(178 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on sensor technology, data recording, and transmission, without mentioning any AI/ML algorithms for analysis or prediction.
Yes
The device is described as assisting physicians and patients in recording and monitoring actuations of prescribed DPI usage and can be used to reduce the frequency of respiratory health symptoms and exacerbations by increasing adherence to DPI medications through feedback, reminders, notifications, and self-management education. These functions directly support disease management and symptom reduction, which are therapeutic goals.
No
The "Intended Use / Indications for Use" section explicitly states: "The output of the Propeller System is not intended to diagnose or replace a diagnosis provided by a licensed physician." This indicates that the device is not for diagnostic purposes.
No
The device description explicitly states that the Propeller System includes the "Propeller Model 2014-D Sensor," which is a physical accessory device that attaches to a DPI. The summary also details hardware-related testing (bench testing, biocompatibility, electrical safety) performed on this sensor. While the system includes software components (Mobile and Web Applications), it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for recording and monitoring DPI usage, reporting on information captured during use, and increasing adherence to medication through feedback and education. It explicitly states that the output is not intended to diagnose or replace a diagnosis.
- Device Description: The device is described as a Dry Powder Inhaler (DPI) / Diskus Accessory.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic or other medical information. This device's function is focused on monitoring and managing medication usage, not on analyzing biological specimens.
N/A
Intended Use / Indications for Use
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.
Product codes
CAF
Device Description
Dry Powder Inhaler (DPI) / Diskus Accessory
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Child (>2 years) to Adult.
Intended User / Care Setting
Physicians, patients, caregivers, healthcare providers, researchers.
Home, work, clinical settings, on aircraft.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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 does not damage the Diskus device or label. Co-existence testing to confirm in-home wireless compatibility.
No clinical testing was required.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing, biocompatibility testing, software verification and validation.
Key results: 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. 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. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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
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4
510(k) Summary
| Submission Date: | June 17, 2015 |
|---|---|
| Submitter: | Reciprocal Labs Corporation |
| 634 W. Main Street, Ste. 102 | |
| Madison, WI 53703 | |
| Submitter and | |
| Official Contact: | David Hubanks |
| VP Operations | |
| Reciprocal Labs | |
| 634 W. Main Street, Ste. 102 | |
| Madison, WI 53703 | |
| +1 (608) 251-0470 | |
| +1 (608) 338-0883 (fax) | |
| david.hubanks@propellerhealth.com | |
| Manufacturing | |
| Site: | Reciprocal Labs Corporation |
| 634 W. Main Street, Ste. 102 | |
| Madison, WI 53703 | |
| Trade Name: | Propeller Model 2014-D Sensor |
| Model Name: | Propeller Model 2014-D Sensor |
| Common Name: | Nebulizer |
| Classification | |
| Name: | NEBULIZER (DIRECT PATIENT INTERFACE) |
| Classification | |
| Regulation: | 21 CFR §868.5630 |
| Product Code: | CAF |
| Device | |
| Description: | Dry Powder Inhaler (DPI) / Diskus Accessory |
| Substantially | |
| Equivalent | |
| Devices: | Propeller System K140638 |
| Intended Use: | The Propeller System includes the Propeller Model 2014-D |
| Sensor. The sensor is an accessory device intended for | |
| single-patient use to assist physicians and patients in recording | |
| K143671 Section 5.1 Page 1 of 7 |
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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.
| Technology
Comparison | Predicate Device:
Propeller System,
Propeller Sensor
Model 2
510k Number:
K140638 | Candidate Device:
Propeller System,
Propeller Sensor
Model 2014-D |
|---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design - Attachment
to Medication
Dispenser | Same | Physically attaches
to dispenser
without inhibiting
patient use |
| Principle of
Operation | The Propeller Health
Sensor attaches to
the top of the
medication canister
and performs wireless
uploading of usage
history of the MDI. | The Propeller
Health Sensor
securely encases
the medication
canister and
performs wireless
uploading of Diskus
usage history. |
| Output port and
Computer Interface | Wireless uploading to
database; viewed by
PC or other
internet-capable
device. | Same |
| Data Collection
Technology | Records date and
time of MDI usage
with button press
switch. | Records date and
time of DPI usage
by monitoring
actuation of the DPI
via sensors |
| Mobile Platforms | ● iOS versions 7
or higher | Same |
| | | |
| | Android operating system | |
| Required Off the
Shelf 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 , Internet
Explorer | Same |
| Mobile Application | The Propeller Health
Mobile Application
records, stores, and
transmits usage
events from the
Propeller Health
Sensor via a feature
or smart phone. In
addition, the mobile
application can be
used to review the
information captured | Same |
| | when using a smart
phone. | |
| Software | The Propeller Health
Web Application is
software intended to
allow users to review
the collected
information and
characteristics of MDI
use, to add detail
associated with a
recorded usage
event, and to share
that information with
their physician in
order to provide
additional
information
associated with the
condition for which
their MDI
medication(s) are
prescribed. | The Propeller
Health Web
Application is
software intended
to allow users to
review the
collected
information and
characteristics of
Diskus use, to add
detail associated
with a recorded
usage event, and to
share that
information with
their physician in
order to provide
additional
information
associated with the
condition for which
their Diskus
medication(s) are
prescribed. |
| Dose Counter | No | Same |
| Records Usage | Yes | Same |
| Records Location of
Usage (GPS
Coordinates) | Geographic
coordinates can be
captured by the
wireless device if
paired with a sensor. | Same |
| Keyboard/Input
Interface | Dual button
Interface: Primary
button and secondary
button. | Single button
interface |
| Digital Display | No | Same |
| Power Source | Single 3V DC Li-ion
Battery | 2 internal 3V DC
Li-ion Batteries |
| Battery Life | 1.5 Years | 1 year |
| Low battery indicator | Yes, light combination;
software display of
battery 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 | Lexan
Polycarbonate |
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.