Synapsys Ulmer Video Nystagmograph

K163558 · Synapsys SA · GWN · Mar 23, 2017 · Neurology

Device Facts

• Record ID: K163558
• Device Name: Synapsys Ulmer Video Nystagmograph
• Applicant: Synapsys SA
• Product Code: GWN · Neurology
• Decision Date: Mar 23, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.1460
• Device Class: Class 2

Indications for Use

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 Story

System captures eye position/movement via infrared video camera goggles (wired or wireless); processes data via software modules (caloric, saccade, pursuit, kinetic, optokinetic, nystagmus); displays results for physician review. Used in doctor's offices/healthcare facilities. Wireless camera (WNS) improves ergonomics/portability. Physician evaluates recorded nystagmus data alongside other clinical findings to diagnose vestibular disorders. Benefits include easier maneuvers and increased portability for patient testing.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by non-clinical bench testing, including electrical safety, electromagnetic compatibility, and software verification.

Technological Characteristics

System comprises software modules and video acquisition hardware (goggles/masks). Cameras use infrared light. Connectivity includes wired and wireless (Wifi) options. Complies with AAMI/ANSI ES 60601-1, AAMI/ANSI IEC 60601-1-2, and AAMI ANSI IEC 62304. Patient-contact materials (foam) remain unchanged from predicate. Operates on standard PC hardware with wireless card for WNS model.

Indications for Use

Indicated for use by physicians to aid in the detection and diagnosis of vestibular disorders in patients undergoing vestibular stimulation tests (saccadic, smooth pursuit, optokinetic, caloric, kinetic).

Regulatory Classification

Identification

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

Predicate Devices

• Ulmer VNG (K982103)

Submission Summary (Full Text)

{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 caduceus symbol, which features three human profiles facing right, overlaid on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.

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.

{1}------------------------------------------------

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 [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 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

{2}------------------------------------------------

### 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)

#### 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 [e-mail]

"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."

{3}------------------------------------------------

# 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: [e-mail]

Office number: [phone]

#### 2. Submission Correspondent

Emergo Europe Consulting

Prinsessegracht 20

The Hague

2514AP

The Netherlands

Contact: Rachel Paul

Title: Senior Consultant, QA&RA

Email: [e-mail]

Cellphone number: 00 33 6 89 83 16 09

Office number: [phone]

Direct number: [phone]

{4}------------------------------------------------

#### 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

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.

#### 7. 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),

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

- -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.

#### 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 Video<br>Nystagmograph System is<br>intended for use by the<br>physician as an aid for the<br>detection and diagnosis of<br>vestibular disorders. The<br>Ulmer VNG detects and<br>displays eye position and<br>movement in response to a<br>number of vestibular<br>stimulations i.e. saccadic test,<br>smooth pursuit, optokinetic<br>nystagmus, caloric tests and<br>kinetic vestibular tests. The | The Ulmer Video<br>Nystagmograph System is<br>intended for use by the<br>physician as an aid for the<br>detection and diagnosis of<br>vestibular disorders. The<br>Ulmer VNG detects and<br>displays eye position and<br>movement in response to a<br>number of vestibular<br>stimulations i.e. saccadic test,<br>smooth pursuit, optokinetic<br>nystagmus, caloric tests and<br>kinetic vestibular tests. The | Same |
| Manufacturer | Synapsys SA | Synapsys Inc | Device Comparison |
| Trade Name | Ulmer VNG | Ulmer VNG (Predicate) | |
| | Ulmer VNG records and<br>analyses the bilateral,<br>monocular, horizontal and<br>vertical aspects of eye<br>position and movement. This<br>device is intended to be used<br>in a doctor's office or health<br>care facility to obtain<br>recorded data of nystagmus<br>by directly observing eye<br>motion by video cameras. The<br>resulting recorded data is<br>evaluated by a trained<br>physician and considered<br>along with other relevant data<br>in diagnosing vestibular<br>disorders. | Ulmer VNG records and<br>analyses the bilateral,<br>monocular, horizontal and<br>vertical aspects of eye<br>position and movement. This<br>device is intended to be used<br>in a doctor's office or health<br>care facility to obtain<br>recorded data of nystagmus<br>by directly observing eye<br>motion by video cameras. The<br>resulting recorded data is<br>evaluated by a trained<br>physician and considered<br>along with other relevant data<br>in diagnosing vestibular<br>disorders. | |
| Mechanism of Action | Eye movements are elicited<br>by visual stimulators then<br>they are recorded and<br>analyzed for detecting<br>nystagmus (involuntary<br>movements of the eyeball) by<br>using a video sensor<br>computer acquisition system.<br>All camera goggles/masks use<br>infrared light. | Eye movements are elicited<br>by visual stimulators then<br>they are recorded and<br>analyzed for detecting<br>nystagmus (involuntary<br>movements of the eyeball) by<br>using a video sensor<br>computer acquisition system.<br>All camera goggles/masks use<br>infrared light. | Same |
| Technological<br>characteristics | The Ulmer VNG is composed<br>by:<br>-a software with optional<br>modules (caloric, saccade,<br>slow pursuit, kinetic,<br>optokinetic, nystagmus)<br>-a goggle camera:<br>• Type VNS (goggle<br>camera wired)<br>• Type WNS (goggle<br>camera wireless)<br>• Type VISIO (goggle<br>camera for visual<br>free field) | The Ulmer VNG is composed<br>by:<br>-a software with optional<br>module (caloric, saccade, slow<br>pursuit, kinetic, optokinetic,<br>nystagmus)<br>-a goggle camera:<br>• Type VNS (goggle<br>camera wired)<br>• Type VISIO (goggle<br>camera for visual<br>free field) | An additional google<br>camera has been<br>integrated into the<br>system. Contrary to the<br>others existing cameras,<br>this new camera is<br>wireless and uses Wifi<br>connection. The modified<br>Ulmer VNG passed the<br>electrical safety and<br>electromagnetic<br>compatibility testing<br>requirements applicable<br>and the residual risks<br>were found acceptable.<br>The benefits associated |
| Manufacturer | Synapsys SA | Synapsys Inc | Device Comparison |
| Trade Name | Ulmer VNG | Ulmer VNG (Predicate) | |
| | -an acquisition video system<br>For Kinetic test: Speed sensor<br>and Rotating Chair (optional) | -an acquisition video system<br>For Kinetic test: Speed sensor<br>and Rotating Chair (optional) | with the device excess<br>each of the residual risks. |
| Configuration | Computer system with basic<br>requirements processor and a<br>Wireless card | Computer system with basic<br>requirements processor | Due to the integration of<br>a wireless camera, a<br>wireless card is needed.<br>The wireless card<br>required in the computer<br>system configuration<br>does not introduce new<br>risk. |
| Camera<br>goggles/masks | VNS masks<br>VISIO masks<br>WNS masks | VNS masks<br>VISIO masks | Due to the integration of<br>a new wireless camera, a<br>new WNS mask has been<br>introduced. No new risk<br>was introduced with the<br>WNS mask as the<br>material used in contact<br>with the patient (foam) is<br>unchanged, the infrared<br>LEDs used are the same<br>for a same distance<br>eye/LED. This<br>modification does not<br>raise new questions of<br>safety and effectiveness. |
| Cameras | Analogic cameras (VNS3X)<br>Numeric cameras (VNS4X)<br>Analog masks (Visio USB<br>50/100 /200Hz)<br>Wireless cameras (WNS)<br>Battery for Wireless camera | Analogic cameras (VNS3X)<br>Numeric cameras (VNS4X)<br>Analog masks (Visio USB<br>50/100 /200Hz) | A wireless camera has<br>been introduced into the<br>system. A battery is<br>provided with. The<br>residual risks introduced<br>by the use of a battery<br>were found to be minor<br>and acceptable. The<br>benefits associated with<br>the use of the device<br>exceed this residual risk. |
| Environment in<br>which Ulmer VNG<br>can be used | -The device must be used in a<br>room suitable for medical<br>examinations. | -The device must be used in a<br>room suitable for medical<br>examinations. | Same |
| Manufacturer | Synapsys SA | Synapsys Inc | Device Comparison |
| Trade Name | Ulmer VNG | Ulmer VNG (Predicate) | |
| | -Temperature: 10-35°C<br>-Humidity: 30-90%<br>-Pressure: 800-1060 hPa | -Temperature: 10-35°C<br>-Humidity: 30-90%<br>-Pressure: 800-1060 hPa | |
| Transport and<br>storage conditions | Transport and storage<br>conditions: | Transport and storage<br>conditions: | Same |
| | Storage temperature: -10°C to<br>+55°C | Storage temperature: -10°C to<br>+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 ISO<br>10993-1 | Yes | Yes | Same |
| Electrical Safety<br>Testing Passed | Yes | Yes | Same |

#### Table 5A - Comparison of Characteristics

{6}------------------------------------------------

{7}------------------------------------------------

{8}------------------------------------------------

#### 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

{9}------------------------------------------------

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.