Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on recording and transmitting usage data, not on analysis or interpretation using AI/ML.

Therapeutic

No
The device is described as an accessory to record and monitor pMDI usage, and its output is not intended for diagnosis. It does not provide any therapeutic effect itself.

Diagnostic

No

The text explicitly states: "The output of the Propeller System is not intended to diagnosis provided by a licensed physician."

SaMD (Software as a Medical Device)

No

The device description explicitly mentions a "Propeller Sensor Model 2018-S" which is a portable sensor that mounts to the pMDI and records inhalation events. This is a hardware component, making the system more than just software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Propeller System is not an In Vitro Diagnostic (IVD).

Here's why:

Intended Use: The intended use clearly states that the system is for recording and monitoring the actuations of prescribed pMDI usage. It is an accessory to a medical device (the pMDI) and helps track its use.
Output: The output of the system is information about pMDI usage (time between actuations, usage events). It is explicitly stated that the output is not intended to diagnosis.
Device Description: The device is described as a pMDI accessory that monitors inhaler usage.
Lack of Biological Samples: IVDs typically involve testing biological samples (blood, urine, tissue, etc.) to provide information about a person's health status. The Propeller System does not interact with or analyze any biological samples.

The Propeller System is a medical device accessory that provides data about the usage of another medical device (the pMDI). This data can be helpful for patients and healthcare providers in managing a condition, but it does not perform a diagnostic test on a biological sample.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Propeller System includes the Propeller Sensor Model 2018-S. The sensor is an accessory device intended for singlepatient use to assist physicians and patients in recording and monitoring the actuations of prescribed pMDI usage for the Symbicort device.

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 pMDI 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 pMDI 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 pMDI, 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 pMDI 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 pMDI 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 pMDI dose counter, nor is it intended to indicate the quantity of medication remaining in an pMDI.

Product codes

CAF

Device Description

Pressurized Metered Dose Inhaler (pMDI) / Symbicort Accessory that monitors inhaler usage. The portable sensor mounts to the back of the pMDI 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, as well as on aircraft. Also used in clinical trials.

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

Software verification and validation testing confirms this result.
Compliance to IEC 60601-1, IEC 60601-2, IEC 60601-6, IEC 60601-11, ISO 10993-5, and ISO 10993-10 was confirmed.
Bench testing included battery performance testing, usability testing, and electrostatic discharge testing (to verify the device does not affect particle size distribution of the medication).

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Test results indicate that the Propeller Sensor Model 2018-S and its predicate Propeller Sensor Model 2017-B 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 10993-5, and ISO 10993-10 was confirmed.
Bench testing included battery performance testing, usability testing, and electrostatic discharge testing (to verify the device does not affect particle size distribution of the medication).
No clinical testing was required

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K180770

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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 two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

March 26, 2020

Reciprocal Labs Corporation Greg Dunkelberger Regulatory Affairs Project Manager 1 S. Pinckney St. Suite 610 Madison, Wisconsin 53703

Re: K192724

Trade/Device Name: Propeller Sensor for Symbicort Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: February 27, 2020 Received: February 28, 2020

Dear Greg Dunkelberger:

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/cdrh/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

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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 Ph.D. Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192724

Device Name Propeller Sensor Model 2018-S

Indications for Use (Describe)