(324 days)
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 is a auditory evoked potential testing device that is capable of measuring auditory steady state responses (ASSR).
The provided text is a 510(k) summary for the SmartEP-ASSR device, which is an auditory evoked potential testing device. The summary primarily focuses on demonstrating substantial equivalence to a predicate device (Bio-logic MASTER Evoked Response System, K021895) through a comparison of technical specifications.
Based on the provided information, there is no detailed study described that establishes explicit acceptance criteria and proves the device meets those criteria in a quantitative performance study. The submission relies on demonstrating substantial equivalence by comparing technical parameters to a legally marketed predicate device. This type of submission usually implies that if the technical specifications are comparable or superior, and there are no new questions of safety or effectiveness, then the device is considered to meet the requirements for marketing.
Here’s a breakdown of the requested information, indicating where the text provides details and where it does not:
1. Table of Acceptance Criteria and Reported Device Performance
As noted above, no explicit acceptance criteria for diagnostic accuracy or performance metrics (like sensitivity, specificity, or agreement rates) are stated, nor is there a study detailing such performance. The provided table focuses on technical specifications for comparing the SmartEP-ASSR to its predicate device. This comparison is the primary method used to argue for "substantial equivalence."
| Parameter | Predicate Device (Bio-Logic Master, K021895) | SmartEP-ASSR (Device Under Review) | Acceptance Criterion/Performance (Implied) |
|---|---|---|---|
| Data Acquisition | |||
| A/D Resolution | 16 bit | 16 bit | At least 16 bit |
| Artifact Rejection | Programmable | Programmable | Programmable |
| Amplifiers | |||
| Channels | 1 Channel Optically Isolated | 1-4 Channels Optically Isolated | At least 1 channel optically isolated |
| Gain | 10k | Variable (30k-300k) | Comparable or improved range of gain |
| Filters | |||
| Slope | 12 dB/octave | 6 dB/octave | Specified filter slope |
| LP (Low Pass) | 1.5k, 3k, 10k, 20k Hz | 30, 100, 300, 500, 1k, 1.5k, 3k, 5k Hz | Comparable or wider range of LP filters |
| HP (High Pass) | 0.1, 0.3, 1, 3, 10, 30, 100, 300Hz | 1, 10, 30, 50, 100, 150, 300, 500 Hz | Comparable or wider range of HP filters |
| Notch | 50/60Hz | 50/60Hz | 50/60Hz |
| Digital Filters | 1-200Hz | User Selectable (1 -5k Hz) | Comparable or wider range of digital filters |
| Noise Level | 0.45 μV RMS (10-3k Hz) | 0.33 μV RMS (1-3k Hz) | Noise level ≤ 0.45 μV RMS (or better) |
| Input Impedance | 100M Ohms | 5M Ohms | Specified input impedance |
| CMR Ratio | 110 dB at 50/60 Hz | 117 dB at 60 Hz and 110 dB at 1k Hz | CMR Ratio ≥ 110 dB |
| Impedance Test | |||
| Signal | 20 Hz Sinewave | 1k Hz Sinewave | Specified impedance test signal |
| Auditory Stimuli | |||
| Presentation | Monaural or Binaural | Monaural or Binaural | Monaural or Binaural |
| Number of Frequencies | 1-4 | 1-8 | At least 1-4 frequencies |
| Test Frequencies | 500, 750, 1k, 1.5k, 2k, 3k, 4k, 6k, 8k Hz | User Selectable: Clicks, Pure Tones and Multifrequency Stimuli (500Hz-8k Hz) | Comparable range of test frequencies |
| Types | Sinewave | Sinewave, Tone Burst | At least Sinewave |
| Envelopes | Linear, Blackman, Gaussian, Hanning Envelopes | Linear, Blackman, Gaussian, Hanning, Rectangular, Triangular, Trapezoidal, Exact Blackman, Cosine, Cosine Squared, Cosine Cubed | Comparable or wider range of envelopes |
| Intensity | 0-125 dB SPL (132 dB Optional) | 0-125 dB SPL | 0-125 dB SPL |
| Masking | White Noise Programmable | 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 | Comparable range of transducers |
| Computer Requirements | |||
| Computer Type | Personal Computer | Personal Computer | Personal Computer |
| Operating System | Microsoft Windows | Microsoft Windows 98SE, ME, 2000, XP | Microsoft Windows (compatible) |
| Interface Connection | Serial | USB (Universal Serial Bus) | Specified interface connection |
The "acceptance criteria" can be inferred as the SmartEP-ASSR meeting or exceeding the technical specifications of the predicate device, thereby demonstrating substantial equivalence for its intended use. For instance, the noise level being 0.33 μV RMS is "better" than the predicate's 0.45 μV RMS, which would contribute to showing equivalence or improvement.
2. Sample size used for the test set and the data provenance
The document does not describe any clinical test set or data derived from study participants for performance evaluation. The submission relies solely on comparing technical specifications to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical test set with ground truth established by experts is described.
4. Adjudication method for the test set
Not applicable, as no clinical test set requiring 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 an auditory evoked potential testing device, not an AI-assisted diagnostic imaging or interpretation tool for human readers. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The SmartEP-ASSR is a medical device for measuring physiological responses, not an algorithm being tested for standalone diagnostic performance in the absence of human interpretation. Its function is to acquire and process evoked potential data for trained personnel to interpret.
7. The type of ground truth used
Not applicable, as no clinical performance study requiring ground truth is described. The "ground truth" equivalent for this type of submission is the established safety and effectiveness of the predicate device and the technical measurements demonstrating the new device performs similarly.
8. The sample size for the training set
Not applicable, as this device does not utilize a machine learning algorithm that requires a training set in the context of the provided document.
9. How the ground truth for the training set was established
Not applicable, as no training set for a machine learning algorithm is discussed.
{0}------------------------------------------------
FEB 2 0 2004
510(k) Summary
| Prepared By: | Intelligent Hearing Systems7356 SW 48th StreetMiami, 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 devicethat is capable of measuring auditory steady state responses(ASSR). |
| Intended Use: | The intended use of the SmartEP-ASSR product is for therecording of auditory steady-state evoked potential data.The product is intended to be used as a diagnostic aid inauditory and hearing related disorders and as an adjunctivetool in the estimation of behavioral hearing thresholds.SmartEP-ASSR can be used for patients of all ages. It isintended to be used by trained personnel in a hospital,nursery, clinic, audiologist's office or other appropriatesetting. |
| Technological Characteristics: | The SmartEP-ASSR device is similar to the predicate devicein 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)ReviewSmartEP-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, 5kHz |
| 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 and110 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, 8kHz | User Selectable: Clicks, Pure Tonesand 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, CosineCubed |
| 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, OAEProbe |
| 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
§ 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).