(115 days)
The DeVilbiss Healthcare DV6WM Wireless Modem is intended to be used as a data collection tool for DeVilbiss IntelliPAP Series with SmartLink II Bluetooth module, IntelliPAP2, and DeVilbiss Blue Series CPAPs for patients in a home or healthcare environment. It is not intended to be used as a diagnostic tool.
The proposed DeVilbiss DV6WM Wireless Modem is an accessory to a DeVilbiss CPAP machine. The proposed device provides automatic wireless telemetry of CPAP usage and performance data to a healthcare provider.
The provided text describes a 510(k) premarket notification for the DeVilbiss DV6WM Wireless Modem. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific quantitative acceptance criteria for a new medical device function. Therefore, much of the requested information regarding specific performance metrics, sample sizes for test/training sets, expert adjudication, or MRMC studies for AI performance is not present.
However, I can extract information related to the device's technical specifications and the non-clinical testing performed to establish safety and effectiveness.
Here's a breakdown of the available information structured as requested:
1. Table of Acceptance Criteria and Reported Device Performance
This device is a wireless modem for CPAPs, not a diagnostic or therapeutic AI device. Its performance is evaluated against technical standards and the functionality of its predicate devices. The "acceptance criteria" here are compliance with relevant standards and functional equivalence.
| Acceptance Criteria (Compliance/Functionality) | Reported Device Performance |
|---|---|
| Adherence to Standards: | |
| IEC 60601-1-2:2007 Ed. 3.0 (EMC) | Device designed and tested to demonstrate compliance and passed all test protocols. |
| IEC 60601-1-11:2010 Ed. 1.0 (Home Use ME) | Device designed and tested to demonstrate compliance and passed all test protocols. Operating/Storage humidity/temperature ranges comply with this standard. |
| FCC Regulation 47 CFR Part 15 Radio Freq. | Device designed and tested to demonstrate compliance and passed all test protocols. |
| Wireless Standards (FCC Part 15, IC RSP-100, | Device designed and tested to demonstrate compliance and passed all test protocols. |
| RTTE 1999/5/EC) | |
| IEC 62133 (LiPo Battery) | Internal LiPo battery certified to IEC 62133. |
| UN 38.3 (LiPo Battery) | Internal LiPo battery certified to UN 38.3. |
| Functional Equivalence: | |
| Intended Use | Similar to predicate device (DeVilbiss DV5M SmartLink System K082209): Data collection tool for CPAPs, not for diagnosis. |
| Operating Principle | Similar to predicate device (Resmed EasyCare Online K093684): Wireless data transfer from CPAP to a secure data server using cellular technology. Uses Bluetooth for CPAP connection. |
| Operating Modes | Similar to predicate device (Resmed EasyCare Online K093684): Wake (read data, send data), Low Power Sleep. Functions include searching for Bluetooth devices, reading data, switching to GSM, contacting server, uploading data, and data integrity checks. |
| Compliance Monitoring | Similar to predicate device (Resmed EasyCare Online K093684): Reads data recorded by host CPAP and transfers to a secure data server. Does not record data itself. |
| Remote Settings Change Function | Similar to predicate devices: Accommodates wireless prescription settings updates from SmartLink Desktop software, relayed via secure data server and modem to the CPAP. Includes verification. |
| Power Requirements | Change from predicate (internally powered by rechargeable LiPo battery) allows for modem placement to optimize cellular signal. Safety of battery certified to IEC 62133 and UN 38.3. |
| User Interface | Modified to indicate new functions (three status LEDs for battery, Bluetooth, GSM; one pushbutton for test call). Status also displayed on host CPAP for IntelliPAP2/Blue Series. Considered to have "no impact on safety or effectiveness." |
| Environmental Ranges | Operating Temperature, Humidity, and Storage Temperature/Atmospheric Pressure ranges are within regulatory/standard limits (IEC 60601-1-11) and comparable/broader than predicate. |
| Physical Characteristics (Dimensions, Weight) | Similar to predicate device DeVilbiss DV5M SmartLink System (K082209). |
| Electrical Safety (IEC 60601-1 Classification) | Change in classification to "Internally Powered ME Equipment" with "No applied part" due to internal battery, no impact on safety or effectiveness. Degree of Protection against Ingress of Water is IP21 (Drip Proof). |
| Shock and Vibration | States "Same as predicate," implying it meets standards for a 30" drop, IEC 68, and ASTM D-4169. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable/not provided. The submission describes non-clinical engineering and usability testing, not performance on a dataset of clinical cases.
- Data Provenance: Not applicable. The device's function is data transmission, not analysis of clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not an AI/diagnostic device requiring expert ground truth for clinical cases.
4. Adjudication method for the test set:
- Not applicable.
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. This device is a data collection tool, not an AI-powered diagnostic aid for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The device's standalone function is to wirelessly collect and transfer CPAP usage/performance data to a secure server. This function was confirmed through non-clinical testing against relevant standards. The "performance testing" section indicates this was verified by passing test protocols for communication, electrical safety, EMC, and environmental factors.
7. The type of ground truth used:
- Not applicable. For a device like this, the "ground truth" would be the successful and accurate transmission of data from the CPAP to the server, and compliance with all technical safety standards. This is verified through engineering testing and certification rather than clinical ground truth like pathology or outcome data.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that uses a training set.
9. How the ground truth for the training set was established:
- Not applicable.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).