ISEN-Goggles with Data Viewer

K163270 · Isent Tech & Trading Company, Ltd. · GWN · Sep 25, 2017 · Neurology

Device Facts

• Record ID: K163270
• Device Name: ISEN-Goggles with Data Viewer
• Applicant: Isent Tech & Trading Company, Ltd.
• Product Code: GWN · Neurology
• Decision Date: Sep 25, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1460
• Device Class: Class 2

Intended Use

The ISEN-Goggles with Data Viewer are used in the assessment of nystagmus by measuring, recording, displaying, and analyzing eye movements.

Device Story

Device consists of opaque, head-worn goggles with dual infrared cameras and two sets of LEDs (one for illumination, one for focal points); internal SD memory; and PC-based Data Viewer software. Goggles capture binocular eye movement video; data transferred via micro-USB to PC. Software performs post-processing analysis of eye movements, including slow phase velocity (SPV) calculation; generates customizable reports; maintains patient database. Used by trained/qualified personnel in clinical settings to assess nystagmus via positional, oculomotor, and caloric testing. Provides near-simultaneous viewing of eye video and movement graphs. Output assists clinicians in diagnosing vestibular or oculomotor disorders by quantifying eye movement characteristics.

Clinical Evidence

No clinical data. Bench testing only, including electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), lamp safety (IEC 62471), battery safety (IEC 62133), biocompatibility (ISO 10993), and hardware/software verification and validation.

Technological Characteristics

Binocular infrared video-oculography system. Components: opaque goggles with dual cameras, IR LEDs, visible LEDs for focal points, SD memory, micro-USB interface. PC-based software for post-processing. Power: battery-operated goggles. Biocompatibility per ISO 10993. Electrical safety per IEC 60601-1; EMC per IEC 60601-1-2; lamp safety per IEC 62471.

Indications for Use

Indicated for the assessment of nystagmus in patients requiring measurement, recording, display, and analysis of eye movements.

Regulatory Classification

Identification

A nystagmograph is a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.

Predicate Devices

• ICS Impulse System Model 1085 (K151504)

Reference Devices

• ISEN-Goggles (K152727)

Submission Summary (Full Text)

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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.

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### 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 [phone] or [phone] 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 [phone] or [phone] 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

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#### 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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# 510(k) SUMMARY - K163270

# Contact Details

| Applicant Name: | ISEN Tech & Trading Company, Ltd.<br>509, Bldg. A Cyber Tower, No. 2 ZHONG GUANCUN South Ave.<br>Beijing, 100086, China<br>[phone] |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| 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<br>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.

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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<br>Viewer K163270 | Otometrics ICS Impulse 1085<br>K151504 |
|------------------------------------|----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Category | | |
| Product code | GWN | GWN |
| IFU | Used in the assessment of<br>nystagmus by measuring,<br>recording, displaying, and<br>analyzing eye movements. | Used in the assessment of<br>[VOR] and nystagmus by<br>measuring, recording,<br>displaying, and analyzing eye<br>and head movements. |
| Test types supported | Positional, oculomotor, caloric | Positional, oculomotor, head<br>impulse |
| User | Trained and qualified<br>personnel | Trained and qualified<br>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<br>eyes | Yes | Yes |
| Records video of eyes | Yes | Yes |
| Records eye movement | Yes | Yes |
| Real-time graph of eye<br>movement | Yes | Yes |
| Records head position | No | Yes |
| Vision stimulus type | LED | Projected lasers |
| Vision denied mode | Yes | Yes |

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| | ISEN-Goggles with Data<br>Viewer K163270 | Otometrics ICS Impulse 1085<br>K151504 |
|--------------------------------------------|------------------------------------------|---------------------------------------------|
| Category | | |
| Analysis software | PC-based, post-processing | PC-based, real-time and post-<br>processing |
| Analysis algorithm | Slow phase velocity (SPV) | Slow phase velocity (SPV) |
| Graphs slow phase<br>velocity | Yes | Yes |
| Playback of<br>synchronized<br>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<br>interface to PC | USB, untethered during<br>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).

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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.