Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary focuses on recording, storing, and transmitting usage data, and comparing the device to a predicate based on performance specifications and compliance testing. There is no mention of AI or ML algorithms being used for data analysis, interpretation, or prediction.

Therapeutic

No.
The device is described as an accessory to monitor inhaler usage and help record and monitor actuations, not to provide therapy itself. It specifically states "The output of the Propeller System is not intended to diagnosis" and "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."

Diagnostic

No

The output of the Propeller System is specifically stated to not be intended for diagnosis. It is designed for recording and monitoring DPI usage and providing information for disease management and technique assessment, but not for making a medical diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system includes a "Propeller Sensor Model 2017-B" which is a "portable sensor mounts on top of a DPI and records inhalation events". This indicates a hardware component is part of the medical device system.

IVD (In Vitro Diagnostic)

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 DPI usage. It helps assess DPI technique and provides information about disease management. Crucially, it explicitly states: "The output of the Propeller System is not intended to diagnosis provided by a licensed physician."
Device Description: The device is described as a DPI/Neohaler accessory that monitors inhaler usage.
Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze any biological specimens.

The Propeller System is a medical device that provides information related to medication adherence and usage patterns, but it does not perform in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Propeller System includes the Propeller Sensor Model 2017-B. The 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 Neohaler and Breezhaler 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 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 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.

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 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 (comma separated list FDA assigned to the subject device)

CAF

Device Description

Dry Powder Inhaler (DPI) / Neohaler Accessory that monitors inhaler usage. The portable sensor mounts on top of a DPI and records inhalation events when the inhaler is used.

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 and patients; home, work, and clinical settings

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 2017-B and its predicate Propeller Sensor Model 2015-E complies with predetermined specifications. Software verification and validation testing confirms this result. Compliance to IEC 60601-1, IEC 60601-2, IEC 60601-6, IEC 60601-11, ISO 10993 Biocompatibility (Primary Skin Irritation, Patch Dermal Sensitization, Cytotoxicity) was confirmed. Bench testing included battery performance testing and particle size distribution (PSD) testing. 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. 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.

K161454

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

Regulation Number and Section

§ 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).

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 1, 2018

Reciprocal Labs Corporation Taylor Mahan-Rudolph Regulatory & Quality Affairs Lead 634 West Main St. Madison, Wisconsin 53703

Re: K180770

Trade/Device Name: Propeller Sensor Model 2017-B Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: May 2, 2018 Received: May 3, 2018

Dear Taylor Mahan-Rudolph:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for

1

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

James J. Lee -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180770

Device Name Propeller Sensor Model 2017-B

Indications for Use (Describe)