The Ulmer Video Nystagmograph System is intended for use by the physician as an aid for the detection and diagnosis of vestibular disorders. The Ulmer VNG detects and displays eye position and movement in response to a number of vestibular stimulations i.e. saccadic test, smooth pursuit, optokinetic nystagmus, caloric tests and kinetic vestibular tests. The Ulmer VNG records and analyses the bilateral, monocular, horizontal and vertical aspects of eye position and movement. This device is intended to be used in a doctor's office or health care facility to obtain recorded data of nystagmus by directly observing eye motion by video cameras. The resulting recorded data is evaluated by a trained physician and considered along with other relevant data in diagnosing vestibular disorders.

Device Description

The Ulmer VNG is a video nystagmograph system composed by a software and hardware components.

The software has optional modules: Caloric, Saccade, Slow Pursuit, Kinetic, Optokinetic, Nystagmus (Nystagmus, Gaze or Vertical Subjective modules). It is provided on a CD Rom and activated with a key licensing.

The hardware components correspond to a video acquisition unit. The video acquisition unit is composed by different camera goggles/masks in order to allow the visualization of the movement of one or both eye of the patient. The types of cameras included are as follows:

-Type VNS (goggle camera wired),
-Type WNS (goggle camera wireless using Wifi), and
-Type VISIO (goggle camera for visual free field).

For Kinetic Test, an optional stimulator system can be used and is composed by a speed sensor velocimeter and a rotating chair.

The modified Ulmer VNG system is a modification of the previously cleared Synapsys Ulmer VNG System (K982103) which allows use of a wireless camera (using Wifi).

The advantage of a wireless camera system resides in both ergonomics: manoeuvers made easier without being disturbed by cable presence; and portability: makes possible to bring a VNG system (PC laptop + wireless camera) to the patient unlike other fixed wired systems.

AI/ML Overview

The provided document is a 510(k) Pre-market Notification for the Synapsys Ulmer Video Nystagmograph (VNG) system (K163558), specifically concerning a modification that allows for the use of a wireless camera. This document focuses on demonstrating substantial equivalence to a predicate device (K982103), rather than presenting a performance study with acceptance criteria for a new AI/algorithm-based device.

Therefore, the information required to answer the prompt regarding acceptance criteria and the study proving the device meets those criteria (especially for an AI/algorithm where detailed performance metrics, ground truth, and human reader studies would be relevant) is not present in this document.

The document states:

"There was no human clinical testing required to support the medical device as the intended use is the same as the predicate device." (page 9)
"The non-clinical testing detailed in this submission supports the substantial equivalence of the device." (page 9)

The non-clinical testing mentioned is primarily related to electrical safety, electromagnetic compatibility, and software verification to ensure that the integration of the wireless camera does not introduce new safety or effectiveness concerns. These are not performance metrics of an AI/algorithm, but rather engineering and regulatory compliance tests for the modified hardware component.

Given the absence of the requested data in the provided text, I cannot fill in the table or answer the specific questions about acceptance criteria, study design, sample sizes, expert involvement, and ground truth for an AI/algorithm.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 23, 2017

Synapsys SA % Ms. Rachel Paul Senior Consultant, QA & RA Emergo Europe Consulting Prinsessegracht 20 The Hague, 2514AP NL

Re: K163558

Trade/Device Name: Synapsys Ulmer Video Nystagmograph Regulation Number: 21 CFR 882.1460 Regulation Name: Nystagmograph Regulatory Class: Class II Product Code: GWN Dated: March 6, 2017 Received: March 9, 2017

Dear Ms. Paul:

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.

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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 the quality systems (QS) 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.

Eric A. Mann -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) K163558

Device Name Synapsys Ulmer VNG

Indications for Use (Describe)

The Ulmer Video Nystagmograph System is intended for use by the detection and diagnosis of vestibular disorders. The Ulmer VNG detects and displays eye position and movement in response to a number of vestibular stimulations i.e. saccadic test, smooth pursuit, optokinetic nystagmus, caloric tests. The Ulmer VNG records and analyses the bilateral, monocular, horizontal and vertical aspects of eye position and movement. This device is intended to be used in a doctor's office or health care facility to obtain recorded data of nystagmus by directly observing eye motion by video cameras. The resulting recorded data is evaluated by a trained physician and considered along with other relevant data in diagnosing vestibular disorders.

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 (Special 510(k))

Ulmer VNG

K163558

1. Submission Sponsor

Synapsys S.A.

2 Rue Marc Donadille

Hotel Technoptic

13013 Marseille

FRANCE

Contact: Laetitia Baconnier

Title: Purchasing and QA&RA Manager

Email: l.baconnier@synapsys.fr

Office number: +33(4) 91 11 75 75

2. Submission Correspondent

Emergo Europe Consulting

Prinsessegracht 20

The Hague

2514AP

The Netherlands

Contact: Rachel Paul

Title: Senior Consultant, QA&RA

Email: project.management@emergogroup.com

Cellphone number: 00 33 6 89 83 16 09

Office number: +31 (0) 70 345 8570

Direct number: +31 (0) 70 850 8249

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3. Date Prepared

December 16, 2016

4. Device Identification

Trade/Proprietary Name:	Synapsys Ulmer Video Nystagmograph
Common/Usual Name:-	Ulmer VNG
Classification Name:-	Nystagmograph
Regulation Number:-	882.1460
Product Code:	GWN
Device Class:	Class II
Classification Panel:	Neurology

5. Legally Marketed Predicate Device(s)

K982103, Ulmer VNG, Synapsys Incorporated.

6. Indication for Use Statement

7. Device Description

The Ulmer VNG is a video nystagmograph system composed by a software and hardware components.

-Type VNS (goggle camera wired),

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-Type WNS (goggle camera wireless using Wifi), and
-Type VISIO (goggle camera for visual free field).

For Kinetic Test, an optional stimulator system can be used and is composed by a speed sensor velocimeter and a rotating chair.

The modified Ulmer VNG system is a modification of the previously cleared Synapsys Ulmer VNG System (K982103) which allows use of a wireless camera (using Wifi).

8. Substantial Equivalence Discussion

The following table compares the modified Ulmer VNG to the unmodified predicate device with respect to indications for use, principles of operation, technological characteristics, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence, and supports that the subject device, as modified, does not raise any new issues of safety or effectiveness than the predicate device.

Manufacturer	Synapsys SA	Synapsys Inc	Device Comparison
Trade Name	Ulmer VNG	Ulmer VNG (Predicate)
510(k) Number	Unknown at this date	K982103	N/A
Product Code	GWN	GWN	Same
Regulation Number	882.1460	882.1460	Same
Regulation Name	Nystagmograph	Nystagmograph	Same
Indications for Use	The Ulmer VideoNystagmograph System isintended for use by thephysician as an aid for thedetection and diagnosis ofvestibular disorders. TheUlmer VNG detects anddisplays eye position andmovement in response to anumber of vestibularstimulations i.e. saccadic test,smooth pursuit, optokineticnystagmus, caloric tests andkinetic vestibular tests. The	The Ulmer VideoNystagmograph System isintended for use by thephysician as an aid for thedetection and diagnosis ofvestibular disorders. TheUlmer VNG detects anddisplays eye position andmovement in response to anumber of vestibularstimulations i.e. saccadic test,smooth pursuit, optokineticnystagmus, caloric tests andkinetic vestibular tests. The	Same
Manufacturer	Synapsys SA	Synapsys Inc	Device Comparison
Trade Name	Ulmer VNG	Ulmer VNG (Predicate)
	Ulmer VNG records andanalyses the bilateral,monocular, horizontal andvertical aspects of eyeposition and movement. Thisdevice is intended to be usedin a doctor's office or healthcare facility to obtainrecorded data of nystagmusby directly observing eyemotion by video cameras. Theresulting recorded data isevaluated by a trainedphysician and consideredalong with other relevant datain diagnosing vestibulardisorders.	Ulmer VNG records andanalyses the bilateral,monocular, horizontal andvertical aspects of eyeposition and movement. Thisdevice is intended to be usedin a doctor's office or healthcare facility to obtainrecorded data of nystagmusby directly observing eyemotion by video cameras. Theresulting recorded data isevaluated by a trainedphysician and consideredalong with other relevant datain diagnosing vestibulardisorders.
Mechanism of Action	Eye movements are elicitedby visual stimulators thenthey are recorded andanalyzed for detectingnystagmus (involuntarymovements of the eyeball) byusing a video sensorcomputer acquisition system.All camera goggles/masks useinfrared light.	Eye movements are elicitedby visual stimulators thenthey are recorded andanalyzed for detectingnystagmus (involuntarymovements of the eyeball) byusing a video sensorcomputer acquisition system.All camera goggles/masks useinfrared light.	Same
Technologicalcharacteristics	The Ulmer VNG is composedby:-a software with optionalmodules (caloric, saccade,slow pursuit, kinetic,optokinetic, nystagmus)-a goggle camera:• Type VNS (gogglecamera wired)• Type WNS (gogglecamera wireless)• Type VISIO (gogglecamera for visualfree field)	The Ulmer VNG is composedby:-a software with optionalmodule (caloric, saccade, slowpursuit, kinetic, optokinetic,nystagmus)-a goggle camera:• Type VNS (gogglecamera wired)• Type VISIO (gogglecamera for visualfree field)	An additional googlecamera has beenintegrated into thesystem. Contrary to theothers existing cameras,this new camera iswireless and uses Wificonnection. The modifiedUlmer VNG passed theelectrical safety andelectromagneticcompatibility testingrequirements applicableand the residual riskswere found acceptable.The benefits associated
Manufacturer	Synapsys SA	Synapsys Inc	Device Comparison
Trade Name	Ulmer VNG	Ulmer VNG (Predicate)
	-an acquisition video systemFor Kinetic test: Speed sensorand Rotating Chair (optional)	-an acquisition video systemFor Kinetic test: Speed sensorand Rotating Chair (optional)	with the device excesseach of the residual risks.
Configuration	Computer system with basicrequirements processor and aWireless card	Computer system with basicrequirements processor	Due to the integration ofa wireless camera, awireless card is needed.The wireless cardrequired in the computersystem configurationdoes not introduce newrisk.
Cameragoggles/masks	VNS masksVISIO masksWNS masks	VNS masksVISIO masks	Due to the integration ofa new wireless camera, anew WNS mask has beenintroduced. No new riskwas introduced with theWNS mask as thematerial used in contactwith the patient (foam) isunchanged, the infraredLEDs used are the samefor a same distanceeye/LED. Thismodification does notraise new questions ofsafety and effectiveness.
Cameras	Analogic cameras (VNS3X)Numeric cameras (VNS4X)Analog masks (Visio USB50/100 /200Hz)Wireless cameras (WNS)Battery for Wireless camera	Analogic cameras (VNS3X)Numeric cameras (VNS4X)Analog masks (Visio USB50/100 /200Hz)	A wireless camera hasbeen introduced into thesystem. A battery isprovided with. Theresidual risks introducedby the use of a batterywere found to be minorand acceptable. Thebenefits associated withthe use of the deviceexceed this residual risk.
Environment inwhich Ulmer VNGcan be used	-The device must be used in aroom suitable for medicalexaminations.	-The device must be used in aroom suitable for medicalexaminations.	Same
Manufacturer	Synapsys SA	Synapsys Inc	Device Comparison
Trade Name	Ulmer VNG	Ulmer VNG (Predicate)
	-Temperature: 10-35°C-Humidity: 30-90%-Pressure: 800-1060 hPa	-Temperature: 10-35°C-Humidity: 30-90%-Pressure: 800-1060 hPa
Transport andstorage conditions	Transport and storageconditions:	Transport and storageconditions:	Same
	Storage temperature: -10°C to+55°C	Storage temperature: -10°C to+55°C
	Humidity: 10 to 95%	Humidity: 10 to 95%
	Pressure: 700 to 1060hPa	Pressure: 700 to 1060hPa
Shelf Life	5 years	5 years	Same
Complies with ISO10993-1	Yes	Yes	Same
Electrical SafetyTesting Passed	Yes	Yes	Same

Table 5A - Comparison of Characteristics

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9. Non-Clinical Performance Data

Electrical safety and electromagnetic compatibility testing and software internal verification confirm that product specifications of the modified Ulmer VNG system are met. These are equivalent to those of the predicate device. The testing results support that the device's change for integration of an additional Wifi camera does not affect the safe and effective use of the device as compared to the unmodified predicate device. Verification testing of the modified Ulmer VNG system, in accordance with design controls, demonstrated the device is safe and effective for its intended use. Verification testing was performed to the following:

AAMI/ANSI ES 60601-1:2005(R)2012 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
. AAMI/ANSI IEC 60601-1-2:2014 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests
AAMI ANSI IEC 62304:2006 Medical device software Software life cycle processes ●

The device passed all testing and software verification and is determined to be substantially equivalent to the unmodified Ulmer VNG Synapsys' device.

10. Clinical Performance Data

There was no human clinical testing required to support the medical device as the intended use is the same as the predicate device. These types of devices, including the predicate devices, have been on the

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market for many years with proven safety and efficacy for the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.

11. Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device has the same intended use and the same technological characteristics as the previously cleared predicate device; or the device has the same intended use and different technological characteristics, but can be demonstrated to be substantially equivalent to the predicate device, and does not raise additional questions regarding its safety and effectiveness.

As such, the Ulmer VNG System, as modified, is determined to be substantially equivalent to the Synapsys Ulmer VNG predicate device.

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).