(160 days)
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.
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.
This document (K152882) describes the 510(k) premarket notification for the Propeller Sensor Model 2014-D. It explicitly states that no new testing was performed for the OTC indication, and no clinical testing was required. The device's substantial equivalence is based on its identity to a previously cleared predicate device (K143671) and another (K142516) with only a change from MDI to DPI.
Therefore, the detailed information requested regarding acceptance criteria, study sample sizes, ground truth establishment, expert involvement, and MRMC studies are not available in this specific regulatory submission as no new performance studies were conducted for this 510(k) clearance.
However, based solely on the provided document, here's what can be inferred and what remains unknown regarding device performance validation:
1. Table of Acceptance Criteria and Reported Device Performance:
Since no new performance testing was conducted, there are no specific numeric acceptance criteria or reported device performance metrics presented in this document for the Propeller Sensor Model 2014-D in its OTC indication. The primary "performance" assessed was functional equivalence to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device continues to meet specified requirements for functionality (e.g., recording and monitoring DPI actuations). | "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." |
| No new safety concerns with OTC indication. | "Hazard Analysis ... was identical to the predicate (K143671). ... No new concerns of safety with the proposed OTC indication were found." |
| Software verification and validation. | "Software verification and validation testing confirms this result." (referring to compliance with predetermined specifications) |
| Tech is identical to predicate. | "The Propeller Sensor Model 2014-D is identical to the predicate (K143671), and therefore there are no technology differences." |
| Effective and safe as predicate. | "The overall testing confirms that the Propeller Sensor Model 2014-D is as safe and as effective as the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable/not provided for new performance testing, as none was conducted specific to this 510(k). The functional testing performed was "bench testing."
- Data Provenance: Not applicable/not provided for new performance testing. The document refers to prior testing for predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable, as no new performance studies with ground truth establishment were conducted for this 510(k). Hazard analysis involved review by (unspecified) experts during the predicate device clearance process.
4. Adjudication Method for the Test Set:
- Not applicable, as no new performance studies were conducted.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No, an MRMC study was not done. The device does not involve human interpretation of medical images or data that would necessitate such a study. It is an accessory to monitor inhaler usage.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The "functional testing" performed would be considered analogous to standalone performance, as it tests the device's ability to record actuations independently. However, no specific metrics like accuracy, sensitivity, or specificity are provided for this functional test for the current submission, as it relied on the established performance of the predicate. The device's primary function is data acquisition and transmission, not algorithmic interpretation requiring performance metrics typical of AI/ML devices.
7. The Type of Ground Truth Used:
- For the predicate device's original clearance, functional ground truth would have been established by comparing the device's recorded actuations against directly observed or mechanically triggered actuations of the DPI/MDI. This document relies on the ground truth established for the predicate device.
8. The Sample Size for the Training Set:
- Not applicable. This device is not described as utilizing a machine learning algorithm that requires a training set in the context of this 510(k). Its function is based on sensor detection, not pattern recognition learned from data.
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 algorithm in this submission.
In summary, this 510(k) clearance (K152882) for the Propeller Sensor Model 2014-D focused on demonstrating substantial equivalence to previously cleared predicate devices (K143671 and K142516) and a change in indication (Prescription Use to OTC). It explicitly states that no new clinical or performance testing was required or performed for this specific submission. The acceptance criteria were implicitly met by demonstrating that the device is identical in technology and functionality to the predicate and that the change to OTC status did not introduce new safety concerns based on hazard analysis and bench testing.
§ 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).