(90 days)
Not Found
No
The description focuses on hardware (cameras, housing, IR illumination) and the function of providing video signals for observation and measurement. There is no mention of AI/ML terms, image processing beyond simple viewing, or any description of algorithms, training, or performance metrics typically associated with AI/ML devices. The predicate device is also a video goggle, suggesting a similar, non-AI technology.
No.
The device is used to observe, record, and measure eye movements, which is a diagnostic function, not a therapeutic one.
Yes
The device is described as making it possible to "observe, record, and measure eye movements during testing of vestibular function," which indicates its use in diagnosing vestibular issues.
No
The device description explicitly states that the device consists of physical components (video cameras, custom housing, cover) and uses infrared illumination, indicating it is a hardware device, not software-only.
Based on the provided information, the ICS Medical Model VG-30 Video Goggles are not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body ("in vitro").
- Device Function: The VG-30 Video Goggles are used to observe, record, and measure eye movements directly on the patient's body ("in vivo"). They capture video signals of the patient's eyes.
- No Specimen Testing: The device does not involve the collection or analysis of any biological specimens from the patient.
Therefore, the function and application of the VG-30 Video Goggles fall outside the scope of In Vitro Diagnostics. They are a device used for in vivo observation and measurement.
N/A
Intended Use / Indications for Use
The ICS Medical Model VG-30 Video Goggles are intended to provide video signals of patient's eyes thus making it possible to observe, record, and measure eye movements during testing of vestibular function.
Product codes
GWN
Device Description
The ICS Medical Model VG-30 Video Goggle consists of two small video cameras mounted in a custom housing to be worn on the face of the patient to view the patients eyes. The goggles use infrared (IR) Illumination to allow the eyes to be viewed in total darkness, a feature produced by a cover that can be installed on the front of the goggle housing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
video signals
Anatomical Site
patient's eyes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The Model VG-30 Video Goggle is designed to meet the same safety standards as the predicate device, i.e. ICS Medical Model VG-10 Video Goggles.
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
DEC 1 0 2001
510(k) SUMMARY
(847)-534-2150
(847)-534-2151
September 7, 2001
125 Commerce Drive Schaumburg, IL 60173-5329
ICS MEDICAL CORPORATION
Submitted by:
Telephone:
FAX:
Contact Person:
Date Summary Prepared:
Classification Name:
Description of Device:
Trade Name of Device:
Video goggle Common Name:
Accessory to: Nystagmograph, Class II, 21 CFR 882.146
Robert M. Simenson, Executive Vice President
ICS Medical Model VG-30 Video Goggie
KO13060
The ICS Medical Model VG-30 Video Goggle consists of two small video cameras mounted in a custom housing to be worn on the face of the patient to view the patients eyes. The goggles use infrared (IR) Illumination to allow the eyes to be viewed in total darkness, a feature produced by a cover that can be installed on the front of the goggle housing.
This device is intended to provide video signals of Intended Use: patient's eyes thus making it possible to observe, record, and measure eye movements during testing of vestibular function.
The Model VG-30 Video Goggles are substantially Substantial Equivalence: equivalent to the Model VG-10 Goggles cleared in 510(k): K991497.
Comparison of Similarities and Differences of Our New Medical Device to the Predicate Device:
| | ICS Video Goggle
(510K : K991497) | ICS Medical Model VG-30
Goggle |
|------------------------------------------------------------------------------|--------------------------------------|-----------------------------------|
| Housing Material | ABS Plastic | ABS Plastic |
| Face Cushion Material | Neoprene Rubber | Polyvinyl Chloride |
| Number of Light Emitting
Diodes (LED's) | 7 per eye ( Total: 14) | Identical |
| Mirror Adjustment Capability to
Center the Image | Yes | Yes |
| Horizontal Image Adjustment
Accomplished by Means of
Mirror Adjustment | Yes | Yes |
ﻠﺴ
1
| Vertical Image Adjustment
Accomplished by Adjusting
| Cameras | Yes | Yes |
|---|---|---|
| Mirror Material | Polycarbonate plastic | Identical |
| Strap Material | Neoprene Rubber | Identical |
| Video Camera Adjustment | ||
| Capability | Yes | Yes |
| Friction Fit Light Occluding | ||
| Cover | Yes | Identical |
| Weight | Approximately 21 oz. | Approximately 18.5 oz. |
Please note that with the exception of the face cushion material both these goggles are virtually identical in design and materials.
The Model VG-30 Video Goggle is designed to meet the same safety standards as the predicate device, i.e. ICS Medical Model VG-10 Video Goggles.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 0 2001
Robert M. Simenson Executive Vice President ICS Medical Corporation 125 Commerce Drive Schaumburg, Illinois 60173-5329
Re: K013060
Trade Name: ICS Medical Model VG-30 Video Goggle Regulation Number: 882.1460 Regulation Name: Nystagmograph Regulatory Class: II Product Code: GWN Dated: September 7, 2001 Received: September 11, 2001
Dear Mr. Simenson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 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.
3
Page 2 - Mr. Robert Simenson
This letter will allow you to begin marketing your device as described in your Section 510(k) I mo letter notification. The FDA finding of substantial equivalence of your device to a legally premated predicated. " 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of Compinates at (201) 594-4639 Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the O wision of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Walker
Image /page/3/Picture/5 description: The image shows a black and white drawing of a symbol. The symbol appears to be a stylized letter or character, with a curved line at the top and a more angular shape at the bottom. The drawing is simple and lacks detail, focusing on the basic form of the symbol.
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page_1__of_1_
510(k) Number (if known): K013060
ICS Medical Model VG - 30 Video Goggles Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The ICS Medical Model VG-30 Video Goggles are intended to provide video signals of patient's eyes thus making it possible to observe, record, and measure eye movements during testing of vestibular function.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ·
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Susan Walker
(Division Sign-Off) Division of General Pestorative and Neurological Devices
510(k) Number_KO13O60