← Product Code [QRA](/submissions/NE/subpart-f%E2%80%94physical-medicine-therapeutic-devices/QRA) · K230825 # Smileyscope System (Therapy Mode) (K230825) _Smileyscope Holding, Inc. · QRA · Sep 25, 2023 · Neurology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/QRA/K230825 ## Device Facts - **Applicant:** Smileyscope Holding, Inc. - **Product Code:** [QRA](/submissions/NE/subpart-f%E2%80%94physical-medicine-therapeutic-devices/QRA.md) - **Decision Date:** Sep 25, 2023 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 890.5800 - **Device Class:** Class 2 - **Review Panel:** Neurology - **Attributes:** Therapeutic, Pediatric ## Indications for Use The Smileyscope System's Therapy Mode is a prescription-use immersive virtual reality system intended to provide adjunctive treatment based on guided relaxation and other evidence-based behavioral methods for patients aged 4-11 years who can cooperate and interact with the device at a developmentally appropriate level. The Smileyscope Therapy Mode is intended to temporarily reduce and/or manage pain and temporarily relieve acute procedural anxiety associated with needle procedures (e.g., venipuncture, IV placement, vaccination, port access, subcutaneous injections). The device is not intended to treat anxiety disorders or specific phobias (e.g. trypanophobia). ## Device Story Smileyscope is an immersive VR system for pediatric patients undergoing needle procedures. The device consists of a head-mounted display (Main Body) and a detachable touchscreen interface (Faceplate) containing an embedded mobile phone. Clinicians configure the device to deliver an interactive 'underwater adventure' VR experience, which incorporates guided relaxation and behavioral techniques. The system provides audio cues to synchronize with the procedure. The device is used in clinical settings to temporarily reduce pain and acute procedural anxiety. By providing an immersive distraction and relaxation experience, the device aims to improve the patient experience during needle-based interventions. The software is designed to minimize motion sickness and disequilibrium by limiting motion and optimizing object distances. ## Clinical Evidence Two randomized controlled studies (n=254 total) conducted outside the U.S. evaluated the device. Primary endpoints were child-rated pain (Faces Pain Scale-Revised) and procedural anxiety. In the Emergency Department study (n=123), the device showed a -1.78 unit pain reduction (95% CI, -3.24 to -0.32; p=0.018) compared to control. In the Outpatient Pathology study (n=129), the device showed a -1.39 unit pain reduction (95% CI, -2.68 to -0.11; p=0.034). Adverse effects were mild, self-limiting, and included nausea, dizziness, headache, and vomiting. ## Technological Characteristics Hardware includes a head-mounted display and detachable touchscreen interface (Google Pixel 3). Materials include PC/ABS and silicone. Sensing/actuation: 3 degrees of freedom head tracking. Connectivity: USB charging. Software: Pre-loaded VR behavioral therapy. Electrical safety: IEC 60950-1, IEC 62368-1. Biocompatibility: ISO 10993-5, ISO 10993-10. Display: 2160x1080 resolution, 60 fps, 90-degree FOV. ## Regulatory 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. ## Special Controls *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. ## Predicate Devices - EaseVRx ([DEN210014](/device/DEN210014.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. September 25, 2023 Smileyscope Holding Inc. Dr. Paul Leong Chief Medical Officer 701 Tillery Street #12 Austin, Texas 78702 Re: K230825 Trade/Device Name: Smileyscope System (Therapy Mode) Regulation Number: 21 CFR 890.5800 Regulation Name: Virtual reality behavioral therapy device for pain relief Regulatory Class: Class II Product Code: QRA Dated: August 28, 2023 Received: August 29, 2023 Dear Dr. Paul Leong: 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 (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 located at https://www.accessdata.fda.gov/scripts/cdrh/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. 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 {1}------------------------------------------------ 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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 mediation-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-regulatoryassistance/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 {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K230825 Device Name Smileyscope System (Therapy Mode) #### Indications for Use (Describe) The Smileyscope System's Therapy Mode is a prescription-use intual reality system intended to provide adjunctive treatment based on guided relaxation and other evidence-based behavioral methods for patients aged 4-1 years who can cooperate and interact with the device at a developmentally appropriate level. The Smileyscope Therapy Mode is intended to temporarily reduce and/or manage pain and temporarily relieve acute procedural with needle procedures (e.g., venipuncture, IV placement, vaccination, port access, subcutaneous injections). The device is not intended to treat anxiety disorders or specific phobias (e.g. trypanophobia). | 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)
| ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(k) Summary | Device Trade Name: | Smileyscope System (Therapy Mode) | |--------------------|-------------------------------------------------------------------------------| | Device Model: | SSVR US | | Common Name: | Virtual Reality Behavioral Therapy Device | | 510(k) Number: | K230825 | | Manufacturer: | Smileyscope Pty Ltd
1/333 Exhibition St
Melbourne VIC 3000
Australia | | Sponsor: | Smileyscope Holding Inc
701 Tillery Street #12
Austin, TX 78702 | | Contact: | Paul Leong
Chief Medical Officer
+1 888 300 7117 | | Prepared by: | MCRA, LLC
803 7th St NW
Washington, DC 20001
Office: 202.552.5800 | | Date Prepared: | September 21, 2023 | | Classification: | 21 CFR 890.5800 (Virtual Reality Behavioral Therapy Device Fo
Pain Relief) | | Class: | II | | Product Codes: | QRA | | Predicate Device: | EaseVRx (AppliedVR Inc), DEN210014 | {4}------------------------------------------------ ### Device Description: Smileyscope is an immersive virtual reality (VR) device, consisting of Hardware and Software components. In Smileyscope Therapy mode, the device delivers 3-dimensional virtual reality treatment based on guided relaxation and other evidence-based behavioral methods to temporarily reduce pain and temporarily relieve acute procedural anxiety in individuals undergoing needle procedures. This prescription-use device uses pre-loaded software on a proprietary hardware and software platform to deliver treatment. The Smileyscope device is supplied with a USB charger and USB cable to facilitate charging. ### Hardware: The physical device consists of two major subcomponents (Figure 1 and Figure 2). First, a detachable mobile interface, or "Faceplate", that clinicians can interact with via a touchscreen. The Faceplate contains an embedded mobile phone (Google Pixel 3) running Smileyscope software. Second, a head-mounted virtual reality headset, or "Main Body". The Main Body is placed on the patient's head and positioned via the Adjustable Head Strap. The Faceplate attaches to the Main Body via magnets (Figure 2, final step in Table 1). Lenses in the Main Body permit the display of virtual reality. Image /page/4/Figure/5 description: The image shows a medical device with three labeled parts: faceplate, main body, and adjustable head strap. The faceplate has a screen that displays the word "Therapy" and options for age and session length. The main body is white and curved, and the adjustable head strap is teal and appears to be made of a flexible material. The device is designed to be worn on the head. Figure 1: Smileyscope System, components labelled. {5}------------------------------------------------ Image /page/5/Picture/8 description: The image shows a SmileyScope device, which is a medical device used to assess pain in children. The device is white with a teal trim and has a head strap attached to it. The device has a screen that displays a smiley face, and there are two buttons on the top of the device, one green and one red. The device also has the word "smileyscope" printed on the side. Figure 2: Smileyscope System, Front View, with Frontplate Attached to Main Body. ### Software: Clinicians use the Smileyscope System to administer the Smileyscope Therapy mode. In this software mode, the Smileyscope System provides evidence-based virtual reality behavioral therapy during a needle procedure. While the patient undergoes the needle procedure in the real world, the Smileyscope Therapy Mode provides an interactive "underwater adventure" virtual reality experience. The virtual reality experience contains evidence-based guided relaxation and behavioral techniques designed to temporarily reduce pain and temporarily relieve acute procedural anxiety during needle procedures. The underwater adventure can be configured by the Clinician to last 1-10 minutes. Audio cues are provided throughout the virtual reality experience which allow the clinician to synchronize the procedure with common needle-based procedures. However, precise timing is not necessary. The experience loops if the procedure takes longer than anticipated. The workflow is elaborated in Table 1. The software has been designed to avoid common adverse effects associated with virtual reality. For example it contains minimal motion (to reduce motion sickness) and objects are positioned at optimal distances in the virtual environment so as to avoid virtual reality disequilibrium. {6}------------------------------------------------ Image /page/6/Figure/0 description: This image is a table describing the Smileyscope Therapy Mode Workflow. The table has two columns, one showing the Clinician Interface and the other providing a description. The Clinician Interface column shows three different screens: the Home Screen, the Smileyscope Therapy Menu, and the Body Part Selection screen. The Description column provides a description of each screen and how the clinician interacts with it. ### Table 1: Smileyscope Therapy Mode Workflow {7}------------------------------------------------ Image /page/7/Picture/0 description: This image shows the Smileyscope Therapy system and its virtual reality capabilities. The top left shows the calibration screen, and the middle left shows how the faceplate attaches to the main body. The right side of the image describes how the Smileyscope Therapy system engages virtual reality and displays two images, one for each eye, during the calibration screen. The bottom left shows the underwater adventure virtual reality view, and the right side describes the virtual reality experience and how it mimics real-world needle experiences. {8}------------------------------------------------ ### Indications For Use: The Smileyscope System's Therapy Mode is a prescription-use immersive virtual reality system intended to provide adjunctive treatment based on guided relaxation and other evidence-based behavioral methods for patients aged 4-11 years who can cooperate and interact with the device at a developmentally appropriate level. The Smileyscope Therapy Mode is intended to temporarily reduce and/or manage pain and temporarily relieve acute procedural anxiety associated with needle procedures (e.g., venipuncture, IV placement, vaccination, port access, subcutaneous injections). The device is not intended to treat anxiety disorders or specific phobias (e.g. trypanophobia). ### Comparison of Technological Characteristics With The Predicate Device and Substantial Equivalence: | Substantial
Equivalence
Criteria | Primary Predicate | Subject Device | Comparison | |----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------| | Indication for Use | EaseVRx, AppliedVR Inc

EaseVRx 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 | Smileyscope System
(Therapy Mode)
Smileyscope
Holding Inc

The Smileyscope
System's Therapy
Mode
is a prescription-use
immersive virtual
reality system
intended to provide
adjunctive treatment
based on guided
relaxation and other
evidence-based
behavioral methods
for patients aged 4-11
years. The
Smileyscope Therapy
Mode is
intended to temporarily
reduce
and/or manage pain
and temporarily
relieve acute
procedural anxiety
associated with
needle procedures | Smileyscope is used

in a pediatric
population, while
EaseVRx is used in
an adult population | ### Table 2: Summary of Substantial Equivalence Criteria, Primary Predicate, and Smileyscope System (Therapy Mode) {9}------------------------------------------------ | | reduction of pain and
pain interference
associated with chronic
lower back pain. | (e.g., venipuncture, IV
placement,
vaccination, port
access, subcutaneous
injections). The device
is not intended to treat
anxiety disorders or
specific phobias (e.g.
trypanophobia). | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------| | Intended Use | The device is intended
for in-home use for the
reduction of pain and
pain interference
associated with chronic
lower back pain. | The Therapy Mode
is intended to
temporarily reduce
and/or manage pain
and temporarily
relieve acute
procedural anxiety
associated with
needle procedures | Both are intended to
reduce pain | | Clinical or
scientific data that
demonstrates that
the device safe and
effective, and does
not raise different
questions of safety
and effectiveness
compared to the
predicate device. | Clinical and scientific
data: randomized
controlled study
demonstrating safety
and efficacy. (n=188)
Randomized, multi-
arm, "blinded" study
with concurrent sham
control. Location of
Study not publicly
available in Decision
Summary. | Clinical and
scientific data: two
randomized
controlled studies
demonstrating safety
and efficacy.
(combined n=254)
Randomized, multi-
arm, "blinded" study
with concurrent
("active") control.
Outside of United
States only. | Both have RCTs with
a large patient
population showing
effectiveness and
safety. | Table 3. Comparison of Technical Characteristics | Substantial
Equivalence Criteria | Primary Predicate | Subject Device | Comparison | |-------------------------------------|--------------------------------------------------------|---------------------------------------------------|------------| | | EaseVRx, AppliedVR
Inc | Smileyscope Therapy
Smileyscope Holding
Inc | | | Headset Manufacturer
and Model # | GoerTek Technology Inc.
Model: A 7510/Pico G2
4K | Smileyscope Hardware
Model: SSVR US | - | | Rating | 5V DC, 2A | 5V DC/3A or 9V/2A | Similar | {10}------------------------------------------------ | Weight | 278 (w/o Band), 470 | 530 grams | Similar, low risk characteristic | |--------|---------------------|-----------|----------------------------------| | | (total) | | | | Framerate in virtual
reality (frame per
second) | 72 fps | 60 fps | Similar | |------------------------------------------------------------------|-------------------------------------------------------------|------------------------------------------------------------------------------------|-------------------------------------| | Screen Resolution | 3840 X 2160 | 2160x1080 pixels | Similar, low risk
characteristic | | Number of pixels
horizontally and
vertically per eye | Horizontally: 1907
Vertically: 1964 | Horizontally: 1072
Vertically: 1072 | Similar, low risk
characteristic | | Luminance | Maximum: 0.06 nits
Minimum: 63.4 nits | 2.4 to 426 nits | Similar1 | | Interpupillary distance
(IPD) and IPD range of
the headset | Default 63mm, optical
adaptive range is from
55~71 mm | 64mm, approximately 55-
70mm usable range | Same | | Tracking degrees of
headset x/y/z 360° | 3 degrees of freedom | 3 degrees of freedom | Same | | Eye relief for
prescription lenses | 17mm | 16mm | Same | | Field of view per eye | Horizontally: 98
Vertically: 101 | Horizontal: 90 degrees
Vertical: 90 degrees | Similar | | Range in depths of the
virtual content in the
software | 2m for optics; 3m for
launcher software | 0.5m to infinity
depending on object
(arms at ~0.5m, horizon
at infinity) | Similar, not
clinically relevant | ### Table 4. Comparison of Device Risks | Primary Predicate: Identified Risk to
Health | Smileyscope Therapy: Mitigation Measure | |--------------------------------------------------------------|---------------------------------------------------------------------------------------------------| | Adverse tissue reaction | Biocompatibility evaluation
Labeling | | Electric shock or burn or interference with
other devices | Electromagnetic compatibility (EMC) testing
Electrical, mechanical, and thermal safety testing | | Nausea and motion sickness | Clinical performance testing
Labeling | | Discomfort | Clinical performance testing
Labeling | {11}------------------------------------------------ | Ineffective treatment | Clinical performance testing | |---------------------------------------------|-----------------------------------------------------------| | | Software verification, validation, and hazard
analysis | | | Labeling | | Use error or improper device use leading to | Labeling | | a delay in treatment | | 1 Nathan Matsuda et al., "Realistic Luminance in VR," in SIGGRAPH Asia 2022 Conference Papers (SA '22: SIGGRAPH Asia 2022, Daegu Republic of Korea: ACM, 2022), 1-8, https://doi.org/10.1145/3550469.3555427. {12}------------------------------------------------ Special Controls were applied to the Primary Predicate. Smileyscope submits that these Special Controls have been met by Smileyscope Therapy Mode. ### Table 5: Special Controls applied from the Primary Predicate ### Special Control from Primary Predicate (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 (iii) A summary of the clinical testing with the device ### Performance Testing Summary: The Smileyscope has undergone performance testing in line with FDA guidance documents, commensurate with the Predicate Device. ### Hardware Smileyscope's hardware has undergone performance testing. A summary is presented below. | Headset | Smileyscope Hardware | |-----------------------------------------------|----------------------------------------------------| | Rating | 5V DC/3A or 9V/2A | | Weight | 530 grams | | Framerate in virtual reality | 60 frames per second (fps) | | Screen Resolution | 2160x1080 pixels | | Horizontal and Vertical pixels per eye | 1072 x 1072 (horizontal x vertical) pixels per eye | | Luminance | 2.4 to 426 nits | | Interpupillary distance and range | 64mm, approximately 55-70mm usable range | | Tracking degrees of headset x/y/z 360 degrees | 3 degrees of freedom | | Eye relief for prescription lenses | 16mm | | Field of view per eye | 90 degrees
90 degrees | ### Table 6: Technical specifications {13}------------------------------------------------ ### Biocompatibility The physical device is constructed of materials found in the Primary Predicate and FDA cleared products (e.g. PC/ABS, silicone etc.). The patient contacting components have undergone Biocompatibility Evaluation per FDA guidance "Use of International Standard ISO 10993-1:2018, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (September 4, 2020). The patient contacting components are categorized as surface contacting with limited contact duration (less than 24 hours) of intact skin. Assessment of the device included the following tests according to the contact classification and duration of the patient-contacting materials: - Cytotoxicity (ISO 10993-5:2009) ● - Sensitization Test (ISO 10993-10:2010) ● - Intracutaneous Reactivity (ISO 10993-10:2010) ● ### Electrical Safety and Electromagnetic Capability The embedded mobile phone hardware has undergone electromagnetic compatibility and electrical, mechanical, and thermal safety testing and declared conformance to the following harmonized standards and normative documents: Electrical Safety: - IEC 60950-1:2005 + A1:2009 + A2:2013 - EN 60950-1:2006 + A11:2009 + A1:2010 + A12:2011 + A2:2013 ● - IEC 62368-1:2014, EN 62368-1:2014 + A11:2017 - EN 62311:2008, EN 62479:2010 ● - EN 50360:2017, EN 62209-1:2016 ● - EN 50566:2017, EN 62209-2:2010 . Electromagnetic Compatibility: - Draft EN 301 489-1 v2.2.0 ● - Final Draft EN 301 489-3 V2.1.1 ● - Draft EN 301 489-17 V3.2.0 - Draft EN 301 489-19 V2.1.0 ● - Draft EN 301 489-52 V1.1.0 . - EN 55032:2015/AC:2016 Class B ● - . EN 55035:2017 ### Software The sponsor provided documentation for software with a "Minor" Level of Concern (LoC), as described in the FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." issued May 11, 2005. Documentation describing the software, software requirements specification, traceability, revision level history, verification, validation, hazard analysis and cybersecurity provides the foundation that the software will operate in a manner as described in the specifications. ### Clinical Performance Testing {14}------------------------------------------------ Smileyscope Therapy Mode has undergone Clinical Performance Testing. Smileyscope Therapy Mode was tested in two independent randomized clinical studies, which have been peer-reviewed and published in the Journal of Pediatrics2. Briefly, in both studies Smileyscope Therapy Mode, consistently demonstrated benefits for the primary endpoint of child-rated pain, and substantially reduced the secondary endpoint of procedural anxiety. The pre-specified primary safety and effectiveness endpoints were met in both studies, which were conducted outside of the United States only, in comparable population(s). These are summarized in Table 3 below. Overall, Smileyscope Therapy Mode was safe, with no significant adverse effects, specifically with regards to the Identified Risks to Health from the Primary Predicate's Special Controls. Adverse effects were mild (nausea, dizziness, headache, vomiting) and were self-limiting; they did not require pharmacotherapy. | Stage | Smileyscope
Therapy Mode Total | Control Arm Total | Total | |--------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|------------------------|-------| | Emergency Department study | | | | | Enrollment | 64 | 59 | 123 | | Treatment | 64 | 59 | 123 | | Primary Safety Endpoint | Nil adverse effects | 4 mild adverse effects | | | Primary Effectiveness Endpoint: Change in Child Self-Rated Pain (Faces Pain Scale-Revised) | -1.39 | +0.39 | | | Between-Group Difference | -1.78 units pain reduction with Smileyscope
Therapy Mode
(95% CI, -3.24 to -0.32)
p=0.018 | | | | Outpatient Pathology study | | | | | Enrollment | 63 | 68 | 131 | | Treatment | 63 | 66 | 129 | | Primary Safety Endpoint | 3 mild adverse effects | 3 mild adverse effects | | | Primary Effectiveness Endpoint: Change in Child Self-Rated Pain (Faces Pain Scale-Revised) | +1.37 | +2.76 | | | Between-Group Difference | -1.39 units pain reduction with Smileyscope
Therapy Mode
(95% CI, -2.68 to -0.11)
p=0.034 | | | | Table 7: Summary of Smileyscope Therapy Mode Clinical Performance Testing | |---------------------------------------------------------------------------| |---------------------------------------------------------------------------| {15}------------------------------------------------ 2 Evelyn Chan et al., "Virtual Reality for Pediatric Needle Procedural Pain: Two Randomized Clinical Trials," The Journal of Pediatrics 209 (April 29, 2019): 160–67, https://doi.org/10.1016/j.jpeds.2019.02.03 ### Conclusion: Smileyscope Therapy Mode and the predicate device have intended use, have different technological characteristics, with appropriate clinical and scientific data that demonstrates the device is as safe and effective as a legally marketed device, and there are no different questions of safety and effectiveness than the predicate. The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performs as well as the Primary Predicate Device. {16}------------------------------------------------ --- **Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/QRA/K230825](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/QRA/K230825) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com