(30 days)
RelieVRx is a prescription-use immersive virtual reality system intended to provide adjunctive treatment based on cognitive behavioral therapy skills and other evidence based behavioral methods for patients (age 18 and older) with a diagnosis of chronic lower back-pain (defined as moderate to severe pain lasting longer than three months). The device is intended for in-home use for the reduction of pain interference associated with chronic lower back pain.
RelieVRx is an immersive virtual reality (VR) system with preloaded software content on a proprietary hardware platform that delivers automated cognitive behavioral therapy (CBT) and other behavioral methods to patients diagnosed with chronic lower back-pain (defined as moderate to severe pain lasting longer than three months). The VR content is delivered while incorporating CBT to enable diaphragmatic breathing exercises and mindfulness strategies, and is intended to be self-administered, unsupervised in the patient's home while the patient is in a seated position. Each device is intended for single patient use during treatment and can be used on multiple patients over the device lifetime. The medical device does not include nonmedical software and is only effective when treating chronic lower back pain.
Similar to the predicate device, EaseVRx (DEN210014), the Relie VRx device consists of an off-the-shelf VR head-mounted display with added Breathing Amplifier and AppliedVR developed software. The Breathing Amplifier is a mechanical attachment added to the commercially available headset which enables diaphragmatic breathing exercises designed to enhance the user's engagement by amplifying the user's exhalation into the on-board microphone. No change is being made to the core RelieVRx program used in the pivotal clinical trial conducted for market authorization; the 8-week theme-based structure, weekly VRexperience structure, and daily session structure is unchanged. Minor changes were made to the content of the 56 VR sessions. Briefly, 46 of 56 VR sessions are unchanged. Of the 10 sessions that have been updated, there were 3 changes to Relaxation/Interoceptive sessions, and 7 changes to Distraction sessions. The 3 Relaxation/Interoceptive sessions include slightly altered minor graphical rendering to improve images. The 7 changes to Distraction sessions include changed background which is dimmer to help to user to achieve the goal of attentional focus (dragonfly). There is no negative impact on safety or effectiveness.
The provided FDA 510(k) summary for RelieVRx (K243417) indicates that clinical testing was NOT performed for this specific submission to demonstrate substantial equivalence. Instead, substantial equivalence was established through the results of nonclinical testing and a comparison of technological characteristics to the predicate device, EaseVRx (DEN210014).
Therefore, I cannot provide information on acceptance criteria and a study that proves the device meets them from this document. The document states:
"Clinical Testing
Substantial equivalence of the subject device to the predicate has been established through the results of nonclinical testing."
Since no clinical study was conducted for this specific submission, the subsequent points regarding sample size, data provenance, ground truth, adjudication, MRMC studies, or standalone performance are not applicable based on the provided text.
§ 890.5800 Virtual reality behavioral therapy device for pain relief.
(a)
Identification. A virtual reality behavioral therapy device for pain relief is a device intended to provide behavioral therapy for patients with pain. Therapy is administered via a virtual reality display that utilizes a software program containing the behavioral therapy content.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing under the labeled conditions for use must validate the model of behavioral therapy as implemented by the device and evaluate all adverse events.
(2) The patient-contacting components of the device must be demonstrated to be biocompatible.
(3) Software verification, validation, and hazard analysis must be performed.
(4) Electromagnetic compatibility and electrical, mechanical, and thermal safety testing must be performed.
(5) Labeling must include the following:
(i) A warning regarding the risk of nausea and motion sickness;
(ii) A warning regarding the risk of discomfort from the device; and
(iii) A summary of the clinical testing with the device.