(88 days)
Not Found
No
The summary describes standard video nystagmography technology and analysis methods without mentioning any AI or ML components. The analysis focuses on traditional measurements and clinical interpretation.
No.
The device is intended to view, record, and measure eye movements to aid in diagnostic recommendations, not to treat a condition.
Yes
The "Intended Use / Indications for Use" states that the device is intended "to aid in diagnostic recommendations" and "to be part of a larger balance assessment battery." The "Device Description" also mentions that the results are combined with other clinical information "to allow qualified medical personnel to determine the health of a patient's vestibular function system." These phrases indicate that the device provides information used in the diagnostic process.
No
The device description explicitly states that the system consists of a "goggles system with a video camera and accelerometers" and "computer monitors and other hardware," in addition to the software. This indicates it is a hardware and software system, not software-only.
Based on the provided information, the Nystagram™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Nystagram™ Function: The Nystagram™ directly measures and records eye movements in a living patient. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for viewing, recording, and measuring eye movements in support of identification of balance disorders. It emphasizes that it does not provide any medical diagnosis and is part of a larger assessment battery.
Therefore, the Nystagram™ falls under the category of a medical device used for physiological measurement and assessment, not an IVD.
N/A
Intended Use / Indications for Use
The Nystagram™ is a video nystagmograph intended to view, record, and measure eye movements in support of identification of balance disorders. The device is intended for use only by qualified, trained medical personnel to aid in diagnostic recommendations. This device does not provide any medical diagnosis and is intended to be part of a larger balance assessment battery.
Product codes (comma separated list FDA assigned to the subject device)
GWN
Device Description
The Nystagram™ is a device that views, records and measures both vertical and horizontal eye movements for support of identification of balance disorders. The results of the video nystagmograph (VNG) tests are combined with other clinical information to allow qualified medical personnel to determine the health of a patient's vestibular function system. The Nystagram™ system consists of a goggles system with a video camera and accelerometers to record eye movements and head position, computer monitors and other hardware and software to control the operation of the patient stimulus and the test administration functions. The system software is used for nystagmus analysis during oculomotor mobility, positional nystagmus, and caloric examinations. The results are presented in visual diagrams for clinical review.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video
Anatomical Site
Eyes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified, trained medical personnel
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
A comparative evaluation was conducted between the Nystagram™ and the GN Otometrics ICS Chartr VNG/ENG (Predicate Device) for the purpose of establishing clinical equivalency. Five (5) subjects' response to stimuli was measured and the resulting nystagmus or lack of nystagmus was recorded using the Predicate Device by an independent Audiologist located in Sugarland, Texas and the Nystagram™ by an independent Audiologist located in The Woodlands, Texas. The two testing sessions were within a 24 hour time period. The test battery included evaluation of Oculomotor function, Positional, Positioning and Spontaneous Nystagmus.
For the Oculomotor tests (Saccades, gaze and optikenetic), data were analyzed regarding symmetry and smoothness of eye movements and presence of nystagmus. Resultant tracings were clinically evaluated and judged to be:
- "Normal" for symmetrical eye movement without cog-wheeling or clinically significant nystagmus, OR
- "Abnormal" for all other findings
For the Positional tests without visual fixation (Supine, Head Right and Head Left), data were analyzed regarding the presence of clinically significant nystagmus. If so, the direction of the nystagmus was noted. Resultant tracings were clinically evaluated and judged to be:
- "Positive" if clinically significant nystagmus was present, OR
- "Negative" if no clinically significant nystagmus was present
For the Positioning Tests (Dix-Hallpike) and Spontaneous Nystagmus Tests, data were analyzed regarding the presence of clinically significant nystagmus. If so, the direction of the nystagmus was noted. Resultant tracings were clinically evaluated and judged to be:
- "Positive" if clinically significant nystagmus was present, OR
- "Negative" if no clinically significant nystagmus was present
The data collected from the Nystagram™ and Predicate Device were compared regarding the clinical findings of "Normal/Abnormal" or "Positive/Negative" for each test and subject.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Type: Bench Testing & Comparative Evaluation
Sample Size: 5 subjects for comparative evaluation
Results: Tests of hardware and software were performed to verify system specifications. Test plans were developed to ensure the product met all the specified requirements. The device conforms to the following standards: IEC 60601-1-1 (2000), IEC 60601-1 (2005), IEC 60601-1-2 (2007), ANSI S3.45(2009). Equivalency between devices was demonstrated when interpretations of the data by each audiologist matched for each test and subject. Test results verified that the devices are equivalent in their ability to capture eye motion, administer VNG test protocols and document Nystagmus for analysis by the clinician.
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
510(k) Summary NystagramTM Video Nystagmography System
APR 2 6 2013
Date Prepared: January 24, 2013
- Submitter: Ototronix LLC 26620 Interstate 45 North Houston, TX 77386 Telephone: 281-203-0253 Fax: 832-550-2116
- Mr. Bernard Horwath Contact: Regulatory Affairs Consultant 4486 Timberline Ct Vadnais Heights, MN 55127 Telephone: 651- 231-1761
Proprietary Name: Nystagram™ Video Nystagmography System
Common/Usual Name: Video Nystagmograph, VNG
Classification Name: Nystagmograph, 21 CFR 882.1460, Class II, Product Code GWN
Establishment Registration Number: 3008612563
Description:
The Nystagram™ is a device that views, records and measures both vertical and horizontal eye movements for support of identification of balance disorders. The results of the video nystagmograph (VNG) tests are combined with other clinical information to allow qualified medical personnel to determine the health of a patient's vestibular function system. The Nystagram™ system consists of a goggles system with a video camera and accelerometers to record eye movements and head position, computer monitors and other hardware and software to control the operation of the patient stimulus and the test administration functions. The system software is used for nystagmus analysis during oculomotor mobility, positional nystagmus, and caloric examinations. The results are presented in visual diagrams for clinical review.
Indications for Use:
The Nystagram™ is a video nystagmograph intended to view, record, and measure eye movements in support of identification of balance disorders. The device is intended for use only by qualified, trained medical personnel to aid in diagnostic recommendations. This device does not provide any medical diagnosis and is intended to be part of a larger balance assessment battery.
1
Substantial Equivalence:
The Nystagram™ Video Nystagmograph System is substantially equivalent to most commercially available VNG systems in the market. Specifically the Nystagram™ is substantially equivalent to the following predicate devices:
- · BalanceBack VNG device (K042529)
- · GN Otometrics ICS Chartr ENG/VNG System (K991497)
- · Interacoustics 2D-VOG System (K072254)
All four devices have the same intended use and use similar technology and components. All patient preparation and test protocols are standard for all four devices.
Technological Characteristics:
Technically from a design and mechanism of action standpoint, the Nystagram™ is substantially equivalent to the predicate devices. They are all designed to record, view, and measure nystagmus in support of identification of balance disorders. The Nystagram and the predicate devices use similar technologies and components. Video cameras mounted to goggles record nystagmus. Infrared (IR) illumination of the eye area aids the cameras. Computer hardware and software detect and measure nystagmus during oculomotor mobility, positional nystagmus, and caloric examinations.
All patient preparation and test protocols are standard for the Nystagram™ and the predicate devices. The Nystagram™ and the predicate devices are designed for safety of the patient as well as the test administrator. All systems used IEC 60601 or variants to analyze safety.
Performance Bench Testing:
Tests of hardware and software have been performed to verify system specifications. Test plans were developed to ensure the product met all the specified requirements. The device conforms to the following standards:
- IEC 60601-1-1 (2000)
- · IEC 60601-1 (2005)
- · IEC 60601-1-2 (2007)
- · ANSI S3.45(2009)
In addition, a comparative evaluation was conducted between the Nystagram™ and the GN Otometrics ICS Chartr VNG/ENG (Predicate Device) for the purpose of establishing clinical equivalency. Five (5) subjects' response to stimuli was measured and the resulting nystagmus or lack of nystagmus was recorded using the Predicate Device by an independent Audiologist located in Sugarland, Texas and the Nystagram™ by an independent Audiologist located in The Woodlands, Texas. The two testing sessions were within a 24 hour time period. The test battery included evaluation of Oculomotor function, Positional, Positioning and Spontaneous Nystagmus.
For the Oculomotor tests (Saccades, gaze and optikenetic), data were analyzed regarding symmetry and smoothness of eye movements and presence of nystagmus. Resultant tracings were clinically evaluated and judged to be:
2
- "Normal" for symmetrical eye movement without cog-wheeling or clinically significant nystagmus, OR
- · "Abnormal" for all other findings
For the Positional tests without visual fixation (Supine, Head Right and Head Left), data were analyzed regarding the presence of clinically significant nystagmus. If so, the direction of the nystagmus was noted. Resultant tracings were clinically evaluated and judged to be:
- · "Positive" if clinically significant nystagmus was present, OR
- · "Negative" if no clinically significant nystagmus was present
For the Positioning Tests (Dix-Hallpike) and Spontaneous Nystagmus Tests, data were analyzed regarding the presence of clinically significant nystagmus. If so, the direction of the nystagmus was noted. Resultant tracings were clinically evaluated and judged to be:
- · "Positive" if clinically significant nystagmus was present, OR
- · "Negative" if no clinically significant nystagmus was present
The data collected from the Nystagram™ and Predicate Device were compared regarding the clinical findings of "Normal/Abnormal" or "Positive/Negative" for each test and subject. Equivalency between devices was demonstrated when interpretations of the data by each audiologist matched for each test and subject.
Test results verified that the devices are equivalent in their ability to capture eye motion, administer VNG test protocols and document Nystagmus for analysis by the clinician.
Conclusion:
Based upon the extensive testing conducted and the comparison to the predicate devices, it is the conclusion of Ototronix that the Nystagram™ is substantially equivalent to the predicate devices already on the market cleared by the 510(k) review process and presents no new concerns about safety or effectiveness.
3
Public Health Service
April 26, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Ototronix, LLC c/o Bernard Horwath 4486 Timberline Ct St. Paul, MN 55127
Re: K130201
Trade/Device Name: Nystagram Video Nystagmography System Regulation Number: 21 CFR 882.1460 Regulation Name: Nystagmograph Regulatory Class: Class II Product Code: GWN Dated: January 24, 2013 Received: January 28, 2013
Dear Mr. Horwath:
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.
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 device-related 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.
4
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Eric A.FMann -S
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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510(k) Number (if known): K130201
Nystagram™ Video Nystagmography System :
Indications for Use:
The Nystagram™ is a video nystagmograph intended to view, record, and measure eye movements in support of identification of balance disorders. The device is intended for use only by qualified, trained medical personnel to aid in diagnostic recommendations. This device does not provide any medical diagnosis and is intended to be part of a larger balance assessment battery.
Prescription Use ਨ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Office of Device Evaluation (ODE)
Cherish RaGiusto 2013.04.19 4:40:36 -04'00'
(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices
510(k) Number K130201