(266 days)
The NeuroEars-Anna™ system provides information to assist in the nystagmographic evaluation, diagnosis, and documentation of vestibular disorders. Nystagmus of the eye is recorded using a head-mounted display equipped with eye-tracking cameras. These images are measured, recorded, displayed, and stored in the software. This information can then be used by trained medical professionals to assist in diagnosing vestibular disorders.
The NeuroEars-Anna™ system is intended for use in individuals aged 12 years and older, based on the physical compatibility of the FOVE VR headset (FOVE Inc., Japan). While the ANSI S3.45 standard does not define age-based limitations, the FOVE VR headset is generally suitable for individuals aged 12 and above. For improved fit, soft materials such as sponge pads may be used in cases where the headset does not conform properly to the user's face. This applies to both pediatric and adult patients. Any additional padding should be used only if it does not interfere with eye-tracking performance or measurement accuracy and must follow the manufacturer's instructions for proper use.
NeuroEars-Anna™ is a standalone software device that analyzes eye movements to assist medical professionals in the nystagmographic evaluation, diagnosis, and documentation of vestibular disorders. The NeuroEars-Anna™ software is intended to be used with off the shelf hardware including the HMD, PC, and monitors.
The NeuroEears-Anna™ software is designed to perform the following vestibular tests:
- Spontaneous Nystagmus Test
- Gaze-Evoked Nystagmus Test
- Head Shaking Nystagmus Test
- Fistula Nystagmus Test
- Dix-Hallpike Test
- Positional Test
- Smooth Pursuit Test
- Random Saccade Test
- Saccadometry Test
- Optokinetic Nystagmus Test
- Subjective Visual Vertical/Subjective Visual Horizontal (SVV/SVH)
- Caloric Test
- Video Frenzel
NeuroEars-Anna™ is a software program that analyzes eye movements recorded from an eye-tracking camera mounted on a head-mounted display (HMD) with eye-tracking specifications suggested by ANSI/ASA S3.45-2009 (Reaffirmed by ANSI April 16, 2024 version). The HMD devices used can be commercial products such as the FOVE0 (powerd by FOVE Inc., Japan), which meet these minimum eye-tracking specifications. The software is intended to run on a Microsoft Windows PC platform.
Here's a breakdown of the acceptance criteria and study information for NeuroEars-Anna™, based on the provided FDA 510(k) Clearance Letter:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Test | Acceptance Criteria | Reported Device Performance | Pass/Fail |
|---|---|---|---|
| Eye Tracking Camera Frame Rate | • Minimum 60 Hz | • Hardware specification standard 120 Hz | Pass |
| Eye Tracking Accuracy | • Horizontal error: 0.1° to 1.0°• Vertical error: 0.4° to 1.0° | • Hardware specification standard: 1.15° median accuracy for uniform distribution across screen (<1 degree in center)• Internal validation results: Error within 1.0° | Pass |
| Visual Fixation Point Requirements | • The visual fixation point should move in various ways and speeds (0.2 Hz – 0.4 Hz) within a sufficient field of view of approximately 20° horizontally• The visual fixation point should be green-yellow or red | • Internal validation results: The visual fixation point moves in various ways and speeds (0.2Hz – 0.4Hz) within a sufficient field of view of approximately 20° horizontally• Internal validation results: The visual fixation point is red | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated for the non-clinical performance tests mentioned. The clinical study section mentions testing "across multiple oculomotor tests," but doesn't quantify the number of patients or cases.
- Data Provenance: Not explicitly stated for the non-clinical performance tests. For the clinical study, it's mentioned that NeuroEars-Anna™ was "tested side by side with its predicate device," but the location or whether the data was retrospective or prospective is not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This information is not provided in the given document. The non-clinical performance tests likely relied on instrument calibration and established measurement standards (like ANSI 3S.45). For the clinical study, it states the data is for "interpretation by qualified medical personnel trained in vestibular diagnostic testing," implying expert review, but the number and qualifications are not detailed.
4. Adjudication Method for the Test Set
- This information is not provided in the given document. For the non-clinical performance tests, adjudication would likely involve comparing device outputs against known or standard measurements. For the clinical study, the method for comparing NeuroEars-Anna™'s measurements to the predicate's and determining agreement or clinical reliability is not described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
- A MRMC comparative effectiveness study that explicitly measures how human readers improve with AI vs. without AI assistance is not explicitly described.
- The document states: "The NeuroEars-Anna™ was tested side by side with its predicate device across multiple oculomotor tests. The results of these tests confirm that the NeuroEars-Anna™ provides clinically reliable and equivalent measurements compared to the predicate..." This suggests a comparison of the device's output to a predicate, not necessarily a human reader performance improvement study. The "assist" nature of the device (providing information for trained medical professionals) implies human-in-the-loop, but the format of the study doesn't detail an explicit MRMC study measuring reader improvement.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Yes, the performance testing described in the "Performance Testing Results" table appears to be a standalone (algorithm only) evaluation against technical acceptance criteria. The "Eye Tracking Camera Frame Rate," "Eye Tracking Accuracy," and "Visual Fixation Point Requirements" are objective measurements of the device's technical capabilities, independent of human interpretation.
- Additionally, the device is described as "standalone software device that analyzes eye movements," reinforcing its independent algorithmic function.
7. The Type of Ground Truth Used
- For the non-clinical performance tests (Eye Tracking Camera Frame Rate, Eye Tracking Accuracy, Visual Fixation Point Requirements), the ground truth appears to be based on:
- Hardware specifications/standards: For frame rate and accuracy, referring to "Hardware specification standard" (e.g., 120 Hz, 1.15° median accuracy).
- Internal validation results: Comparing measurements against expected or reference values derived during internal testing, aligning with the ANSI 3S.45 standard.
- For the clinical study, the ground truth is implicitly established by comparison to a "predicate device" which is "clinically reliable." This suggests the predicate device's measurements serve as the reference standard for "equivalent measurements."
8. The Sample Size for the Training Set
- The document does not provide information on the sample size used for the training set. It focuses on the clearance process based on comparisons and specific performance tests.
9. How the Ground Truth for the Training Set Was Established
- The document does not provide information on how the ground truth for the training set was established, as the training set details are not included.
FDA 510(k) Clearance Letter - NeuroEars-Anna™
Page 1
August 25, 2025
NeuroEars Inc.
Hannah Taggart
Regulatory Associate
Empirical Technologies
4628 Northpark Drive
Colorado Springs, Colorado 80918
Re: K243709
Trade/Device Name: NeuroEars-Anna™
Regulation Number: 21 CFR 882.1460
Regulation Name: Nystagmograph
Regulatory Class: Class II
Product Code: GWN
Dated: November 27, 2024
Received: December 2, 2024
Dear Hannah Taggart:
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/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.
Page 2
K243709 - Hannah Taggart Page 2
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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
Page 3
K243709 - Hannah Taggart Page 3
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,
Shuchen Peng -S
Shu-Chen Peng, Ph.D.
Assistant Director
DHT1B: Division of Dental and ENT Devices
OHT1: Office of Ophthalmic, Anesthesia,
Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K243709
Device Name: NeuroEars-Anna™
Indications for Use (Describe):
The NeuroEars-Anna™ system provides information to assist in the nystagmographic evaluation, diagnosis, and documentation of vestibular disorders. Nystagmus of the eye is recorded using a head-mounted display equipped with eye-tracking cameras. These images are measured, recorded, displayed, and stored in the software. This information can then be used by trained medical professionals to assist in diagnosing vestibular disorders.
The NeuroEars-Anna™ system is intended for use in individuals aged 12 years and older, based on the physical compatibility of the FOVE VR headset (FOVE Inc., Japan). While the ANSI S3.45 standard does not define age-based limitations, the FOVE VR headset is generally suitable for individuals aged 12 and above. For improved fit, soft materials such as sponge pads may be used in cases where the headset does not conform properly to the user's face. This applies to both pediatric and adult patients. Any additional padding should be used only if it does not interfere with eye-tracking performance or measurement accuracy and must follow the manufacturer's instructions for proper use.
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."
Page 5
510(K) SUMMARY
| Submitter's Name: | NeuroEars Inc. |
|---|---|
| Submitter's Address: | (24232) 209-2F, 7, Huseok-ro 462beon-gilChuncheon-si, Gangwon-do, Republic of Korea |
| Submitter's Telephone: | +82-10-8919-4380 |
| Contact Person: | Hannah Taggart, MSEmpirical Technologies719- 457-1152htaggart@empiricaltech.com |
| Date Summary was Prepared: | August 25, 2025 |
| Trade or Proprietary Name: | NeuroEars-Anna™ |
| Device Classification Name: | Nystagmograph, vestibular analysis |
| Classification & Regulation #: | Class II per 21 CFR §882.1460 |
| Product Code: | GWN |
| Classification Panel: | Neurology |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
NeuroEars-Anna™ is a standalone software device that analyzes eye movements to assist medical professionals in the nystagmographic evaluation, diagnosis, and documentation of vestibular disorders. The NeuroEars-Anna™ software is intended to be used with off the shelf hardware including the HMD, PC, and monitors.
The NeuroEars-Anna™ software is designed to perform the following vestibular tests:
- Spontaneous Nystagmus Test
- Gaze-Evoked Nystagmus Test
- Head Shaking Nystagmus Test
- Fistula Nystagmus Test
- Dix-Hallpike Test
- Positional Test
- Smooth Pursuit Test
- Random Saccade Test
- Saccadometry Test
- Optokinetic Nystagmus Test
- Subjective Visual Vertical/Subjective Visual Horizontal (SVV/SVH)
- Caloric Test
- Video Frenzel
The NeuroEars-Anna™ system is to be used by trained personnel only, such as audiologists, ENT surgeons, doctors, hearing healthcare professionals, or personnel with a similar level of qualifications. The device should not be used without the necessary knowledge and training to understand its use and how to interpret the results.
The target population for the NeuroEars-Anna™ system is any individual who can wear the HMD according to the manufacturer's instructions for use.
Page 6
INDICATIONS FOR USE
The NeuroEars-Anna™ system provides information to assist in the nystagmographic evaluation, diagnosis, and documentation of vestibular disorders. Nystagmus of the eye is recorded using a head-mounted display equipped with eye-tracking cameras. These images are measured, recorded, displayed, and stored in the software. This information can then be used by trained medical professionals to assist in diagnosing vestibular disorders.
The NeuroEars-Anna™ system is intended for use in individuals aged 12 years and older, based on the physical compatibility of the FOVE VR headset (FOVE Inc., Japan). While the ANSI S3.45 standard does not define age-based limitations, the FOVE VR headset is generally suitable for individuals aged 12 and above. For improved fit, soft materials such as sponge pads may be used in cases where the headset does not conform properly to the user's face. This applies to both pediatric and adult patients. Any additional padding should be used only if it does not interfere with eye-tracking performance or measurement accuracy and must follow the manufacturer's instructions for proper use.
TECHNOLOGICAL CHARACTERISTICS
The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are identical between the subject and predicate device:
- Indications for Use
- Intended User Population
- Intended Patient Population
- Technological Characteristics
- Vestibular Tests
Predicate Device
| 510k Number | Trade or Proprietary or Model Name | Manufacturer | Product Code |
|---|---|---|---|
| K143607 | I-Portal® Neuro Otologic Test Center (NOTC) I-Portal® Video Nystagmography System (VNG) IPortal® Video Oculography Eye Tracking System (VOG) | Neuro Kinetics, Inc. | GWN |
Predicate Comparison Table
| Subject Device | Predicate | Comparison | |
|---|---|---|---|
| NeuroEars-Anna™ | I-Portal Neuro Otologic Test Center (NOTC), I-Portal Video Nystagmography System (VNG), and I-Portal Video Oculography Eye Tracking System (VOG) (K143607) | ||
| Regulation Number No. | 21 CFR 882.1460 | 21 CFR 882.1460 | Same |
| Product Code | GWN | GWN | Same |
| Indications for use | The NeuroEars-Anna™ system provides information to assist in the nystagmographic evaluation, diagnosis, and documentation of vestibular disorders. Nystagmus of the eye is recorded using a head-mounted display | I-Portal® Video-Nystagmography System (VNG)I-Portal® Video-Nystagmography System (VNG) is used in vestibular and neuro otologic diagnostic testing. The VNG provides stimuli to a patient through visual cues, monitors the patient's response, and | Same. The subject device has the same indications for use as the predicate device but uses a head-mounted display with eye-tracking cameras while the predicate is used with goggles with mounted cameras. |
Page 7
| Subject Device | Predicate | Comparison | |
|---|---|---|---|
| NeuroEars-Anna™ | I-Portal Neuro Otologic Test Center (NOTC), I-Portal Video Nystagmography System (VNG), and I-Portal Video Oculography Eye Tracking System (VOG) (K143607) | ||
| equipped with eye-tracking cameras. These images are measured, recorded, displayed, and stored in the software. This information can then be used by trained medical professionals to assist in diagnosing vestibular disorders.The NeuroEars-Anna™ system is intended for use in individuals aged 12 years and older, based on the physical compatibility of the FOVE VR headset (FOVE Inc., Japan). While the ANSI S3.45 standard does not define age-based limitations, the FOVE VR headset is generally suitable for individuals aged 12 and above. For improved fit, soft materials such as sponge pads may be used in cases where the headset does not conform properly to the user's face. This applies to both pediatric and adult patients. Any additional padding should be used only if it does not interfere with eye-tracking performance or measurement accuracy and must follow the manufacturer's instructions for proper use. | presents the data for interpretation by qualified medical personnel trained in vestibular diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.I-Portal® Video Oculography (VOG) SystemI-Portal® Video Oculography (VOG) System is used to monitor and record eye movements from various stimuli used in vestibular diagnostic testing. The system measures and records horizontal, vertical, and torsional eye movements, as well as pupil area. It is used in conjunction with various stimuli (rotary chair, manual (done by clinician) positional maneuvers, caloric tests, external stimulus) to detect and record nystagmus and eye tracings for interpretation by qualified medical personnel trained in vestibular diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations. | ||
| Description | NeuroEars-Anna™ is a software program that analyzes eye movements recorded from an eye-tracking camera mounted on a head-mounted display (HMD) with eye-tracking specifications suggested by ANSI/ASA S3.45-2009 (Reaffirmed by ANSI April 16, 2024 version). The HMD devices used can be commercial products such as the FOVE0 (powerd by FOVE Inc., Japan), which meet these minimum eye-tracking specifications. The software is intended to run on a Microsoft Windows PC platform. | The I-Portal device functions as a nystagmograph, defined by 21 CFR 882.1460 as "a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball." Through its nystagmograph functionality, the device is indicated for use as a diagnostic tool to assist trained physicians in their analysis of vestibular disorders, which requires the separation of central and peripheral nervous system deficits. The I-Portal is used in an institutional environment on the order of a physician.To achieve safe and effective clinical operation, the I-Portal device uses a battery of tests within a family of products: the NOTC, the VNG, and the VOG.The I-Portal NOTC features a rotational chair, the OKN optical stimulus, the PT laser target generator, the I-Portal VOG, and a test enclosure equipped with a communication system. Through the use of these elements and the VEST™ analysis software, the physician is able to schedule a set of tests isolating oculomotor and vestibular functions to help the physician understand possible vestibular disorders.The I-Portal VNG offers a subset of the NOTC tests and different vestibular tests through a device with a smaller physical footprint. The VNG has many of the same elements used in the NOTC configuration: the OKN optical stimulus, the PT laser target generator, the VOG, and the VEST | Same. The subject device analyzes eye tracking movements and is intended to be run on a Microsoft Windows PC platform like the predicate device. |
Page 8
| Subject Device | Predicate | Comparison | |
|---|---|---|---|
| NeuroEars-Anna™ | I-Portal Neuro Otologic Test Center (NOTC), I-Portal Video Nystagmography System (VNG), and I-Portal Video Oculography Eye Tracking System (VOG) (K143607) | ||
| equipped with eye-tracking cameras. These images are measured, recorded, displayed, and stored in the software. This information can then be used by trained medical professionals to assist in diagnosing vestibular disorders.The NeuroEars-Anna™ system is intended for use in individuals aged 12 years and older, based on the physical compatibility of the FOVE VR headset (FOVE Inc., Japan). While the ANSI S3.45 standard does not define age-based limitations, the FOVE VR headset is generally suitable for individuals aged 12 and above. For improved fit, soft materials such as sponge pads may be used in cases where the headset does not conform properly to the user's face. This applies to both pediatric and adult patients. Any additional padding should be used only if it does not interfere with eye-tracking performance or measurement accuracy and must follow the manufacturer's instructions for proper use.NeuroEars-Anna™ is a software program that analyzes eye movements recorded from an eye-tracking camera mounted on a head-mounted display (HMD) with eye-tracking specifications suggested by ANSI/ASA S3.45-2009 (Reaffirmed by ANSI April 16, 2024 version). The HMD devices used can be commercial products such as the FOVE0 (powerd by FOVE Inc., Japan), which meet these minimum eye-tracking specifications. The software is intended to run on a Microsoft Windows PC platform. | presents the data for interpretation by qualified medical personnel trained in vestibular diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.I-Portal® Video Oculography (VOG) SystemI-Portal® Video Oculography (VOG) System is used to monitor and record eye movements from various stimuli used in vestibular diagnostic testing. The system measures and records horizontal, vertical, and torsional eye movements, as well as pupil area. It is used in conjunction with various stimuli (rotary chair, manual (done by clinician) positional maneuvers, caloric tests, external stimulus) to detect and record nystagmus and eye tracings for interpretation by qualified medical personnel trained in vestibular diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.software platform. However, unlike the NOTC, it does not have the rotational chair, and does not utilize the enclosure / communication system, but the VNG can collect and analyze data from caloric and position tests. The VNG configuration is typically used in smaller clinics or conditions requiring device mobility.The third configuration of the NKI I-Portal is a digital eye tracking system – the I-Portal VOG. The VOG is incorporated within the NOTC and VNG configurations; however, the VOG can be used as a stand-alone product with the VEST software, but offering a subset of the tests afforded by either the NOTC or VNG.The I-Portal device functions as a nystagmograph, defined by 21 CFR 882.1460 as "a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball." Through its nystagmograph functionality, the device is indicated for use as a diagnostic tool to assist trained physicians in their analysis of vestibular disorders, which requires the separation of central and peripheral nervous system deficits. The I-Portal is used in an institutional environment on the order of a physician.To achieve safe and effective clinical operation, the I-Portal device uses a battery of tests within a family of products: the NOTC, the VNG, and the VOG.The I-Portal NOTC features a rotational chair, the OKN optical stimulus, the PT laser target generator, the I-Portal VOG, and a test enclosure equipped with a communication system. Through the use of these elements and the VEST™ analysis software, the physician is able to schedule a set of tests isolating oculomotor and vestibular functions to help the physician understand possible vestibular disorders.The I-Portal VNG offers a subset of the NOTC tests and different vestibular tests through a device with a smaller physical footprint. The VNG has many of the same elements used in the NOTC configuration: the OKN optical stimulus, the PT laser target generator, the VOG, and the VEST | Same. The subject device analyzes eye tracking movements and is intended to be run on a Microsoft Windows PC platform like the predicate device. |
Page 9
| Subject Device | Predicate | Comparison | |
|---|---|---|---|
| NeuroEars-Anna™ | I-Portal Neuro Otologic Test Center (NOTC), I-Portal Video Nystagmography System (VNG), and I-Portal Video Oculography Eye Tracking System (VOG) (K143607) | ||
| Description | software platform. However, unlike the NOTC, it does not have the rotational chair, and does not utilize the enclosure / communication system, but the VNG can collect and analyze data from caloric and position tests. The VNG configuration is typically used in smaller clinics or conditions requiring device mobility.The third configuration of the NKI I-Portal is a digital eye tracking system – the I-Portal VOG. The VOG is incorporated within the NOTC and VNG configurations; however, the VOG can be used as a stand-alone product with the VEST software, but offering a subset of the tests afforded by either the NOTC or VNG. | ||
| Intended User Population (operator) | The NeuroEars-Anna™ system is to be used by trained personnel only, such as audiologists, ENT surgeons, doctor's, hearing healthcare professionals, or personnel with a similar level of qualifications. The device should not be used without the necessary knowledge and training to understand its use and how to interpret the results. | The modified I-Portal has the same intended use and indications for use as the predicate device cleared per K083603. Both the modified I-Portal and its predicate device are intended to be used as a nystagmograph. The indications for use for the modified I-Portal device and the predicate device cleared per K083603 are identical, and are as follows:NOTCI-Portal® Neuro Otologic Test Center (NOTC) is a rotary chair system used in vestibular and neurootologic diagnostic testing. The NOTC provides stimuli to a patient through motion profiles and/or visual cues, monitors the patient's response, and presents the data for interpretation by qualified medical personnel trained in vestibular diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.VNGI-Portal® Video-Nystagmography System (VNG) is used in vestibular and neuro otologic diagnostic testing. The VNG provides stimuli to a patient through visual cues, monitors the patient's response, and presents the data for interpretation by qualified medical personnel trained in vestibular diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.VOGI-Portal® Video Oculography (VOG) System is used to monitor and record eye movements from various stimuli used in vestibular diagnostic testing. The system measures and records horizontal, vertical, and torsional eye movements, as well as pupil area. It is used in conjunction with various stimuli (rotary chair, manual (done by clinician) positional maneuvers, caloric tests, external stimulus) to detect and record | Same |
Page 10
| Subject Device | Predicate | Comparison | |
|---|---|---|---|
| NeuroEars-Anna™ | I-Portal Neuro Otologic Test Center (NOTC), I-Portal Video Nystagmography System (VNG), and I-Portal Video Oculography Eye Tracking System (VOG) (K143607) | ||
| nystagmus and eye tracings for interpretation by qualified medical personnel trained in vestibular diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.The modified I-Portal has the same intended use and indications for use as the predicate device cleared per K083603. Both the modified I-Portal and its predicate device are intended to be used as a nystagmograph. The indications for use for the modified I-Portal device and the predicate device cleared per K083603 are identical, and are as follows:NOTCI-Portal® Neuro Otologic Test Center (NOTC) is a rotary chair system used in vestibular and neurootologic diagnostic testing. The NOTC provides stimuli to a patient through motion profiles and/or visual cues, monitors the patient's response, and presents the data for interpretation by qualified medical personnel trained in vestibular diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.VNGI-Portal® Video-Nystagmography System (VNG) is used in vestibular and neuro otologic diagnostic testing. The VNG provides stimuli to a patient through visual cues, monitors the patient's response, and presents the data for interpretation by qualified medical personnel trained in vestibular diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.VOGI-Portal® Video Oculography (VOG) System is used to monitor and record eye movements from various stimuli used in vestibular diagnostic testing. The system measures and records horizontal, vertical, and torsional eye movements, as well as pupil area. It is used in conjunction with various stimuli (rotary chair, manual (done by clinician) positional maneuvers, caloric tests, external stimulus) to detect and record nystagmus and eye tracings for interpretation by qualified medical personnel trained in vestibular diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations. | |||
| Intended Patient Population | The target population for the NeuroEars-Anna™ system is any individual who can wear the HMD according to the manufacturer's instructions for use. | 18 years and above | The subject device is intended to be used with patients aged 12 and older. The predicate device was intended for ages 18+. The subject device included patients within this age group during clinical study to confirm this difference does not raise any questions for safety and efficacy of the subject device. |
| Technological characteristics | The NeuroEars-Anna™ system is intended to incorporate various Head mounted goggle with eye tracking camera, FOVE Inc. | The modified I-Portal has identical technological characteristics as the previously cleared predicate I-Portal (K083603), with the exception of the following modifications:User-defined normative data input and displayThe addition of user-defined normative data input and display does not alter the raw data or analysis results gathered from the patient. In current clinical practice, users may store normative data ranges in various locations (separate electronic files, written notes) or they may rely solely on their clinical judgment. This feature provides the user with a safe and convenient storage location for this information, as well as a way to easily analyze patient results with respect to the clinician's choice of normal values. By providing this feature, the software will eliminate the need to draw the normal areas by hand on screenshot printouts of every patient graph. Validation testing has been conducted to demonstrate that users can safely and effectively use the I-Portal with user-defined normative data input.Controlled rotation Head Impulse Test (crHIT)The crHIT test is a high acceleration inter aural rotation test performed in the I-Portal NOTC chair to examine the high-frequency properties of the peripheral vestibular system. The crHIT test is substantially equivalent to the head thrust test, previously cleared for the predicate device, as both tests collect similar data, include similar calculations, and provide similar outputs. Verification testing confirmed that hardware modifications do not impact the functionality of the I-Portal. Therefore, the addition of crHIT does not raise new questions of safety or effectiveness. | Different. The subject device is intended to be used with a head-mounted display similar to the predicate which is used with head mounted goggles. The predicate device also has a wider range of compatible hardware components. The subject device was tested in verification and validation testing to confirm the FOVE hardware is compatible with the subject software. |
| Hardware Platform | Commercial head mount goggles with 2D or 3D eye tracking camera FOVE Inc. | Goggles with mounted cameras | Similar. The subject device is intended to be used with a commercially available head |
Page 11
| Subject Device | Predicate | Comparison | |
|---|---|---|---|
| NeuroEars-Anna™ | I-Portal Neuro Otologic Test Center (NOTC), I-Portal Video Nystagmography System (VNG), and I-Portal Video Oculography Eye Tracking System (VOG) (K143607) | ||
| mount display while the predicate device is used with goggles mounted with cameras. The subject device is intended to be used with patients aged 12 and older. The predicate device was intended for ages 18+. The subject device included patients within this age group during clinical study to confirm this difference does not raise any questions for safety and efficacy of the subject device. Different. The subject device is intended to be used with a head-mounted display similar to the predicate which is used with head mounted goggles. The predicate device also has a wider range of compatible hardware components. The subject device was tested in verification and validation testing to confirm the FOVE hardware is compatible with the subject software. |
Vestibular tests
| Test | Subject Device | Predicate | Comparison |
|---|---|---|---|
| Calibration | Not Included | N/A | |
| Spontaneous Nystagmus Test | Spontaneous Nystagmus Test | Same. | |
| Gaze-Evoked Nystagmus Test | Gaze Nystagmus Vertical and Horizontal | Same. | |
| Dix-Hallpike Test | Dix-Hallpike Test | Same. | |
| Positional Test | Positional Test | Same. | |
| Caloric Test | Caloric Test | Same. | |
| Smooth Pursuit Test | Smooth Pursuit (CPT 92546) Vertical and Horizontal | Same. | |
| Random Saccade Test | Random Saccade Test | Same. | |
| Saccadometry Test | Saccade Vertical and Horizontal | Same. | |
| Optokinetic Nystagmus Test | Full Field Optokinetic (CPT 92544) | Same. | |
| Subjective Visual Vertical / Subjective Visual Horizontal (SVV/SVH) | Subjective Visual Vertical and Horizontal | Same. | |
| Video Frenzel | Video Frenzel | Same. | |
| Video Recording | Video Recording | Same. | |
| Head Shaking Nystagmus Test | Head Shaking Nystagmus Test | Same. | |
| Fistula Nystagmus Test | Not Included | N/A |
PERFORMANCE DATA
The NeuroEars-Anna™ was evaluated in performance testing to verify whether the system meets the required performance criteria for conducting Videonystagmography (VNG) in accordance with the ANSI 3S.45 standard.
Performance Testing Results
| Performance Test | Acceptance Criteria | Test Results | Pass/Fail |
|---|---|---|---|
| Eye Tracking Camera Frame Rate | • Minimum 60 Hz | • Hardware specification standard 120 Hz | Pass |
| Eye Tracking Accuracy | • Horizontal error: 0.1° to 1.0°• Vertical error: 0.4° to 1.0° | • Hardware specification standard: 1.15° median accuracy for uniform distribution across screen (<1 degree in center)• Internal validation results: Error within 1.0° | Pass |
| Visual Fixation Point Requirements | • The visual fixation point should move in various ways and speeds (0.2 Hz – 0.4 Hz) within a sufficient field of view of approximately 20° horizontally• The visual fixation point should be green-yellow or red | • Internal validation results: The visual fixation point moves in various ways and speeds (0.2Hz – 0.4Hz) within a sufficient field of view of approximately 20° horizontally• Internal validation results: The visual fixation point is red | Pass |
The results of this non-clinical testing show and support that the subject device is substantially equivalent to its legally marketed predicate device.
CLINICAL STUDY
Page 12
The NeuroEars-Anna™ was tested side by side with its predicate device across multiple oculomotor tests. The results of these tests confirm that the NeuroEars-Anna™ provides clinically reliable and equivalent measurements compared to the predicate and is therefore suitable for use in vestibular and neuro-otologic evaluations, with validated normative data and performance metrics supporting its intended diagnostic application.
CONCLUSION
The overall technological characteristics and mechanical performance data lead to the conclusion that the NeuroEars-Anna™ is substantially equivalent to the predicate device.
§ 882.1460 Nystagmograph.
(a)
Identification. A nystagmograph is a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.(b)
Classification. Class II (performance standards).