(29 days)
No
The summary does not mention AI, ML, or related terms, and the description focuses on standard hardware and software for evoked potential testing.
No.
The device is used for detection of hearing loss and lesions in the auditory pathway, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is indicated for "auditory evoked potential testing as an aid in detecting hearing loss and lesions in the auditory pathway." This points to its use in diagnosing or aiding in the diagnosis of certain conditions.
No
The device description explicitly states that the system consists of software modules and hardware components including an isolation transformer, hardware platform, pre-amp, mains adapter, stimulation devices, and recording devices.
Based on the provided information, the ICS Chartr EP 200 is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The ICS Chartr EP 200 is described as a system for auditory evoked potential testing. This involves stimulating the auditory pathway and recording the electrical responses from the body. It does not involve the analysis of specimens taken from the body.
- 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 is a diagnostic test performed on the patient, not on a sample from the patient.
Therefore, the ICS Chartr EP 200 falls under the category of a medical device used for physiological measurement and diagnosis, but not an In Vitro Diagnostic.
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.
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.
Product codes
EWO, GWJ
Device 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.
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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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.
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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'.
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