Who is the manufacturer of ICS CHARTR EP 200?

Gn Otometrics filed the 510(k) submission for ICS CHARTR EP 200 (K092373).

What is the FDA product code for ICS CHARTR EP 200?

GWJ. It is classified under 21 CFR 882.1900 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for ICS CHARTR EP 200?

510(k) clearance (submission type: Special).

What are the predicate devices for ICS CHARTR EP 200?

ICS Medical Chartr EP with ASSR and Chartr OAE System (K031986); ICS CHARTR EP 200 (K083399).

Who can help prepare an FDA 510(k) submission like ICS CHARTR EP 200?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ICS CHARTR EP 200

K092373 · Gn Otometrics · GWJ · Sep 3, 2009 · Neurology

Device Facts

Record ID	K092373
Device Name	ICS CHARTR EP 200
Applicant	Gn Otometrics
Product Code	GWJ · Neurology
Decision Date	Sep 3, 2009
Decision	SESE
Submission Type	Special
Regulation	21 CFR 882.1900
Device Class	Class 2
Attributes	Pediatric

Intended 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.

Device Story

ICS Chartr EP 200 is a PC-based system for auditory evoked potential testing; used in clinical settings by healthcare professionals. System components include software modules, isolation transformer, hardware platform, pre-amplifier, mains adapter, stimulation devices, and recording devices. Hardware connects to PC via USB. Device records auditory evoked potentials; processes signals to assist clinicians in identifying hearing loss or auditory pathway lesions. Modification adds Auditory Steady State Response (ASSR) functionality and software-based electrode switching. Output displayed on PC for clinician review; aids in diagnostic decision-making regarding patient auditory function.

Clinical Evidence

No clinical data provided. Effectiveness is based on the device being an auditory evoked response system of a technology type already available and accepted in the market. Bench testing and compliance with safety standards (EN 60601 series) are cited.

Technological Characteristics

PC-based system; external hardware platform with USB interface. Components: pre-amp, stimulation/recording devices, isolation transformer. Software-based electrode switching. Power: Mains. Safety standards: EN 60601-1, EN 60601-1-1, EN 60601-1-2, EN 60601-1-4, EN 60601-2-26, EN 60601-2-40. OS: Windows XP.

Indications for Use

Indicated for auditory evoked potential testing to aid in detection of hearing loss and auditory pathway lesions in patients of all ages.

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

ICS Medical Chartr EP with ASSR and Chartr OAE System (K031986)
ICS CHARTR EP 200 (K083399)

Related Devices

K083399 — ICS CHARTR EP 200 · Gn Otometrics A/S · Feb 20, 2009
K070696 — INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME) · Interacoustics A/S · Jun 29, 2007
K073626 — BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM · Bio-Logic Systems Corp. · Feb 5, 2008
K031051 — SMARTEP-ASSR, MODEL M811007 · Intelligent Hearing Systems · Feb 20, 2004
K193033 — GSI Audera Pro · Grason Stadler · Apr 24, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ K092373 Pg 1 of 2 #### 510(K) Summary K09 Submitter Name and address: GN Otometrics A/S Dybendalsvaenget 2 DK-2630 Taatrup Denmark (US) Phone: 847-534-2150 (US) Fax: 847-534-2153 Dan Sansonetti July 29, 2009 Device Name: Contact Person: Summary prepared: Common/Usual Name: Auditory Evoked Potential System Trade/Proprietary name: ICS CHARTR EP 200 Classification name: Stimulator, Auditory, Evoked Response Predicate devices The GN Otometrics ICS CHARTR EP 200 is similar to these relevant Chartr products: K031986, ICS Medical Chartr EP with ASSR and Chartr OAE System Product Code: EWO Regulation Number: 882.1050 K083399, ICS CHARTR EP 200 Product Code: GWJ Regulation Number: 882.1900 (without ASSR and Chartr OAE System) The modified ICS CHARTR EP 200 has the same external hardware platform with USB connection to PC as K083399 and it adds ASSR (from K031986) and minor software enhancements and user interface enhancements. #### Description The ICS CHARTR EP 200 is a PC-based svstem, 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 pre-amp, which is connected to the hardware platform, which is connected to the PC via USB cable - no hardware installation inside the PC is required. This submission is for a modification to K083399. The same hardware is used but the software has the additional ASSR (Auditory Steady State Response) feature as implemented on the system described in K031986. #### Intended Use The ICS Chartr EP 200 is indicated for auditory evoked potential testing as an aid in detecting hearing loss and lesions in the auditory pathway. SEP - 3 2009 {1}------------------------------------------------ ## echnological Characteristics | Device Specifications | ICS Medical Chartr EP with ASSR and Chartr OAE K031986 - | ICS Chartr EP 200 K083399 | ICS Chartr EP 200 (This submission) | |------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------| | Indication for Use EP | Indication for auditory evoked potential testing as an aid in detecting hearing loss and lesions in the auditory pathway | Indication for auditory evoked potential testing as an aid in detecting hearing loss and lesions in the auditory pathway | Indication for auditory evoked potential testing as an aid in detecting hearing loss and lesions in the auditory pathway | | Indication for use OAE | Indication for the determination of cochlear function in infants, children, and adults which provides information about hearing without subjective response from the individual being tested. | Does not have OAE · | Does not have OAE | | ASSR Protocol (Auditory Steady State Response) | Included | Does not have ASSR | ASSR added. | | Software based electrode switching | Not available | Not available | Implemented. | | Hardware implementation | PC-based system with built-in hardware and peripherals | PC-based system with external hardware platform and peripherals (USB interface) | PC-based system with external hardware platform and peripherals (USB interface) Identical to K083399 | | Software | Windows 98 | Windows XP | Windows XP | | Power source | Mains | Mains | Mains | Safety (Unchanged) The ICS Chartr EP 200 is designed to provide safety to the patient as well as the user and complies with: EN 60601-1:1990, UL 60601-1;2003, CAN/CSA-C22.2 NO 601.1-90:1990 Medical Electrical. Part 1: General requirements for safety. EN 60601-1-1:2001 Medical Electrical Equipment. Part 1: General requirements for safety. 1. Collateral ◆ standard: Safety requirements for medical electrical systems. EN 60601-1-2:2001 Medical Electrical equipment. Part 1-2: General requirements for safety -. Collateral standard: Electromagnetic compatibility - Requirements and tests. EN 60601-1-4: 2000 Edition 1.1 Consolidated Edition, Medical electrical equipment Part 1-4: General . requirements for Safety -collateral Standard: Programmable Electrical Medical Systems. EN 60601-2-26: 2002 Medical electrical equipment - Part 2-26: Particular requirements for the Safety � of electroencephalographs. EN 60601-2-40:1998 Medical electrical equipment — Part 2-40: Particular requirements for the safety . of electromyography and evoked response equipment. ## Effectiveness (Unchanged) The ICS CHARTR EP 200 is an Auditory Evoked Response device for replacement of an existing product of a technology type that is available and accepted in the market. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002 ## SEP - 3 2009 GN Otometrics c/o Daniel Kamm, P.E. Submission Correspondent Kramm & Associates 333 Milford Rd. Deerfield, IL 60015 Re: K092373 Trade/Device Name: ICS Chartr EP 200 Regulation Number: 21 CFR 882.1900 Regulation Name: Evoked Response Auditory Stimulator Regulatory Class: II Product Code: GWJ Dated: July 29, 2009 Received: August 5, 2009 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. 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-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. {3}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours. Quchthn Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # K092373 Indications for Use 510(k) Number (if known): K09 2373 Device Name:__ICS Chartr EP 200 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. - Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Image /page/4/Picture/11 description: The image shows a document with the text 'Prescription Use (Per 21 CFR 801.109)' and a checkmark. Below that, it says '(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices'. There is a signature above this text. The document also includes '510(k) Number' and the number 'K092373'. Page 1 of 1