(324 days)
Not Found
No
The document does not mention AI, ML, or any related terms, and the device description focuses on standard evoked potential testing.
No
The device is described as a diagnostic aid in auditory and hearing related disorders and an adjunctive tool in the estimation of behavioral hearing thresholds, not for treating conditions.
Yes
The "Intended Use / Indications for Use" states that the product is "intended to be used as a diagnostic aid in auditory and hearing related disorders".
No
The device description states it is an "auditory evoked potential testing device," which implies hardware components are necessary to generate and measure the evoked potentials. The summary does not explicitly state it is software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body. They are used to detect diseases, conditions, or infections.
- Device Function: The SmartEP-ASSR device records auditory steady-state evoked potential data. This involves measuring the body's physiological response to auditory stimuli, not analyzing samples taken from the body.
- Intended Use: The intended use is for recording auditory evoked potential data as a diagnostic aid and for estimating hearing thresholds. This is a functional assessment of the auditory system, not a test on a biological sample.
Therefore, the SmartEP-ASSR falls under the category of a medical device used for physiological measurement and diagnosis, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the SmartEP-ASSR product is for the recording of auditory steady-state evoked potential data. The product is intended to be used as a diagnostic aid in auditory and hearing related disorders and as an adjunctive tool in the estimation of behavioral hearing thresholds.
SmartEP-ASSR can be used for patients of all ages. It is intended to be used by trained personnel in a hospital, nursery, clinic, audiologist's office or other appropriate setting.
Product codes (comma separated list FDA assigned to the subject device)
GWJ
Device Description
SmartEP-ASSR is a auditory evoked potential testing device that is capable of measuring auditory steady state responses (ASSR).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
all ages
Intended User / Care Setting
trained personnel in a hospital, nursery, clinic, audiologist's office or other appropriate setting.
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
§ 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
FEB 2 0 2004
510(k) Summary
| Prepared By: | Intelligent Hearing Systems
7356 SW 48th Street
Miami, FL 33155 |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone: | (305) 668-6102 |
| FAX: | (305) 668-6103 |
| Contact Person: | Edward Miskiel, Ph.D. |
| Date Summary prepared: | February 13, 2004 |
| Name of the Device: | SmartEP-ASSR |
| Common Name: | Evoked Response System |
| Classification Name: | Evoked Response Auditory Stimulator (per CFR 874.1900) |
| Predicate Device: | Bio-logic MASTER Evoked Response System (K021895) |
| Device Description: | SmartEP-ASSR is a auditory evoked potential testing device
that is capable of measuring auditory steady state responses
(ASSR). |
| Intended Use: | The intended use of the SmartEP-ASSR product is for the
recording of auditory steady-state evoked potential data.
The product is intended to be used as a diagnostic aid in
auditory and hearing related disorders and as an adjunctive
tool in the estimation of behavioral hearing thresholds.
SmartEP-ASSR can be used for patients of all ages. It is
intended to be used by trained personnel in a hospital,
nursery, clinic, audiologist's office or other appropriate
setting. |
| Technological Characteristics: | The SmartEP-ASSR device is similar to the predicate device
in its intended use and data processing methodologies. |
INTELLIGENT HEARING SYSTEMS
· Miami, Florida 33155 · Telephone: 305-668-6102 · FAX: 305-668-6103 7356 S.W. 48th Street Email Address: info@ihsys.com = www.ihsys.com Page E1
1
Substantial Equivalence Based on Assessment of Performance Data:
The SmartEP-ASSR is substantially equivalent to the Bio-logic MASTER Evoked Response System device marketed by Bio-logic Systems Corp. with FDA 510(k) clearance number K021895. Comparisons of technical parameters are shown in the table below.
| Parameter | Predicate Device
(Non-Prcamendmant Device)
Bio-Logic Master (K021895) | Device Under Current 510(k)
Review
SmartEP-ASSR |
|-----------------------|-----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Data Acquisition | | |
| A/D Resolution | 16 bit | 16 bit |
| Artifact Rejection | Programmable | Programmable |
| Amplifiers | | |
| Channels | 1 Channel Optically Isolated | 1-4 Channels Optically Isolated |
| Gain | 10k | Variable (30k-300k) |
| Filters | | |
| Slope | 12 dB/octave | 6 dB/octave |
| LP | 1.5k, 3k, 10k, 20k Hz | 30, 100, 300, 500, 1k, 1.5k, 3k, 5k
Hz |
| HP | 0.1, 0.3, 1, 3, 10, 30, 100, 300Hz | 1, 10, 30, 50, 100, 150, 300, 500 Hz |
| Notch | 50/60Hz | 50/60Hz |
| Digital Filters | 1-200Hz | User Selectable (1 -5k Hz) |
| Noise Level | 0.45 μV RMS (10-3k Hz) | 0.33 μV RMS (1-3k Hz) |
| Input Impedance | 100M Ohms | 5M Ohms |
| CMR Ratio | 110 dB at 50/60 Hz | 117 dB at 60 Hz and
110 dB at 1k Hz |
| Impedance Test | | |
| Signal | 20 Hz Sinewave | 1k Hz Sinewave |
| Auditory Stimuli | | |
| Presentation | Monaural or Binaural | Monaural or Binaural |
| Number of Frequencies | 1-4 | 1-8 |
| Test Frequencies | 500, 750, 1k, 1.5k, 2k, 3k, 4k, 6k, 8k
Hz | User Selectable: Clicks, Pure Tones
and Multifrequency Stimuli (500Hz-
8k Hz) |
| Types | Sinewave | Sinewave, Tone Burst |
| Envelopes | Linear, Blackman, Gaussian,
Hanning Envelopes | Linear, Blackman, Gaussian,
Hanning, Rectangular, Triangular,
Trapezoidal, Exact Blackman,
Cosine, Cosine Squared, Cosine
Cubed |
| Intensity | 0-125 dB SPL
(132 dB Optional) | 0-125 dB SPL |
| Masking | White Noise Programmable | White Noise Programmable |
| Transducers | TDH Earphones, Insert Earphones,
Bone Conduction, Sound Field | TDH Earphones, Insert Earphones,
Bone Conduction, Sound Field, OAE
Probe |
| Computer Requirements | | |
| Computer Type | Personal Computer | Personal Computer |
| Operating System | Microsoft Windows | Microsoft Windows 98SE, ME,
2000, XP |
| Interface Connection | Serial | USB (Universal Serial Bus) |
2
:
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three horizontal bars that curve upwards, resembling a stylized human figure. The symbol is black, and the text is also black.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 0 2004
Edward Miskiel, Ph.D. President and CEO Intelligent Hearing Systems 7356 S.W. 48" Street Miami, Florida 33155
Rc: K031051
Trade/Device Name: SmartEP- ASSR Regulation Number: 21 CFR 882.1900 Regulation Name: Evoked response auditory stimulator Regulatory Class: II Product Code: GWJ Dated: December 18, 2004 Received: December 23, 2004
Dear Dr. Miskiel:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bootion of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encreased 976, the enactment date of the Medical Device Amendments, or 10 commerce print to May 2017 - 7:37
devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, de nees mat nave been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merelore, manes of the Act include requirements for annual registration, listing of general controls provisions and prohibitions against misbranding and adulteration.
If your device is classificd (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 I hat FDA has made a determination that your device complies with other requirements of the Act that I Dr Has Intact a and regulations administered by other Federal agencies. You must of any I edetar statutes and regirements, including, but not limited to: registration and listing (21 Cliff Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K I art 607), latoring (21 OS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 - Edward Miskiel, Ph.D.
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and A yours finding of substantial equivalence of your device to a legally premarket notication: "The Presults 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 If you desire specific accept (301) 594-4659. 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 other general 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,
Sincerely yours,
Mark N Milken
elia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K031051
Device Name: SmartEP-ASSR
Indications For Use:
The intended use of the SmartEP-ASSR product is for the recording of auditory steadystate evoked potential data. The product is intended to be used as a diagnostic aid in auditory and hearing related disorders and as an adjunctive tool in the estimation of behavioral hearing thresholds.
SmartEP-ASSR can be used for patients of all ages. It is intended to be used by trained personnel in a hospital, nursery, clinic, audiologist's office or other appropriate setting.
Prescription Use _ × (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)
| (Division Sign-Off) | |
| Division of General, Restorative, | |
| and Neurological Devices |
| 510(k) Number | K031051 |
|---|---|
| --------------- | --------- |
Page 1 of