(30 days)
EaseVRx (DEN210014)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on preloaded software content delivering automated therapy based on established behavioral methods, not adaptive or learning algorithms.
Yes
The device is described as "a prescription-use immersive virtual reality system intended to provide adjunctive treatment" and its purpose is for "the reduction of pain interference associated with chronic lower back pain," indicating its therapeutic intent.
No
Explanation: The device is described as an "adjunctive treatment" for chronic lower back pain, delivering therapy, and is not mentioned to be used for diagnosing any condition.
No
The device description explicitly states it is "preloaded software content on a proprietary hardware platform" and includes a "Breathing Amplifier," which is a mechanical attachment. This indicates the device is a combination of software and hardware, not software-only.
Based on the provided information, the RelieVRx device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- RelieVRx Function: The RelieVRx device is a virtual reality system that delivers therapeutic content based on cognitive behavioral therapy and other behavioral methods. It is used to treat chronic lower back pain by providing adjunctive treatment and reducing pain interference.
- Lack of Sample Analysis: The description of RelieVRx does not mention any analysis of samples taken from the patient's body. Its function is based on delivering immersive content and guiding behavioral exercises.
Therefore, RelieVRx falls under the category of a therapeutic device rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
ORA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower back
Indicated Patient Age Range
age 18 and older
Intended User / Care Setting
in-home use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Substantial equivalence of the subject device to the predicate has been established through the results of nonclinical testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
EaseVRx (DEN210014)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "U.S. Food & Drug Administration" in blue.
December 4, 2024
AppliedVR Michael Chibbaro Vice President, Quality Affairs and Regulatory Affairs 16760 Stagg St Van Nuys, California 91406
Re: K243417
Trade/Device Name: RelieVRx Regulation Number: 21 CFR 890.5800 Regulation Name: Virtual reality behavioral therapy device for pain relief Regulatory Class: Class II Product Code: ORA Dated: October 31, 2024 Received: November 4, 2024
Dear Michael Chibbaro:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrb/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
2
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Amber T. Ballard -S
Amber Ballard, PhD Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K243417
Device Name RelieVRx
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY - K243417
| Manufacturer/Submitter: | AppliedVR
16760 Stagg St
Van Nuys, CA, 91406
Phone: (844) 857-0010 |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Contact: | Michael Chibbaro
Vice President, QA/RA
Phone: (408) 718-5657
Email: mchibbaro@appliedvr.io |
| Date Prepared: | December 4, 2024 |
| Device Trade Name: | RelieVRx |
| Regulation and
Classification Description: | 21 CFR 890.5800, Virtual reality behavioral therapy device for pain relief |
| Class: | II |
| Product Code: | QRA |
| Predicate Device: | EaseVRx (DEN210014) |
Indications for Use
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 and pain interference associated with chronic lower back pain.
Device Description
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
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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.
Principles of Operation
Similar to the predicate device, EaseVRx (DEN210014), RelieVRx is designed to scaffold learning of pain relief skills by delivering therapeutic principles in VR through an 8-week, 56-day program. Each of the 56 VR sessions is 2-16 minutes in length (average of 6 minutes). The content and associated scripts are structured in a logical sequence such that informational content (cognitive) is delivered in conjunction with experiential content (behavioral), allowing the user to become educated and skilled in the techniques necessary to mitigate their pain.
| | RelieVRx
(K243417, Subject device) | EaseVRx
(DEN210014, Predicate device) |
|---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation/
Product Code | 21 CFR 890.5800 (Virtual reality
behavioral therapy device for pain
relief) | 21 CFR 890.5800 (Virtual reality
behavioral therapy device for pain relief) |
| | QRA (Virtual Reality Behavioral
Therapy Device For Pain Relief) | QRA (Virtual Reality Behavioral
Therapy Device For Pain Relief) |
| Indications
for Use | RelieVRx is a prescription-use
immersive virtual reality system
indicated 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). | EaseVRx is a prescription-use immersive
virtual reality system indicated 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 and pain
interference associated with chronic
lower back pain. | The device is intended for in-home use
for the reduction of pain and pain
interference associated with chronic
lower back pain. |
| Head-Mounted Device (HMD) Specifications | | |
| HMD Manufacturer and
Model Number: | GoerTek Technology Inc.
Model: A7Q10/Pico G3 | GoerTek Technology Inc.
Model: A7510/Pico G2 4K |
| HMD Reference Number | RVX-3001 | Not publicly available |
| Rating: | 5VDC 3.0A and 9VDC 3A | 5V DC, 2A |
| Screen Resolution | 3664 x 1920 | 3840 x 2160 |
| | RelieVRx
(K243417, Subject device) | EaseVRx
(DEN210014, Predicate device) |
| Number of Pixels Per Eye
(horizontal / vertical): | 1832 x 1920 | 1907 x 1964 |
| Field of View Per Eye
(horizontal / vertical): | 98 / 98 | 98 / 101 |
| Luminance (Minimum and
maximum) | 20nit and 90nit | 0.06nit and 64.7nits |
| CPU: | Qualcomm XR2 | Not publicly available |
| Weight: | 380g (w/o Band), 604g (total) | 278g (w/o Band), 470g (total) |
| Frame-Rate: | 90 fps | 72 fps |
| Minimum Frame-Rate
Using the Software: | 60 fps | Not publicly available |
| Interpupillary Distance
(IPD) and IPD Range: | Default 63mm,
adjustable range from 58mm - 69mm | Default 63mm,
optical adaptive range is from 55~71mm |
| Range in Depths of the
Virtual Content in the
Software: | 2m for optics;
3m for launcher software | 2m for optics;
3m for launcher software |
| Eye Relief for Prescription
Lenses: | 17mm | 17mm |
| Storage: | 128GB | Not publicly available |
| Tracking degree of headset
x/y/z 360°: | 3 Degrees of Freedom (3DoF) | 3 Degrees of Freedom (3DoF) |
| Number of Discharge
Cycles: | 500 | Not publicly available |
| Expected Service Life of
the ME Equipment: | 3 year | Not publicly available |
| Type BF applied parts | Type BF applied parts | Not publicly available |
| Technical Specification of
USB-C Charger: | I/P: 100-240 Vac, 50/60Hz, 0.6A,
Class II
O/P 3.6-6V DC, 3A; 6-9V DC, 2A;
9-12V DC, 1.5A
I/P: 100-240 Vac, 50/60Hz, 0.5A,
Class II
O/P 5V DC, 3A; 9V DC, 2A; 12V
DC, 1.5A
I/P: 110-240 Vac, 50/60Hz, 0.6A,
Class II
O/P 5V DC, 3A; 9V DC, 2A; 12V
DC, 1.5A | Not publicly available |
| | RelieVRx
(K243417, Subject device) | EaseVRx
(DEN210014, Predicate device) |
| Frequency Range
(Bluetooth): | 2400-2483.5 MHz | Not publicly available |
| Max Output Power
(Bluetooth) | 10 mW | Not publicly available |
| Frequency Range (WiFi): | 2400 - 2483.5 MHz, 5150 - 5350
MHz Indoor use only, 5470 - 5725
MHz | Not publicly available |
| Max Output Power (WiFi): | 100 mW | Not publicly available |
| Prescription
or OTC | Prescription | Prescription |
| Energy Source | Rechargeable lithium battery through
a USB power supply port. | Rechargeable lithium battery through a
USB power supply port. |
Comparison of Technological Characteristics with the Predicate Device
Table 1: Comparison of Subject and Predicate Devices
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The indication for use (IFU) statements of the subject and the predicate devices are identical. The differences in technological characteristics are as follows:
- The RelieVRx (RVX-3001) uses a new head mounted device (Pico G3 VR HMD) whereas the predicate device uses the Pico G2 4K VR head mounted device.
- The RelieVRx (RVX-3001) contains a new user interface for the home screen. ●
- The RelieVRx (RVX-3001) contains updates to onboarding sequence to include reorientation and IPD ● (inter pupillary distance) adjustment.
- The RelieVRx (RVX-3001) changed its reorientation functionality from long press to short press. ●
- The RelieVRx (RVX-3001) contains visual enhancements and other minor adjustments such as: Hocus Focus environment update, onboarding timing and SFX adjustments, skip confirmation modal, analytics improvements, and session pause while in-app menu is active for quality-of-life updates.
- The RelieVRx (RVX-3001) contains bug fixes that were not present in EaseVRx. ●
Non-clinical Performance Testing
The following nonclinical performance testing was conducted to demonstrate substantial equivalence.
Electromagnetic Compatibility and Electrical Safety
RelieVRx was tested according to the following FDA-recognized consensus standards:
- IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020, "Medical Electrical Equipment; Part 1: General requirements for basic safety and essential performance." Results demonstrated that the device is compliant to this standard.
- IEC 60601-1-2: Edition 4.1 (2020), "Medical Electrical Equipment -Part 1-2: General Requirements for Basic Safety and Essential Performance-Collateral Standard: Electromagnetic disturbances -Requirements and Tests."
- IEC 60601-1-11:2015, IEC 60601-1-11:2015/AMD1:2020, "Medical electrical equipment: General ● requirements for basic safety and essential performance -Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare
8
environment."
Biocompatibility
Same as the predicate device, EaseVRx (DEN210014), device components that come in contact with the patient during use include: the Pico G3 headset face pad (Polyurethane or PU), straps (Silicone, PU, Polyethylene Terephthalate or PET, Polyurethane Fabric or Spandex, and Polyamides or Nylon), battery compartment (PU) and controller (Polycarbonate or PC, Acrylonitrile Butadiene Styrene or ABS). These components are considered surface medical device components with intact skin contact, for a cumulative limited contact duration (