Who is the manufacturer of ICS CHARTR EP 200?

Gn Otometrics A/S filed the 510(k) submission for ICS CHARTR EP 200 (K083399).

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: Traditional).

What are the predicate devices for ICS CHARTR EP 200?

ICS Medical Chartr EP system (K960097); ICS Medical Chartr EP and OAE System (K002985); ICS Medical Chartr EP with ASSR and Chartr OAE System (K031986).

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

K083399 · Gn Otometrics A/S · GWJ · Feb 20, 2009 · Neurology

Device Facts

Record ID	K083399
Device Name	ICS CHARTR EP 200
Applicant	Gn Otometrics A/S
Product Code	GWJ · Neurology
Decision Date	Feb 20, 2009
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1900
Device Class	Class 2

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.

Device Story

ICS CHARTR EP 200 is a PC-based auditory evoked potential system. It consists of software modules, isolation transformer, hardware platform, pre-amplifier, mains adapter, and stimulation/recording devices. Stimulation and recording devices connect to the pre-amp, which links to the hardware platform, connecting to a PC via USB. The system performs auditory evoked potential testing (ALR, AMLR, P300, PediScreen) to aid in detecting hearing loss and auditory pathway lesions. Used in clinical settings by healthcare professionals. Output is displayed on the PC for clinician interpretation to support diagnostic decision-making regarding patient hearing status.

Clinical Evidence

No clinical data provided. The device is an auditory evoked response system for replacement of existing, market-accepted technology. Safety and effectiveness are established through bench testing and compliance with international standards for medical electrical equipment (EN 60601-1, EN 60601-1-2, EN 60601-2-26, EN 60601-2-40).

Technological Characteristics

PC-based system with external hardware platform; USB connectivity to PC. Complies with EN 60601-1 (general safety), EN 60601-1-2 (EMC), EN 60601-2-26 (electroencephalographs), and EN 60601-2-40 (evoked response equipment). Software runs on Windows XP (32-bit). Power source: Mains. Includes pre-amplifier, stimulation, and recording devices.

Indications for Use

Indicated for auditory evoked potential testing as an aid in detecting hearing loss and lesions in the auditory pathway in patients requiring clinical assessment.

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 system (K960097)
ICS Medical Chartr EP and OAE System (K002985)
ICS Medical Chartr EP with ASSR and Chartr OAE System (K031986)

Related Devices

K092373 — ICS CHARTR EP 200 · Gn Otometrics · Sep 3, 2009
K193033 — GSI Audera Pro · Grason Stadler · Apr 24, 2020
K991853 — INTERACOUSTICS EP 15 ABR STAND ALONE UNIT · Idem (Int'L Dist. of Electronics For Medicine) · Oct 25, 1999
K012415 — AURIS AEP · Synapsys, Inc. · Dec 18, 2001
K061443 — SMART USBLITE, MODEL M011120 · Intelligent Hearing Systems · Jun 23, 2006

Submission Summary (Full Text)

{0}------------------------------------------------ 1083399 # 2.0 510(K) Summery of Safety and Effectiveness #### Submitter FEB 2:0 2009 | Name and address: | GN Otometrics A/S Dybendalsvaenget 2 DK-2630 Taatrup Denmark | |-------------------|-----------------------------------------------------------------------| | Phone: | 847-534-2150 | | Fax: | 847-534-2153 | | Contact Person: | Dan Sansonetti | | Summery prepared: | November 1st, 2008 | Amended: January 23, 2009 February 10th, 2009 #### Device Name: Common/Usual Name: Trade/Proprietary name: Classification name: Auditory Evoked Potential System ICS CHARTR EP 200 Stimulator, Auditory, Evoked Response Predicate devices The GN Otometrics ICS CHARTR EP 200 is similar to these relevant Chartr products: ICS Medical Chartr EP system (K960097) Product Code: GWJ Regulation Number: 882.1900 February 21st, 1997 Released: ICS Medical Chartr EP and OAE System (K002985) Product Code: GWJ & EWO Regulation Number: 882.1900 December 13th, 2000 Released: ICS Medical Chartr EP with ASSR and Chartr OAE System 510(K) Number: K031986 Product Code: EWO Regulation Number: 882.1050 July 24th, 2003 Released: ICS CHARTR EP 200 differs from the above in the following ways: - > External hardware platform with USB connection to PC > Does not have ASSR or OAE. Minor Software User Interface enhancements {1}------------------------------------------------ # Description 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 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. ## 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. | Device Specifications | ICS Medical Chartr EP 960097 - 2/21/1997 | ICS Medical Chartr EP and Chartr OAE - K002985 - 12/13/2000 | ICS Medical Chartr EP with ASSR and Chartr OAE - K031986 - 7/24/03 | ICS Chartr EP 200 K083399 (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 auditory evoked potential testing as an aid in detecting hearing loss and lesions in the auditory pathway | | Indication for use OAE | Does not have 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. | 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 | | Accessories EP | Identical | Identical | Identical | Identical | | EP Features Included | ALR, AMLR | ALR, AMLR, P300, 40 Hz Test, PediScreen | ALR, AMLR, P300, 40 Hz Test, PediScreen, ASSR | ALR, AMLR, P300, PediScreen | | Electrical Safety | Designed to comply with EN 60601-1 (UL 2601) | Designed to comply with EN 60601-1 (UL 2601) | Designed to comply with EN 60601-1 (UL 2601) | Designed to comply with EN 60601-1 (UL 2601) | | EMI Compatibility | Designed to comply with EN 60601-1-2 | Designed to comply with EN 60601-1-2 | Designed to comply with EN 60601-1-2 | Designed to comply with EN 60601-1-2 | | Specifications for electroencephalo graphs | Designed to comply with EN60601-2-26 | Designed to comply with EN60601-2-26 | Designed to comply with EN60601-2-26 | Designed to comply with EN60601-2-26 | | Specifications for electromyograph s & evoked response | Designed to comply with EN60601-2-40 | Designed to comply with EN60601-2-40 | Designed to comply with EN60601-2-40 | Designed to comply with EN60601-2-40 | ### Technological Characteristics {2}------------------------------------------------ | equipment | | | | | |-----------------------|--------------------------------------------------------------|--------------------------------------------------------------|--------------------------------------------------------------|--------------------------------------------------------------------------| | Operating System | Windows 95 | Windows 98 | Windows XP | Windows XP | | Software | 16 Bit | 32 Bit | 32 Bit | 32 Bit | | Construction type | PC-based system with built-in hardware and peripherals | PC-based system with built-in hardware and peripherals | PC-based system with built-in hardware and peripherals | PC-based system with external hardware platform and peripherals | | Power source | Mains | Mains | Mains | Mains | | Computer interface | Integrated in computer | Integrated in computer | Integrated in computer | USB cable connection | ### Safety 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: Programable Electrical Medical Systems. - . EN 60601-2-26: 2002 Medical electrical equipment - Part 2-26: Particular requirements for the Safety of electroencphalographs. - EN 60601-2-40:1998 Medical electrical equipment -- Part 2-40: Particular requirements for . the safety of electromyographs and evoked response equipment. The ICS CHARTR EP 200 is designed, developed and manufactured according to the following standards: - . ISO 9001:2000 Quality Managements Systems - Requirements. - ISO 13485:2003 Quality Management Systems Requirements for regulatory purposes. . #### Effectiveness 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. {3}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The seal is black and white and appears to be a scanned image. #### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 GN Otometrics A/S % GN Otometrics North America Mr. Dan Sansonetti 125 Commerce Drive Schaumburg, Illinois 60173 Re: K083399 Trade/Device Name: ICS Chartr EP 200 Regulation Number: 21 CFR 882.1900 Regulation Name: Evoked response auditory stimulator Regulatory Class: II - 1 Product Code: GWJ Dated: January 23, 2009 Received: January 27, 2009 Dear Mr. Sansonetti: 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. FEB 2 0 2009 If your dovice is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls: Existing . gaips 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); good manufacturing practice requirements as set forth in 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. {4}------------------------------------------------ # Page 2- Mr. Dan Sansonetti Enclosure This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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, For Pete Plummer Mark N. Melkerson as P.O.R Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health {5}------------------------------------------------ # Indications for Use : 、 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name; ICS Chartr EP 200 : and and the comments of Indications for Use: .. ﺗﻬ . . The Chartr EP 200 is indicated for auditory evoked potential testing as an aid in detecting hearing loss and lesions in the auditory pathway. . and the control of the count | Prescription Use | X | |-----------------------------|---| | (Part 21 CFR 801 Subpart D) | | AND/OR | Over-The-Counter Use | | |------------------------|--| | (21 CFR 801 Subpart C) | | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of General, Restorative, and Neurological Devices 1 of 1 | 510(k) Number | 168399 | |---------------|--------| |---------------|--------|