(142 days)
Propeller System K140638
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on recording, monitoring, and reporting usage data without mentioning any analytical or predictive capabilities typically associated with AI/ML.
No
The device is an accessory intended to record and monitor actuations of prescribed SMI usage and is not intended for diagnosis or to provide therapy.
No
The "Intended Use / Indications for Use" section explicitly states, "The output of the Propeller System is not intended to diagnosis provided by a licensed physician."
No
The device description explicitly states "Electronic Soft-Mist Inhaler (SMI) Accessory" and the intended use mentions the "Propeller SMI Model 2014-R Sensor is an accessory device". This indicates a hardware component is part of the system, even though software is also involved.
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 SMI usage, reviewing collected information, reporting symptoms, and sharing information. It explicitly states that the output is not intended to diagnosis and is not for use as an SMI dose counter or to indicate remaining medication.
- Device Description: It is described as an "Electronic Soft-Mist Inhaler (SMI) Accessory."
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
The device functions as a data collection and monitoring tool for medication usage, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Propeller System includes the Propeller SMI Model 2014-R 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 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 under the care of a physician 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 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 (comma separated list FDA assigned to the subject device)
CAF
Device Description
Electronic Soft-Mist Inhaler (SMI) 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, 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 Sensor Model 2014-R 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.
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): 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.
Propeller System K140638
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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 5, 2015
Reciprocal Labs, Corp. David Hubanks VP Operations 634 W. Main Street, Suite 102 Madison, Wisconsin 53703
Re: K142960
Trade/Device Name: Propeller System Model 2014-R Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer (Direct Patient Interface) Regulatory Class: Class II Product Code: CAF Dated: February 10, 2015 Received: February 11, 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 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) K142960
Device Name Propeller Sensor Model 2014-R
Indications for Use (Describe)
The Propeller System includes the Propeller SMI Model 2014-R 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 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 under the care of a physician 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 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)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Premarket Notification Reciprocal Labs Corporation Propeller Sensor Model 2014-R
510(k) Summary
| Submission Date: | September 26, 2014 |
|---|---|
| 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 |
| Model Name: | 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: | Propeller System K140638 |
| Intended Use: | The Propeller System includes the Propeller SMI Model |
| 2014-R 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 SMI | |
| usage. |
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510(k) Premarket Notification Reciprocal Labs Corporation Propeller Sensor Model 2014-R
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 under the care of a physician 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.
Technology The subject device uses technology similar to the predicate Comparison: device including Bluetooth wireless connectivity which connects to the same previously cleared Propeller Health software system together with a mobile phone or wireless
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510(k) Premarket Notification Reciprocal Labs Corporation Propeller Sensor Model 2014-R
| | gateway. The Sensor Model 2014-R is different from the
Sensor Model 2 in that it contains enclosure size differences
required to install on the SMI inhaler and electronic sensors
to detect Propeller Sensor 2014-R use rather than a button
which was used in the predicate device. |
|------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Test Summary: | Test results indicate that the Propeller Sensor Model 2014-R
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 |
| Conclusion: | The technology differences are minor and validation through
testing has demonstrated the subject device is as safe and
effective as the predicate device. |