(273 days)
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 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.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
The provided document details a performance comparison test to demonstrate substantial equivalence to a predicate device. The acceptance criteria are implicit in the conclusion that the device "meets the pre-specified acceptance criteria" and that all criteria generated a "Pass" status.
Table of Acceptance Criteria and Reported Device Performance
| Description | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Calibration | Equivalent to predicate device | Met (indicated as "same") |
| Spontaneous nystagmus | Equivalent to predicate device | Met (indicated as "same") |
| Gaze | Equivalent to predicate device | Met (indicated as "same") |
| Saccade | Equivalent to predicate device | Met (indicated as "same") |
| Pursuit | Equivalent to predicate device | Met (indicated as "same") |
| Optokinetic | Equivalent to predicate device | Met (indicated as "same") |
| Positional | Equivalent to predicate device | Met (indicated as "same") |
| Calibration ability | Pass | Passed |
| Eye movement direction | Pass | Passed |
| Deming regression results | Within 95% CI agreement with predicate device | Passed (analyzed and plotted for comparison) |
Study Details
1. Sample Size and Data Provenance:
- Test Set Sample Size: 10 subjects.
- Data Provenance: The document does not explicitly state the country of origin. It appears to be a prospective study as subjects underwent testing with both devices specifically for this evaluation.
2. Number and Qualifications of Experts for Ground Truth:
- Number of Experts: Two (2) healthcare professionals (referred to as "Evaluators").
- Qualifications of Experts: They are described as "experienced healthcare professionals." More specific qualifications (e.g., audiologist, neurologist, years of experience) are not provided.
3. Adjudication Method for the Test Set:
- The evaluation involved "two experienced healthcare professionals (Evaluators)" who were responsible for "observing the eye movements, generating test reports for each vestibular function test, and comparing the results between the two devices."
- A "data analyzer utilized the Deming regression method (95% CI) to analyze and plot the data for comparison."
- Finally, "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."
- This suggests a consensus-based adjudication method where both evaluators assessed and rated the results, likely agreeing on the "Pass/Fail" status after reviewing the data and Deming regression analysis. It's not a specified 2+1 or 3+1 method; rather, it appears to be a joint assessment and rating by the two evaluators, supported by quantitative analysis.
4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was it done?: No, a traditional MRMC study comparing human readers with and without AI assistance was not conducted. This study's purpose was to demonstrate the equivalence of the new NeuroSwift Pro device to a predicate device, not the improvement of human reader performance with AI. The device itself (NeuroSwift Pro) is for "viewing and recording eye movements in support of identifying vestibular disorders" and "provides no diagnosis and does not provide diagnostic recommendations." Therefore, it's not an AI-assisted diagnostic tool in the typical sense that would necessitate an MRMC "human + AI vs human only" study.
- Effect Size: N/A, as an MRMC study comparing human readers with AI assistance was not performed.
5. Standalone Performance (Algorithm Only):
- Was it done?: Yes, to an extent. While not explicitly framed as "algorithm only performance," the study conducted a performance comparison test where the device's output (eye movements, test reports, and quantitative data like slow phase velocity, eye position shift, and trace) was compared to that of the predicate device. The Deming regression analysis specifically evaluated the agreement of quantitative measurements between the two devices. This could be considered a form of standalone performance evaluation in the context of device function and measurement accuracy, rather than diagnostic accuracy.
6. Type of Ground Truth Used:
- The ground truth in this comparative study was the performance of the legally marketed predicate device (VisualEyes 505/515/525) and the expert assessment of the evaluators. The study aimed to demonstrate that the NeuroSwift Pro's measurements and qualitative assessments ("Pass/Fail" for calibration, eye movement direction) were equivalent to those obtained from the predicate device, as interpreted by experienced healthcare professionals. It's a comparative ground truth rather than an independent gold standard like pathology or long-term clinical outcomes.
7. Sample Size for Training Set:
- The document does not provide information on a training set for any machine learning components. This is likely because the device primarily functions as an eye movement recording and analysis system (nystagmograph), not explicitly an AI/ML diagnostic algorithm that would require a separate training dataset for model development. The focus is on the accuracy and equivalence of its measurements and recording capabilities.
8. How Ground Truth for Training Set was Established:
- N/A, as information on a training set is not provided.
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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
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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
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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)
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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
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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.
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Predicate Device(s):
| Predicate Device | Manufacturer | 510(K) Number |
|---|---|---|
| VisualEyes 505/515/525 | INTERACOUSTICSA/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 DeviceNeuroSwift Pro | Predicate DeviceVisualEyes 505/515/ 525 | EquivalenceDiscussion | |
|---|---|---|---|
| 510(k) number | K223047 | K200534 | -- |
| Product code | GWN | GWN | Same |
| Classification | Class II | Class II | Same |
| Indications foruse | NeuroSwift Pro is intendedfor viewing and recording eyemovements in support ofidentifying vestibulardisorders. The system is tobe used by trained healthcarepersonnel in an appropriatehealthcare setting. Thissystem provides no diagnosisand does not providediagnostic recommendations.The target population is 12+years of age. | The VisualEyes systemprovides information to assist inthe nystagmographicevaluation, diagnosis anddocumentation of vestibulardisorders. Nystagmus of theeye is recorded by use of agoggle mounted with cameras.These images are measured,recorded, displayed and storedin the software. Thisinformation then can be usedby a trained medical | Similar.The age limitation isdifferent. TheNeuroSwift Progoggle is notdesigned for childrenunder 12 as it maynot fit smaller facesadequately. Weassess it as havingsimilar indications,considering it as apractical limitation. |
| professional to assist indiagnosing vestibular disorders.The target population forVisualEyes system is 5 years ofage and above. | |||
| Technology | Eye-tracking software andmanufacturer-providedhardware. | Eye-tracking software to beused with various goggle /cameras, rotary chairs,irrigators and other accessories | Same.Both use trackingsoftware andgoggles to achievetheir intended use. |
| OperationPrinciple | Infrared video camerasmounted inside goggledisplay the patient's eyemovements on a connectedcomputer. The goggles arelight-weight and equippedwith adjustable head band.The eye cover part isdesigned with magnetattachment to be easilyattach/ detach to the goggle.The cameras are connectedto the computer via USBcable. The software on theconnected computer isperformed to support therecording, viewing,monitoring and analyzing ofeye position and movement. | VisualEyes 505/515/525 is asoftware program that analyzeseye movements recorded froma camera mounted to a videogoggle. The VisualEyes is asoftware system is intended toincorporate variousgoggle/cameras, rotary chairs,irrigators and otheraccessories. | Same.Both use wearablecameras andsoftware to displayand record thepatient's eyemovement. |
| Weight | 400 g (face cushion, eyecover, goggle and cable) | Side mounted camera goggles385 g (occluded view) | Similar.The non-clinical andclinical performancetesting confirm thatboth devices meet |
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| the required safetyand effectivenessstandards, fulfillingthe intended use. | |||||
|---|---|---|---|---|---|
| Materials | Polyamide, glass | Unknown | Different.The Biocompatibilityevaluation confirmsthat the subjectdevice does notraise new questionsof biocompatibility. | ||
| Infrared (IR)Source | (2) IR LEDs @ 940 nmwavelength | Dual IR LED infraredillumination: 940 nm | Same | ||
| Infrared (IR)Control | On when goggles areplugged in and system is on. | On when goggles are pluggedin and system is on. | Same | ||
| Energy Source | External via USB powered bycomputer | External via USB powered bycomputer | Same | ||
| Test protocols | Test Battery | SubjectDevice | PredicateDevice | Different.The test protocol ofthe subject device isa subset of the testprotocol of thepredicate device.The performancetesting as describedin ANSI S3.45confirms agreementof quantitativemeasurementsbetween subject andpredicate 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 | ● |
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| Ocular Counter Roll | • | ||
|---|---|---|---|
| VORTEQ AHR | • | ||
| VORTEQ vHIT | • | ||
| Dynamic Visual Acuity | • | ||
| Lateral Head Roll | • | ||
| VideoRecording andPlaybackCapability | Yes | Yes | Same |
| SystemInterface | A computer interface thatallows for display of botheyes on computer monitorand provides power for theinfrared video cameras andthe LEDs | The complete system isoperated from a standardPC/Laptop via a standard USBconnection. The PC applicationsoftware controls the camerarecordings and shows theresults 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
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- 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).
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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.
§ 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).