DizzyDoctor System 1.0.0

K182214 · Dizzydoctor Systems, LLC · GWN · Sep 14, 2018 · Neurology

Device Facts

• Record ID: K182214
• Device Name: DizzyDoctor System 1.0.0
• Applicant: Dizzydoctor Systems, LLC
• Product Code: GWN · Neurology
• Decision Date: Sep 14, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1460
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The DizzyDoctor® System 1.0.0 Eye Movement Monitor is indicated for use in the medical office, and in the home setting for monitoring patients with a diagnosis of dizziness caused by peripheral vestibular disorders who are under the supervision of a physician. The device detects abnormal eye movements in standard positional maneuvers by recording, tracking, storing and displaying vertical, horizontal eye movements. This device provides no diagnosis and does not provide diagnostic recommendations.

Device Story

DizzyDoctor® System 1.0.0 monitors eye movements in patients with peripheral vestibular disorders. System comprises Vertigo Recording Goggles (VRG) with secure iPhone docking station, macro lens, and LED illumination. Patient uses iPhone app for audio-guided Dix-Hallpike maneuvers; gyroscopic feedback ensures correct head positioning. iPhone camera records eye movements; video data stored and uploaded via web-based platform. Used in medical office by professionals or at home by patients under physician supervision. Physicians access processed videos via desktop computer to evaluate vestibular function. Device provides no diagnosis or recommendations; aids clinical decision-making by providing video evidence of abnormal eye movements.

Clinical Evidence

No clinical trials; evidence based on bench testing and usability studies. Three human factors studies (n=25 total) confirmed user competency in device setup, self-testing, and data management. Audiologist evaluation (n=2) showed 100% agreement between DDS 1.0.0 and predicate device in identifying pathological nystagmus. Bench testing confirmed compliance with electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and biocompatibility (ISO 10993) standards.

Technological Characteristics

Monocular goggle frame with light-occluding design; LED illumination; iPhone-based camera with macro lens. Powered by CR2 3V battery. Connectivity via web-based platform for video upload. Software-based recording and storage. Biocompatible materials per ISO 10993. Conforms to ANSI S3.45-2009 for vestibular testing.

Indications for Use

Indicated for patients with a diagnosis of dizziness caused by peripheral vestibular disorders, under physician supervision, for monitoring abnormal eye movements during standard positional maneuvers in medical office or home settings.

Regulatory Classification

Identification

A nystagmograph is a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.

Predicate Devices

• VisualEYES Video Eye Monitor (K964325)

Submission Summary (Full Text)

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September 14, 2018

DizzyDoctor® Systems, LLC % Mark Job Responsible Third Party Reviewer Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, MN 55313

Re: K182214

Trade/Device Name: DizzyDoctor® System 1.0.0 Regulation Number: 21 CFR 882.1460 Regulation Name: Nystagmograph Regulatory Class: Class II Product Code: GWN Dated: June 2, 2018 Received: August 15, 2018

Dear Mark Job:

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/cfpm/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.

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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 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 (reporting of medical devicerelated adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html: 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely yours,

# Srinivas Nandkumar -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K182214

Device Name DizzyDoctor® System 1.0.0

#### Indications for Use (Describe)

The DizzyDoctor® System 1.0.0 Eye Movement Monitor is indicated for use in the medical office, and in the home setting for monitoring patients with a diagnosis of dizziness caused by peripheral vestibular disorders who are under the supervision of a physician. The device detects abnormal eye movements in standard positional maneuvers by recording, tracking, storing and displaying vertical, horizontal eye movements. This device provides no diagnosis and does not provide diagnostic recommendations.

Type of Use (Select one or both, as applicable):

| <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
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# 510(k) Summary

Date of Summary Preparation: 06/02/2018

## 1. Submitter Information

DizzyDoctor® Systems, LLC 7625 Mesa College Drive, Suite 200A San Diego, CA 92111

Tel: [phone] Contact: Ian Purcell MD, PhD

## 2. Device Identification

| Proprietary Name: | DizzyDoctor® System 1.0.0 |
|-----------------------|---------------------------------------------------|
| Common Name: | Eye Movement Monitor |
| Classification Name: | Nystagmograph (21CRF 882.1460) |
| Product Code: | GWN |
| Device Class: | Class 2 |
| Panel: | Neurology |
| 3. Predicate Devices: | VisualEYES Video Eye Monitor; K964325; 07/15/1997 |

Micromedical Technologies.

Indications for Use: The DizzyDoctor® System 1.0.0 Eye Movement Monitor is indicated for use in the medical office, and in the home setting for monitoring patients with a diagnosis of dizziness caused by peripheral vestibular disorders who are under the supervision of a physician. The device detects abnormal eye movements in response to standard positional maneuvers by recording, tracking, storing and displaying vertical, horizontal and torsional eye movements. This device provides no diagnosis and does not provide diagnostic recommendations.

Device Description: Dizziness and postural instability are common in patients in Otolaryngology practice. Accurate diagnosis and choice of treatment is hampered by difficulties in obtaining thorough histories and perceptions that physical examination is complex. The DizzyDoctor® System 1.0.0 broadens physician access to video recordings of abnormal eye movement disorders with an easily operated device for in-office use by health professionals and for in-home use by patients experiencing exacerbating episodes of dizziness outside the office setting.

Using mobile and web-based technology, The DizzyDoctor® System 1.0.0 allows recording of patient of abnormal eye movements in response to standard head positions used for monitoring peripheral vestibular disorders such as Benign Paroxysmal Vertigo. It consists of Vertigo Recording Googles (VRG) with a secure holder for the patient's iPhone Application for step-by-step audio instructions for medically-recognized Dix-Hallpike maneuvers, gyroscopic feedback for enabling correct head positioning, and accurate video-recording of eye movements in response to standard head positions used for assessing balance disorders.

The VRG secure docking station for the iPhone which aligns with the patient's pupil. The VRG has no direct electrical connection with external devices or equipment, and uses light from two LEDs during

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recording sessions. The VRG uses a standard iPhone compatible macro lens to adjust the focal length of the iPhone camera lens, and secures with a flexible headband.

Key components of the patient's iPhone support the DizzyDoctor® System 1.0.0 including: an accelerometer and gyroscope, a video camera, storage of video recordings, audio voice/speaker system for real-time interaction with the patient, standard software for downloading and playing mobile applications from external App vendors, software for web-based processes including uploading stored videos.

The DizzyDoctor® Mobile App provides audio support for step-by-step procedures in recording eye movements in relation to positional changes during self-testing, The DizzyDoctor® System is supported by a comprehensive web-based platform for secure patient and physician registration, as well as uploading, processing and downloading videos from the professional- and self-testing for abnormal eye movements. Processed videos are accessed and viewed by physicians on their desk-top office computers.

| VisualEyes Video Monitor | DizzyDoctor® System 1.0.0 eye<br>movement monitor | Assessment of Substantial<br>Equivalence |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Anatomical Site: | | |
| Human Eye | Human Eye | Same |
| Intended Use: | | |
| Support evaluation and<br>diagnosis of vestibular disorders<br>from observation of eye<br>movements from various stimuli | Support evaluation and<br>diagnosis of vestibular disorders<br>using standard positional<br>maneuvers. | Same with respect to stimuli<br>from positional maneuvers. |
| Indications for Use: | | |
| The Eye Movement Monitor is<br>used to observe eye movements<br>from various stimuli used in<br>vestibular diagnostic testing. It<br>allows observation of horizontal,<br>vertical and torsional eye<br>movements. | The DizzyDoctor® System 1.0.0<br>is indicated for use in the med-<br>ical office, and in the home<br>setting for patients with a<br>diagnosis of dizziness caused by<br>peripheral vestibular disorders<br>who are under the supervision of<br>a physician. The device detects<br>abnormal eye movements in<br>response to standard positional<br>maneuvers by recording,<br>tracking, storing and displaying<br>vertical, horizon-tal and<br>torsional eye move-ments. This<br>device provides no diagnosis<br>and does not provide diagnostic<br>recommendations.<br>Caution: Federal law restricts<br>this device to sale by or on the<br>order of a physician. | Substantially equivalent, except<br>for the following differences.<br><br>DDS 1.0.0 is intended for use in<br>the medical office as well as by<br>the patient in the home setting,<br>as prescribed by the patient's<br>doctor. The predicate device is<br>not used in the home setting.<br><br>DDS 1.0.0 is indicated for<br>monitoring in patients with a<br>diagnosis of peripheral<br>vestibular disorders.<br>DDS 1.0.0 does not support<br>caloric testing; the predicate<br>can.<br><br>DDS 1.0.0 is a monocular<br>device; the predicate is<br>monocular and binocular.<br><br>DDS 1.0.0 uploads videos of<br>eye movement testing in the<br>medical office or home settings<br>directly to the DDS website for<br>viewing by patients or patient's |
| | | physician. For the predicate<br>access is limited to the doctor,<br>and remote access to remote in-<br>home testing observations is not<br>possible. |
| <b>Intended Use:</b><br>For observing eye movements<br>during vestibular testing to<br>support diagnostic testing of<br>vestibule-ocular disorders. | For observing eye movements<br>during vestibular testing to<br>support diagnostic testing of<br>vestibule-ocular disorders. | Substantially equivalent |
| <b>Mechanical Construction:</b><br>A light occluding goggle frame<br>on which a small camera views<br>the eye. | A light occluding goggle frame<br>on which a small camera views<br>the eye. | Substantially equivalent |
| <b>Method of Viewing:</b><br>Monocular or binocular | Monocular | Substantially equivalent |
| LED side-lights<br>Built in light shielding to block<br>external light | LED side lights built into goggle<br>Built-in light shielding to block<br>external light | Substantially equivalent |
| Viewed by direct observation<br>optionally on video tape with<br>separate device | Viewed on physician's office<br>computer or laptop and patient's<br>computer | Substantially equivalent |
| <b>Power Source/Control:</b><br>Mains/electrical outlet | CR2 3V battery | Substantially equivalent |
| On/off button switch on goggles to<br>start, stop and abort recordings<br>during Dix-Hallpike and Positional<br>Tests. | Button switch on googles to turn<br>LED illumination on/off. Button<br>on iPhone mounted on google<br>allows on/off control during<br>recording sessions. | Substantially equivalent |
| <b>Camera:</b><br>Cameras mounted on top of goggles<br>and close to the forehead | Camera is in patient's or<br>physician's iPhone, which is<br>affixed at eye level eye to the<br>goggle's Mounting Plate that<br>aligns the iPhone camera to the<br>patient's eye. | Substantially equivalent |
| <b>Remote Access to Recordings:</b><br>Not available | Remote access to eye movement<br>videos recorded in the home<br>setting through uploads from the<br>patient's iPhone to the DDS<br>website which can be down-<br>loaded by patients and their<br>physicians. | Different |
| Human Factors: | | |
| Physician or technician guided<br>testing in the medical office | Physician or technician guided<br>testing for first use of the VRG,<br>and helper-guided testing for in-<br>home setting | Substantially equivalent<br><br>For remote recording in the<br>home setting, the patient's<br>helper is trained at the doctor's<br>office, and supported by audio-<br>instructions on the iPhone<br>during positional maneuvers and<br>eye movement recoding. |
| American National Standard<br>Institute (ANSI) Procedures<br>for Testing Basic Vestibular<br>Function. | | |
| Not reported for predicate by<br>manufacturer | Conformance by comparative<br>performance testing of DDS<br>1.0.0 with predicate for position-<br>ing and positional Nystagmus.<br>ANSI S3.45-2009 (2014) | Substantially equivalent |
| Conformance to ISO, IEC,<br>EN, CISPR, ASTM standards<br>listed below. | | |
| Not reported for predicate by<br>manufacturer | Conformance to standards listed<br>in table below. | Substantially equivalent |

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Testing: Testing showed the DizzyDoctor® System 1.0.0 to be in compliance with standards listed in the table. Quality System Management approaches were employed in the development of the DizzyDoctor® System 1.0.0 per 21CFR 820.

Biocompatibility testing was undertaken for Applied Parts of the VRG that may come in contact with a health professional or patient during testing. The DizzyDoctor® System 1.0.0 complied with the following recognized standards, as listed in the table: ISO10993-1: 2009, Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process; ISO10993-5:2009, Biological Evaluation of Medical Devices- Part 5: Tests for In Vitro Cytotoxicity ISO10993-10:2010; Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization. Additional durability testing of the VRG labels showed them to be resistant to abrasion and peel.

Software verification and validation was undertaken, and documents were provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Device." The software for this device was considered as a "moderate" level of concern, since a failures or latent design flaws in the software could lead to incorrect or delayed information that could result in non-serious injury of the patient. The device provides no diagnosis, and is one of a battery of tests that are currently used by physicians for vertiginous patients.

Usability/human factors (engineering) testing was performed in three studies. In Study 1, testing of the 30 unique user interface parameters for the DizzyDoctor® System 1.0.0 was performed in 10 subjects who were vertiginous and 10 who were non-vertiginous users. The results revealed that subjects completed the interface tasks competently. Even though two subjects were observed to have difficulty a task at a particular interface, they were able to self-correct and complete the set-up, self-test and after-test activities completely and accurately. In Study 2, methodology similar to that in Study 1 was adopted, and this study extended to two audiologists' evaluations of in-use eye movement recordings and nystagmographs from the DizzyDoctor® System and from the predicate device. The results indicated that

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the audiologists agreed 100% of the time with respect to the presence or absence of pathological nystagmus in the video recordings from the subject and predicate devices. Study 3 was performed in five subjects using similar methodology as in Studies 1 and 2, but aimed at determining whether changes for a software revision might interfere with functions of the user interface. The results indicated that all subjects accomplished the operational tasks. The software revision used in Study 3 was adopted as the production version of the DDS software (i.e., iOS App and Website/Web portal).

Performance, biocompatibility, electrical safety and electromagnetic compatibility (EMC) testing was undertaken on the DizzyDoctor® System 1.0.0, as itemized in the table below, in accordance with the requirements of the design control regulations and established quality assurance procedures. The device passed all testing and conformance standards listed, and represents a low level of residual risk.

Conclusion: The DizzyDoctor® System 1.0.0 Eye Movement Monitor is substantially equivalent to the predicate device.

| # | Standard | Name | Date | FDA<br>Recog-<br>nition |
|--------------------------------|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|-------------------------|
| 1 | IEC 60601-1:2005<br>+CORR 2006<br>+CORR 2:2007 +<br>AM1:2012 | Medical electrical equipment - Part 1: General<br>requirements for basic safety and essential<br>performance. | 2012 | 19-4 |
| 2 | IEC 60601-1-11 | Medical electrical equipment -- Part 1-11: General<br>requirements for basic safety and essential<br>performance -- Collateral standard: Requirements<br>for medical electrical equipment and medical<br>electrical systems used in the home healthcare<br>environment. | 2015 | 19-6 |
| 3 | IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General<br>requirements for basic safety and essential<br>performance - Collateral Standard: Electromagnetic<br>disturbances - Requirements and tests. | 2014 | 19-8 |
| 4 | CISPR<br>11:2009+A1:2010 | Industrial, scientific and medical (ism) radio<br>frequency equipment - radio disturbance<br>characteristics - limits and methods of<br>measurement. | 2009 | No |
| 5 | IEC 61000-4-2:2008 | Electromagnetic compatibility - testing and<br>measurement techniques - electrostatic discharge<br>immunity test. | 2008 | No |
| 6 | IEC 61000-4-3:2006<br>A1:2007 + A2:2010 | Electromagnetic compatibility - testing and<br>measurement techniques -radiated radio frequency<br>electromagnetic field immunity test. | 2006 | No |
| 7 | IEC 61000-4-4:2011 | Electromagnetic compatibility - testing and<br>measurement techniques - electrical fast transient /<br>burst immunity. | 2011 | No |
| 8 | IEC 61000-4-5:2005 | Electromagnetic compatibility - testing and<br>measurement techniques - surge immunity test. | 2005 | No |
| 9 | IEC 61000-4-6:2003<br>+ A1:2004 +<br>A2:2006 | Electromagnetic compatibility, testing and<br>measurement techniques, conducted radio<br>frequency electromagnetic field, immunity test. | 2003 | No |
| 10 | IEC 61000-4-8:2009 | Electromagnetic compatibility - testing and<br>measurement techniques - for power frequency<br>magnetic field, immunity test. | 2009 | No |
| 11 | IEC 61000-4-<br>11:2004 | Electromagnetic compatibility - testing and<br>measurement techniques - voltage dips, short<br>interruptions and voltage variations immunity tests. | 2004 | No |
| 12 | ISO 10993-1 | Biological Evaluation of Medical Devices - Part 1:<br>Evaluation and Testing Within a Risk Management<br>Process. (Biocompatibility) | 2009 | 2-156 |
| 13 | ISO 10993-5 | Biological evaluation of medical devices - part 5:<br>tests for in vitro cytotoxicity. | 2009 | 2-153 |
| 14 | ISO 10993-10 | Biological evaluation of medical devices - part 10:<br>tests for irritation and skin sensitization. | 2010 | 2-173 |
| 15 | ASTM D903 | Standard Test Method for Peel or Stripping<br>Strength of Adhesive Bonds. | 2010 | 5-42 |
| 16 | ASTM D1319 | Standard Test Method for Hydrocarbon Types in<br>Liquid Petroleum Products by Fluorescent Indicator<br>Adsorption, as modified Crock Test - Dry Rub &<br>Wet Rub | 2015 | No |
| 17 | ASTM 5135 | Standard Test Method for Analysis of Styrene by<br>Capillary Gas Chromatography. | 2016 | No |
| 18 | IEC 61000-4-28 | Electromagnetic compatibility (EMC) - Part 4-28:<br>Testing and measurement techniques - Variation of<br>power frequency, immunity test for equipment with<br>input current not exceeding 16 A per phase. | 2009 | No |
| 19 | ISO 14971:2007 | Medical devices - Application of risk management<br>to medical devices. | 2007 | 5-40 |
| 20 | ISO 15223 | BS EN ISO 15223-1: 2016. Medical devices—<br>Symbols to be used with medical device labels,<br>labeling and information to be supplied. Part 1:<br>General requirements, ISO 7000 Reg. No. 1641. | 2016 | 5-117 |
| 21 | EN 50419 | BS EN 50419:2006. Marking of electrical and<br>electronic equipment in accordance with Article<br>11(2) of Directive 2002/96/EC (WEEE). | 2002 | No |
| 22 | ANSI S3.45-2009<br>(Reaffirmed 2014) | American National Standard Procedures for Testing<br>Basic Vestibular Function. (Dental/ENT):<br>Positioning and Positional Nystagmus. | 2014 | 4-185 |
| END OF DOCUMENT<br>vf_06012018 | | | | |

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