(152 days)
Not Found
No
The summary describes a system for recording eye movements in response to stimuli and presenting the data for interpretation by a trained professional. There is no mention of AI or ML algorithms being used for data analysis, interpretation, or any other function. The device explicitly states it does not provide diagnoses or diagnostic recommendations.
No.
The device is used for diagnostic testing and does not provide therapy or treatment.
No
The device is used in diagnostic testing and provides data for interpretation, but the "Intended Use / Indications for Use" section explicitly states "This device does not provide diagnoses nor does it provide diagnostic recommendations."
No
The device description explicitly lists multiple hardware components including a head-mounted apparatus, digital display, infrared lights, mirrors, cameras, optical focus knobs, a computer, isolation transformer, connection cables, foot pedals, and a hand-held control box. The performance studies also mention verification and validation of both software and hardware requirements.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The I-PAS system works by providing visual stimuli to a patient and recording their eye movements (nystagmus) in response. This is a direct interaction with the patient's body and does not involve analyzing samples taken from the body.
- Intended Use: The intended use clearly states it's for "vestibular and neuro otologic diagnostic testing" and "monitors the patient's response." This aligns with in-vivo testing, not in-vitro testing.
- Device Description: The description details a head-mounted apparatus with cameras and displays, which are used to interact with the patient directly, not to analyze biological samples.
Therefore, the I-PAS system falls under the category of a medical device used for diagnostic purposes, but it is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
I-Portal® Portable Assessment System™ - Nystagmograph (I-PAS™) is used in vestibular and neuro otologic diagnostic testing. The I-PAS 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 diagnosic testing. This device does not provide diagnoses nor does it provide diagnostic recommendations.
Product codes
GWN
Device Description
All I-Portal® devices, including the proposed I-PAS, function as nystagmographs, 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 I-PAS is indicated for use as a diagnostic 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-PAS and all other I-Portal devices are used in an institutional environment on the order of a physician.
The I-Portal devices use a battery of oculomotor and vestibular tests across a family of products: including the I-Portal NOTC, I-Portal VNG, and I-Portal VOG. This application seeks to add I-PAS to this family. The VNG testing battery included on the I-PAS and other I-Portal devices include ten (10) oculomotor and subjective visual tests.
The I-PAS is a head-mounted apparatus enclosing a digital display, infrared lights, dual mirrors, dual cameras, and optical focus knobs. It is attached to the head with straps. The head mounted goggle system displays independent stimuli separately to each eye on a small digital display while simultaneously recording motion from each eye independently with digital video cameras. The system also includes: a computer with Neuro Kinetics' I-Portal and VEST software packages: isolation transformer and connection cables; foot pedals and a hand-held control box with buttons that can be pressed to register motor responses. As with the I-Portal VNG, I-PAS includes the standard battery of VNG tests and can operate in conjunction with caloric test equipment.
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 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
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-PAS, and to demonstrate its conformance with ANSI-ASA S3.45-2009, FDA's applicable consensus standard. Compliance with applicable IEC 60601 standards is confirmed via 3d party testing. 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 I-PAS and that the user interface was operating as intended. The verification and validation test results confirm that the I-PAS performs as intended. Clinical studies were also run and confirmed that the I-PAS visual cues are functionally indistinguishable from the predicate visual cues and that I-PAS stimuli do not cause dizziness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
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.
November 22, 2018
Neuro Kinetics, Inc. Brian Sullivan, COO 128 Gamma Drive Blawnox, PA 15238
Re: K171884
Trade/Device Name: I-Portal® Portable Assessment System™ - Nystagmograph (I-PAS™) Regulation Number: 21 CFR 882.1460 Regulation Name: Nystagmograph Regulatory Class: Class II Product Code: GWN Dated: October 19, 2017 Received: October 23, 2017
Dear Brian Sullivan:
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.
1
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 (OS) regulation (21 CFR Part 820); 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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)
K171884
Device Name
I-Portal® Portable Assessment System™ - Nystagmograph (I-PASTM)
Indications for Use (Describe)
I-Portal® Portable Assessment System™ - Nystagmograph (I-PAS™) is used in vestibular and neuro otologic diagnostic testing. The I-PAS 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 diagnosic testing. This device does not provide diagnoses 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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3
510(k) SUMMARY
NKI's I-PAS™
| 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: | June 20, 2017 |
| Trade/Proprietary Name: | I-Portal® Portable Assessment System™ Nystagmograph (I-
PAS™) |
| Common Name: | Nystagmograph |
| Classification Name: | Nystagmograph (21 CFR 882.1460, Product Code GWN) |
| Predicate Device | I-Portal® VNG (K083603 & K143607) |
Device Description
All I-Portal® devices, including the proposed I-PAS, function as nystagmographs, 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 I-PAS is indicated for use as a diagnostic 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-PAS and all other I-Portal devices are used in an institutional environment on the order of a physician.
The I-Portal devices use a battery of oculomotor and vestibular tests across a family of products: including the I-Portal NOTC, I-Portal VNG, and I-Portal VOG. This application seeks to add I-PAS to this family. The VNG testing battery included on the I-PAS and other I-Portal devices include ten (10) oculomotor and subjective visual tests.
4
The I-PAS is a head-mounted apparatus enclosing a digital display, infrared lights, dual mirrors, dual cameras, and optical focus knobs. It is attached to the head with straps. The head mounted goggle system displays independent stimuli separately to each eye on a small digital display while simultaneously recording motion from each eye independently with digital video cameras. The system also includes: a computer with Neuro Kinetics' I-Portal and VEST software packages: isolation transformer and connection cables; foot pedals and a hand-held control box with buttons that can be pressed to register motor responses. As with the I-Portal VNG, I-PAS includes the standard battery of VNG tests and can operate in conjunction with caloric test equipment.
Intended Use / Indications for Use
The modified I-Portal has the same intended use and indications for use as the predicate cleared per K083603 & K143607. Both the I-PAS and its predicate device are intended for use as a nystagmograph. The indications for use for the modified I-Portal device and the predicate device cleared per K083603 & K143607 are identical, and are as follows:
I-PASTM
I-Portal® Portable Assessment System Nystagmograph (I-PAS) is used in vestibular and neuro otologic diagnostic testing. The I-PAS 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.
Technological Characteristics
The I-PAS has identical technological characteristics as the previously cleared predicate (K083603 & K143607), with the exception of the following modifications:
Integrated head mounted display/monitor inches from the eyes replacing projection devices /monitors that display visual cues on a surface at a distance of feet.
A small screen or monitor (smart phone display) is divided into two halves, each providing visual cue(s) to a single eye displayed approximately 3 inches from each eve in the head mounted screen that create a perceived distance, or digital equivalents that subtend the same location, angles, and speeds of the visual stimuli, i.e., dots. The visual cues are functionally equivalent to predicate visual cues projected by the pursuit tracker laser and optokinetic (OKN) on to a surface between 2 to 3 feet away from the subiect. The embedded optics of the I-PAS are also adjustable to optimize the image for patients whose eyes require a prescription, since it is not possible to wear eyeglasses while wearing I-PAS.
Fully enclosed unit that keeps out ambient light
Unlike the predicate, I-PAS is portable and the stimulus presentation and eye tracking are completely self-contained within the head mounted system. The same light seal for all I-Portal devices provides a test environment without ambient light. The predicate device projects stimuli on a wall in a dark room while the subject viewed the stimuli while wearing eyetracking goggles.
Use of 6DOF sensor to provide head position measurements during vestibular tests, e.g. Subjective Visual tests
5
The I-PAS includes a 6DOF sensor to help make I-PAS portable. A patient's head may not always be stationary, i.e.. secured in a headrest. As a result, if the patient tilts their head away from earth vertical, tests such as the subjective visual tests can generate inaccurate results. The 6DOF provides an accurate measure of head and stimulus orientation to either enable the tester to orient the patient's head correctly, and or for a comparison of subjective visual results to earth ground.
The clinical testing performed confirms that the visual cues are functionally indistinguishable from the predicate, and that I-PAS stimuli do not cause dizziness. Additionally, bench testing confirms that the I-PAS complies with ANSI-ASA S3.45-2009 and verification and validation testing demonstrate that users can safely and effectively use the I-PAS.
Non-Clinical and Clinical Performance Data
Both bench and clinical testing provide significant support for this application.
Bench tests were executed to verify and validate the I-PAS, and to demonstrate its conformance with ANSI-ASA S3.45-2009, FDA's applicable consensus standard.
Compliance with applicable IEC 60601 standards is confirmed via 3d party testing.
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 I-PAS and that the user interface was operating as intended.
The verification and validation test results confirm that the I-PAS performs as intended.
Clinical studies were also run and confirmed that the I-PAS visual cues are functionally indistinguishable from the predicate visual cues and that I-PAS stimuli do not cause dizziness.
Substantial Equivalence
The I-PAS is substantially equivalent to its predicate. It has the same intended use, the same indications for use and equivalent technological and equivalent clinical characteristics and equivalent principles of operation. The technological differences do not present any new issues of safety or effectiveness, which is supported by performance data.
The I-PAS is substantially equivalent to its predicate (K083603 & K143607) device.