(146 days)
ICS Medical Corp. Chartr EP System
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No
The document describes a standard diagnostic tool for evoked response measurements and electroencephalogram activation, with no mention of AI or ML capabilities.
No
The device is described as a "diagnostic tool" for "evoked response measurements or electroencephalogram activation," indicating its use for diagnosis rather than treatment.
Yes
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state that "The Interacoustics EP15 ABR Stand Alone Unit is a diagnostic tool".
No
The description explicitly states the device "produces a sound stimuly," which implies a hardware component is involved in generating the sound.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The description of the Interacoustics EP15 ABR Stand Alone Unit clearly states its intended use is for evoked response measurements or electroencephalogram activation. These are tests performed directly on the patient's body (measuring electrical activity in response to stimuli), not on specimens taken from the body.
Therefore, the device falls under the category of a diagnostic medical device but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Interacoustics EP15 ABR Stand Alone Unit is a diagnostic tool for computer-based testing. Data is collected in a Windows 95,98 database format that allows for easy inspection of results. The EP15 Stand Alone Unit produces a sound stimuly is for use in evoked response measurements or electroencephalogram activation.
Product codes (comma separated list FDA assigned to the subject device)
GWJ
Device Description
The Interacoustics EP15 ABR Stand Alone Unit is a diagnostic tool for computerbased testing. Data is collected in a Windows 95,98 database format that allows for easy inspection of results. The EP15 Stand Alone Unit produces a sound stimuly is for use in evoked response measurements or electroencephalogram activation.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
ICS Medical Corp. Chartr EP System
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.
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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).
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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).
0
OCT 2 5 1999
Page 1 of 3
510(k) SUMMARY
K 991853
INTERNATIONAL DISTRIBUTORS OF PREPARED BY: ELECTRONICS FOR MEDICINE, INC. (IDEM) 4814 East Second Street Benicia, CA 94510
CONTACT PERSON:
Donna Ward, President
TELEPHONE:
707-746-6334
May 28, 1999
DATE ON WHICH THE SUMMARY WAS PREPARED:
NAME IF DEVICE:
Interacoustics Model EP15 ABR Stand Alone Unit
COMMON NAME:
Evoked Response Auditory Stimulator
PREDICATE DEVICE:
ICS Medical Corp. Chartr EP System
DESCRIPTION OF DEVICE:
The Interacoustics EP15 ABR Stand Alone Unit is a diagnostic tool for computerbased testing. Data is collected in a Windows 95,98 database format that allows for easy inspection of results. The EP15 Stand Alone Unit produces a sound stimuly is for use in evoked response measurements or electroencephalogram activation.
1
Comparison of the Interacoustics Model EP15 and the ICS Medical Chartr EP System:
Indication for use – Identical for both units.
Similarities and differences:
| EP15 ABR | Chartr EP |
|---|---|
| Display Description: | |
| 12.1" Wide Angle Industrial TFT | 15" SVGA Monitor (others available) |
| Software Features: | |
| Windows 95/98 Operating System | Same |
| AMPLIFIERS: | |
| Channels: 2 | 2 (optionally up to 8) |
| Gain: 80 dB | X50 - X5000000 |
| PREAMPLIFIERS: | |
| Frequency response: 100 to 8000 Hz | Same |
| CMR Ratio: >120dB at 50/60 Hz. | >100dB at 50/60 Hz |
| Noise: 5.5nV/Hz, 0.3µV RMS (0-3 kHz); | |
| (Division Sign-Off) | |
| Division of General Restorative Devices | K991853 |
| 510(k) Number |
Prescription Use
OR
Over-The-Counter Use
મ
Prescription Use_ (Por 21 CFR 801.109)
... : (Optional Formal 1-2-96)