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.

AI/ML Overview

The provided text from the 510(k) notification for the ISEN-Goggles with Data Viewer (K163270) specifically states:

"No clinical testing is included in this 510(k)."

Therefore, based on the provided document, the following points cannot be addressed as no study was presented to prove the device meets acceptance criteria.

1. A table of acceptance criteria and the reported device performance: Not available.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not available.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not available.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as no clinical testing was performed for the algorithm component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not available.
8. The sample size for the training set: Not applicable, as no clinical testing was performed for the algorithm component.
9. How the ground truth for the training set was established: Not applicable, as no clinical testing was performed for the algorithm component.

The 510(k) submission primarily relies on non-clinical testing and substantial equivalence to a predicate device (ICS Impulse System Model 1085, K151504). The non-clinical testing included:

Electrical safety testing: IEC 60601-1
Electromagnetic compatibility testing: IEC 60601-1-2
Lamp safety: IEC 62471
FCC regulations: 47 CFR Part 15
Battery testing: IEC 62133
Biocompatibility testing: ISO 10993
Hardware and software verification and validation.

Summary

{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)

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."

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

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 Model1085	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").

{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 DataViewer K163270	Otometrics ICS Impulse 1085K151504
Category
Product code	GWN	GWN
IFU	Used in the assessment ofnystagmus by measuring,recording, displaying, andanalyzing eye movements.	Used in the assessment of[VOR] and nystagmus bymeasuring, recording,displaying, and analyzing eyeand head movements.
Test types supported	Positional, oculomotor, caloric	Positional, oculomotor, headimpulse
User	Trained and qualifiedpersonnel	Trained and qualifiedpersonnel
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 ofeyes	Yes	Yes
Records video of eyes	Yes	Yes
Records eye movement	Yes	Yes
Real-time graph of eyemovement	Yes	Yes
Records head position	No	Yes
Vision stimulus type	LED	Projected lasers
Vision denied mode	Yes	Yes

{5}------------------------------------------------

	ISEN-Goggles with DataViewer K163270	Otometrics ICS Impulse 1085K151504
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 phasevelocity	Yes	Yes
Playback ofsynchronizedvideo/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 partinterface to PC	USB, untethered duringsession	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.

Regulation Number and Section

§ 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).