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.

Device Description

AI/ML Overview

This document is a 510(k) premarket notification for the Propeller System Model 2 OTC. It is primarily focused on seeking approval for over-the-counter (OTC) use of a device previously approved for prescription use. As such, the information provided relates more to the comparison with a predicate device and the validation for the change in use status, rather than a detailed study proving performance against new, specific acceptance criteria for a novel device.

Given the information provided, it states: "No clinical testing was required" and "The device is identical to the predicate device." Therefore, a traditional study proving the device meets acceptance criteria as would be for a de novo or novel device is not present here. The focus is on demonstrating that the previously established performance and safety remain valid for OTC use.

However, I can extract information related to the validation testing for OTC and the conclusion regarding safety, which can be interpreted as fulfilling new "acceptance criteria" for the change in intended use.

Here's an attempt to structure the information based on your request, acknowledging the limitations of the provided text:

Acceptance Criteria and Study to Prove the Device Meets Acceptance Criteria

The provided document describes a 510(k) premarket notification for the Propeller System Model 2 OTC, which is a re-marketing of a previously approved prescription-use device (Propeller System Model 2) for over-the-counter (OTC) use. The primary goal of this submission is to demonstrate that the device continues to meet specified requirements for the change in status from "Prescription Use" to "OTC". Therefore, the "acceptance criteria" and "study" are framed around this change in intended use, rather than a de novo evaluation of the device's fundamental performance.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category (for OTC use)	Reported Device Performance (from the document)
Overall Compliance with Predetermined Specifications	"Test results indicate that the Propeller System Model 2 OTC and its predicate Propeller System Model 2 complies with predetermined specifications."
Electromagnetic Compatibility (EMC)	"Completed EMC... testing confirms this result." (Implied compliance)
Electrical Safety	"Completed ... electrical, safety... testing confirms this result." (Implied compliance)
Mechanical Durability	"Completed ... mechanical durability... testing confirms this result." (Implied compliance)
Software Verification and Validation	"Completed ... software verification and validation testing confirms this result." (Implied compliance)
Suitability for OTC use	"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."
No New Safety Concerns for OTC Use	"Hazard Analysis for OTC [...] No new concerns of safety with the proposed OTC indication were found."
No New Effectiveness Issues for OTC Use	"Conclusion: There are no new safety or effectiveness issues with classification as an over-the-counter medical device."
Device is Identical to Predicate Device (Technology Comparison)	"The device is identical to the predicate device."

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "No clinical testing was required". This indicates that the validation for OTC use did not involve a study with human subjects or a test set in the traditional sense of a clinical trial. The testing performed was likely bench testing, software validation, and a hazard analysis related to the change in labeling and intended use. Therefore, a "sample size for the test set" is not applicable in the context of clinical performance data, and "data provenance" (country of origin, retrospective/prospective) is not relevant to this type of regulatory submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. As no clinical testing was required and the device is stated to be identical to its predicate, there was no "test set" requiring expert ground truth establishment in a clinical performance study. The "ground truth" here is the established safety and performance of the predicate device and the assessment that these characteristics are maintained for OTC use.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable, as no clinical test set requiring adjudication was performed.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The Propeller System is an electronic MDI accessory for recording and monitoring inhaler actuations, not an AI-powered diagnostic imaging tool. Therefore, an MRMC study and effects on "human readers" are not relevant to this device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device itself (the Propeller MDI Model 2 OTC Sensor) operates in a standalone manner to record actuations. The accompanying mobile and web applications also process and display data. The document confirms that "Completed EMC, electrical, safety, mechanical durability, software verification and validation testing confirms this result." This implies that the device's core functions (including its algorithms for detecting actuations) were validated. However, the document does not provide details on the performance metrics of these algorithms (e.g., accuracy of actuation detection) as this was likely established and accepted with the predicate device. The focus here is on the transition to OTC.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

For the validation of the device itself (as opposed to its OTC reclassification), the ground truth for actuation detection would typically be established against physical measurements or manual observations of MDI actuations. However, this information pertains to the predicate device's initial approval and is not detailed in this 510(k) submission which focuses on the OTC change. For the OTC reclassification, the "ground truth" was essentially the confirmed safety and effectiveness of the identical predicate device and the absence of new hazards identified through the hazard analysis for OTC.

8. The Sample Size for the Training Set

Not applicable. This device is an electronic MDI accessory, not an AI/machine learning model that typically requires a training set of data. Its function is based on sensor data interpretation, not predictive modeling from a large dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" in the context of this device's function as described.

Summary

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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

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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

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Indications for Use

510(k) Number (if known)

Device Name Propeller System Model 2 OTC

Indications for Use (Describe)

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.

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.

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.

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510(k) Premarket Notification Reciprocal Labs Corporation Propeller System Model 2 OTC

510(k) Summary

Submission Date:	May 15, 2015
Submitter:	Reciprocal Labs Corporation634 W. Main Street, Ste. 201Madison, WI 53703
Submitter andOfficial Contact:	David HubanksVP OperationsReciprocal Labs634 W. Main Street, Ste. 102Madison, WI 53703+1 (608) 251-0470+1 (608) 338-0883 (fax)david.hubanks@propellerhealth.com
ManufacturingSite:	Reciprocal Labs Corporation634 W. Main Street, Ste. 102Madison, WI 53703
Trade Name:	Propeller System
Common Name:	Nebulizer
ClassificationName:	NEBULIZER (DIRECT PATIENT INTERFACE)
ClassificationRegulation:	21 CFR §868.5630
Product Code:	CAF
DeviceDescription:	Electronic MDI Accessory
SubstantiallyEquivalentDevices:	Propeller System K140638

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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 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.

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510(k) Premarket Notification Reciprocal Labs Corporation Propeller System Model 2 OTC

	The Propeller System may also be used in clinical trialswhere researchers need to know information about the useof MDI medication(s) by a participant.
	The output of the Propeller System is not intended todiagnose or replace a diagnosis provided by a licensedphysician. The Propeller System is not intended for use asan MDI dose counter, nor is it intended to indicate thequantity of medication remaining in an MDI.
Note	Propeller System Model 2 OTC is the remarketing of thepreviously approved Propeller System Model 2 for OTCuse.
TechnologyComparison:	The device is identical to the predicate device.
Test Summary:	Test results indicate that the Propeller System Model 2OTC and its predicate Propeller System Model 2 complieswith predetermined specifications. Completed EMC,electrical, safety, mechanical durability, softwareverification and validation testing confirms this result.
Clinical Testing	No clinical testing was required
ValidationTesting for OTC	Validation testing has been completed and confirms thatthe device continues to meet the specified requirementsfor the change from "Prescription Use" to "OTC" status.
Hazard Analysisfor OTC	Hazard Analysis for OTC included a review of existinghazards as well as how the patient obtains and learnsabout the system, registers for the system, installs thesensor, uses the Propeller System to track MDI medicationuse, shares data with their physician/care team andobtains help & support with OTC labeling. No newconcerns of safety with the proposed OTC indication werefound.
Conclusion:	There are no new safety or effectiveness issues withclassification as an over-the-counter medical device.

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).