INTERACOUSTICS EP 15 ABR STAND ALONE UNIT

{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); | <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, 5000<br>Hz, none (12000Hz). 33 taps FIR filter. | 15 Hz to 25 kHz, 12 dB/octave | | High pass: None (5 Hz), 50, 100, 150, 300<br>500 Hz. 6dB/octave. | DC, 0.002 – 1 kHz, 6 dB/octave | | STIMULATORS: | | | Stimuli: Click, Tone Burst, Blackman,<br>Gaussian, Hanning, Hamming, Bartlett,<br>Rectangle, Manual (rise/plateau/fall) | Click, Tone Burst | | Parameters for tonal stimuli; frequency,<br>intensity, rise/fall time, plateau duration,<br>envelope shape: Programmable | Programmable<br>0.1 - 100/sec | | Rate: 7.1, 13.1, 21.1, 23.1, 29.1, 31.1, 35.1,<br>41.1, 45.1, 49.1 Hz, ext. trigger input | | | Intensity: 20 dB to 130 dB peSPL; 10 dB to<br>100 dB HL In 1 dB step. | -12 dB to +128 dB SPL | | Masking: White noise; masking ear is<br>opposite side of stimulus | White noise, programmable intensity | | Transducers: EAR 3A Insert Phones-ABR | TDH-49 earphones, insert earphones, bone<br>conduction transducer | | SAFETY CHARACTERISTICS: | | | Optical isolation: Yes | Yes | | Built-in isolation transformer: Yes | Yes | | (CONTINUED – COMPARISON) | | | EP15 ABR | Chartr EP | | Controlled parameters: Stimuli Rate; Number<br>of Stimuli; Stimuli Polarity; Click; Tone Burst<br>(frequency, number of sin waves, window);<br>Stimulus Intensity; Number of Curve Pr.<br>Intensity; Intensity (ascend, descend); Soft<br>Attenuator; Stimulus Ear (right, left,<br>simultaneously); Masking Level; Preliminary<br>Filter Setting (low, high pass filter); Recording<br>Onset; Automatic Next Intensity (wave repro<br>level setting); Ext. Trigger Output Duration;<br>Rejection System Rejection Level; Gain<br>(manual, automatic); Display Options (Invert<br>curves on screen; Origin line; Latency Norm.<br>Report Templates; After Filtering; Print out;<br>Manual Stimulus to Familiarization; Talk<br>Forward; Talk Back Monitor. | Stimulated Ear, Masked Ear, Stimulus Intensity,<br>Masking Stimulus, Stimulus Transducer,<br>Stimulus Type, Stimulus Polarity, Stimulus<br>Characteristics, Number of Sweeps Acquires,<br>Stimulus Presentation Rate, Sweep Time,<br>Number of Channels, Amplifier Gain, Filter<br>Characteristics, Inclusion of Notch Filter,<br>Inclusion of Artifact Rejection | | Data Collection: Impedance Test; Waveform<br>Buffer (A/B, contra, ipsi-contra, A-B=Noise);<br>Curve (Hide, Fixate, Merge, Delete); Show<br>Online EEG, Store Waveforms in unlimited<br>Storage database | Tests Impedance of Patient Electrode<br>Connections, Display Waveform Buffers<br>During Examination, Displays on-going EEG<br>Activity, Stores Waveforms, Stores the<br>Waveform 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 VAC<br>Universal Input Switch Mode; Safety: VDE750,<br>EN60601-1, IEC601, IEC1010, UL544, CSA<br>22.2 | 200 Watts, 50/60 Hz, 120 or 240 volts | | Keyboard:<br>101-key IBM standard | 101 - key IBM standard | | Ancillary Functions: Help system.<br>Exports data of one patient to diskette. | Help system.<br>Exports data of one patient to diskette.<br>Backup procedure automatically implemented. | {2}------------------------------------------------ ## 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) {3}------------------------------------------------ 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. {4}------------------------------------------------ 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 {5}------------------------------------------------ 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) | | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | <div align="center"> <img height="30" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAUAAAAFCAYAAACNbyblAAAAHElEQVQI12P4//8/w+r8/08gZSAgYGRgYGBgYAAJzQG35+5X0AAAAABJRU5ErkJggg==" width="100"/></div> | | | (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)