The FDA issued Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. During this emergency and while the policy is in effect, the FDA does not intend to object to limited modifications to indications, claims, functionality, hardware, or software of cleared non-invasive remote monitoring devices that are used to support patient monitoring without prior submission of a 510(K) where the modifications do not create an undue risk. Based on this guidance, Hillrom has released the Welch Allyn Spot Vital Signs 4400 Device for use in the home with Hillrom Connex software.
When the device is used in the home, it is not intended for use in the diagnosis, cure, treatment or prevention of disease on its own. It is not intended as a substitute for medical care by a healthcare provider. It is not intended for emergency use or real-time monitoring.
Modifications to FDA Cleared Indications for Use (Modifications are underlined)
Intended use (Spot 4400)
The Welch Allyn® Spot Vital Signs 4400 (device) is intended to be used by patients to initiate spot-check/single measurement of noninvasive blood pressure, pulse rate, noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and body temperature in oral and axillary modes of adult and pediatric patients greater than 12 years of age under the direction of clinicians or other medical professionals. The intended use locations for patients to be measured are in the home environment. Patient vitals captured on the device will be sent to a software designed to collect and transmit health information.
Intended use (Hillrom Connex App)
The Hillrom™ Connex® software is designed to collect, track, trend, and retrospectively transmit health information (e.g., blood pressure, SpO2, temperature, and pulse rate) from commercially available wireless FDA cleared medical in-home devices, and health and wellness devices, to an online (cloud) database. With user’s consent, this information will be shared with a healthcare provider.
The Hillrom Connex software is not intended for use in the diagnosis, cure, treatment, or prevention of disease. It is not intended as a substitute for medical care by a health care provider. It is not intended for emergency use or real-time monitoring.
Validation of the integration of the Bluetooth radio, the home user screen and power cord into the Welch Allyn® Spot Vital Signs 4400 device was completed through software verification testing and design validation of the changes to the user interface, power cord and Bluetooth radio, and IFU. The Spot 4400 device has been tested and shown to comply with IEC 60601-1 Edition 3.1, IEC 60601-1-2 4th Edition and IEC 60601-1-11 2nd edition. A Risk assessment has been performed according to ISO 14971. Any identified hazards have been found to be acceptable.
See the Instructions for Use included on the enclosed CD, the Addendum, and the Quick Reference for a complete list of Warnings and Cautions.
For Further information on the Hillrom Welch Allyn Spot4400 Home, including the Instructions for Use, Addendum and Quick Reference please visit Hillrom.com.