(109 days)
No
The device description focuses on providing a normative database and comparing patient data to this database using statistical methods (univariate general linear model, non-parametric methods for reference intervals). There is no mention of AI or ML algorithms being used for analysis or interpretation.
No.
The device is a quantitative tool for the comparison of patient measurements to a database of known normal subjects for diagnostic purposes, not for treatment.
Yes
The device, I-Norm 100_18-45 along with the I-Portal® devices, is explicitly stated to be "intended for use in vestibular and neurotologic diagnostic testing" and facilitates "analysis of vestibular and neurotologic disorders."
Yes
The device is described as a "software package that contains normative data" and is an "add[ition]... to the VEST™ software." While it is used with hardware devices (I-Portal® family), the submission focuses on the software component (the normative database) and its integration with existing software (VEST™). The performance studies and non-clinical data specifically address the software's functionality and integration, not the hardware itself.
Based on the provided information, the device I-Norm 100_18-45 is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: An IVD is a medical device intended for use in vitro for the examination of specimens, including blood and tissue donations, derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes.
- I-Norm 100_18-45's Function: I-Norm 100_18-45 is a software package that provides a database of normative data for comparison with patient measurements obtained from nystagmograph devices. It analyzes data related to eye movements, reaction time, and cognitive responses, which are physiological measurements taken directly from the patient's body, not from in vitro specimens.
- Intended Use: The intended use clearly states it's a "quantitative tool for the comparison of patient measurements to a database of known normal subjects." These patient measurements are obtained through the I-Portal® devices, which are nystagmographs.
- Device Description: The device description emphasizes that the I-Portal® devices function as nystagmographs, measuring involuntary movements of the eyeball. The I-Norm software adds a normative database to this system.
- Lack of Specimen Examination: There is no mention of examining any specimens derived from the human body (like blood, tissue, urine, etc.) in vitro.
Therefore, I-Norm 100_18-45, as described, is a software component that enhances the functionality of nystagmograph devices by providing normative data for comparison of in vivo measurements. It does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
I-Norm 100_18-45 is a quantitative tool for the comparison of patient measurements to a database of known normal subjects ages 18-45. I-Norm 100_18-45 presents data for interpretation by qualified medical personnel trained in vestibular, neurotologic, and neuro-ophthalmic diagnostic testing. I-Norm 100 18-45 is applicable to individuals only in the 18-45 age range.
The proposed intended use for I-Norm 100 18-45 is as following:
I-Norm 100 18-45 is designed to be used with the family of I-Portal® devices:
-
I-Portal® Neuro Otologic Test Center (NOTC) (cleared by K083603, K143607)
-
I-Portal® Video-Nystagmography System (VNG) SVNG-2 (cleared by K143607)
-
I-Portal® Portable Assessment System™ Nystagmograph (I-PAS™) (cleared by K171884)
The I-Portal® devices with I-Norm 100_18-45 are nystagmograph devices intended for use in vestibular and neurotologic diagnostic testing. The addition of the I-Norm 100_18-45 does not change the intended use or the indication for use for these devices from their original clearances listed above.
Product codes
GWN
Device Description
I-Norm 100_18-45 is a software package that contains normative data for the segment of population ages 18 to 45, for oculomotor, vestibular, reaction time and cognitive (OVRT-C) tests delivered on the family of I-Portal® devices. All I-Portal® devices function as nystagmographs, defined by 21 CFR 882.1460 as "devices used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball." Through their nystagmograph functionality, the I-Portal® devices are indicated for use as a measurement tool to assist trained physicians in their analysis of vestibular and neurotologic disorders, requiring a separation of central and peripheral nervous system deficits. The I-Portal® devices are used in an institutional environment on the order of a physician.
The I-Portal® NOTC features a rotational chair, optokinetic (OKN) optical stimulus, Pursuit Tracker (PT) laser target generator, I-Portal Video Oculography (VOG), I-Portal® and VEST™ software, and a test enclosure equipped with a communication system.
The I-Portal® VNG offers a subset of the NOTC tests and additional vestibular tests through a device with a smaller physical footprint. The VNG has many of the same elements used in the NOTC configuration: OKN optical stimulus, PT laser target generator, VOG, I-Portal and VEST™ software platforms.
The I-PAS™ is a portable, compact, 3D, head-mounted display system with integrated eye tracking that offers a set of tests equivalent to the VNG and additional vestibular and oculomotor tests, but with a smaller physical footprint. Stimuli are presented on a high-resolution digital screen (2560 x 1440 pixels) mounted in a virtual reality-like goggle system.
Software: All I-Portal® devices use VEST™ software to deliver a battery of oculomotor, vestibular, reaction time and cognitive (OVRT-C) tests and I-Portal® software to record eye movements and reaction time responses during these tests. The analysis of OVRT-C tests performed by VEST™ software provides the clinician with a number of physiological measurements to aid in the assessment of vestibular and neurotologic disorders. This application seeks to add I-Norm 100_18-45, a normative oculomotor, vestibular, reaction time and cognitive test database for ages 18-45 to the VEST™ software. The normative database will be a quantitative tool for the comparison of patient measurements to a database of known 18-45 year old subjects without oculomotor and vestibular disorders (clinical data that support this application are presented in the normative data user manual).
Mentions image processing
I-Portal® software captures, time stamps, and analyzes the digital images of the eye, collecting horizontal, vertical, torsional, and pupil data.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video images transmitted from two high speed digital infrared cameras (940nm; sampling rate 100 to 500 frames/sec)
Anatomical Site
Anatomical site is not explicitly mentioned, but the device measures and records involuntary movements of the eyeball.
Indicated Patient Age Range
18-45
Intended User / Care Setting
Qualified medical personnel trained in vestibular, neurotologic, and neuro-ophthalmic diagnostic testing. Used in an institutional environment on the order of a physician.
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
Data were collected from a total of 466 males and females ages 18-45 of all races that met the inclusion/exclusion criteria approved by IRB protocols. Subjects were recruited at 3 different sites: the University of Miami, Naval Medical Center San Diego and Madigan Army Medical Center. Subjects were recruited from the intended population of use, which included nonprofessional athletes who participate in intercollegiate athletics, civilians and military service members. Exclusion criteria were focused on conditions/diseases that could impact the oculomotor and vestibular tests. The participants were tested with a battery of oculomotor, vestibular, reaction time and cognitive (OVRT-C) tests, on either the NOTC (300 subjects) or I-PAS™ (166 subjects) devices. The data obtained from the two devices were pooled.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Performance Data:
Study Type: Clinical data collection and analysis to establish normative data for OVRT-C tests.
Sample Size: 466 subjects (300 on NOTC, 166 on I-PAS™).
Key Results: Data were analyzed using a univariate general linear model for the effect of age, gender and combined age x gender on variables describing OVRT-C tests. When statistical significance was demonstrated differences were evaluated and when deemed appropriate data were partitioned by groups. Using non-parametric methods, the 95% (2.5th and 97.5th) reference interval (RI) with 90% confidence interval (CI) on lower and upper limits was calculated. For one sided variables either the 2.50 or 97.50 percentile is presented. The results constitute a normative oculomotor and vestibular database for ages 18-45.
Non-Clinical Performance Data:
Study Type: Software Verification and Validation Testing.
Key Results: Verification testing consisted of verification of the software requirements and hardware requirements. Validation testing was performed to ensure that users were able to properly install, uninstall and use the I-Norm 100_18-45 and that the user interface was operating as intended, i.e. displaying norm values as intended. The verification and validation test results confirm that the I-Portal® devices with the added I-Norm 100 18-45 performs as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
95% (2.5th and 97.5th) reference interval (RI) with 90% confidence interval (CI) on lower and upper limits, and percentiles for various oculomotor, vestibular, reaction time, and cognitive test variables.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
November 29, 2019
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Neuro Kinetics, Inc. Aura Kullmann Clinical Trial Manager 128 Gamma Drive Pittsburgh, Pennsylvania 15238
Re: K192186
Trade/Device Name: I-Norm 100 18-45 Regulation Number: 21 CFR 882.1460 Regulation Name: Nystagmograph Regulatory Class: Class II Product Code: GWN Dated: October 24, 2019 Received: October 31, 2019
Dear Aura Kullmann:
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 Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael J. Ryan Division Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192186
Device Name
I-Norm 100_18-45
Indications for Use (Describe)
I-Norm 100_18-45 is a quantitative tool for the comparison of patient measurements to a database of known normal subjects ages 18-45. I-Norm 100_18-45 presents data for interpretation by qualified medical personnel trained in vestibular, neurotologic, and neuro-ophtalmic diagnostic testing. I-Norm 100_18-45 is applicable to individuals only in the 18-45 age range.
The proposed intended use for I-Norm 100 18-45 is as following:
I-Norm 100 18-45 is designed to be used with the family of I-Portal® devices:
-
I-Portal® Neuro Otologic Test Center (NOTC) (cleared by K083603, K143607)
-
I-Portal® Video-Nystagmography System (VNG) SVNG-2 (cleared by K143607)
-
I-Portal® Portable Assessment System™ Nystagmograph (I-PAS™) (cleared by K171884)
The I-Portal® devices with I-Norm 100_18-45 are nystagmograph devices intended for use in vestibular and neurotologic diagnostic testing. The addition of the I-Norm 100_18-45 does not change the intended use or the indication for use for these devices from their original clearances listed above.
| 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) |
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3
510(k) SUMMARY
l. Submitter
Aura Kullmann Clinical Trial Manager Neurolign USA, LLC 128 Gamma Drive Pittsburgh, PA 15238 Phone: (412) 963-6649 Fax: (412) 963-6722 Email: akullmann@neuro-kinetics.com October 24, 2019 Date Prepared:
II. Device
| Trade Name | Proprietary Name |
|---|---|
| • I-Portal® Neuro Otologic Test Center | |
| (NOTC) with I-Norm 100_18-45 | • I-Portal® Neuro Otologic Test Center |
| (NOTC) with I-Norm 100_18-45 | |
| • I-Portal® Video Nystagmography System | |
| (VNG) with I-Norm 100_18-45 | • I-Portal® Super VNG System 2 (SVNG-2) with I-Norm 100_18-45 |
| • I-Portal® Portable Assessment System | |
| Nystagmograph (I-PAS™) with I-Norm 100_18-45 | • I-Portal® Portable Assessment System |
| Nystagmograph (I-PAS™) with I-Norm 100_18-45 |
Common/Usual Name: Nystagmograph Classification Name: Nystaqmoqraph Product Classification: Class II, § 882.1460, Product Code GWN
III. Predicate Device
Predicate Devices cleared by K083603, K143607, K171884 with VEST™ software (K181025)
- I-Portal® Neuro Otologic Test Center (NOTC) (K083603, K143607)
- I-Portal® Video Nystagmography System (VNG) (K143607) ●
- I-Portal® Portable Assessment System Nystagmograph (I-PAS™) (K171884) ●
IV. Device Description
I-Norm 100_18-45 is a software package that contains normative data for the segment of population ages 18 to 45, for oculomotor, vestibular, reaction time and cognitive (OVRT-C) tests delivered on the family of I-Portal® devices described below.
4
All I-Portal® devices function as nystagmographs, defined by 21 CFR 882.1460 as "devices used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball." Through their nystagmograph functionality, the I-Portal® devices are indicated for use as a measurement tool to assist trained physicians in their analysis of vestibular and neurotologic disorders, requiring a separation of central and peripheral nervous system deficits. The I-Portal® devices are used in an institutional environment on the order of a physician.
The I-Portal® NOTC features a rotational chair, optokinetic (OKN) optical stimulus, Pursuit Tracker (PT) laser target generator, I-Portal Video Oculography (VOG), I-Portal® and VEST™ software, 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 designed to help isolate, identify and understand oculomotor, neurologic and vestibular functions and related possible disorders.
The I-Portal® VNG offers a subset of the NOTC tests and additional vestibular tests through a device with a smaller physical footprint. The VNG has many of the same elements used in the NOTC configuration: OKN optical stimulus, PT laser target generator, VOG, I-Portal and VEST™ software platforms. However, unlike the NOTC, it does not have either the rotational chair or 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 a smaller sized device or some mobility.
The I-PAS™ is a portable, compact, 3D, head-mounted display system with integrated eye tracking that offers a set of tests equivalent to the VNG and additional vestibular and oculomotor tests, but with a smaller physical footprint. Stimuli are presented on a high-resolution digital screen (2560 x 1440 pixels) mounted in a virtual reality-like goggle system. The nature of the integrated display monitor in I-PAS™ obstructs the patients' view of the external environment and ambient light.
Software: All I-Portal® devices use VEST™ software to deliver a battery of oculomotor, vestibular, reaction time and cognitive (OVRT-C) tests and I-Portal® software to record eye movements and reaction time responses during these tests. The analysis of OVRT-C tests performed by VEST™ software provides the clinician with a number of physiological measurements to aid in the assessment of vestibular and neurotologic disorders. This application seeks to add I-Norm 100_18-45, a normative oculomotor, vestibular, reaction time and cognitive test database for ages 18-45 to the VEST™ software. The normative database will be a quantitative tool for the comparison of patient measurements to a database of known 18-45 year old subjects without oculomotor and vestibular disorders (clinical data that support this application are presented in the normative data user manual). This comparison will enable physicians to evaluate possible abnormalities by identifying values outside of normal ranges, and therefore used by physicians in their diagnosis of vestibular disorders.
5
V. Intended Use / Indications for Use
The indication for use for I-Norm 100 18-45 is as following:
"I-Norm 100_18-45 is a quantitative tool for the comparison of patient measurements to a database of known normal subjects ages 18-45. I-Norm 100_18-45 presents data for interpretation by qualified medical personnel trained in vestibular. neurotologic, and neuro-ophthalmic diagnostic testing. I-Norm 100 18-45 is applicable to individuals only in the 18-45 age range."
The intended use for I-Norm 100 18-45 is as following:
I-Norm 100 18-45 is designed to be used with the family of I-Portal® devices:
- . I-Portal® Neuro Otologic Test Center (NOTC) (cleared by K083603, K143607)
- I-Portal® Video-Nystagmography System (VNG) SVNG-2 (cleared by K143607) .
- I-Portal® Portable Assessment Svstem™ Nystagmograph (I-PAS™) (cleared by ● K171884)
The I-Portal® devices with I-Norm 100 18-45 are nystagmograph devices intended for use in vestibular and neurotologic diagnostic testing. The I-Norm 100 18-45 does not change the intended use or the indication for use for these devices from their original clearances listed above.
VI. Technological Characteristics
The modified I-Portal® devices with the addition of VEST™ with I-Norm 100 18-45 have the same technological characteristics as their predicate devices, as cleared by K083603, K143607 and K171884.
I-Portal® devices provide visual and auditory stimuli while recording the horizontal, vertical, torsional, and pupil changes of a subject's eves. NOTC provides additional motion stimuli. The subject's motor reaction times are recorded via a small, wired, hand-held trigger button box. Two high speed digital infrared cameras (940nm; sampling rate 100 to 500 frames/sec) transmit video images to a computer via a USB3 communication protocol. Spatial resolution for horizontal and vertical eye tracking and torsion is