(273 days)
Not Found
No
The summary describes standard video recording and analysis of eye movements based on pre-defined test protocols and calculations (slow phase velocity, eye position shift). There is no mention of AI/ML algorithms being used for analysis, interpretation, or decision support beyond these standard measurements. The performance study focuses on comparing the device's measurements to a predicate device using statistical methods (Deming regression), not on validating an AI/ML model's performance.
No
The device is intended for viewing and recording eye movements to support the identification of vestibular disorders, not for direct treatment or therapy. It provides information for clinicians but no diagnosis or diagnostic recommendations.
No
The device description explicitly states: "This system provides no diagnosis and does not provide diagnostic recommendations." It is intended to provide information for clinicians as a supplement in clinical decision-making by viewing and recording eye movements.
No
The device description explicitly states that the NeuroSwift Pro is a "combination of hardware and software" and includes physical components like goggles, light reflectors, a USB cable, head strap, face cushion, and eye cover.
Based on the provided information, the NeuroSwift Pro is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The NeuroSwift Pro directly observes and records eye movements of a living patient. It does not analyze biological samples like blood, urine, or tissue.
- The intended use is for viewing and recording eye movements in support of identifying vestibular disorders. This is a direct assessment of a physiological function, not an analysis of a biological specimen.
- The device description details hardware (goggles, cameras) and software for capturing and analyzing eye movements. This aligns with a device used for direct physiological measurement.
Therefore, the NeuroSwift Pro falls under the category of a medical device used for physiological measurement and assessment, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
NeuroSwift Pro is intended for Viewing and recording eye movements in support of identifying vestibular disorders.The system is to be used by trained healthcare personnel in an appropriate healthcare setting. This system provides no diagnosis and does not provide diagnostic recommendations. The target population is 12+ years of age.
Product codes
GWN
Device Description
The NeuroSwift Pro is intended for viewing and recording eye movements in support of identifying vestibular disorders. The system is to be used by trained healthcare personnel in an appropriate healthcare setting. This system provides no diagnosis and does not provide diagnostic recommendations. NeuroSwift Pro. model NS01-2 contains goggles and software. The NeuroSwift Pro is a combination of hardware and software, designed to provide information for clinicians as a supplement in clinical decision-making by eye movements. The NeuroSwift Pro goggle is a see-through binocular video goggle with a pair of light reflectors and 3 metered, nylon braided USB cable connecting to the computer interface. Accompanying components include a stable and sturdy head strap, face cushion, and a lightweight eye cover. The hardware provides high-definition video recording capability. The NeuroSwift Pro software is a computer interface designed to record eye movement videos and simultaneously display the visual target(s) on the computer screen. The software provides vestibular test modes and calibration functions. Initially, the software instructs the users to follow calibration functions. Then, the examiner can observe spontaneous nystagmus using the eye cover. The examiner can perform oculomotor tests with the goggles, while the patient follows visual targets on the screen. During gaze tests, the patient will fixate on stationary white spots that are positioned at center, right, left, up and down. In saccade tests the patient is asked to stare at the target moving in horizontal, vertical, or mixed pattern. In pursuit tests the patient's ability to track a target that moves in a sinusoidal or triangular pattern across the screen. The optokinetic function provides a large moving checkerboard pattern on the screen. Patients can change in various body positions as directed by the clinician. The software measures the eye movement via slow phase velocity and measures the eye position shift and trace. The recorded video and test protocols are processed in the NeuroSwift Pro software. The NeuroSwift Pro generates the traces of eye movements, eye velocities, and analytical data, which allows the clinician to determine the response of the patient according to the test functions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Infrared video cameras mounted inside goggle
Anatomical Site
Eye
Indicated Patient Age Range
12+ years of age
Intended User / Care Setting
trained healthcare personnel in an appropriate healthcare setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Clinical Performance Testing: 10 subjects were evaluated using both the subject device and a legally marketed device (predicate device). Two experienced healthcare professionals (Evaluators) observed eye movements, generated test reports for each vestibular function test, and compared results between the two devices. The data analyzer utilized the Deming regression method (95% CI) to analyze and plot the data for comparison. The evaluators then assessed and rated the "Pass/Fail" status for all criteria of all tested subjects, including the calibration ability, eye movement direction, and Deming regression results.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Comparison Test: Two experienced healthcare professionals (Evaluators) evaluated the vestibular functions of 10 subjects using both the subject device and a legally marketed device (predicate device). Each subject underwent one round of testing with each device. The evaluators observed eye movements, generated test reports, and compared results. The data was analyzed using the Deming regression method (95% CI). The evaluators assessed "Pass/Fail" status for calibration ability, eye movement direction, and Deming regression results. The test results successfully met all pre-specified acceptance criteria, demonstrating equivalent performance between the subject device and the predicate device for Calibration, Spontaneous nystagmus, Gaze, Saccade, Pursuit, Optokinetic, and Positional tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 29, 2023
Neurobit Technologies Co., Ltd. % Tyra Chiu Regulatory Consultant Intellrac Consulting Ltd. 1 F., No. 28, Ln. 18, Shude 1st. St., Taiping Dist. Taichung City, 411 Taiwan
Re: K223047
Trade/Device Name: NeuroSwift Pro Regulation Number: 21 CFR 882.1460 Regulation Name: Nystagmograph Regulatory Class: Class II Product Code: GWN Dated: May 1, 2023 Received: May 30, 2023
Dear Tyra Chiu:
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 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
1
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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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,
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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K223047
Device Name NeuroSwift Pro
Indications for Use (Describe)
NeuroSwift Pro is intended for Viewing and recording eye movements in support of identifying vestibular disorders.The system is to be used by trained healthcare personnel in an appropriate healthcare setting. This system provides no diagnosis and does not provide diagnostic recommendations. The target population is 12+ years of age.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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FORM FDA 3881 (6/20)
3
510(k) Summary
Date: June 28, 2023 Manufacturer: Neurobit Technologies Co., Ltd. 2F, No.320 Sec. 4, Zhongxiao E. Rd. Taipei City, 106, Taiwan. Contact Person: Dr. Chun-Chen Yang Regulatory Manager 2F, No.320 Sec. 4, Zhongxiao E. Rd. Taipei City, 106, Taiwan. Phone: +886-2-27710618 E-mail: info@neurobittech.com
| Device: Trade Name: | NeuroSwift Pro |
|---|---|
| Common Name: | Nystagmograph |
| Classification Names: | Nystagmograph |
| Device Class | II |
| Classification Panel: | Neurology |
| Product Code: | GWN |
| Regelation Number | 882.1460 |
Device Description The NeuroSwift Pro is intended for viewing and recording eye And Technology movements in support of identifying vestibular disorders. The Characteristics system is to be used by trained healthcare personnel in an appropriate healthcare setting. This system provides no diagnosis and does not provide diagnostic recommendations. NeuroSwift Pro. model NS01-2 contains goggles and software. The NeuroSwift Pro is a combination of hardware and software, designed to provide information for clinicians as a supplement in clinical decision-making by eye movements. The NeuroSwift Pro goggle is a see-through binocular video goggle with a pair of light reflectors and 3 metered, nylon braided USB cable connecting to the computer interface. Accompanying components include a stable and sturdy head strap, face cushion, and a lightweight eye cover. The hardware provides high-definition video recording capability. The NeuroSwift Pro software is a computer interface designed to record eye movement videos and simultaneously display the visual target(s) on the
4
computer screen. The software provides vestibular test modes and calibration functions. Initially, the software instructs the users to follow calibration functions. Then, the examiner can observe spontaneous nystagmus using the eye cover. The examiner can perform oculomotor tests with the goggles, while the patient follows visual targets on the screen. During gaze tests, the patient will fixate on stationary white spots that are positioned at center, right, left, up and down. In saccade tests the patient is asked to stare at the target moving in horizontal, vertical, or mixed pattern. In pursuit tests the patient's ability to track a target that moves in a sinusoidal or triangular pattern across the screen. The optokinetic function provides a large moving checkerboard pattern on the screen. Patients can change in various body positions as directed by the clinician. The software measures the eye movement via slow phase velocity and measures the eye position shift and trace. The recorded video and test protocols are processed in the NeuroSwift Pro software. The NeuroSwift Pro generates the traces of eye movements, eye velocities, and analytical data, which allows the clinician to determine the response of the patient according to the test functions.
The device contains the following vestibular test protocols:
- Calibration -
- Spontaneous nystagmus test -
- -Gaze test
- -Saccade test
- Pursuit test -
- Optokinetic test -
- Positional test -
- NeuroSwift Pro is intended for viewing and recording eye Intended Use movements in support of identifying vestibular disorders. The system is to be used by trained healthcare personnel in an appropriate healthcare setting. This system provides no diagnosis and does not provide diagnostic recommendations. The target population is 12+ years of age.
5
Predicate Device(s):
| Predicate Device | Manufacturer | 510(K) Number |
|---|---|---|
| VisualEyes 505/515/525 | INTERACOUSTICS | |
| A/S | K200534 |
Substantial The subject device has same intended use, technology, operation Equivalence principle and technical characteristics with the predicate device(s). Design Verification activities were performed on subject device and all tests were verified to meet the required acceptance criteria. The verification tests demonstrate that the differences in the device do not affect the intended use of the device or raise any unsolved issues. There are no significant differences between subject device and the predicate device(s) that would adversely affect the use of the product. We conclude that subject device is substantially equivalent to predicate devices.
| | Subject Device
NeuroSwift Pro | Predicate Device
VisualEyes 505/515/ 525 | Equivalence
Discussion |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K223047 | K200534 | -- |
| Product code | GWN | GWN | Same |
| Classification | Class II | Class II | Same |
| Indications for
use | NeuroSwift Pro is intended
for viewing and recording eye
movements in support of
identifying vestibular
disorders. The system is to
be used by trained healthcare
personnel in an appropriate
healthcare setting. This
system provides no diagnosis
and does not provide
diagnostic recommendations.
The target population is 12+
years of age. | The VisualEyes system
provides information to assist in
the nystagmographic
evaluation, diagnosis and
documentation of vestibular
disorders. Nystagmus of the
eye is recorded by use of a
goggle mounted with cameras.
These images are measured,
recorded, displayed and stored
in the software. This
information then can be used
by a trained medical | Similar.
The age limitation is
different. The
NeuroSwift Pro
goggle is not
designed for children
under 12 as it may
not fit smaller faces
adequately. We
assess it as having
similar indications,
considering it as a
practical limitation. |
| | | | |
| | | professional to assist in
diagnosing vestibular disorders.
The target population for
VisualEyes system is 5 years of
age and above. | |
| Technology | Eye-tracking software and
manufacturer-provided
hardware. | Eye-tracking software to be
used with various goggle /
cameras, rotary chairs,
irrigators and other accessories | Same.
Both use tracking
software and
goggles to achieve
their intended use. |
| Operation
Principle | Infrared video cameras
mounted inside goggle
display the patient's eye
movements on a connected
computer. The goggles are
light-weight and equipped
with adjustable head band.
The eye cover part is
designed with magnet
attachment to be easily
attach/ detach to the goggle.
The cameras are connected
to the computer via USB
cable. The software on the
connected computer is
performed to support the
recording, viewing,
monitoring and analyzing of
eye position and movement. | VisualEyes 505/515/525 is a
software program that analyzes
eye movements recorded from
a camera mounted to a video
goggle. The VisualEyes is a
software system is intended to
incorporate various
goggle/cameras, rotary chairs,
irrigators and other
accessories. | Same.
Both use wearable
cameras and
software to display
and record the
patient's eye
movement. |
| Weight | 400 g (face cushion, eye
cover, goggle and cable) | Side mounted camera goggles
385 g (occluded view) | Similar.
The non-clinical and
clinical performance
testing confirm that
both devices meet |
6
7
| | | | | | the required safety
and effectiveness
standards, fulfilling
the intended use. |
|--------------------------|------------------------------------------------------|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Materials | Polyamide, glass | Unknown | Different.
The Biocompatibility
evaluation confirms
that the subject
device does not
raise new questions
of biocompatibility. | | |
| Infrared (IR)
Source | (2) IR LEDs @ 940 nm
wavelength | Dual IR LED infrared
illumination: 940 nm | Same | | |
| Infrared (IR)
Control | On when goggles are
plugged in and system is on. | On when goggles are plugged
in and system is on. | Same | | |
| Energy Source | External via USB powered by
computer | External via USB powered by
computer | Same | | |
| Test protocols | Test Battery | | Subject
Device | Predicate
Device | Different.
The test protocol of
the subject device is
a subset of the test
protocol of the
predicate device.
The performance
testing as described
in ANSI S3.45
confirms agreement
of quantitative
measurements
between subject and
predicate device. |
| | Calibration | | ● | ● | |
| | Spontaneous nystagmus | | ● | ● | |
| | Gaze | | ● | ● | |
| | Saccade | | ● | ● | |
| | Pursuit | | ● | ● | |
| | Optokinetic | | ● | ● | |
| | Positional | | ● | ● | |
| | Dix-Hallpike | | | ● | |
| | Caloric | | | ● | |
| | Saccadometry | | | ● | |
| | Sinusoidal Harmonic Acceleration | | | ● | |
| | Step Velocity | | | ● | |
| | VOR Suppression | | | ● | |
| | Visual VOR | | | ● | |
| | Subjective Visual Vertical (SVV) –
Static/Dynamic | | | ● | |
8
| Ocular Counter Roll | • | ||
|---|---|---|---|
| VORTEQ AHR | • | ||
| VORTEQ vHIT | • | ||
| Dynamic Visual Acuity | • | ||
| Lateral Head Roll | • | ||
| Video | |||
| Recording and | |||
| Playback | |||
| Capability | Yes | Yes | Same |
| System | |||
| Interface | A computer interface that | ||
| allows for display of both | |||
| eyes on computer monitor | |||
| and provides power for the | |||
| infrared video cameras and | |||
| the LEDs | The complete system is | ||
| operated from a standard | |||
| PC/Laptop via a standard USB | |||
| connection. The PC application | |||
| software controls the camera | |||
| recordings and shows the | |||
| results of the tests | Same |
Performance Data ANSI AAMI IEC ES60601-1:2005/(R)2012 and A1:2012, Non-Clinical Tests: C1:2009/(R)2012 and A2:2010/(R)2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- ANSI AAMI IEC 60601-1-2:2014 Medical electrical equipment, Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance --Collateral Standard: Electromagnetic disturbances --Requirements and tests
- IEC 62304:2006+AMD1:2015, Medical device software --Software life cycle processes, Ed.1.1
9
- Guidance for the Content of Premarket Submissions for -Software Contained in Medical Devices
- ISO 14971:2019, Medical devices Application of risk management to medical devices
- IEC 62366-1:2015, Medical devices Part 1: Application of usability engineering to medical devices
- ISO10993-1, Fifth edition, 2018-08, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- IEC 62471 First edition 2006-07, Photobiological safety of lamps and lamp systems
- ANSI/ASA S3.45-2009, American National Standard -Procedures for Testing Basic Vestibular Function
Evaluation was completed following above standards and documents. Conformity to these standards demonstrates that the proposed subject device met the standards' established acceptance criteria for the device. This supports substantial equivalence to its predicates.
Clinical Performance A performance comparison test was conducted to support the Testing substantial equivalence of the subject device. For this test, two experienced healthcare professionals (Evaluators) were recruited to evaluate the vestibular functions of 10 subjects using both the subject device and a legally marketed device (predicate device).
10
During the test, each subject underwent one round of testing with the subject device and another round of testing with the predicate device. The evaluators were responsible for observing the eye movements, generating test reports for each vestibular function test, and comparing the results between the two devices. The data analyzer utilized the Deming regression method (95% CI) to analyze and plot the data for comparison. The evaluators then assessed and rated the "Pass/Fail" status for all criteria of all tested subjects, including the calibration ability, eye movement direction, and Deming regression results. The test results successfully met all pre-specified acceptance criteria, demonstrating the equivalent performance between the subject device and the predicate device.
| Description | Equivalence |
|---|---|
| Calibration | same |
| Spontaneous nystagmus | same |
| Gaze | same |
| Saccade | same |
| Pursuit | same |
| Optokinetic | same |
| Positional | same |
- Conclusion: The verification and validation testing, NeuroSwift Pro meets the pre-specified acceptance criteria, that are considered essential for its intended use and is considered substantially equivalent to the predicate device.