(266 days)
The CapMedic is intended to be used in adults and children 5 years of age and above, who are prescribed CapMedic to be used with their MDIs by their physician.
The CapMedic device is an accessory intended for single-patient use to assist physicians and patients in recording and monitoring the MDI (Metered Dose Inhaler) actuations and conducting PEF (Peak Expiratory Flow) and FEV1 (Forced Expiratory Volume for 1 second) spirometry tests. CapMedic measures of MDI use and records it for review by the physician and/or the patient. Furthermore, CapMedic reminds the patient on important steps of MDI use through audio-visual-haptic cues during their MDI use. With the provided PEF/FEV 1 adapter, CapMedic can also perform PEF/FEV1 spirometry test and provides LED feedback based on the measured FEV1. CapMedic can securely transmit MDI usage data and PEF/FEV1 test results to a Bluetooth enabled device running data collection software meeting the CapMedic secure interface protocol over a Bluetooth connection.
CapMedic can be used in the home, work, healthcare, and clinical use environments/settings.
The CapMedic device may also be used in clinical trials where researchers need to know information about the use of MDI medication(s) by a participant.
CapMedic may be used with any of the following MDIs: Ventolin HFA, Advair HFA, Flovent HFA, Xopenex HFA, Symbicort HFA, Atrovent HFA, Proventil HFA, Alvesco HFA, and Asmanex HFA and is attached with a specific adapter for the MDIs.
The CapMedic device includes a reusable sensing module that attaches to the Metered Dose Inhaler (MDI) to measure when and how patients use their inhalers. CapMedic has on-board visual, audio and haptic user interfaces (Uls) to remind patients to use their inhaler correctly through Ul prompts. The recorded parameters of MDI use are MDI shaking, orientation, coordination between MDI actuation and the start of inspiration, and inhalation duration. During MDI use, CapMedic can provide just-in-time reminders, in the form of Ul prompts, for various steps of MDI use, namely, MDI shaking, MDI upright orientation, correct coordination, breathe long and hold breath at the end. CapMedic also optionally provides dosing reminders through UI prompts at times preset by the user.
Further, CapMedic has a built-in peak-flow meter functionality with a separate mouthpiece attachment to the bottom of the sensing module to measure peak expiratory flow (PEF) and forced expiratory volume in 1 second (FEV1). CapMedic can securely transmit MDI usage data and PEF/FEV1 test results to a Bluetooth enabled device running data collection software meeting the CapMedic secure interface protocol over a Bluetooth connection. The CapMedic is powered by a rechargeable Lithium Polymer battery and can be charged via a micro-USB cable.
Here's a summary of the acceptance criteria and study information for the CapMedic device, based on the provided FDA 510(k) summary:
Acceptance Criteria and Device Performance for CapMedic (K183586)
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary does not explicitly list numerical acceptance criteria with corresponding device performance metrics in a table format. Instead, it broadly states that extensive testing was conducted to demonstrate performance and substantial equivalence to predicate devices. The document indicates that the device's performance benchmarks were met for MDI use measurement and lung function parameters.
Therefore, the acceptance criteria are implicitly defined by the successful demonstration of:
- MDI use measurement parameters: MDI shaking, orientation, coordination between MDI actuation and start of inspiration, and inhalation duration.
- Lung function parameters: Peak Expiratory Flow (PEF) and Forced Expiratory Volume in 1 second (FEV1), measured according to ATS guidance.
- Compatibility: Aerosol Particle Size Distribution (APSD) and Delivered Drug Uniformity (DDU) with specified MDIs.
- Safety: Biocompatibility (ISO 10993-1) and electrical requirements (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-1-8, IEC 60601-1-6).
- Connectivity and Security: Bluetooth data transfer complying with "Radio Frequency Wireless Technology in Medical Devices guidance" and "Management of Cybersecurity in Medical Devices" guidance.
- Usability, Software, and System Verification.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set in terms of patient data. The provided information focuses on nonclinical testing (bench testing):
- MDI use measurement parameters and UI: "extensively tested to demonstrate the performance and substantial equivalence." No specific number of tests or samples (e.g., number of MDI actuations or inhalers) is provided.
- Lung function parameters: "tested according to the ATS guidance on standardization of spirometry, published in 2005." This implies adherence to a standard, but doesn't specify the number of tests or subjects.
- Aerosol Particle Size Distribution (APSD) and Delivered Drug Uniformity (DDU) tests: Conducted to demonstrate compatibility with supported MDIs. No specific number of MDIs or tests specified.
- Biocompatibility tests: Conducted and passed according to ISO 10993-1.
- Electrical requirements tests: Conducted for IEC 60601 series standards.
- Bluetooth data transfer and interfaces tests: Conducted to comply with FDA guidance.
- Usability testing, software, and system verification: Conducted.
Data Provenance: All listed tests are "nonclinical tests," indicating they were likely conducted in a laboratory or simulated environment, rather than with human subjects in a clinical setting. No country of origin is specified for these tests, but the company is US-based. These appear to be prospective tests conducted for the purpose of the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document. As the listed tests are primarily nonclinical (bench tests), the concept of "experts establishing ground truth for a test set" in a clinical sense (e.g., radiologists interpreting images) is not directly applicable. The "ground truth" for these tests would be defined by the specifications of the MDI device, spirometry standards (ATS), biocompatibility standards (ISO), and electrical/connectivity standards (IEC, FDA guidance).
4. Adjudication Method for the Test Set
This information is not provided and is not typically applicable to nonclinical bench testing. Adjudication methods like 2+1 or 3+1 are used in clinical studies for resolving discrepancies among expert readers, which was not performed here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "Clinical testing was not required to determine substantial equivalence of CapMedic." Therefore, an MRMC comparative effectiveness study was not conducted.
6. Standalone (Algorithm Only) Performance
The device is a physical accessory with sensors and embedded logic, not a pure "algorithm only" device in the typical sense (e.g., AI for image analysis). Its performance is inherently linked to its interaction with the MDI and the patient. However, the nonclinical testing described (e.g., MDI use measurement parameters, lung function parameters) reflects the device's standalone technical performance in measuring and recording these physical parameters, independent of human interpretation or assistance beyond operating the device. The reported "performance bench-marked" indicates its technical accuracy in these measurements.
7. Type of Ground Truth Used
The ground truth for the nonclinical tests was based on:
- Industry Standards: ATS guidance on standardization of spirometry, ISO 10993-1 for biocompatibility, IEC 60601 series for electrical requirements, and FDA guidance for wireless technology and cybersecurity.
- Device Specifications/Engineering Standards: For MDI use measurement parameters (shaking, orientation, coordination, inhalation duration) and compatibility with MDIs (APSD, DDU).
- Pre-defined Parameters: For usability testing, software, and system verification, where ground truth would be adherence to design specifications and user requirements.
8. Sample Size for the Training Set
This information is not provided. The document describes performance testing for regulatory submission rather than a machine learning model development process that typically involves a distinct training set. The device's functionality appears to be based on embedded logic and sensor interpretation rather than a learned AI model that requires a "training set" in the common sense.
9. How the Ground Truth for the Training Set Was Established
As no "training set" in the context of machine learning is explicitly mentioned or implied, this question is not applicable. The device's operation is based on pre-programmed algorithms and sensor thresholds, not a learned model from a data training set.
§ 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).