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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the ICS CHARTR EP 200 device:

The provided text is a 510(k) summary for the ICS CHARTR EP 200, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a novel clinical study. As such, many of the requested data points for a traditional clinical study are not present in this document.

The "Effectiveness" section explicitly states: "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." This indicates that the regulatory pathway is based on similarity to already approved devices, not on proving new performance metrics.

1. A table of acceptance criteria and the reported device performance

Based on the 510(k) summary, formal "acceptance criteria" in the sense of specific performance targets (e.g., sensitivity, specificity, accuracy for a diagnostic device) and corresponding "reported device performance" from a dedicated study are not explicitly stated or provided.

Instead, acceptance is demonstrated by showing substantial equivalence to predicate devices. The "performance" is implicitly deemed acceptable because the device's technical characteristics and intended use are similar to those of devices already on the market.

The closest we get to "acceptance criteria" are the compliance with recognized electrical safety and EMI/EMC standards, and the statement of "Indication for use EP."

Acceptance Criteria (Implied)	Reported Device Performance (as stated in document)
Indication for use EP is "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" (Identical to predicate devices).
Compliance with EN 60601-1 (Electrical Safety)	"Designed to comply with EN 60601-1 (UL 2601)" (and other related standards like EN 60601-1-1, -1-4, -2-26, -2-40).
Compliance with EN 60601-1-2 (EMI Compatibility)	"Designed to comply with EN 60601-1-2."
Compliance with ISO 9001 and ISO 13485 (Quality Management Systems)	"Designed, developed and manufactured according to... ISO 9001:2000... ISO 13485:2003."
Functional similarity to predicate devices	External hardware platform with USB connection to PC; no ASSR or OAE; minor software UI enhancements. These are described as differences, but the overall function (EP testing) is maintained and similar to predicates.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable/Not provided. This document does not describe a clinical study with a "test set" sample size or data provenance in the way one would for a new diagnostic or prognostic device's performance evaluation. The device type (auditory evoked potential system) is well-established, and the focus is on demonstrating safety and efficacy through equivalence to existing technology, rather than a de novo clinical trial.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not provided. Since there's no clinical study described with a "test set" and corresponding "ground truth" to be established by experts for performance evaluation, this information is not present.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided. As there is no clinical study described that involved expert adjudication of a test set, this information is not available.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable/Not provided. An MRMC study is relevant for evaluating the impact of an AI algorithm on human reader performance, particularly in image interpretation. The ICS CHARTR EP 200 is an auditory evoked potential system, not an AI-assisted diagnostic imaging device, and the submission is a 510(k) for substantial equivalence, not a new technology requiring such a study.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable/Not provided. The device is an Auditory Evoked Potential System, which is inherently a human-in-the-loop diagnostic tool, used by clinicians to perform tests and interpret results. It is not an "algorithm only" device in the context of standalone performance evaluation like an AI diagnostic tool.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable/Not provided. As no dedicated performance study is described, no specific "ground truth" for evaluating the device's diagnostic accuracy is mentioned in the document.

8. The sample size for the training set

Not applicable/Not provided. The device is not an AI/machine learning product that requires a "training set" in the conventional sense. Its development is based on established principles of auditory evoked potential measurement and engineering standards.

9. How the ground truth for the training set was established

Not applicable/Not provided. As there is no "training set" for an AI algorithm described, the method for establishing its ground truth is not relevant or mentioned.

Summary of the Study and Device Performance as Presented in the 510(k):

The provided document, a 510(k) summary, demonstrates the device's substantial equivalence to legally marketed predicate devices primarily through comparison of:

Intended Use: Identical to predicates for auditory evoked potential testing.
Technological Characteristics: Similar to predicates, with minor differences (e.g., external hardware, USB connection, lack of OAE/ASSR features present in some, but not all, predicates).
Safety Standards: Compliance with recognized international and national electrical safety and EMI/EMC standards (EN 60601 series, UL, CAN/CSA).
Quality Management Systems: Compliance with ISO 9001 and ISO 13485.

The submission relies on the established safety and effectiveness of the predicate devices in the market, rather than a new clinical study to establish performance against novel acceptance criteria. The "study" here is essentially the detailed comparison showing that the new device's features, intended use, and adherence to safety standards are sufficiently similar to approved devices.

Summary

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1083399

2.0 510(K) Summery of Safety and Effectiveness

Submitter

FEB 2:0 2009

Name and address:	GN Otometrics A/SDybendalsvaenget 2DK-2630 TaatrupDenmark
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

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Description

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.

DeviceSpecifications	ICS Medical ChartrEP 960097 - 2/21/1997	ICS Medical ChartrEP and Chartr OAE -K002985 - 12/13/2000	ICS Medical ChartrEP with ASSR andChartr OAE -K031986 - 7/24/03	ICS Chartr EP 200K083399(this submission)
Indication foruse EP	Indication for auditoryevoked potential testingas an aid in detectinghearing loss and lesionsin the auditory pathway	Indication for auditoryevoked potential testingas an aid in detectinghearing loss and lesionsin the auditory pathway	Indication for auditoryevoked potential testingas an aid in detectinghearing loss and lesionsin the auditory pathway	Indication for auditoryevoked potential testingas an aid in detectinghearing loss and lesionsin the auditory pathway
Indication foruse OAE	Does not have OAE	Indication for thedetermination ofcochlear function ininfants, children, andadults which providesinformation abouthearing withoutsubjective responsefrom the individualbeing tested.	Indication for thedetermination ofcochlear function ininfants, children, andadults which providesinformation abouthearing withoutsubjective responsefrom the individualbeing tested.	Does not have OAE
Accessories EP	Identical	Identical	Identical	Identical
EP FeaturesIncluded	ALR, AMLR	ALR, AMLR, P300, 40Hz Test, PediScreen	ALR, AMLR, P300, 40Hz Test, PediScreen,ASSR	ALR, AMLR, P300,PediScreen
Electrical Safety	Designed to complywith EN 60601-1 (UL2601)	Designed to complywith EN 60601-1 (UL2601)	Designed to complywith EN 60601-1 (UL2601)	Designed to complywith EN 60601-1 (UL2601)
EMICompatibility	Designed to complywith EN 60601-1-2	Designed to complywith EN 60601-1-2	Designed to complywith EN 60601-1-2	Designed to complywith EN 60601-1-2
Specificationsforelectroencephalographs	Designed to complywith EN60601-2-26	Designed to complywith EN60601-2-26	Designed to complywith EN60601-2-26	Designed to complywith EN60601-2-26
Specificationsforelectromyographs & evokedresponse	Designed to complywith EN60601-2-40	Designed to complywith EN60601-2-40	Designed to complywith EN60601-2-40	Designed to complywith EN60601-2-40

Technological Characteristics

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equipment
OperatingSystem	Windows 95	Windows 98	Windows XP	Windows XP
Software	16 Bit	32 Bit	32 Bit	32 Bit
Constructiontype	PC-based system withbuilt-in hardware andperipherals	PC-based system withbuilt-in hardware andperipherals	PC-based system withbuilt-in hardware andperipherals	PC-based system withexternal hardwareplatform andperipherals
Power source	Mains	Mains	Mains	Mains
Computerinterface	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.

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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.

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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

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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
---------------	--------

Regulation Number and Section

§ 882.1900 Evoked response auditory stimulator.

(a)
Identification. An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.(b)
Classification. Class II (performance standards).