined specifications" and that the device "meets the performance specification." |
| Insertion and removal force | Device meets the performance specification for insertion and removal force and does not damage the Diskus device or label. |
| Air-flow | Bench testing included air-flow. (No specific performance data given) |
| PSD Safety Assessment using Electrostatic Measurements and analysis of Electric Fields from the sensor on the Diskus medication | Bench testing performed. (No specific performance data given) |
| In-home wireless compatibility | Co-existence testing to confirm in-home wireless compatibility. (No specific performance or results given) |
| Biocompatibility (primary skin irritation, dermal sensitization, ISO Agarose Overlay, ISO Guinea Pig Maximization Sensitization, ISO MEM Elution, ISO Intracutaneous Irritation, ISO MEM Elutiion Post-Cleaning) | Compliance confirmed. (No specific results or acceptance criteria values given) |
| Compliance to IEC 60601-1, IEC60601-2, IEC60601-6, IEC60601-11, ISO 10993 | Compliance confirmed. (No specific results or acceptance criteria values given) |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified.
- Data provenance: The testing appears to be bench testing and software verification/validation conducted by the manufacturer, Reciprocal Labs Corporation, as part of their 510(k) submission. No specific country of origin for test data or whether it was retrospective/prospective is mentioned, but it generally refers to pre-market testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The document outlines bench testing, software testing, and compliance with standards, but does not refer to expert-established ground truth in the context of diagnostic accuracy for this type of device. The ground truth for actuation detection would likely be based on physical detection during bench tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. This type of adjudication is typically used in clinical studies for diagnostic devices, which was stated as "No clinical testing was required" for this device.
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. The device is a sensor system for recording DPI actuations and providing user information/feedback, not an AI-assisted diagnostic tool for human readers. "No clinical testing was required."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The listed tests (bench testing, software verification/validation, compliance to standards) would evaluate the device's performance independently of human interaction in the loop, beyond basic usability. The device's primary function (recording actuations) is automated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the core function of detecting DPI actuations, the ground truth would have been established through controlled physical actuations on the bench, likely using mechanical or human operation with direct observation or other validated measurement methods (e.g., measuring force, movement, etc.). For software and system functionality (data transmission, app features), ground truth would be established against documented functional requirements.
8. The sample size for the training set:
- Not applicable/Not provided. The document describes a "sensor" and "system" that perform specific functions (recording actuations, transmitting data, providing reminders), rather than a machine learning or AI model that requires a training set in the typical sense.
9. How the ground truth for the training set was established:
- Not applicable/Not provided, as there is no mention of a training set for an AI/ML model.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads in profile, facing right. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 19, 2015
Reciprocal Labs Corporation David Hubanks VP Operations 634 W. Main Street, Suite 102 Madison, WI 53703
Re: K143671
Trade/Device Name: Propeller Sensor Model 2014-D Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: May 20, 2015 Received: May 21, 2015
Dear Mr. 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.
{1}------------------------------------------------
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 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Small Manufacturers, International and Consumer Assistance 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. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K143671
Device Name Propeller Model 2014-D Sensor
Indications for Use (Describe)
The Propeller System includes the Propeller Model 2014-D 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 Diskus 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 under the care of a physician 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.
When used under the care of a physician with a prescribed DPI, the system can be used to reduce the frequency of respiratory health symptoms and exacerbations by increasing adherence to DPI 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; 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.
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: | June 17, 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 |
| ManufacturingSite: | Reciprocal Labs Corporation |
| 634 W. Main Street, Ste. 102Madison, WI 53703 | |
| Trade Name: | Propeller Model 2014-D Sensor |
| Model Name: | Propeller Model 2014-D Sensor |
| Common Name: | Nebulizer |
| ClassificationName: | NEBULIZER (DIRECT PATIENT INTERFACE) |
| ClassificationRegulation: | 21 CFR §868.5630 |
| Product Code: | CAF |
| DeviceDescription: | Dry Powder Inhaler (DPI) / Diskus Accessory |
| SubstantiallyEquivalentDevices: | Propeller System K140638 |
| Intended Use: | The Propeller System includes the Propeller Model 2014-DSensor. The sensor is an accessory device intended forsingle-patient use to assist physicians and patients in recording |
| K143671 Section 5.1 Page 1 of 7 |
{5}------------------------------------------------
and monitoring the actuations of prescribed DPI usage for the Diskus 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 under the care of a physician 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.
When used under the care of a physician with a prescribed DPI, the system can be used to reduce the frequency of respiratory health symptoms and exacerbations by increasing adherence to DPI 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 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.
{6}------------------------------------------------
Technology Comparison and Device Description:
The subject device uses technology similar to the predicate device including Bluetooth wireless connectivity which connects to the same previously cleared Propeller Health software system together with a mobile phone or wireless gateway. The Sensor Model 2014-D is different from the Sensor Model 2 in that it contains enclosure size differences required to install on the DPI inhaler and electronic sensors to detect Propeller Sensor 2014-D use rather than a button which was used in the predicate device.
| TechnologyComparison | Predicate Device:Propeller System,Propeller SensorModel 2510k Number:K140638 | Candidate Device:Propeller System,Propeller SensorModel 2014-D |
|---|---|---|
| Design - Attachmentto MedicationDispenser | Same | Physically attachesto dispenserwithout inhibitingpatient use |
| Principle ofOperation | The Propeller HealthSensor attaches tothe top of themedication canisterand performs wirelessuploading of usagehistory of the MDI. | The PropellerHealth Sensorsecurely encasesthe medicationcanister andperforms wirelessuploading of Diskususage history. |
| Output port andComputer Interface | Wireless uploading todatabase; viewed byPC or otherinternet-capabledevice. | Same |
| Data CollectionTechnology | Records date andtime of MDI usagewith button pressswitch. | Records date andtime of DPI usageby monitoringactuation of the DPIvia sensors |
| Mobile Platforms | ● iOS versions 7or higher | Same |
| Android operating system | ||
| Required Off theShelf Hardware | Apple smartphones or devices with Bluetooth, iOS 7 or higher Android smartphones or devices with Bluetooth and operating system version of 4.3 and up for app Internet capable device; no processor or memory requirements (see Required Browser) | Same |
| Required Browser | Firefox, Chrome,Safari , InternetExplorer | Same |
| Mobile Application | The Propeller HealthMobile Applicationrecords, stores, andtransmits usageevents from thePropeller HealthSensor via a featureor smart phone. Inaddition, the mobileapplication can beused to review theinformation captured | Same |
| when using a smartphone. | ||
| Software | The Propeller HealthWeb Application issoftware intended toallow users to reviewthe collectedinformation andcharacteristics of MDIuse, to add detailassociated with arecorded usageevent, and to sharethat information withtheir physician inorder to provideadditionalinformationassociated with thecondition for whichtheir MDImedication(s) areprescribed. | The PropellerHealth WebApplication issoftware intendedto allow users toreview thecollectedinformation andcharacteristics ofDiskus use, to adddetail associatedwith a recordedusage event, and toshare thatinformation withtheir physician inorder to provideadditionalinformationassociated with thecondition for whichtheir Diskusmedication(s) areprescribed. |
| Dose Counter | No | Same |
| Records Usage | Yes | Same |
| Records Location ofUsage (GPSCoordinates) | Geographiccoordinates can becaptured by thewireless device ifpaired with a sensor. | Same |
| Keyboard/InputInterface | Dual buttonInterface: Primarybutton and secondarybutton. | Single buttoninterface |
| Digital Display | No | Same |
| Power Source | Single 3V DC Li-ionBattery | 2 internal 3V DCLi-ion Batteries |
| Battery Life | 1.5 Years | 1 year |
| Low battery indicator | Yes, light combination;software display ofbattery life. | Same |
| Patient Reminder | Yes | Same |
| Support | Yes | Same |
| Patient Data Storage with Software | Yes | Same |
| Patient Data Report Generation with Software | Yes | Same |
| Patient Data Graphs Generation | Yes | Same |
| Data Retrieval from Device w/ Software | Yes | Same |
| Case Material - Patient Contact by Intact Skin (hands) | Lexan Polycarbonate | Same |
| Case Material - Patient Contact by breached skin (lips) | N/A | LexanPolycarbonate |
{7}------------------------------------------------
{8}------------------------------------------------
{9}------------------------------------------------
Test Summary: Test results indicate that the Propeller Sensor Model 2014-D and its predicate Propeller System Model 2 complies with predetermined specifications. Software verification and validation testing confirms this result.
Compliance to IEC 60601-1, IEC60601-2, IEC60601-6, IEC60601-11, ISO 10993 Biocompatibility (primary skin irritation, dermal sensitization, ISO Agarose Overlay, ISO Guinea Pig Maximization Sensitization, ISO MEM Elution, ISO Intracutaneous Irritation, ISO MEM Elutiion Post-Cleaning ) was confirmed.
Bench testing included air-flow and PSD Safety Assessment using Electrostatic Measurements and analysis of Electric Fields from the sensor on the Diskus medication. Insertion-removal measurements were performed to insure the device meets the performance specification for insertion and removal force and
{10}------------------------------------------------
does not damage the Diskus device or label. Co-existence testing to confirm in-home wireless compatibility.
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 and validation through testing has demonstrated no impact to safety or effectiveness. The overall testing confirms that the Propeller Sensor Model 2014-D is as safe and effective and performs as well 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).