(217 days)
Not Found
No
The description mentions "image processor" but provides no details suggesting AI/ML is used for analysis or interpretation, and there is no mention of AI, DNN, or ML in the document.
No.
The device is used to record and display eye movements for diagnostic purposes, not to treat a condition.
Yes
The device is used to "record and visually display movements of the eyes including nystagmus," which are observations made to assess a patient's condition.
No
The device description explicitly details hardware components such as goggles, LCD display, LED lights, internal memory, cameras, and a micro-USB port. The performance studies also include testing of hardware components like electrical safety and electromagnetic compatibility.
Based on the provided information, the ISEN-Goggles are not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- ISEN-Goggles Function: The ISEN-Goggles directly record and display eye movements. They do not analyze biological specimens taken from the body.
- Intended Use: The intended use is to record and display eye movements, specifically nystagmus, which is a direct observation of a physiological function, not an analysis of a biological sample.
Therefore, the ISEN-Goggles fall under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ISEN-Goggles are used to record and visually display movements of the eyes including nystagmus.
Product codes
GWN
Device Description
This device consists of patient eye goggles with an adjustable, elastic headband, an LCD display, two green LED lights to provide optional focal points, eight infrared LED lights to provide illumination for the internal cameras, an internal SD-type memory, and buttons to operate the device's function. There is also a micro-USB port to facilitate transfer of data captured and stored in the device's SD-type memory.
The patient eye goggles are an opaque, facially worn device fitted with two small video cameras, and two wavelengths of light emitting diodes (LEDs). One set of lights provides illumination for the cameras. The other allows the user to provide a focus point for the patient, if this is desired. These signals are processed by the image processor that allows for nearsimultaneous viewing of the video images from both eyes on the attached LCD screen.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Non-clinical testing for the ISEN-Goggles included electrical safety testing of the Goggles and battery charger to IEC 60601-1, electromagnetic compatibility testing of the Goggles and battery charger to IEC 60601-1-2, lamp safety to IEC 62471, compatibility with FCC regulations per 47 CFR Part 15, battery testing to IEC 62133, and biocompatibility testing to ISO 10993. In addition, hardware and software verification and validation was completed.
No clinical testing is included in this 510(k).
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing right, stacked on top of each other, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 26, 2016
Isen Tech & Trading Company, Ltd. % Linda Bovard, RAC President Bovard Consulting LLC 378 Hardy Avenue Eugene, Oregon 97404
Re: K152727
Trade/Device Name: Isen-goggles Regulation Number: 21 CFR 882.1460 Regulation Name: Nystagmograph Regulatory Class: Class II Product Code: GWN Dated: March 22, 2016 Received: March 28, 2016
Dear Ms. Bovard:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
William J. Heetderks -A
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152727
Device Name ISEN-Goggles
Indications for Use (Describe)
The ISEN-Goggles are used to record and visually display movements of the eyes including nystagmus.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) SUMMARY
Contact Details
| Applicant Name: | ISEN Tech & Trading Co., Ltd. |
|---|---|
| Rm509, Bldg A, Cyber Tower, No. 2 Zhongguancun South Ave. | |
| Beijing, 100086, China | |
| +86-10-5162-7073 | |
| Contact: | Martin Liu, CEO |
| martin@isen.com.cn | |
| Date Prepared: | March 20, 2016 |
Device Name
Trade Name: ISEN-Goggles
Common Name: IR/Video Eye Movement Viewer/Recorder
Classification Name: 882.1460 Nystagmograph; GWN Nystagmograph
Legally Marketed Predicate Device(s)
| 510(k) Number | Product Code | Trade Name | Applicant |
|---|---|---|---|
| K972631 | GWN | ICS Medical VEMR Video | |
| Eye Movement Recorder | ICS Medical Corp. |
Device Description
This device consists of patient eye goggles with an adjustable, elastic headband, an LCD display, two green LED lights to provide optional focal points, eight infrared LED lights to provide illumination for the internal cameras, an internal SD-type memory, and buttons to operate the device's function. There is also a micro-USB port to facilitate transfer of data captured and stored in the device's SD-type memory.
The patient eye goggles are an opaque, facially worn device fitted with two small video cameras, and two wavelengths of light emitting diodes (LEDs). One set of lights provides illumination for the cameras. The other allows the user to provide a focus point for the patient, if this is desired. These signals are processed by the image processor that allows for nearsimultaneous viewing of the video images from both eyes on the attached LCD screen.
4
Intended Use/Indications for use
The ISEN-Goggles are used to record and visually display movements of the eyes including nystagmus.
Substantial Equivalence Comparison
The predicate device for this submission is the ICS Medical VEMR Video Eye Movement Recorder (ICS VEMR) from ICS Medical that was cleared under K972631.
Table 5-1 Summary of Similarities and Differences
| Category | ISEN-Goggles | ICS VEMR
K972631 |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Goggles fitted with IR
sensitive video cameras | Yes | Yes |
| IR Source | IR LEDs
Peak Wavelengths ( $λ$ ) = 940nm (red) | IR LEDs
Peak Wavelength ( $λ$ ) = 940nm (red) |
| Lights for visual focus point | Yes – 573nm (green) | No |
| Light blocking opaque
goggles | Yes | Yes |
| Energy Source | Internal Rechargeable Battery | External Power Supply |
| Components | Goggles
Mask 1 and 2
Battery Charger
Rechargeable Li-ion Battery (not
supplied but required) | Goggles
VCR and Remote
Separate 17" Display Monitor |
| Weight | 17.6 oz. (mask plus goggles) | 12-15oz – Goggles
9lb 4oz – VCR and Remote
37lb 5oz – 17" Display Monitor
TOTAL: 47lb 5oz – 47lb 8 oz |
| Interface to control device | Buttons located on goggle-mounted
LCD. | Remote Control |
| Images Splitter/Power
supply interface | Image Splitter not necessary with this
technology | Yes |
| Video Recording Capability | Yes (built-in SD-type memory
drive). A micro-USB port is
provided to enable data transfer. | Yes (built-in VCR) |
| Video-Goggle interface | An LCD display is attached to the
goggles, allowing for simultaneous
display of both eyes from two video
cameras within the mask. | An interface that allows for display
of both eyes on video monitor and
provides the power for the video
cameras and the LEDs |
Both devices are essentially goggles with internal cameras and LED lights. There are some differences. For example, the ICS VEMR product has only one type of LED that displays red light (940 nm) while the ISEN-Goggles has red (940nm) LEDs for illuminating the image
5
being recorded and green (573nm) LEDs to provide the option of a focal point for the patient during the test.
Many of the other differences relate to the miniaturization of components since the marketing of the ICS VEMR. The ISEN-Goggles combines many of the separate features of the ICS VEMR into one device instead of three separate devices that work together. This contributes to the reduction in overall weight and size of the system. The ISEN-Goggles weigh only 17.6 oz while the ICS VEMR system weighed 471b 5oz to 471b 8oz for the ICS VEMR system. The energy sources are also different.
However, these differences do not affect the substantial equivalence; they are still using the same technological basis to accomplish the same purpose.
Non-clinical Testing
Non-clinical testing for the ISEN-Goggles included electrical safety testing of the Goggles and battery charger to IEC 60601-1, electromagnetic compatibility testing of the Goggles and battery charger to IEC 60601-1-2, lamp safety to IEC 62471, compatibility with FCC regulations per 47 CFR Part 15, battery testing to IEC 62133, and biocompatibility testing to ISO 10993. In addition, hardware and software verification and validation was completed.
Clinical Testing
No clinical testing is included in this 510(k).
Summarv
The ISEN-Goggles are substantially equivalent to the ICS VEMR in intended use, device features, and use parameters.