(27 days)
Not Found
No
The description mentions "computer algorithms" and "statistical algorithm" for detecting responses, but does not use terms like AI, ML, deep learning, or neural networks. The process described is a deterministic statistical analysis based on predetermined thresholds, not a learning-based approach.
No.
The device is indicated for testing hearing and detecting lesions, which are diagnostic purposes, not therapeutic ones.
Yes
The "Intended Use / Indications for Use" states that the device is "indicated for auditory evoked potential testing as an aid in detecting hearing loss and lesions in the auditory pathway" and for "determination of cochlear function...which provides information about hearing." These actions are directly related to diagnosing a medical condition.
No
The description mentions detecting responses through analysis of the patient's EEG, which implies the need for hardware (EEG electrodes and recording equipment) to acquire the physiological signals. The software processes these signals, but it is not a standalone software device.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The device description clearly states that the CHARTR® EP with ASSR System detects responses through analysis of the patient's electroencephalogram (EEG), which is a measurement of electrical activity within the body. The CHARTR® OAE determines cochlear function, which is also a measurement of a physiological process within the body.
- The intended use is for in vivo testing. The system is used for "auditory evoked potential testing" and "determination of cochlear function," both of which are performed directly on the patient.
Therefore, this device falls under the category of in vivo diagnostic devices, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The CHARTR® EP with ASSR System is indicated for auditory evoked potential testing as an aid in detecting hearing loss and lesions in the auditory pathway.
The CHARTR® OAE is indicated for the determination of cochlear function in infants, children, and adults which provides information about hearing without subjective response from the individual being tested.
Product codes (comma separated list FDA assigned to the subject device)
EWO
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Auditory pathway, cochlear
Indicated Patient Age Range
infants, children, and adults
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.
Not Found
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
§ 874.1050 Audiometer.
(a)
Identification. An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.(b)
Classification. Class II. Except for the otoacoustic emission device, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, if it is in compliance with American National Standard Institute S3.6-1996, “Specification for Audiometers,” and subject to the limitations in § 874.9.
0
231986
JUL 2 4 2003
510(k) SUMMARY
| Submitted by: | ICS MEDICAL
125 Commerce Drive
Schaumburg, IL 60173-5329 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone: | (847)-534-2150 |
| Fax: | (847)-534-2151 |
| Contact Person: | Delmar F. Bloem, President |
| Date Summary Prepared: | June 26, 2003 |
| Trade Name of Device: | ICS Medical CHARTR® EP with
ASSR and CHARTR® OAE
Systems |
| Common Name: | Auditory Evoked Potential
System and Otoacoustic
Emissions Analyzer System. |
| Classification Name: | Auditory Evoked Potential
System and Audiometer |
| Substantial Equivalence: | The CHARTR® EP with ASSR
CHARTR® OAE Systems
Product is substantially
equivalent to the CHARTR® EP
and CHARTR OAE Systems
which has a cleared 510(k):
K002985. |
Intended Use:
The CHARTR® EP with ASSR System is indicated for auditory evoked potential testing as an aid in detecting hearing loss and lesions in the auditory pathway.
The CHARTR® OAE is indicated for the determination of cochlear function in infants, children, and adults which provides information about hearing without subjective response from the individual being tested
Scientific Principle:
1
ASSR (Auditory Steady-State Response) testing is based on the longestablished principle that stimuli presented at fast rates evoke brain responses that overlap (so-called "steady-state" responses). The overlap results in a stable sinusoidal pattern in the patient's electroencephalogram (EEG). The pattern is detectable with computer algorithms, and is stable only in the EEG of patients whose auditory system responds to the stimulus.
With auditory stimuli, amplitude- and/or frequency-modulation of a sine wave (pure tone) results in a stimulus that is both relatively frequencyspecific and capable of evoking a detectable steady-state response. Research studies have demonstrated that when several such stimuli are presented to a patient simultaneously, the response to each stimulus can be extracted from the (composite) EEG, and the results are comparable to those obtained when the stimuli are presented sequentially. This technique enables assessment of hearing at several frequencies at once.
Responses are detected through analysis of digital samples of the patient's EEG. The analysis consists of two stages: estimation and statistical detection. Estimation involves calculations performed on the EEG samples to produce periodic values for amplitude and/or phase of each response sought. Estimates for each response are passed to a statistical algorithm that calculates the confidence, in percent, that the estimates are consistent with a stable response to the corresponding stimulus. The software declares a response to be present when the confidence reaches a predetermined threshold (i.e. 95%). If the confidence does not reach this threshold within a predetermined amount of time (i.e. 5 minutes of testing), the software declares that no response could be found.
Electrical Safety:
Both Systems are designed to meet EN 60601-1 standard for Medical devices.
EMI Compatibility:
Both Systems are designed to meet EN 60601-1-2 standard.
2
| CHARTR EP | CHARTR EP with ASSR | |
|---|---|---|
| Stimulus | Click or tone burst | Modulated continuous pure tone |
| Transducers | Insert, bone | Insert, bone, speaker |
| Intensity | 0-90 db HL | 0-120 dB HL |
| Electrode montage | Low forehead, high | |
| forehead and both ears | Low forehead, high forehead and | |
| one ear | ||
| Patient state | Sleeping or resting | |
| quietly | Same | |
| Interpretation | Audiologist subjectively | |
| identifies responses | Algorithm objectively identifies | |
| responses | ||
| Clinical purpose | Indicated for auditory | |
| evoked potential testing | ||
| as an aid in detecting | ||
| hearing loss and lesions | ||
| in the auditory pathway | Same | |
| Patient population | Adults, children, and | |
| infants. | Same | |
| Hardware | ||
| configuration | Audio board | Audio board with daughter board to |
| provide multiple AM/FM modulated | ||
| tones | ||
| Operating system | Win98 | Same |
| Software - protocol | ||
| with ASSR | No | Yes |
| Electrical Safety | Designed to comply with | |
| EN 60601-1 (UL2601) | Same | |
| EMI Compatibility | Designed to comply with | |
| EN 60601-1-2 | Same | |
| Computer System | MCU-90 (IBM | |
| compatible tower) and | ||
| Portable (TFT active | ||
| matrix screen) computer | Same | |
| Labeling | Identical for both units | Same |
| Operator Manual | Covers CHARTR EP | |
| version 2.0 | Contains updates for EP versions | |
| 3.0 and 4.0 |
Comparison Table for
CHARTR® EP vs. CHARTR® EP with ASSR
.
:
3
Image /page/3/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized symbol consisting of three curved lines above two wavy lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 4 2003
ICS Medical c/o Delmar F. Bloem, President 125 Commerce Drive Schaumburg, IL 60173-5329
Re: K031986
Trade/Device Name: ICS MEDICAL CHARTR® EP WITH ASSR AND CHARTR® OAE SYSTEMS
Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: II Product Code: EWO Dated: June 26, 2003 Received: June 27, 2003
Dear Mr. Bloem:
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 such 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); 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.
4
Page 2 - Delmar F. Bloem, President
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 Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A. halyi Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page_1_of_1
510(k) Number (if known):_Ko 3 1986
Device Name: ICS Medical CHARTR® EP with ASSR and CHARTR® OAE Systems Indications For Use:
The CHARTR® EP System is indicated for auditory evoked potential testing as an aid in detecting hearing loss and lesions in the auditory pathway.
The CHARTR® OAE is indicated for the determination of cochlear function in infants, children, and adults which provides information about hearing without subjective response from the individual being tested.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Orms K. Kan, Ph D
Division Sign-Off
Division of Ophthalmic Ear,
Nose and Throat Devices
510(k) Number K031582
(Optional Format 3-10-98)