(95 days)
No
The summary does not mention AI, ML, or any related concepts in the device description, intended use, or other sections.
No
The device is used for "detecting hearing loss and lesions," which indicates a diagnostic rather than therapeutic purpose.
Yes
The device is indicated for "auditory evoked potential testing as an aid in detecting hearing loss and lesions in the auditory pathway," which are diagnostic activities.
No
The device description explicitly lists multiple hardware components including an isolation transformer, hardware platform, pre-amp, mains adapter, stimulation devices, and recording devices, in addition to the software.
Based on the provided information, the ICS Chartr EP 200 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "auditory evoked potential testing as an aid in detecting hearing loss and lesions in the auditory pathway." This involves measuring physiological responses from the patient's body (electrical signals from the auditory pathway) rather than analyzing samples taken from the body (like blood, urine, or tissue).
- Device Description: The description details hardware for stimulating and recording electrical signals from the patient. There is no mention of analyzing biological samples.
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens.
- Detecting or measuring substances in biological samples.
- Providing information about a patient's health status based on analysis of biological samples.
Therefore, the ICS Chartr EP 200 is a medical device used for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
GWJ
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
auditory pathway
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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 |
|---|---|
| --------------- | -------- |