(70 days)
Not Found
Not Found
No
The description focuses on basic video recording and display technology from the late 1990s (indicated by VCR and VEMR™ name). There is no mention of AI, ML, or advanced algorithms for analysis or interpretation of the eye movements. The "image processor" is described as simply allowing simultaneous viewing.
No
The device is described as a recorder and display system for eye movements, intended for observation and documentation, not for treatment or therapy.
Yes
Explanation: The "Intended Use / Indications for Use" states that the device is "used to record and visually display movements of the eyes including nystagmus." Recording and displaying nystagmus (involuntary eye movements) is a diagnostic function, as it helps in identifying and characterizing a medical condition.
No
The device description explicitly lists multiple hardware components including patient eye goggles, a video image splitter/power-supply, a VCR video monitor console, and a remote control accessory. The performance studies also include tests on the physical goggle material and electrical tests on the system, indicating it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: This device directly observes and records eye movements in vivo (within the living body). It does not analyze samples taken from the patient.
- Intended Use: The intended use is to "record and visually display movements of the eyes," which is an in vivo measurement.
Therefore, the VEMR™ Eye Movement Recorder falls under the category of a medical device used for in vivo assessment, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This device is used to record and visually display movements of the eyes including nystagmus.
Product codes (comma separated list FDA assigned to the subject device)
84GWN
Device Description
The VEMR™ Eye Movement Recorder is used to observe or record eye movements on a video monitor or video recording tape respectively. This device consists of: patient eye goggles, a video image splitter/power-supply, a video tape cassette recorder (VCR) video monitor console, and a remote control accessory. There is also a built-in microphone in the eye goggles to provide simultaneous voice recording's on a video recording tape.
The patient eye goggles are an opaque, facially worn device fitted with tiny video cameras, infrared light emitting diodes (LED's), and a microphone. The diodes illuminate the eyes for video cameras that produce video signals. These signals are processed by the image processor that essentially allows for simultaneous viewing the video images of both eyes on the video screen. The microphone allows for recording of voices to help document events recorded on video tape. The remote control accessory provides remote control of the various functions (e.g. play, record etc.) on the VCR/video monitor console.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video
Anatomical Site
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)
Summary of Non-Clinical Tests:
The plastic portion of the goggle material that is in contact with the skin was subjected to:
- MEM Elution Cytotoxicity Test (performed according to GLP regulations) The test article does meet the requirements of this test.
- Primary Skin Irritation Test on Rabbits (performed according to GLP regulations) -Findings: " ... the test article, Sellstrom Gold PVC Goggle; lot Identification: May 7, 1997, is not considered an irritant.
The ICS VEMR™, Video Eye Movement Recorder was subjected to a battery of EMI (Electromagnetic interference) and other electrical tests.
The system passed the requirements of the following standard tests:
CISPR 11 B (EN55011) Conducted Emissions
CISPR 11 A (EN55011) Radiated Emissions
Military Standard 461 RE 101 Magnetic Emissions
ENV 50140 (IEC 1000-4-3) Radiated Susceptibility Test
EN 61000-4-2 Electrostatic Discharge Test
EN 610 00-4-4 Transient Susceptibility Test
EN 61000-4-5 Surge Immunity Test
Tests on the VEMR™ performed at ICS Medical demonstrated that this units meets the requirements of UL-544/42 (dielectric withstand) and UL-544/46 (leakage current).
radiometric measurements of the infrared emitting diodes in the VEMR Goggles were made in order to determine whether the spectral radiance and irradiance is within the Threshold Limit Values (TLV's) recommended by the American Conference of Governmental Industrial Hygienists (ACGIH). We determined that the maximum irradiance of the infrared diodes used in the VEMR goggles is approximately 1/270 of the recommended ACGIH TLV of 10 milliwatts/cm2.
Likewise the maximum radiance emitted by the VEMR infrared diodes was shown to be approximately 1/1700 of the recommended ACGIH TLV of TLV of 35.3 watts/cm2 (sr).
Based on the above radiometric findings the infrared energy emitted by the small diodes in the VEMR Goggles is well below the recommended ACGIH TLV guidelines thus posing no threat to the patient's eyes.
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.
Not Found
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
SEP 2 2 1997
510(k) SUMMARY
| Submitted by: | ICS MEDICAL CORPORATION
2227 Hammond Drive
Schaumburg, IL 60173-3860 |
|------------------------|----------------------------------------------------------------------------|
| Telephone: | (847)-397-2150 |
| Fax: | (847)-397-0666 |
| Contact Person: | Delmar F. Bloem, President |
| Date Summary Prepared: | July 3, 1997 |
| Trade Name of Device: | ICS VEMRTM Eye Movement Recorder |
| Common Name: | IR/Video Eye Movement Viewer/Recorder |
| Classification Name: | Nystagmograph (CFR882.1460) |
Substantial Equivalence: The ICS VEMR™ Eye Movement Recorder is substantially equivalent to the one used in the House InfraRed/Video Electronystagmograph System for which the company received their 510(k) approval except that our unit is a stand-alone device that only permits viewing of the eyes and recording their movements on video tape. Our device does not perfom any analyses or measurements of the images.
Description of the Device:
The VEMR™ Eye Movement Recorder is used to observe or record eye movements on a video monitor or video recording tape respectively. This device consists of: patient eye goggles, a video image splitter/power-supply, a video tape cassette recorder (VCR) video monitor console, and a remote control accessory. There is also a built-in microphone in the eye goggles to provide simultaneous voice recording's on a video recording tape.
The patient eye goggles are an opaque, facially worn device fitted with tiny video cameras, infrared light emitting diodes (LED's), and a microphone. The diodes
1
illuminate the eyes for video cameras that produce video signals. These signals are processed by the image processor that essentially allows for simultaneous viewing the video images of both eyes on the video screen. The microphone allows for recording of voices to help document events recorded on video tape. The remote control accessory provides remote control of the various functions (e.g. play, record etc.) on the VCR/video monitor console.
Intended Use:
This device is used to record and visually display movements of the eyes including nystagmus.
Summary of Technological Similarities and Differences to the Predicate Device:
| Item | ICS VEMR | Jedmed House Ir/video
Vue Goggle System |
|-------------------------------------------------------|----------------------------------------------------|----------------------------------------------------|
| Goggles fitted
with IR sensitive
video cameras. | Yes | Yes |
| IR Source | IR LEDs
Peak Wavelength (λ)
= 940 nanometers | IR LEDs
Peak Wavelength (λ)
= 940 nanometers |
| Light tight
eyegoggles | Yes | Yes |
| Material in contact
with face | Soft PVC plastic | Foam material
(unknown composition) |
| Image splitter/power
supply interface | Yes | Yes |
| Built-in microphone | Yes | No |
| Intended use | Identical for both units | |
| Video recording
capability | Yes (built-in VCR) | Yes (need optional VCR) |
2
interface
Both units have an interface that allows for display of both eyes on video monitor and provides the power for the video cameras and the LEDs.
Summary of Non-Clinical Tests:
The plastic portion of the goggle material that is in contact with the skin was subjected to:
-
- MEM Elution Cytotoxicity Test (performed according to GLP regulations) The test article does meet the requirements of this test.
-
- Primary Skin Irritation Test on Rabbits (performed according to GLP regulations) -Findings: " ... the test article, Sellstrom Gold PVC Goggle; lot Identification: May 7, 1997, is not considered an irritant.
The ICS VEMR™, Video Eye Movement Recorder was subjected to a battery of EMI (Electromagnetic interference) and other electrical tests.
The system passed the requirements of the following standard tests:
CISPR 11 B (EN55011) Conducted Emissions CISPR 11 A (EN55011) Radiated Emissions Military Standard 461 RE 101 Magnetic Emissions ENV 50140 (IEC 1000-4-3) Radiated Susceptibility Test EN 61000-4-2 Electrostatic Discharge Test EN 610 00-4-4 Transient Susceptibility Test EN 61000-4-5 Surge Immunity Test
The VEMR unit, based on above findings, will require the following labeling in the VEMR instruction manual:
Warning - This is a Class A product. In a domestic environment this product may cause radio interference in which case the user may be required to take adequate measures.
Tests on the VEMR™ performed at ICS Medical demonstrated that this units meets the requirements of UL-544/42 (dielectric withstand) and UL-544/46 (leakage current).
Finally, radiometric measurements of the infrared emitting diodes in the VEMR Goggles were made in order to determine whether the spectral radiance and irradiance is within the Threshold Limit Values (TLV's) recommended by the American Conference of Governmental Industrial Hygienists (ACGIH). We determined that the maximum irradiance of the infrared diodes used in the VEMR goggles is approximately 1/270 of the recommended ACGIH TLV of 10 milliwatts/cm2 .
3
Likewise the maximum radiance emitted by the VEMR infrared diodes was shown to be approximately 1/1700 of the recommended ACGIH TLV of TLV of 35.3 watts/cm2 (sr).
Based on the above radiometric findings the infrared energy emitted by the small diodes in the VEMR Goggles is well below the recommended ACGIH TLV guidelines thus posing no threat to the patient's eyes.
4
Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure, with three profiles merging into one, resembling a bird-like shape.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 2 1997
Mr. Delmar F. Bloem ICS Medical Corporation 2227 Hammond Drive Schaumburg, Illinois 60173-3860
Re: K972631 ICS Medical VEMR Video Eye Movement Recorder Trade Name: Regulatory Class: II Product Code: 84GWN July 11, 1997 Dated: Received: July 14, 1997
Dear Mr. Bloem:
We have reviewed your Section 510(k) 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
5
Page 2 - Mr. Delmar F. Bloem
obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597.
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, 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): _ K972631
Device Name: ICS Medical VEMR
Indications For Use:
This device is used to record and visually display movements of the eyes including nystagmus.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Thomas J. Gillespie
(Division Sign-Off)
Division of Cardiovascular, Respiratory. and Neurological Devices 510(k) Number J
Prescription Use_X (Per 21 CFR 801.109)
ભાગમાં આવેલા ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં મુખ્યત્વે ખેત-ઉ
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
. V