(249 days)
Not Found
No
The summary describes a system for tracking medication usage and providing reminders and feedback, but it does not mention any AI or ML capabilities. The performance studies focus on compliance with specifications and safety, not on the performance of an AI/ML algorithm.
Yes
The device aids in managing respiratory health symptoms and exacerbations by increasing adherence to MDI or other inhaled medications through feedback, reminders, and self-management education when used under the care of a physician, thereby directly affecting the patient's health outcomes.
No
The "Intended Use / Indications for Use" section explicitly states: "The output of the Propeller System is not intended to diagnose provided by a licensed physician."
No
The device description explicitly states that the Propeller System includes the "Propeller MDI Model 2 OTC Sensor," which is described as an "accessory device." This indicates the presence of a hardware component in addition to the software applications.
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 the actuations of prescribed MDI usage, reviewing collected information, reporting symptoms, and sharing data. It explicitly states that the output is not intended to diagnose.
- Nature of the Device: The device is an accessory sensor for an MDI and associated software applications. It collects data about medication usage and patient-reported information.
- Lack of Diagnostic Function: IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not perform any such analysis on biological specimens.
The device's function is focused on tracking medication adherence, providing feedback, and facilitating communication between patients and healthcare providers, which falls outside the scope of an IVD.
N/A
Intended Use / Indications for Use
The Propeller System includes the Propeller MDI Model 2 OTC Sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed MDI 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 MDI 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 respiratory medication(s) and its use, to capture other patientreported information and outcomes, and to allow that information to be shared with their caregivers, physicians and health care providers.
When used with a prescribed MDI, 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 MDI technique.
When used under the care of a physician with a prescribed MDI, or other inhaled medication, the system can be used to reduce the frequency of respiratory health symptoms and exacerbations by increasing adherence to MDI or other inhaled 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 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 aircraff.
The Propeller System may also be used in clinical trials where researchers need to know information about the use of MDI or other inhaled medication(s) by a participant.
The output of the Propeller System is not intended to diagnose provided by a licensed physician. The Propeller System is not intended for use as an MDI or inhaled medication dose counter, nor is it intended to indicate the quantity of medication remaining in an MDI or inhaled medication.
Product codes
CAF
Device Description
Electronic MDI 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
used under the care of a physician, home, work and clinical settings, as well as 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 results indicate that the Propeller System Model 2 OTC and its predicate Propeller System Model 2 complies with predetermined specifications. Completed EMC, electrical, safety, mechanical durability, software verification and validation testing confirms this result.
Validation testing has been completed and confirms that the device continues to meet the specified requirements for the change from "Prescription Use" to "OTC" status.
Hazard Analysis for OTC 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 MDI medication use, shares data with their physician/care team and obtains help & support with OTC labeling. No new concerns of safety with the proposed OTC indication were found.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No clinical testing was required
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Propeller System K140638
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 consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol featuring three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 15, 2015
Reciprocal Labs David Hubanks VP Operations 634 W. Main Street, Suite 102 Madison, WI 53703
Re: K142516
Trade/Device Name: Propeller System Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer (Direct Patient Interface) Regulatory Class: Class II Product Code: CAF Dated: April 11, 2015 Received: April 15, 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.
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
1
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.
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)
Device Name Propeller System Model 2 OTC
Indications for Use (Describe)
The Propeller System includes the Propeller MDI Model 2 OTC Sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed MDI 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 MDI 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 respiratory medication(s) and its use, to capture other patientreported information and outcomes, and to allow that information to be shared with their caregivers, physicians and health care providers.
When used with a prescribed MDI, 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 MDI technique.
When used under the care of a physician with a prescribed MDI, or other inhaled medication, the system can be used to reduce the frequency of respiratory health symptoms and exacerbations by increasing adherence to MDI or other inhaled 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 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 aircraff.
The Propeller System may also be used in clinical trials where researchers need to know information about the use of MDI or other inhaled medication(s) by a participant.
The output of the Propeller System is not intended to diagnose provided by a licensed physician. The Propeller System is not intended for use as an MDI or inhaled medication dose counter, nor is it intended to indicate the quantity of medication remaining in an MDI or inhaled medication.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (1/14)
Page 1 of 2
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
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4
510(k) Premarket Notification Reciprocal Labs Corporation Propeller System Model 2 OTC
510(k) Summary
| Submission Date: | May 15, 2015 |
|---|---|
| Submitter: | Reciprocal Labs Corporation |
| 634 W. Main Street, Ste. 201 | |
| 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 System |
| Common Name: | Nebulizer |
| Classification | |
| Name: | NEBULIZER (DIRECT PATIENT INTERFACE) |
| Classification | |
| Regulation: | 21 CFR §868.5630 |
| Product Code: | CAF |
| Device | |
| Description: | Electronic MDI Accessory |
| Substantially | |
| Equivalent | |
| Devices: | Propeller System K140638 |
5
510(k) Premarket Notification Reciprocal Labs Corporation Propeller System Model 2 OTC
The Propeller System includes the Propeller MDI Model 2 Sensor. The sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed MDI 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 MDI 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 MDI 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.
Intended Use:
When together with a prescribed MDI, 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 MDI technique.
When together with a prescribed MDI, the system can be used to reduce the frequency of respiratory health symptoms and exacerbations by increasing adherence to MDI 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.
6
510(k) Premarket Notification Reciprocal Labs Corporation Propeller System Model 2 OTC
| | The Propeller System may also be used in clinical trials
where researchers need to know information about the use
of MDI 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 MDI dose counter, nor is it intended to indicate the
quantity of medication remaining in an MDI. |
| Note | Propeller System Model 2 OTC is the remarketing of the
previously approved Propeller System Model 2 for OTC
use. |
| Technology
Comparison: | The device is identical to the predicate device. |
| Test Summary: | Test results indicate that the Propeller System Model 2
OTC and its predicate Propeller System Model 2 complies
with predetermined specifications. Completed EMC,
electrical, safety, mechanical durability, software
verification and validation testing confirms this result. |
| Clinical Testing | No clinical testing was required |
| Validation
Testing for OTC | Validation testing has been completed and confirms that
the device continues to meet the specified requirements
for the change from "Prescription Use" to "OTC" status. |
| Hazard Analysis
for OTC | Hazard Analysis for OTC 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 MDI medication
use, shares data with their physician/care team and
obtains help & support with OTC labeling. No new
concerns of safety with the proposed OTC indication were
found. |
| Conclusion: | There are no new safety or effectiveness issues with
classification as an over-the-counter medical device. |