(201 days)
Not Found
No
The summary describes a system for measuring and recording eye movements and presenting data for interpretation by trained personnel. There is no mention of AI or ML in the intended use, device description, or performance studies. The system provides data, not diagnoses or recommendations, which is a common characteristic of devices that do not employ AI/ML for interpretation.
No.
The device is described as a diagnostic tool used to monitor and analyze eye movements for vestibular and neuro-otologic diagnostic testing; it does not provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section states that the devices are "used in vestibular and neuro-otologic diagnostic testing." Additionally, the "Device Description" section explicitly refers to the device as "a diagnostic tool to assist trained physicians in their analysis of vestibular disorders".
No
The device description explicitly mentions hardware components such as a rotational chair, OKN optical stimulus, PT laser target generator, and a test enclosure, in addition to the VEST™ analysis software. While software is a key component, it is integrated with and relies on these physical elements.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Definition of IVD: An IVD is a medical device used to perform tests on samples such as blood, urine, or tissue to detect diseases or other conditions. These tests are performed in vitro (in a lab setting, outside the body).
- Device Function: The I-Portal system (NOTC, VNG, VOG) works by applying stimuli (motion, visual cues) to a patient and monitoring their physiological response, specifically eye movements (nystagmus). This is an in vivo process (performed on a living organism).
- Sample Type: The device does not analyze biological samples like blood or tissue. It directly interacts with the patient's body.
- Intended Use: The intended use is for "vestibular and neuro-otologic diagnostic testing" by monitoring and recording eye movements in response to stimuli. This is a functional assessment, not a biochemical or cellular analysis of a sample.
The device is clearly described as a "nystagmograph," which is a device used to measure eye movements, not to perform tests on biological samples.
N/A
Intended Use / Indications for Use
I-Portal® Neuro Otologic Test Center (NOTC) is a rotary chair system used in vestibular and neuro-otologic 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.
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 presents the data for interpretation by qualified medical personnel trained in vestibular diagnostic testing. This device provides nor does it provide diagnostic recommendations.
I-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 eve 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 nor does it provide diagnostic recommendations.
Product codes
GWN
Device Description
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eyeball
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified medical personnel trained in vestibular diagnostic testing; 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench tests were executed to verify and validate the I-Portal. Verification testing consisted of verification of the software requirements and hardware requirements. Validation testing was performed to ensure that users were able to properly use the I-Portal and that the user interface was operating as intended. Clinical testing was also performed to evaluate the crHIT test outputs for 22 control subjects and 20 subjects with complaints of dizziness to demonstrate the equivalence of the test outputs between the crHIT test and the head thrust test. The verification and validation test results confirm that the I-Portal performs as intended.
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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are white against a dark background.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 8, 2015
Neuro Kinetics, Inc. Mr. J. Howison Schroeder President and CEO 128 Gamma Drive Pittsburgh, PA 15238
Re: K143607
Trade/Device Name: I-Portal Neuro Otologic Test Center (NOTC), I-Portal Video Nystagmography System (VNG), and I-Portal Video Oculography Eye Tracking System (VOG) Regulation Number: 21 CFR 882.1460 Regulation Name: Nystagmograph
Regulatory Class: Class II Product Code: GWN Dated: June 5, 2015 Received: June 5, 2015
Dear Mr. Schroeder,
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. 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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Eric A. Mann -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
I-Portal® Neuro Otologic Test Center (NOTC), N/A; I-Portal® Video Nystagmography System (VNG), N/A; I-Portal® Video Oculography Eve Tracking System (VOG). N/A
Indications for Use (Describe)
I-Portal® Neuro Otologic Test Center (NOTC)
I-Portal® Neuro Otologic Test Center (NOTC) is a rotary chair system used in vestibular and neuro-otologic 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.
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 presents the data for interpretation by qualified medical personnel trained in vestibular diagnostic testing. This device provides nor does it provide diagnostic recommendations.
I-Portal® Video Oculography (VOG) System
I-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 eve 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 nor does it provide diagnostic recommendations.
| 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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510(k) Summary
| Submitter | J. Howison Schroeder
President & CEO
Neuro Kinetics, Inc.
128 Gamma Drive
Pittsburgh, PA 15238
Phone: (412) 963-6649
Fax: (412) 963-6722 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | December 18, 2014 |
| Trade/Proprietary Name: | I-Portal® Neuro Otologic Test Center (NOTC)
I-Portal® Video Nystagmography System (VNG)
I-Portal® Video Oculography Eye Tracking System (VOG) |
| Common Name: | Nystagmograph |
| Classification Name: | Nystagmograph (21 CFR 882.1460, Product Code GWN) |
| Predicate Device | |
I-Portal® NOTC, I-Portal® VNG, I-Portal® 4D VOG System (K083603)
Device Description
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
4
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 Use / Indications for Use
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:
NOTC
I-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.
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 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.
VOG
I-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.
Technological Characteristics
The modified I-Portal has identical technological characteristics as the previously cleared predicate I-Portal (K083603), with the exception of the following modifications:
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User-defined normative data input and display
The 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.
Performance Data
Bench tests were executed to verify and validate the I-Portal. Verification testing consisted of verification of the software requirements and hardware requirements. Validation testing was performed to ensure that users were able to properly use the I-Portal and that the user interface was operating as intended. Clinical testing was also performed to evaluate the crHIT test outputs for 22 control subjects and 20 subjects with complaints of dizziness to demonstrate the equivalence of the test outputs between the crHIT test and the head thrust test. The verification and validation test results confirm that the I-Portal performs as intended.
Substantial Equivalence
The modified I-Portal and its predicate device cleared per K083603 have the same intended use and indications for use and similar technological characteristics and principles of operation. The technological differences do not change the intended use or present any new issues of safety or effectiveness. Performance data demonstrate that the modified I-Portal is as safe and effective as its predicate device. Thus, the modified I-Portal is substantially equivalent to its predicate device.