ICS CHARTR EP 200 WITH VEMP

K143670 · Gn Otometrics A/S · GWJ · Oct 23, 2015 · Neurology

Device Facts

• Record ID: K143670
• Device Name: ICS CHARTR EP 200 WITH VEMP
• Applicant: Gn Otometrics A/S
• Product Code: GWJ · Neurology
• Decision Date: Oct 23, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1900
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The ICS Chartr EP 200 with VEMP is indicated for auditory evoked potential testing as an aid in assessing hearing loss and lesions in the auditory pathway. The Vestibular Evoked Myogenic Potential is indicated for vestibular evoked potential testing as an aid in assessing vestibular function in adult patients. The device is to be used only by qualified medical personnel with prior knowledge of the medical and scientific facts underlying the procedure.

Device Story

PC-based system for auditory and vestibular evoked potential testing; used in hospitals, ENT clinics, or audiology offices by qualified medical personnel. Inputs: acoustic stimuli (e.g., 500 Hz tone bursts) and EEG/EMG signals from surface electrodes. System averages EEG/EMG activity to extract responses from noise. Includes VEMP monitor to assess tonic EMG levels (low/good/high) via visual indicator. Output: evoked potential waveforms and EMG monitoring status. Clinicians use output to assess auditory/vestibular function and aid in diagnosis. Benefits: provides objective, reproducible data for clinical assessment of hearing and vestibular disorders.

Clinical Evidence

Clinical study conducted at two facilities (USA/Canada) with 60 normal cVEMP subjects, 58 pathologic cVEMP subjects, and 20 normal oVEMP subjects. Evaluated reproducibility of VEMP waveforms using correlation analysis. Results showed high correlation values for normal subjects (0.89-0.93) and lower values for pathologic subjects (0.75-0.80) due to absent/abnormal responses. Study confirms VEMP waveform reproducibility is comparable to other evoked potential procedures.

Technological Characteristics

PC-based system; external hardware platform; USB interface. Components: isolation transformer, pre-amp, stimulation/recording devices. VEMP monitor: 2.9cm x 6.2cm x 9.5cm. Standards: EN 60601-1, EN 60601-1-2. Connectivity: USB. Software: Windows 7/8 compatible. Power: AC line via isolation transformer.

Indications for Use

Indicated for auditory evoked potential testing to assess hearing loss and auditory pathway lesions in children and adults, and vestibular evoked potential testing to assess vestibular function in adult patients. Contraindications not specified.

Regulatory Classification

Identification

An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.

Predicate Devices

• Chartr EP200 (K092373)

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

October 23, 2015

GN Otometrics A/S % Mr. Daniel Kamm, P.E. Principal Consultant Kamm & Associates 8870 Ravello Ct Naples, Florida 34114

Re: K143670

Trade/Device Name: ICS Chartr EP 200 with VEMP Regulation Number: 21 CFR 882.1900 Regulation Name: Evoked Response Auditory Stimulator Regulatory Class: Class II Product Code: GWJ Dated: September 22, 2015 Received: September 25, 2015

Dear Mr. Kamm:

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 device

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related 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,

Kesia Y. Alexander -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

Enclose

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# Indications for Use

510(k) Number (if known) K143670

Device Name ICS Chartr EP 200 with VEMP

#### Indications for Use (Describe)

The ICS Chartr EP 200 with VEMP is indicated for auditory evoked potential testing as an aid in assessing hearing loss and lesions in the auditory pathway. The Vestibular Evoked Myogenic Potential is indicated for vestibular evoked potential testing as an aid in assessing vestibular function in adult patients. The device is to be used only by qualified medical personnel with prior knowledge of the medical and scientific facts underlying the procedure.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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510(K) Summary, 510(k) K143670 Submitter: GN Otometrics A/S Hoerskaetten 9 Taastrup, DENMARK DK-2630 Registration number: 9612197 (US) Phone: [phone] Contact: Anders Rasmussen [e-mail] Date Prepared: October 14, 2015

- 1. Identification of the Device: Proprietary-Trade Name: Chartr EP 200 with VEMP Classification Name: Stimulator, Auditory, Evoked Response Common/Usual Name: Auditory Evoked Response Stimulator. Product code: GWJ Classification Panel: Neurology Device Class: Class II FDA CFR Section: 21CFR 882.1900
#### 2. Equivalent legally marketed devices: Chartr EP200, K092373, GN Otometrics

- 3. Description of the Device: "Vestibular Evoked Myogenic Potentials (VEMPs) are short latency electromyograms (EMGs) evoked by high level acoustic stimuli recorded from surface electrodes over the tonically contracted sternocleidomastoid (SCM) muscle." Akin FW & Murnane OD (2001).
The ICS Chartr EP 200 with VEMP is used to test the auditory and vestibular functions of children and adults in a hospital, in an Ear, Nose and Throat Clinic or in an Audiology office. The ICS Chartr EP 200 system measures evoked potentials from the patient using repeated auditory stimuli and averaging EEG or EMG activity in order to abstract the response from the noise resulting in an analysis of the auditory/vestibular system functions.

The ICS Chartr EP 200 is a PC-based system, which consists of software modules for installation on a PC, an isolation transformer, a hardware platform, pre-amp, a mains adapter, stimulation devices and recording devices. The stimulation and recording devices are connected to the preamp, which is connected to the hardware platform, which is connected to the PC via a USB cable - no hardware installation inside the PC is required. The PC and hardware platform are powered from the isolation transformer which is powered from the mains.

One added item as compared to the standard EP200 is the VEMP monitor. The Chartr EP (USB) VEMP monitor assesses the level of tonic EMG and displays if the level is adequate or inadequate. The monitor light will display the following based on the EMG level: Low (blue) -EMG level is below the Min value- Good (green) - EMG level is between Min value and the Max value - High (amber) - EMG level is above the Max value

Summary: VEMP is an evoked potential (EP) just like ABR obtained using any commercially available EP system. The unique feature with the ICS Chartr EP 200 is the ability to perform EMG monitoring during VEMP data collection.

The VEMP function of the EP 200 does not make a diagnosis. The diagnosis is made by a medical professional.

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- 4. Indications for Use: The ICS Chartr EP 200 with VEMP is indicated for auditory evoked potential testing as an aid in assessing hearing loss and lesions in the auditory pathway. The Vestibular Evoked Myogenic Potential is indicated for vestibular evoked potential testing as an aid in assessing vestibular function in adult patients. The device is to be used only by qualified medical personnel with prior knowledge of the medical and scientific facts underlying the procedure.
- 5. Safety and Effectiveness, comparison to predicate device. The ICS Chartr EP 200 with VEMP is uses the same construction as the predicate K092373 and adds VEMP required software and hardware, i.e. a VEMP monitor channel.

| | Chartr EP200, K092373, GN Otometrics | Chartr EP200 with VEMP, GN Otometrics, K143670 |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: | The ICS Chartr EP 200 System is indicated for auditory evoked potential testing as an aid in detecting hearing loss and lesions in the auditory pathway. | The ICS Chartr EP 200 with VEMP is indicated for auditory evoked potential testing as an aid in assessing hearing loss and lesions in the auditory pathway. The Vestibular Evoked Myogenic Potential is indicated for vestibular evoked potential testing as an aid in assessing vestibular function in adult patients. The device is to be used only by qualified medical personnel with prior knowledge of the medical and scientific facts underlying the procedure. |
| Configuration | PC-based system with external hardware platform and external hardware peripherals (USB interface) | SAME |
| Photo | Image: The appearance of the equipment has not changed | |
| Hardware Implementation | PC-based system with external hardware platform and peripherals (USB interface) | SAME |
| Tests Performed | Electrocochleography (ECochG)<br>Auditory Middle Latency Response (AMLR)<br>Auditory Late Response (ALR)<br>P300 - optional | Electrocochleography (ECochG)<br>Auditory Middle Latency Response (AMLR)<br>Auditory Late Response (ALR)<br>P300 - optional<br>Auditory Steady State Response (ASSR) – optional |
| | Chartr EP200, K092373, GN<br>Otometrics | Chartr EP200 with VEMP, GN Otometrics,<br>K143670 |
| | Auditory Steady State Response (ASSR) –<br>optional | New: Vestibular Evoked Myogenic Potential<br>(VEMP) - optional |
| Size | Chartr EP 200 main unit: 4.9cm x 34.2cm<br>x 28.7cm (2" x 13.6" x 11.3") – 2.7kg (5<br>lbs 7oz)<br>Chartr EP 200 Preamp: 3cm x 9.9cm x<br>16.4cm (1.19" x 3.88" x 6.44") – .27kg<br>(9.5oz) | Chartr EP 200 main unit: 4.9cm x 34.2cm x<br>28.7cm (2" x 13.6" x 11.3") – 2.7kg (5 lbs 7oz)<br>Chartr EP 200 Preamp: 3cm x 9.9cm x 16.4cm<br>(1.19" x 3.88" x 6.44") – .27kg (9.5oz)<br>Chartr VEMP Monitor: 2.9cm x 6.2cm x 9.5cm<br>(1.13" x 2.44" x 3.75") – 2.0kg (4.5oz) |
| VEMP Monitor | Not applicable | VEMP monitor (described above)<br>Image: VEMP Monitor |
| Computer<br>Operating<br>System | Microsoft XP Professional - Service Pack 2<br>or Vista Business, | Windows 7, 32 or 64 bit<br>Windows 8, 32 or 64 bit |
| Power | AC line | SAME |
| Isolation<br>Transformer | POWERTRONIX Isolation Station | SAME |
| Display | Minimum screen resolution of 1024<br>(horiz) x 768 (vert) at 96 dpi.<br>At Large size (120 dpi) setting, minimum<br>resolution is 1280 (horiz) x 960 (vert)<br>Display Color: 32 bit color. | SAME |
| Safety<br>Standards | EN 60601-1 + A1 + A2; EN 60601-1-2 | SAME |

## 6. Substantial Equivalence Chart

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- 7. Summary of non-clinical testing: (Performed in K092373): Bench testing demonstrated compliance with system hardware and software specifications. There are no changes in electrical safety or EMC characteristics as compared to our predicate Chartr EP200. Software validation and risk analysis was performed to confirm the proper functions of the VEMP protocol.
- 8. Summary of clinical testing: VEMP is a well-documented and studied technique. Numerous clinical references are available using various equipment including our Chartr EP200. We presented clinical studies of the VEMP response using the EP200 in our submission. We also performed studies to confirm the reproducibility of the VEMP waveform. The reproducibility of the VEMP waveform is very similar to that of any other evoked potential waveform.

Summary the clinical data for our correlation study:

Studies were collected at two different facilities, one in the USA and one in Canada. Subjects: Adults:

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There are a total of 60 normal cVEMP subjects. There are 58 pathologic (patients with disorders) .cVEMP subjects. There are 20 oVEMP normal subjects cVEMP normal group consisted of 29 males and 31 females. oVEMP normal group consisted of 7 males and 13 females. cVEMP pathologic group consisted of 27 males and 31 females. Each facility uses the same test parameters:

| Minimum number of runs per ear | 2 |
|--------------------------------|------------------------------|
| Number of channels | 2 |
| Transducer | Insert phones |
| Gain | 5,000 |
| Stimulus | 500 Hz tone burst (Blackman) |
| Rate | 5.1 |
| dbHL | 90-95 dBHL |
| High Pass Filter | 10 Hz |
| Low Pass Filter | 1000 Hz |

The correlation results were as follows:

For normal subjects cVEMP we calculated the following Correlation values:

| CORR R (entire window) | 0.893448276 |
|------------------------|-------------|
| CORR L (entire window) | 0.903448276 |
| 5-35ms CORR R | 0.914655172 |
| 5-35ms CORR L | 0.916206897 |

For patients with disorders, we calculated the following Correlation values:

| CORR R (entire window) | 0.751964286 |
|------------------------|-------------|
| CORR L (entire window) | 0.75637931 |
| 5-35ms CORR R | 0.775172414 |
| 5-35ms CORR L | 0.805 |

For normal oVEMP subjects we calculated the following Correlation values:

| CORR R | 0.897 |
|----------|--------|
| CORR L | 0.8915 |
| 4-20ms R | 0.926 |
| 4-20ms L | 0.93 |

There was a lower correlation value in the patients with disorders because many of these patients may have absent or abnormal cVEMPs (reduced, inconsistent, etc). This inevitably brings the correlation value down since there is no correlation (0.00%) when there is no response. Conclusion: As with other evoked potential procedures, VEMP shows reproducibility which makes it useful to the clinician.

- 9. Conclusion: After analyzing bench testing, safety, EMC, software, and clinical validation testing we conclude that the Chartr EP200 with VEMP (the expanded indication for use) is as safe and effective as the predicate device, and has essentially the same technological characteristics, thus rendering it substantially equivalent to the predicate devices.