(186 days)
Not Found
No
The document describes a sensor that records and transmits usage data, and software that displays this data. There is no mention of AI or ML being used for analysis, interpretation, or prediction.
No
The device is described as an "accessory device" intended to record and monitor the actuations of prescribed SMI usage, not to provide therapy itself. It collects and transmits data for review but explicitly states it is "not intended to diagnose or replace a diagnosis" and "not intended for use as an SMI dose counter."
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."
No
The device description explicitly states that the Propeller System includes the "Propeller Sensor Model 2014-R," which is described as a "small device that attaches to the top an existing inhaler." This sensor is a hardware component, making the system more than just software.
Based on the provided information, the Propeller System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Propeller System Function: The Propeller System's intended use is to record and monitor the actuations of prescribed SMI usage. It collects data about how and when an inhaler is used, patient-reported symptoms, and other disease management information.
- No Biological Samples: The system does not involve the collection or analysis of any biological samples from the patient.
- Focus on Device Usage and Patient-Reported Data: The system's output is based on the interaction with the inhaler and information provided by the user, not on the analysis of bodily fluids or tissues.
- Explicit Statement: The intended use explicitly states, "The output of the Propeller System is not intended to diagnose or replace a diagnosis provided by a licensed physician." This further reinforces that it is not performing a diagnostic test.
Therefore, the Propeller System falls under the category of a medical device that assists in monitoring and managing a condition, but it does not perform in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Propeller System includes the Propeller Sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed SMI usage.
The Propeller Mobile Application records, stores, and transmits usage events from Propeller Sensors, or via manual user entry, to a remote storage system. With the Propeller Mobile Application the user can review information collected from the SMI sensor, and report and review symptoms and other information about their disease management and its impact. The user may also share their information with their caregivers, physician, and healthcare providers.
The Propeller Web Application is software that, like the Propeller Mobile Application, is intended to allow users to review the collected information and characteristics of their SMI and its use, to capture other patient-reported information and outcomes, and to allow that information to be shared with their caregivers, physicians, and health care providers.
When used with a prescribed SMI, the system can report on information captured during the normal course of use, such as the time between actuations that can be helpful in assessing SMI technique.
The Propeller System is intended to be used in populations from Child (>2 years) to Adult.
The Propeller System can be used both indoors; home, work, and clinical settings, as well as on aircraft.
The Propeller System may also be used in clinical trials where researchers need to know information about the use of SMI medication(s) by a participant.
The output of the Propeller System is not intended to diagnose or replace a diagnosis provided by a licensed physician. The Propeller System is not intended for use as an SMI dose counter, nor is it intended to indicate the quantity of medication remaining in an SMI.
Product codes
CAF
Device Description
The Propeller Sensor Model 2014-R keeps track of medication use, with a record when a soft mist inhaler is used. The sensor is a small device that attaches to the top an existing inhaler. Both the subject device and the predicate device use technology that includes bluetooth wireless connectivity which connects to the same previously cleared Propeller Health software system together with a mobile phone or wireless gateway.
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
The Propeller System can be used both indoors; home, work, and clinical settings, as well as on aircraft. The user may also share their information with their caregivers, physician, and healthcare providers.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Test results indicate that the Propeller Sensor Model 2014-R and its predicate Propeller Sensor Model 2014-R complies with predetermined specifications.
Compliance to IEC 60601-1, IEC60601-2, IEC60601-6, IEC60601-11, ISO 10993 Biocompatibility (primary skin irritation, dermal sensitization, cytotoxicity) was confirmed. Additional testing to ESD levels of 10V/m was performed to ensure safety in a home health environment.
Validation testing including EMC, electrical, safety, mechanical durability, and functional testing has been completed and confirms that the device continues to meet the specified requirements for the change from "Prescription Use" to "OTC" status.
No clinical testing was required.
Conclusion: There are no new safety or effectiveness issues with classification as an over-the-counter medical device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 4, 2016
Reciprocal Labs David Hubanks VP Operations 634 W. Main Street, Suite 102 Madison, Wisconsin 53703
Re: K152482
Trade/Device Name: Propeller Sensor Model 2014-R Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: February 2, 2016 Received: February 3, 2016
Dear David Hubanks:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152482
Device Name Propeller Sensor Model 2014-R
Indications for Use (Describe)
The Propeller System includes the Propeller Sensor is an accessory device intended for singlepatient use to assist physicians and patients in recording and monitoring the actuations of prescribed SMI usage.
The Propeller Mobile Application records, stores, and transmits usage events from Propeller Sensors, or via manual user entry, to a remote storage system. With the Propeller Mobile Application the user can review information collected from the SMI sensor, and report and review symptoms and other information about their disease management and its impact. The user may also share their information with their caregivers, physician, and healthcare providers.
The Propeller Web Application is software that, like the Propeller Mobile Application, is intended to allow users to review the collected information and characteristics of their SMI and its use, to capture other patient-reported information and outcomes, and to allow that information to be shared with their caregivers, physicians, and health care providers.
When used with a prescribed SMI, the system can report on information captured during the normal course of use, such as the time between actuations that can be helpful in assessing SMI technique.
The Propeller System is intended to be used in populations from Child (>2 years) to Adult.
The Propeller System can be used both indoors; home, work, and clinical settings, as well as on aircraft.
The Propeller System may also be used in clinical trials where researchers need to know information about the use of SMI medication(s) by a participant.
The output of the Propeller System is not intended to diagnose or replace a diagnosis provided by a licensed physician. The Propeller System is not intended for use as an SMI dose counter, nor is it intended to indicate the quantity of medication remaining in an SMI.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
510(k) Summary
| Submission Date: | November 10, 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 Sensor Model 2014-R |
| Common Name: | Nebulizer |
| Classification Name: | NEBULIZER (DIRECT PATIENT INTERFACE) |
| Classification | |
| Regulation: | 21 CFR §868.5630 |
| Product Code: | CAF |
| Device | |
| Description: | Electronic Soft-Mist Inhaler (SMI) Accessory |
| Substantially | |
| Equivalent Devices: | K14 2960, Propeller Sensor Model 2014-R (Rx) |
| K142516, Propeller Sensor Model 2 (OTC) | |
| Intended Use: | The Propeller System includes the Propeller Sensor |
| Model 2014-R. The sensor is an accessory device | |
| intended for single-patient use to assist physicians and | |
| patients in recording and monitoring the actuations of | |
| prescribed SMI usage. | |
| The Propeller Mobile Application records, stores, and | |
| transmits usage events from Propeller Sensors, or via | |
| manual user entry, to a remote storage system. With | |
| the Propeller Mobile Application the user can review |
5
information collected from the SMI sensor, and report and review symptoms and other information about their disease management and its impact. The user may also share their information with their caregivers, physician, and healthcare providers.
The Propeller Web Application is software that, like the Propeller Mobile Application, is intended to allow users to review the collected information and characteristics of their SMI and its use, to capture other patient-reported information and outcomes, and to allow that information to be shared with their caregivers, physicians, and health care providers.
When used with a prescribed SMI, the system can report on information captured during the normal course of use, such as the time between actuations that can be helpful in assessing SMI technique.
The Propeller System is intended to be used in populations from Child (>2 years) to Adult.
The Propeller System can be used both indoors and outdoors; home, work, and clinical settings, as well as on aircraft.
The Propeller System may also be used in clinical trials where researchers need to know information about the use of SMI medication(s) by a participant.
The output of the Propeller System is not intended to diagnose or replace a diagnosis provided by a licensed physician. The Propeller System is not intended for use as an SMI dose counter, nor is it intended to indicate the quantity of medication remaining in an SMI.
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| Note: | This 510k is for expanded indications for use adding the
over-the-counter indication to the previously cleared
Propeller Sensor Model 2014-R (K142960). |
| ------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
Technology The Propeller Sensor Model 2014-R keeps track of Comparison and medication use, with a record when a soft mist inhaler Device Description: is used. The sensor is a small device that attaches to the top an existing inhaler. Both the subject device and the predicate device use technology that includes bluetooth wireless connectivity which connects to the same previously cleared Propeller Health software system together with a mobile phone or wireless gateway.
The Propeller Sensor Model 2014-R is identical to the predicate (K142960), and therefore there are no technology differences.
| Technology
Comparison | Predicate Device:
Propeller System,
Propeller Sensor
Model 2014-R
510k Number:
K142960 | Candidate Device:
Propeller System,
Propeller Sensor
Model 2014-R (OTC) |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Design - Attachment
to Medication
Dispenser | Physically attaches
to SMI without
inhibiting patient
use | Same |
| Principle of
Operation | The Propeller
Health Sensor
attaches to the top
of the medication
canister and
performs wireless
uploading of usage
history of the SMI. | Same |
| 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 SMI usage
by monitoring
actuation of the SMI
via sensors | Same |
| Mobile Platforms | • iOS versions 7
or higher
• Android
operating
system | Same |
| 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 | Same |
| | can be used to
review the
information
captured 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
SMI 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 SMI
medication(s) are
prescribed. | Same |
| 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 | Single button
interface | Same |
| Digital Display | No | Same |
| Power Source | 2 internal 3V DC
Li-ion Batteries | Same |
| | | |
| Battery Life | 1 Years | Same |
| Low battery indicator | Yes, light
combination;
software display of
battery life. | Same |
| Patient Reminder | Yes | Enhanced audio
reminder
component which is
louder than the
predicate. |
| 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 |
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8
9
Test Summary: Test results indicate that the Propeller Sensor Model 2014-R and its predicate Propeller Sensor Model 2014-R complies with predetermined specifications.
Compliance to IEC 60601-1, IEC60601-2, IEC60601-6, IEC60601-11, ISO 10993 Biocompatibility (primary skin irritation, dermal sensitization, cytotoxicity) was confirmed. Additional testing to ESD levels of 10V/m was performed to ensure safety in a home health environment.
- Validation testing including EMC, electrical, safety, Validation Testing mechanical durability, and functional testing has been for OTC completed and confirms that the device continues to meet the specified requirements for the change from "Prescription Use" to "OTC" status.
10
| Hazard Analysis
for OTC | Hazard Analysis for OTC was identical to the predicate
(K142516) included a review of existing hazards as well
as how the patient obtains and learns about the system,
registers for the system, installs the sensor, uses the
Propeller System to track SMI medication use, shares
data with their physician/care team and obtains help &
support with SMI labeling. No new concerns of safety
with the proposed OTC indication were found. |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical Testing | No clinical testing was required |
| Conclusion: | There are no new safety or effectiveness issues with
classification as an over-the-counter medical device. |