(249 days)
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.
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.
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.
§ 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).