(308 days)
No
The summary describes image processing and data analysis but does not mention AI, ML, or related concepts like neural networks or training/test sets.
No.
The device is used for assessment and analysis of eye movements, not for treatment.
Yes
The device is used in the "assessment of nystagmus by measuring, displaying, and analyzing eye movements," which indicates its role in identifying or characterizing a medical condition.
No
The device description explicitly states that the device consists of both patient eye goggles (hardware) and a software application. The goggles contain various hardware components like cameras, LEDs, memory, and buttons.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The ISEN-Goggles with Data Viewer directly measures and analyzes eye movements in a living patient. It does not involve the collection or analysis of specimens taken from the body.
- Intended Use: The intended use is the assessment of nystagmus by measuring, displaying, and analyzing eye movements. This is a direct physiological measurement, not an in vitro test.
Therefore, the device falls outside the scope of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The ISEN-Goggles with Data Viewer are used in the assessment of nystagmus by measuring, displaying, and analyzing eye movements. The ISEN-Goggles with Data Viewer are used in the assessment of nystagmus by measuring, recording, displaying, and analyzing eye movements.
Product codes (comma separated list FDA assigned to the subject device)
GWN
Device Description
This device consists of patient eye goggles ("ISEN-Goggles"), previously cleared under K152727, and a software application for data visualization and analysis ("Data Viewer").
The ISEN-Goggles have 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.
The Data Viewer software retrieves data from the goggles, displays it, performs analysis functions, and exports customizable reports. It includes a patient database.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video
Anatomical Site
Eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained and qualified 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
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): 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.
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
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 stylized eagle with three lines representing its body and wings. The eagle is positioned to the right of the text, which is arranged in a circular pattern around the left side of the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 25, 2017
ISEN Tech & Trading Company,ltd. % Tom Renner Ouality, Efficiency & Regulatory Affairs Consultant Vision28 915 SW Rimrock Way, STE 201 PMB 402 Redmond, OR 97756
Re: K163270
Trade/Device Name: ISEN-Goggles With Data Viewer Regulation Number: 21 CFR 882.1460 Regulation Name: Nystagmograph Regulatory Class: Class II Product Code: GWN Dated: August 18, 2017 Received: August 24, 2017
Dear Tom Renner:
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.
1
Page 2 - Tom Renner
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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,
Bradley S. Cunningham -S
for 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
2
Indications for Use
510(k) Number (if known)
K163270
Device Name ISEN-Goggles with Data Viewer
Indications for Use (Describe)
The ISEN-Goggles with Data Viewer are used in the assessment of nystagmus by measuring, displaying, and analyzing eye movements.
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)
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FORM FDA 3881 (8/14)
3
510(k) SUMMARY - K163270
Contact Details
| Applicant Name: | ISEN Tech & Trading Company, Ltd.
509, Bldg. A Cyber Tower, No. 2 ZHONG GUANCUN South Ave.
Beijing, 100086, China
+86-10-5162-7073 |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Martin Liu, CEO |
| Date Prepared: | September 25, 2017 |
Device Name
Trade Name: ISEN-Goggles with Data Viewer
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 |
|---|---|---|---|
| K151504 | GWN | ICS Impulse System Model | |
| 1085 | GN Otometrics |
Device Description
This device consists of patient eye goggles ("ISEN-Goggles"), previously cleared under K152727, and a software application for data visualization and analysis ("Data Viewer").
The ISEN-Goggles have 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
ISEN-Goggles with Data Viewer 510(k) Notification
The Data Viewer software retrieves data from the goggles, displays it, performs analysis functions, and exports customizable reports. It includes a patient database.
Intended Use/Indications for use
The ISEN-Goggles with Data Viewer are used in the assessment of nystagmus by measuring, recording, displaying, and analyzing eye movements.
Substantial Equivalence Comparison
The ISEN-Goggles with Data Viewer is a modification of the ISEN-Goggles, previously submitted to the agency and cleared under K152727. However, the predicate device being used to establish substantial equivalence in this submission is the ICS Impulse System Model 1085 from GN Otometrics that was cleared under K151504.
Table 5-1 Summary of Similarities and Differences
| | ISEN-Goggles with Data
Viewer K163270 | Otometrics ICS Impulse 1085
K151504 |
|------------------------------------|----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Category | | |
| Product code | GWN | GWN |
| IFU | Used in the assessment of
nystagmus by measuring,
recording, displaying, and
analyzing eye movements. | Used in the assessment of
[VOR] and nystagmus by
measuring, recording,
displaying, and analyzing eye
and head movements. |
| Test types supported | Positional, oculomotor, caloric | Positional, oculomotor, head
impulse |
| User | Trained and qualified
personnel | Trained and qualified
personnel |
| Patient-applied part | Goggles | Goggles |
| Built-in calibration | Yes | Yes |
| Per-patient calibration | Yes | Yes |
| Eye tracking | Binocular | Monocular (right eye only) |
| Eye illumination | Infra-red LED | Infra-red LED |
| Real-time display of
eyes | Yes | Yes |
| Records video of eyes | Yes | Yes |
| Records eye movement | Yes | Yes |
| Real-time graph of eye
movement | Yes | Yes |
| Records head position | No | Yes |
| Vision stimulus type | LED | Projected lasers |
| Vision denied mode | Yes | Yes |
5
| | ISEN-Goggles with Data
Viewer K163270 | Otometrics ICS Impulse 1085
K151504 |
|--------------------------------------------|------------------------------------------|---------------------------------------------|
| Category | | |
| Analysis software | PC-based, post-processing | PC-based, real-time and post-
processing |
| Analysis algorithm | Slow phase velocity (SPV) | Slow phase velocity (SPV) |
| Graphs slow phase
velocity | Yes | Yes |
| Playback of
synchronized
video/graph | Yes | Yes |
| Patient database | Yes | Yes |
| Customizable reports | Yes | Yes |
| Report output format | Word .doc | Adobe PDF |
| Operating system | Windows 7 | Windows 8 or 7 |
| Patient-applied part
interface to PC | USB, untethered during
session | USB, tethered during session |
Both devices are goggles that record eye movements, coupled with PC-based analysis software. There are some differences. For example, the ICS Impulse System Model 1085 product only records and analyzes monocular eye data, while the ISEN-Goggles with Data Viewer records and analyzes binocular data. The ICS Impulse System Model 1085 records head position, but the ISEN-Goggles do not. The ISEN-Goggles can perform a caloric calculation, but the ICS Impulse System Model 1085 cannot.
Other differences relate to the specific components used for implementation. The ISEN-Goggles utilize battery power, while the ICS Impulse System Model 1085 goggles obtain power via USB. The ISEN-Goggles use LEDs for stimulus, while the ICS Impulse System Model 1085 uses lasers to project LED-like dots.
However, these differences do not affect the substantial equivalence; both devices 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).
6
ISEN-Goggles with Data Viewer 510(k) Notification
Summary
The ISEN-Goggles with Data Viewer are substantially equivalent to the ICS Impulse System Model 1085 in intended use, device features, and use parameters.