(29 days)
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 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.
The provided document K092373 describes a software modification to an existing medical device, the ICS CHARTR EP 200, which is an Auditory Evoked Potential System. This submission focuses on adding the Auditory Steady State Response (ASSR) feature and minor software and user interface enhancements to an already cleared hardware platform. As such, the acceptance criteria and supporting study are primarily focused on demonstrating the equivalence of the modified device to a predicate device, rather than proving novel performance metrics in a clinical study.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) for a modification to an existing device, the "acceptance criteria" are primarily established through substantial equivalence claims to predicate devices rather than novel performance benchmarks. The performance is assessed by comparing the new device's features and safety/effectiveness to those of the predicate devices.
| Acceptance Criteria (Implied by 510(k) for device modification) | Reported Device Performance (as stated in the submission) |
|---|---|
| Intended Use Equivalence: The modified device has the same intended use as the predicate device(s). | 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." (Identical to predicate K031986). This claim is explicitly stated on page 1 of the 510(k) summary and the "Indications for Use" enclosure. |
| Technological Characteristics Equivalence: Key technological characteristics are substantially similar or modifications do not raise new questions of safety or effectiveness. | ASSR Protocol: "ASSR added." (Implemented from predicate K031986, which "Included" ASSR). Software based electrode switching: "Implemented." (Not available on predicates K031986 or K083399). This is a minor software enhancement. Hardware implementation: "Identical to K083399." (PC-based system with external hardware platform and peripherals (USB interface)) Software: "Windows XP" (Same as predicate K083399) Power source: "Mains" (Same as predicates) |
| Safety and EMC Compliance: The modified device complies with recognized safety and electromagnetic compatibility standards. | Safety (Unchanged): The ICS Chartr EP 200 "complies with" a list of specific safety standards (e.g., EN 60601-1, UL 60601-1, EN 60601-1-2 regarding EMC, etc.). This implies testing was done to verify compliance of the device as modified. |
| Effectiveness Equivalence: The device continues to be effective for its intended use, leveraging established technologies. | 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." This statement asserts that the inherent effectiveness of the technology has been previously established with predicate devices. |
2. Sample size used for the test set and the data provenance
The document does not describe a specific clinical "test set" with a sample size of patient data. This submission is a 510(k) for a device modification, focusing on documenting substantial equivalence through technical specifications, safety standard compliance, and a logical comparison to predicate devices, rather than a clinical performance study with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As noted above, there is no clinical "test set" and thus no ground truth established by experts.
4. Adjudication method for the test set
Not applicable. No test set requiring expert adjudication is described.
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. This device is not an AI-assisted diagnostic tool where human reader performance would be evaluated with and without AI. It is an auditory evoked potential system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to the performance of the Auditory Evoked Potential (AEP) system itself in generating and processing auditory evoked potentials, particularly the new ASSR feature. The document implies that the ASSR algorithm's performance is accepted based on its implementation from the cleared predicate device K031986. The submission states: "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." This suggests either:
* The original K031986 submission had data supporting the ASSR algorithm's standalone performance.
* The ASSR algorithm is a well-established and accepted method in the scientific community, and thus, its re-implementation in a new software simply needs to demonstrate correct functionality, not re-prove its fundamental performance characteristics.
The document does not explicitly describe a new standalone performance study for the modified device, relying instead on the established performance of the predicate device's ASSR feature and the device's compliance with electrical safety and EMC standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For an Auditory Evoked Potential system, the "ground truth" for its diagnostic performance would typically be established through comparison to:
- Clinical diagnosis: Established by an audiologist or medical doctor based on multiple tests and patient history.
- Behavioral audiometry: Pure tone audiometry, speech audiometry, which define the patient's hearing thresholds.
- Pathology/imaging: In cases of lesions in the auditory pathway, this could serve as anatomical ground truth.
However, the provided 510(k) summary does not detail any new clinical studies or the type of ground truth used for such studies for THIS submission. The statement "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" implies that the underlying technology's ability to detect hearing loss and lesions has been previously validated and accepted.
8. The sample size for the training set
Not applicable. This device is not described as using machine learning or AI that would require a "training set" of data in the typical sense. It is a signal processing and measurement device.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a machine learning model.
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K092373
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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
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echnological Characteristics
| DeviceSpecifications | ICS Medical Chartr EPwith ASSR and ChartrOAE K031986 - | ICS Chartr EP 200 K083399 | ICS Chartr EP 200(This submission) |
|---|---|---|---|
| Indication for UseEP | Indication for auditoryevoked potential testing asan aid in detecting hearingloss and lesions in theauditory pathway | Indication for auditory evokedpotential testing as an aid indetecting hearing loss andlesions in the auditory pathway | Indication for auditoryevoked potential testingas an aid in detectinghearing loss and lesions inthe auditory pathway |
| Indication for useOAE | Indication for thedetermination of cochlearfunction in infants,children, and adults whichprovides information abouthearing without subjectiveresponse from theindividual being tested. | Does not have OAE · | Does not have OAE |
| ASSR Protocol(Auditory SteadyState Response) | Included | Does not have ASSR | ASSR added. |
| Software basedelectrodeswitching | Not available | Not available | Implemented. |
| Hardwareimplementation | PC-based system withbuilt-in hardware andperipherals | PC-based system with externalhardware platform andperipherals (USB interface) | PC-based system withexternal hardwareplatform andperipherals (USBinterface) Identical toK083399 |
| 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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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.
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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
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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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§ 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).