(299 days)
The Ochsner Connected Inhaler Sensor System includes the Ochsner Connected Inhaler Sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring actuations of prescribed MDI usage.
The Ochsner Connected Inhaler Sensor Mobile Application records, stores, and transmits usage events from the Sensors to a remote storage system. With the Mobile Application, the user can review information collected from the Sensors 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, physicians, and health care providers.
When used with a prescribed MDL, 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, the System can assist in the management of respiratory health symptoms and exacerbations by providing feedback through reminders, notifications, and self-management education.
The System is intended to be used in populations from Child (>2 years) to adult.
The System can be used both indoors and outdoors; home, work, and clinical settings, as well as on aircraft.
The System may also be used in clinical trials where researchers need to know information about the use of MDI medications by a participant.
The output of the System is not intended to diagnose or replace a diagnosis provided by a licensed physician. The 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 Ochsner Connected Inhaler Sensor System includes the Ochsner Connected Inhaler Sensor. The Sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring actuations of prescribed MDI usage. The Ochsner Connected Inhaler Sensor Mobile Application records, stores, and transmits usage events from the Sensors to a remote storage system. With the Mobile Application, the user can review information collected from the Sensors 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, 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, the System can assist in the management of respiratory health symptoms and exacerbations by providing feedback through reminders, notifications, and self-management education.
The provided text describes the Ochsner Connected Inhaler Sensor, an accessory device to assist in recording and monitoring actuations of prescribed MDI usage. The document is a 510(k) summary for FDA clearance.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present specific acceptance criteria in a quantitative table format. Instead, it relies on demonstrating equivalence to a predicate device and adherence to general medical device standards. The "Comparison Table" provides a detailed comparison of technological characteristics between the Ochsner Connected Inhaler Sensor and its predicate device (Propeller System Model 2 OTC).
However, based on the "Test Summary" and "Software Testing" sections, the implied acceptance criteria revolve around:
- Compliance with Predetermined Specifications: The device must meet its own design specifications.
- Correct Functionality: The MDI actuation sensor system must accurately log data for MDI usage.
- Equivalence to Predicate Device: Performance should be equivalent to the predicate device.
- Adherence to Standards: Compliance with IEC 60601 series (electrical safety, EMC) and ISO 10993 series (biocompatibility).
- Wireless Technology Performance: Compliance with FDA's guidance on radio-frequency wireless technology and successful FCC licensing tests.
- Safety for OTC Use: No safety concerns for the proposed Over-The-Counter indication.
The table below summarizes the reported device performance in relation to these implied criteria:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| I. Functional Performance | |
| 1. Compliance with Predetermined Specifications | Test results indicate that the Ochsner Sensor complies with predetermined specifications. Software verification and validation testing confirms this result. The above testing confirms that the device is substantially equivalent to the predicate device. |
| 2. Correct Functionality (MDI actuation recording) | Performance testing of the MDI actuation sensor system ensured data is logged accurately for MDI usage. This established correct functionality of the Ochsner System according to the requirements. |
| 3. Equivalent Performance to Predicate Device | Technological characteristics are largely equivalent. The Ochsner System employs technological characteristics in a similar way to the predicate device. Verified and validated to establish equivalent performance. |
| 4. Wireless/Bluetooth Technology Performance | Successful performance testing for wireless/Bluetooth technology in accordance with specifications and "FDA's Guidance on Radio-Frequency Wireless Technology in Medical Devices". Tests required for FCC licensing were successful. |
| II. Safety & Compliance | |
| 5. Electrical Safety (IEC 60601-1) | The Ochsner Sensor has successfully completed patient safety testing according to IEC 60601-1. |
| 6. Electromagnetic Compatibility (IEC 60601-1-2) | The Ochsner Sensor has successfully completed EMC testing Compatibility according to IEC 60601-1-2. |
| 7. Biocompatibility (ISO 10993 series) | Third party testing for biocompatibility was completed by accredited laboratories. (Case Material - Patient Contact by Intact Skin (Hands) is Similar to predicate, even with different material (Silicon Rubber vs. Lexan polycarbonate), as both are biocompatible and meet ISO 10993). |
| 8. Safety for Over-The-Counter (OTC) Indication | Hazard Analysis for OTC included a review of existing hazards and how the patient interacts with the system (obtains, learns, registers, installs, uses, shares data, obtains help). No concerns of safety with the proposed OTC indication were found. |
| III. Software & Firmware Quality | |
| 9. Software/Firmware Development Process Compliance | Designed and developed according to a robust software development process aligned with "Design Control Guidance for Medical Device Manufacturers", "The Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", "Guidance for Off the Shelf Software Use in Medical Devices", and verified and validated using guidance from the "General Principles of Software Validation". |
2. Sample size used for the test set and the data provenance
The document indicates "Non-clinical testing has been carried out to cover functional verification and device performance. This included completion of software verification and validation procedures, with performance testing of the MDI actuation sensor system to ensure data is logged accurately for MDI usage." and "Performance Testing - Bench: The Ochsner System has successfully completed performance testing according to applicable standards and internal testing."
However, the specific sample size used for performance testing (test set) is not explicitly mentioned. The provenance of the data is also not specified beyond being "internal testing" and "third party testing." There is no indication of retrospective or prospective data collection from human subjects for these performance tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document describes device performance testing against engineering specifications and standards, not a diagnostic or interpretive task that would require expert-established ground truth for a test set in the same way a medical image analysis AI would. The "ground truth" for the MDI actuation sensor is the actual physical actuation of the inhaler, measured by the device itself or a reference system during bench testing.
4. Adjudication method for the test set
Not applicable. As noted above, the testing described is primarily engineering and performance verification against specifications, rather than a clinical interpretation task requiring adjudication of expert opinions.
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, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing: No clinical testing was required." The device is cleared based on substantial equivalence to a predicate device and non-clinical performance and safety testing. The device assists physicians and patients in recording and monitoring usage, rather than providing diagnostic interpretations that would typically be evaluated in an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, standalone performance testing was conducted for the device's core functions. The "Software Testing" and "Performance Testing - Bench" sections indicate that the device's ability to log MDI usage accurately and its compliance with various standards (electrical safety, EMC, wireless technology) were evaluated independently. The device's primary function is to automatically record actuations, and this capability was tested on its own.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the performance testing related to MDI actuation, the ground truth would likely be physical actuation events as detected by a controlled testing setup or a reference measurement system during bench testing. For compliance with standards like IEC 60601 and ISO 10993, the ground truth is adherence to the specific criteria outlined in those standards.
8. The sample size for the training set
Not applicable. This device is an electronic accessory sensor that detects physical inhaler actuations and transmits the data. It is not an AI/ML device that requires a "training set" in the conventional sense for learning algorithms (e.g., for image recognition or predictive analytics). Its software and firmware are developed and verified, but not "trained" on data in the same way an AI model would be.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of an AI/ML model for this device. The software and firmware are developed based on functional requirements and verified against those requirements.
§ 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).