Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary focuses on recording, monitoring, and transmitting usage data, with no mention of AI/ML for analysis or interpretation beyond basic reporting of events and timing.

Therapeutic

No
The device is an accessory that monitors inhaler usage and records events, helping users track medication use. It is explicitly stated that "The output of the Propeller System is not intended to diagnosis provided by a licensed physician," and is "not intended for use as an DPI dose counter, nor is it intended to indicate the quantity of medication remaining in an DPI." This indicates it does not provide direct therapeutic intervention or diagnosis.

Diagnostic

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."

SaMD (Software as a Medical Device)

No

The device description explicitly states it includes a "portable sensor" which is a hardware component that mounts on the inhaler. While there is software involved (mobile and web applications), the system includes hardware.

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, reviewing collected information, and sharing data. It explicitly states that the output is not intended for diagnosis.
Device Description: The device is described as an accessory that monitors inhaler usage by recording inhalation events. This is a functional measurement related to device use, not a diagnostic test performed on a biological sample.
Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), which is a core characteristic of IVD devices.

Therefore, the Propeller System, as described, falls outside the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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 DPI usage for the Diskus 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

CAF

Device Description

Dry Powder Inhaler (DPI) / Diskus Accessory that monitors inhaler usage. The portable sensor mounts on top of a DPI and records inhalation events when the medication 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; indoors home, work, and clinical settings, as well as on aircraft; 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

Not Found

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

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. Hazard Analysis for OTC was identical to the predicate (K143671). It 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 Diskus medication use, shares data with their physician/care team and obtains help & support with Diskus labeling. No new concerns of safety with the proposed OTC indication were found. Test results indicate that the Propeller Sensor Model 2014-D and its predicate Propeller System Model 2 complies with predetermined specifications. Software verification and validation testing confirms this result. Bench testing performed was identical to the predicate device. No new testing was performed for the OTC indication. No clinical testing was required. The technology is identical to the predicate device. The overall testing confirms that the Propeller Sensor Model 2014-D is as safe and as effective as the predicate 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.

K143671, K142516

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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 8, 2016

Reciprocal Labs Mr. David Hubanks VP Operations 634 W. Main Street, Suite 102 Madison, Wisconsin 53703

Re: K152882

Trade/Device Name: Propeller Sensor Model 2014-D Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: February 4, 2016 Received: February 5. 2016

Dear Mr. 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

1

the quality systems (OS) 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,

Erin I. Keith -S

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) K152882

Device Name Propeller Sensor Model 2014-D

Indications for Use (Describe)