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.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called "ISEN-Goggles". The purpose of this notification is to demonstrate that the ISEN-Goggles are substantially equivalent to a legally marketed predicate device. As such, it does not contain a detailed study proving the device meets specific acceptance criteria in the way a clinical trial might.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (ICS Medical VEMR, K972631) by comparing similar technical characteristics and intended use.

Here's an analysis of the provided text in relation to your questions:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria and reported device performance in the typical sense of a clinical or performance study. Its primary goal is to show equivalence. The "performance" is implicitly demonstrated by the comparison to the predicate device in functionality.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

There is no clinical test set or data described in this 510(k) submission. The document explicitly states: "No clinical testing is included in this 510(k)."

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 applicable, as no clinical testing or test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical testing or test set is described.

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 applicable. The device described, "ISEN-Goggles," is an IR/Video Eye Movement Viewer/Recorder, not explicitly an AI-driven image analysis or diagnostic tool that would typically undergo an MRMC study for improved human reader performance. No such study is mentioned or implied.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable, as the device is not an algorithm for standalone performance. It's a tool to view and record eye movements, which a human operator then interprets.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable, as no clinical testing is described.

8. The sample size for the training set

Not applicable, as no algorithm training or clinical data is mentioned for this purpose.

9. How the ground truth for the training set was established

Not applicable, as no algorithm training or clinical data is mentioned.

Summary of what the document DOES provide regarding "acceptance":

The "acceptance criteria" in the context of this 510(k) are implicitly focused on demonstrating substantial equivalence to the predicate device, K972631. This is achieved by:

Matching Intended Use/Indications for Use: Both the ISEN-Goggles and the predicate device are used to "record and visually display movements of the eyes including nystagmus."
Technological Comparison (Table 5-1): The document provides a detailed comparison of features, highlighting similarities (e.g., goggles with IR sensitive video cameras, IR LEDs) and explaining differences (e.g., miniaturization, combined components, energy source) as not affecting substantial equivalence.
Non-clinical Testing: This type of testing serves as "acceptance criteria" for safety and performance under various standards.
- Tests Performed:
  - Electrical safety: IEC 60601-1
  - Electromagnetic compatibility: IEC 60601-1-2
  - Lamp safety: IEC 62471
  - FCC regulations: 47 CFR Part 15
  - Battery testing: IEC 62133
  - Biocompatibility: ISO 10993
  - Hardware and software verification and validation.
- Reported Device Performance: The document states that these tests were "completed," implying successful conformance to the respective standards. The specific performance values or pass/fail criteria for each test are not detailed in this summary, but the successful completion is a form of "acceptance criteria met."

In essence, for a 510(k) submission, "acceptance" largely means demonstrating that the new device is as safe and effective as a legally marketed predicate, primarily through technical and non-clinical data, rather than extensive clinical efficacy studies comparing it against a 'gold standard' for a particular diagnostic outcome.

Summary

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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

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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

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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)

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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 VideoEye Movement Recorder	ICS Medical Corp.

Device Description

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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 VEMRK972631
Goggles fitted with IRsensitive video cameras	Yes	Yes
IR Source	IR LEDsPeak Wavelengths ( $λ$ ) = 940nm (red)	IR LEDsPeak Wavelength ( $λ$ ) = 940nm (red)
Lights for visual focus point	Yes – 573nm (green)	No
Light blocking opaquegoggles	Yes	Yes
Energy Source	Internal Rechargeable Battery	External Power Supply
Components	GogglesMask 1 and 2Battery ChargerRechargeable Li-ion Battery (notsupplied but required)	GogglesVCR and RemoteSeparate 17" Display Monitor
Weight	17.6 oz. (mask plus goggles)	12-15oz – Goggles9lb 4oz – VCR and Remote37lb 5oz – 17" Display MonitorTOTAL: 47lb 5oz – 47lb 8 oz
Interface to control device	Buttons located on goggle-mountedLCD.	Remote Control
Images Splitter/Powersupply interface	Image Splitter not necessary with thistechnology	Yes
Video Recording Capability	Yes (built-in SD-type memorydrive). A micro-USB port isprovided to enable data transfer.	Yes (built-in VCR)
Video-Goggle interface	An LCD display is attached to thegoggles, allowing for simultaneousdisplay of both eyes from two videocameras within the mask.	An interface that allows for displayof both eyes on video monitor andprovides the power for the videocameras 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

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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.

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).