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.

Device Description

Electronic Soft-Mist Inhaler (SMI) Accessory

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the Propeller System Model 2014-R, which is an accessory device intended to assist physicians and patients in recording and monitoring the actuations of prescribed Soft-Mist Inhaler (SMI) usage. The document focuses on establishing substantial equivalence to a legally marketed predicate device (Propeller System K140638) rather than presenting a detailed study proving the device meets specific acceptance criteria related to its direct performance as a diagnostic or therapeutic tool.

Therefore, much of the requested information, particularly regarding diagnostic performance metrics, expert adjudication, ground truth establishment for a test set, and multi-reader multi-case studies, is not applicable or cannot be extracted from this type of regulatory submission. The device is primarily a data collection and transmission accessory.

However, based on the Test Summary provided, some information can be inferred or directly stated regarding the device's functional performance and safety.

Here's the breakdown of what can be extracted:

1. A table of acceptance criteria and the reported device performance

The document states: "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."

While specific numerical acceptance criteria and reported performance values are not provided in this summary, the statement implies that the device met all established specifications within these categories.

Category	Acceptance Criteria (Implied)	Reported Device Performance
Functional Performance	Complies with predetermined specifications for recording and monitoring SMI actuations.	Complies with predetermined specifications.
Electromagnetic Compatibility (EMC)	Meets relevant EMC standards.	EMC testing completed and confirmed compliance.
Electrical Safety	Meets relevant electrical safety standards.	Electrical testing completed and confirmed compliance.
Mechanical Durability	Meets predetermined mechanical durability requirements.	Mechanical durability testing completed and confirmed compliance.
Software Verification and Validation	Software functions as intended, is reliable, and meets specifications.	Software verification and validation testing completed and confirmed compliance.

2. Sample size used for the test set and the data provenance

The document does not specify the sample size (e.g., number of devices tested, number of actuations recorded) for the various tests mentioned (EMC, electrical, safety, mechanical durability, software V&V). It also does not mention the data provenance in terms of country of origin or whether the tests were retrospective or prospective, as these are typically part of a detailed test report not included in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and not provided. The device (Propeller Sensor Model 2014-R) is not a diagnostic device that requires expert-established ground truth for its core function of recording SMI actuations. The "ground truth" for its performance would likely be a known physical actuation or a simulated event, verified by test equipment or direct observation, not expert clinical consensus.

4. Adjudication method for the test set

This information is not applicable and not provided for the same reasons as #3.

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

No such study was mentioned or required. The device is an accessory to an SMI, primarily for data collection and monitoring, not for AI-assisted human reading of medical images or diagnostic tests. The document explicitly states: "No clinical testing was required."

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

The device itself is a sensor that records physical events (SMI actuations). Its "standalone performance" would be its accuracy in detecting and transmitting these events. The software verification and validation testing would cover the algorithm's performance within the system, but the document does not detail specific metrics like recall, precision, or F1-score for this function as it's not a diagnostic algorithm.

7. The type of ground truth used

For the functional aspects (e.g., detecting an actuation), the ground truth would likely be a direct physical actuation of the SMI, verified by mechanical means or direct observation during testing. For electrical, EMC, and safety, the ground truth would be established by reference to relevant industry standards and objective measurements. The document does not specify this in detail.

8. The sample size for the training set

This is not applicable and not provided. The device is a hardware sensor with associated software for data collection. It does not appear to involve machine learning models that require a "training set" in the traditional sense for diagnostic prediction. Its software performs data capture, storage, and transmission, which are typically validated through testing against requirements, not trained on extensive datasets.

9. How the ground truth for the training set was established

Not applicable, as there is no mention of a training set for a machine learning model.

Summary

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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

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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 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) K142960

Device Name Propeller Sensor Model 2014-R

Indications for Use (Describe)

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.

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 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
Manufacturing Site:	Reciprocal Labs Corporation634 W. Main Street, Ste. 102Madison, WI 53703
Trade Name:	Propeller System
Model Name:	Sensor Model 2014-R
Common Name:	Nebulizer
ClassificationName:	NEBULIZER (DIRECT PATIENT INTERFACE)
ClassificationRegulation:	21 CFR §868.5630
Product Code:	CAF
Device Description:	Electronic Soft-Mist Inhaler (SMI) Accessory
SubstantiallyEquivalent Devices:	Propeller System K140638
Intended Use:	The Propeller System includes the Propeller SMI Model2014-R Sensor. The sensor is an accessory device intendedfor single-patient use to assist physicians and patients inrecording and monitoring the actuations of prescribed SMIusage.

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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 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 theSensor Model 2 in that it contains enclosure size differencesrequired to install on the SMI inhaler and electronic sensorsto detect Propeller Sensor 2014-R use rather than a buttonwhich was used in the predicate device.
Test Summary:	Test results indicate that the Propeller Sensor Model 2014-Rand its predicate Propeller System Model 2 complies withpredetermined specifications. Completed EMC, electrical,safety, mechanical durability, software verification andvalidation testing confirms this result.
Clinical Testing	No clinical testing was required
Conclusion:	The technology differences are minor and validation throughtesting has demonstrated the subject device is as safe andeffective as the predicate 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).