(190 days)
No
The summary does not mention AI, ML, or related terms, and the description of the device's function (measuring, recording, displaying, and analyzing data) does not inherently require AI/ML.
No
The device measures, records, and displays eyeball movements and provides no diagnoses or diagnostic recommendations, indicating it is for diagnostic assessment rather than therapeutic intervention.
No
The "Intended Use / Indications for Use" section explicitly states, "This device provides no diagnoses nor does it provide diagnostic recommendations."
No
The device description explicitly states that its components include video goggles or surface electrodes, a PC interface, and various stimulation devices, which are all hardware components.
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: This device measures and records the movements of the eyeballs in a living patient. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it measures and displays involuntary movements and assists in testing vestibular function by observing eye movements. This is a physiological measurement, not an in vitro test.
Therefore, this device falls under the category of a medical device used for physiological measurement and assessment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The device is intended to measure, record and display the movements of the eyeballs during their involuntary movements (nystagmus) and while testing the patient's vestibular function.
The device is for prescription use only and it is intended for use by qualified medical personnel trained in the use of nystagmographs. This device provides no diagnoses nor does it provide diagnostic recommendations.
Product codes
GWN
Device Description
The device is a PC-based system for measuring, recording and displaying the eye movements. Its components include video goggles or surface electrodes to record the eye movements, a PC interface to acquire the data, a series of software modules to display and analyze the data and various stimulation devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video / Electrode based system
Anatomical Site
eyeballs (eye movements)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified medical personnel trained in the use of nystagmographs.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K991497, K010059, K964325, K982103, K781268
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 word "DIFRA" next to a circular logo with a line going through the middle. The line has an arrow on each end, with one pointing to the left and the other pointing to the right. The logo and the word "DIFRA" are in black.
510(k) Summary
Submitter Information:
| Name and Address: | S.A. INSTRUMENTATION DIFRA |
|---|---|
| Rue de l'Eglise 84 | |
| Welkenraedt | |
| B-4840 | |
| Belgium | |
| Phone: +32 (87) 89.80.80 | |
| Fax: +32 (87) 89.80.89 | |
| Email: info@difra.be | |
| www.difra.be | |
| Registration Number: | 9710334 |
| Contact Person: | Guido Pagnacco, Ph.D., US Agent |
| Summary Date: | July 5, 2007 |
Device Information:
Common/Usual Name: Trade/Proprietary Name: Regulation Number: Regulation Name: Regulatory Class: Product Code:
Nystagmographer (video or electrode) EyeTracker, IDEAS 882.1460 Nystagmograph II GWN
(Premarket Notification [510(k)] Number)
Page 1 of 4
-- DIFRA S.A./N.V.
Roe de l'église, 84 B 4840 WEKENRAD) • 161. 132 (0)67 89 80 80 • Filmeil mitoedra.ne • www.ditabe
1
Substantial Equivalency:
The device is substantially equivalent to:
- the CHARTR ENG/VNG Diagnostic System (K991497) marketed by ICS 必 Medical Corporation
-
- the ENGPLUS (K010059) marketed by Western System Research, Inc.
-
- the VISUAL EYES (K964325) marketed by Micromedical Technologies, Inc.
For its ability to record torsional movements, the device is substantially equivalent to:
- the ULMER (VNG) VIDEO NYSTAGMOGRAPH (K982103) marketed by な Synapsys, Inc.
- the I-PORTAL, also known as I-PORTAL VNG, part of the NEURO-彩 OTOLOGIC TEST CENTER (K781268) marketed by Neuro Kinetics, Inc.
Description of the device:
The device is a PC-based system for measuring, recording and displaying the eve movements. Its components include video goggles or surface electrodes to record the eve movements, a PC interface to acquire the data, a series of software modules to display and analyze the data and various stimulation devices.
Intended use:
The device is intended to measure, record and display the movements of the eyeballs during their involuntary movements (nystagmus) and while testing the patient's vestibular function.
The device is for prescription use only and it is intended for use by qualified medical personnel trained in the use of nystagmographs. This device provides no diagnoses nor does it provide diagnostic recommendations.
2
| Device
specifications | EYETRACKER
/ IDEAS | CHARTR
ENG/VNG | ENGPLUS | VISUAL
EYES | ULMER (VNG)
VIDEO
NYSTAGMOGRAPH | I-PORTAL,
(NEURO-
OTOLOGIC
TEST
CENTER) |
|--------------------------|-----------------------------------------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------------|--------------------------------------------------------------------------------|
| Safety
compliance | EN 60601-1 | EN 60601-1 | EN 60601-1 | EN 60601-1 | EN 60601-1 | EN 60601-1-2 |
| Type | Video / Electrode
based system | Video /
Electrode
based system | Electrode based
system | Video based
system | Video based
system | Video based
system |
| Construction
type | PC-based system
with built-in
hardware and
peripherals | PC-based
system with
built-in
hardware and
peripherals | PC-based
system with
external
hardware
platform and
peripherals | PC-based
system with
external
hardware
platform and
peripherals | PC-based system with
built-in hardware and
peripherals | PC-based
system with
external
hardware
platform and
peripherals |
| Power source | Mains | Mains | Mains | Mains | Mains | IEEE firewire
cable |
| Computer
interface | Integrated in
computer | Integrated in
computer | Serial or USB
connection | USB
connection | Integrated in computer | IEEE firewire
cable |
Technological Characteristics:
3
Safety:
The device is designed to provide safety to the patient as well as the user and complies with:
-
- EN 60601-1:1990 Medical Electrical Equipment. Part 1: General requirements for safety
-
- EN 60601-1-2:2001 Medical Electrical Equipment. Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility -Requirements and tests
The device is designed, developed and manufactured according to the following standards:
- な ISO 9001:2000 Quality Management Systems-Requirements
-
- ISO13485:2003 Quality management Systems Requirements
The device satisfies all the requirements of the European Community Medical Device Directive MDD 93/42/EEC and bears the CE mark.
4
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle with its wings spread, composed of thick, black lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 8 2007
S.A. Instrumentation DIFRA % Vestibular Technologies, LLC Guido Pagnacco. Ph.D. 205 Co. Rd., 128A Suite 200 Cheyenne, WY 82007
Re: K070670
Trade/Device Name: EyeTracker, IDEAS Regulation Number: 21 CFR 882.1460 Regulation Name: Nystagmograph Regulatory Class: Class II Product Code: GWN Dated: July 5, 2007 Received: July 6, 2007
Dear Dr. Pagnacco:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set
5
Page 2 – Guido Pagnacco, Ph.D.
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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerelv vours.
Sincerely yours,
Mark A Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K070670
Device Name: EyeTracker, IDEAS
Indications For Use:
The device is intended to measure, record and display the movements of the eyeballs during their involuntary movements (nystagmus) and while testing the patient's vestibular function.
The device is for prescription use only and it is intended for use by qualified medical personnel trained in the use of nystagmographs. This device provides no diagnoses nor does it provide diagnostic recommendations.
Prescription Use X (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 CDRH Office of Device Evaluation (ODE) | |
|---|---|
| ------------------------------------------------------- | -- |
Mark M
K070670
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | K070670 |
|---|---|
| Page 1 of ____ |