(146 days)
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.
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.
The provided 510(k) summary (K991853) is for the Interacoustics Model EP15 ABR Stand Alone Unit. Based on the document, this is a comparison study against a predicate device, not a study proving device performance against specific acceptance criteria in the typical sense of a new technology. The summary mainly outlines the technical specifications and functional equivalency to the predicate device, not empirical performance data from clinical trials.
Therefore, many of the requested fields regarding acceptance criteria, study sample sizes, expert involvement, and ground truth are not applicable or cannot be extracted from this type of regulatory submission. The 510(k) process for this device focuses on demonstrating substantial equivalence to a legally marketed predicate device.
However, I can extract the comparative "acceptance criteria" through the lens of technical specifications between the proposed device and its predicate.
1. Table of Acceptance Criteria (as inferred from comparison to predicate) and Reported Device Performance
For this 510(k) submission, "acceptance criteria" are implicitly met by demonstrating that the proposed device, Interacoustics Model EP15 ABR, is either identical to or has equivalent or superior specifications compared to the predicate device, ICS Medical Corp. Chartr EP System, for key functional and safety aspects. The reported device performance is presented as its technical specifications.
| Feature / Acceptance Criteria Category | Predicate Device (Chartr EP) | Proposed Device (EP15 ABR) | Substantial Equivalence Justification / Performance |
|---|---|---|---|
| Indications for Use | Same | Same | Identical |
| Display Description | 15" SVGA Monitor | 12.1" Wide Angle Industrial TFT | Different size/type, but both provide necessary display. |
| Software Features | Windows 95/98 Operating System | Windows 95/98 Operating System | Same operating system implies similar user interface and functionality. |
| Amplifier Channels | 2 (optionally up to 8) | 2 | Equivalent baseline channels. |
| Amplifier Gain | X50 - X5000000 | 80 dB | Expressed differently, but assumed to meet diagnostic needs. (Specific dB gain needs to be evaluated against voltage gain range for direct comparison, but for 510k, it's considered functionally equivalent if appropriate for ABR). |
| Preamplifier Frequency Response | Same (as EP15) | 100 to 8000 Hz | Identical. |
| Preamplifier CMR Ratio | >100dB at 50/60 Hz | >120dB at 50/60 Hz | EP15 ABR is superior in Common Mode Rejection. |
| Preamplifier Noise | <1.5 µV RMS (0.1 Hz – 5 kHz) | 0.3µV RMS (0-3 kHz); 0.5µV RMS (100-8000 Hz) | EP15 ABR claims lower noise, indicating potentially better signal quality. |
| Points Per Trace | 600 | 450 (30 kHz sample) | Different, but 450 points at 30kHz sample often sufficient for ABR. |
| Low Pass Filter | 15 Hz to 25 kHz, 12 dB/octave | 1000, 1500, 2000, 3000, 5000 Hz, none (12000Hz). 33 taps FIR filter. | Different ranges/types, both provide filtering for ABR. |
| High Pass Filter | DC, 0.002 – 1 kHz, 6 dB/octave | None (5 Hz), 50, 100, 150, 300 500 Hz. 6dB/octave. | Different ranges/types, both provide filtering for ABR. |
| Stimuli Types | Click, Tone Burst | Click, Tone Burst, Blackman, Gaussian, Hanning, Hamming, Bartlett, Rectangle, Manual | EP15 ABR offers a broader range of stimuli, indicating potentially greater flexibility. |
| Stimulus Rate | Programmable 0.1 - 100/sec | 7.1, 13.1, 21.1, 23.1, 29.1, 31.1, 35.1, 41.1, 45.1, 49.1 Hz, ext. trigger input | Both programmable, EP15 lists specific rates. Functionally equivalent. |
| Intensity Range | -12 dB to +128 dB SPL | 20 dB to 130 dB peSPL; 10 dB to 100 dB HL | Both offer a wide and clinically relevant intensity range. |
| Masking | White noise, programmable intensity | White noise; masking ear is opposite side of stimulus | Both offer white noise masking. |
| Transducers | TDH-49 earphones, insert earphones, bone conduction transducer | EAR 3A Insert Phones-ABR | Different specific types, but both provide appropriate transducers for ABR. |
| Optical Isolation | Yes | Yes | Identical for safety. |
| Built-in Isolation Transformer | Yes | Yes | Identical for safety. |
| Controlled Parameters (Examples) | Stimulated Ear, Masked Ear, Stimulus Intensity, etc. | Stimuli Rate; Number of Stimuli; Stimulus Polarity; Click; Tone Burst (frequency, etc.); Stimulus Intensity; etc. | Both offer comprehensive control over testing parameters appropriate for an evoked response stimulator. |
| Data Collection Features | Tests Impedance, Display Waveform Buffers, Displays EEG, Stores Waveforms | Impedance Test, Waveform Buffer, Show Online EEG, Store Waveforms in unlimited Storage database | Both offer essential data collection and display features. |
| Power Supply Safety | 200 Watts, 50/60 Hz, 120 or 240 volts | Input volts: 90 to 250 VAC Universal Input Switch Mode; Safety: VDE750, EN60601-1, IEC601, IEC1010, UL544, CSA 22.2 | EP15 specifies compliance with multiple international safety standards. |
2. Sample size used for the test set and the data provenance:
- Not Applicable. This 510(k) relies on a comparison of technical specifications and safety standards, not a clinical test set 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. No ground truth for a test set was established as per this document. The assessment is based on technical specifications and compliance with recognized standards.
4. Adjudication method for the test set:
- Not Applicable. No test set requiring adjudication was used.
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 stimulator, not an AI-powered diagnostic tool requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a hardware device for generating stimuli and collecting data for evoked responses, not an algorithm.
7. The type of ground truth used:
- Not Applicable. No explicit "ground truth" was established for a performance study. Equivalence is based on adherence to technical specifications and safety standards, and functional similarity to the predicate.
8. The sample size for the training set:
- Not Applicable. This is a hardware device, not an AI/machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Not Applicable. No training set or associated ground truth.
Summary of the Study (510(k) Submission Approach):
The "study" presented in this 510(k) is a comparison study demonstrating substantial equivalence to a predicate device, the ICS Medical Corp. Chartr EP System. The manufacturer establishes this equivalence by detailing the technical specifications of the Interacoustics Model EP15 ABR Stand Alone Unit and comparing them point-by-point with those of the predicate device. The claim is that the device shares the same indications for use and has similar technological characteristics, and any differences either do not raise new questions of safety and effectiveness or are demonstrated to be as safe and effective as the predicate. The compliance with various performance and safety standards (e.g., VDE750, EN 60601 series, EN 60645-3) is also cited to support safety and effectiveness. This is a common approach for Class II medical devices seeking 510(k) clearance, where demonstrating equivalence to an already legally marketed device is the primary pathway to market.
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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.
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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); | <1.5 µV RMS (0.1 Hz – 5 kHz) |
| 5.5nV/Hz, 0.5µV RMS (100-8000 Hz) | |
| Points Per Trace: 450 (30 kHz sample) | 600 |
| ANALOG FEATURES: | |
| Low pass: 1000, 1500, 2000, 3000, 5000Hz, none (12000Hz). 33 taps FIR filter. | 15 Hz to 25 kHz, 12 dB/octave |
| High pass: None (5 Hz), 50, 100, 150, 300500 Hz. 6dB/octave. | DC, 0.002 – 1 kHz, 6 dB/octave |
| STIMULATORS: | |
| Stimuli: Click, Tone Burst, Blackman,Gaussian, Hanning, Hamming, Bartlett,Rectangle, Manual (rise/plateau/fall) | Click, Tone Burst |
| Parameters for tonal stimuli; frequency,intensity, rise/fall time, plateau duration,envelope shape: Programmable | Programmable0.1 - 100/sec |
| Rate: 7.1, 13.1, 21.1, 23.1, 29.1, 31.1, 35.1,41.1, 45.1, 49.1 Hz, ext. trigger input | |
| Intensity: 20 dB to 130 dB peSPL; 10 dB to100 dB HL In 1 dB step. | -12 dB to +128 dB SPL |
| Masking: White noise; masking ear isopposite side of stimulus | White noise, programmable intensity |
| Transducers: EAR 3A Insert Phones-ABR | TDH-49 earphones, insert earphones, boneconduction transducer |
| SAFETY CHARACTERISTICS: | |
| Optical isolation: Yes | Yes |
| Built-in isolation transformer: Yes | Yes |
| (CONTINUED – COMPARISON) | |
| EP15 ABR | Chartr EP |
| Controlled parameters: Stimuli Rate; Numberof Stimuli; Stimuli Polarity; Click; Tone Burst(frequency, number of sin waves, window);Stimulus Intensity; Number of Curve Pr.Intensity; Intensity (ascend, descend); SoftAttenuator; Stimulus Ear (right, left,simultaneously); Masking Level; PreliminaryFilter Setting (low, high pass filter); RecordingOnset; Automatic Next Intensity (wave reprolevel setting); Ext. Trigger Output Duration;Rejection System Rejection Level; Gain(manual, automatic); Display Options (Invertcurves on screen; Origin line; Latency Norm.Report Templates; After Filtering; Print out;Manual Stimulus to Familiarization; TalkForward; Talk Back Monitor. | Stimulated Ear, Masked Ear, Stimulus Intensity,Masking Stimulus, Stimulus Transducer,Stimulus Type, Stimulus Polarity, StimulusCharacteristics, Number of Sweeps Acquires,Stimulus Presentation Rate, Sweep Time,Number of Channels, Amplifier Gain, FilterCharacteristics, Inclusion of Notch Filter,Inclusion of Artifact Rejection |
| Data Collection: Impedance Test; WaveformBuffer (A/B, contra, ipsi-contra, A-B=Noise);Curve (Hide, Fixate, Merge, Delete); ShowOnline EEG, Store Waveforms in unlimitedStorage database | Tests Impedance of Patient ElectrodeConnections, Display Waveform BuffersDuring Examination, Displays on-going EEGActivity, Stores Waveforms, Stores theWaveform Presentation |
| Dimensions: 14" x 10" x 15" | 22.5" x 17.5" x 7.8" |
| Weight: 26.5 lbs. | 58 lbs. |
| Power Supply: Input volts: 90 to 250 VACUniversal Input Switch Mode; Safety: VDE750,EN60601-1, IEC601, IEC1010, UL544, CSA22.2 | 200 Watts, 50/60 Hz, 120 or 240 volts |
| Keyboard:101-key IBM standard | 101 - key IBM standard |
| Ancillary Functions: Help system.Exports data of one patient to diskette. | Help system.Exports data of one patient to diskette.Backup procedure automatically implemented. |
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SAFETY AND EFFECTIVENESS:
ﺎﺭ ﺍﻟﻤﺮﺍﺟﻊ
The Interacoustics Model EP15 ABR Stand Alone Unit is in compliance with the following performance and safety standards:
VDE750; EN 60601-01 (General Safety) Class I, Type BF; EM 60601-1-1 (Safety of Systems); EN 60601-1-2 (EMC); EN 60601-2-26 (Electroencephalographs); EN 60645-3 (Auditory test signals)
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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 stylized caduceus symbol, which features a staff with a snake winding around it, combined with three human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR - 9 2012
Ms. Donna Ward President IDEM INTERNATIONAL DISTRIBUTORS OF ELECTRONICS FOR MEDICINE, INC. 4814 East Second Street Benicia, California 94510
Re: K991853
Trade/Device Name: Interacoustics Model EP15 ABR Stand Alone Unit Regulation Number: 21 CFR 882.1900 Regulation Name: Evoked response auditory stimulator Regulatory Class: II Product Code: GWJ Dated (Date on orig SE ltr): August 5, 1999 Received (Date on orig SE ltr): August 20, 1999
Dear Ms. Ward:
This letter corrects our substantially equivalent letter of October 25, 1999.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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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.
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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Kesia Alexander
Image /page/4/Picture/7 description: The image shows a signature on the left side and some text on the right side. The signature appears to be a stylized cursive signature, possibly initials. The text on the right is arranged in lines, but the content is not clear enough to read.
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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Page 1 of 1
510(k) Number (if known): K991853
Interacoustics Model EP15 ABR Stand Alone Unit
Device Name:
Indications For Usc:
The Interacoustics EP15 ABR Stand Alone Unit is a diagnostic tool for computerrne interacoucilled in a Windows 98 database format that allows for easy inspection of results. The EP15 Stand Alone Unit produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.
(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 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)
§ 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).