SMARTSCREENER-PLUS2

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for Intelligent Hearing Systems. The logo has a graphic to the left of the words "Intelligent Hearing" stacked on top of "Systems". The graphic is a square with rounded corners and a series of concentric arcs inside. The letters in "Systems" are each in their own square. # 0(k) Summarv JUL - 7 2009 | Submitter: | Intelligent Hearing Systems<br>6860 SW 81st Street<br>Miami, FL 33143 | |---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------| | Telephone:<br>FAX:<br>Contact Person: | (305) 668-6102<br>(305) 668-6103<br>Edward Miskiel, Ph.D. | | Date Summary Prepared: | June 18, 2009 | | Trade Name: | SmartScreener-Plus2 | | Common Name(s): | Auditory Evoked Potential Device, Otoacoustic Emissions Device,<br>Automated Hearing Screener. | | Classification Name: | Auditory Evoked Response Stimulator (per CFR.882.1900)<br>& Audiometer (per CFR 874.1050) | | Predicate Device(s): | Bio-logic ABaer Cub with integrated OAE and ABR functions<br>510(k) #K021801<br>Intelligent Hearing Systems SmartEP-ASSR 510(k) #K031051 | ### Description of the Device: The SmartScreener-Plus2 is a noninvasive device used to test for hearing and related neurological abnormalities. The device is especially indicated for use in the screening of infants to determine hearing loss. The SmartScreener-Plus2 device records and detects auditory evoked potentials (AEPs) and otoacoustic emissions (OAEs) which are generated in response to a series of auditory stimuli delivered to the patient. AEPs are electrical signals produced by the patient's nourological activity and are picked up by electrodes attached to the patient's skin. The portion of the AEP that originates from the anatomical structures of the inner ear to the auditory brainstem is commonly called the Auditory Brainstem Response (ABR). Otoacoustic emissions are acoustic signals produced by the patient's inner ear and are picked up by a sensitive microphone located in an OAE probe. The SmartScreener-Plus2 device is capable of recording Transient Evoked OAEs (TEOAEs or TrOAEs), and Distortion Product OAEs (DPOAEs) The SmartScreener-Plus2 uses advanced signal processing technology to separate AEPs and OAEs from background noise and other physiological activity. The device uses proven statistical algorithms to automatically determine if there is an AEP or OAE response present to the auditory stimuli delivered to the patient. A user, with device administrator approved password security clearance, is able to set the output level of the stimulus. AEP stimulus levels {1}------------------------------------------------ between 30 to 40 dB nHL, and TEOAE stimulus level of 85 dB SPL, and DPOAE stimulus levels of 65 and 55 dB SPL are commonly used for newborn hearing screening applications. The SmartScreen-Plus2 device is simple to operate. It does not require any special technical skills or interpretation of results. Basic training is sufficient to learn how to use the device. ## Indications for Use: . The SmartScreener-Plus2 device is indicated for use in the recording and automated analysis of human physiological data necessary (auditory brainstem responses and/or otoacoustic emissions) for the diagnosis of auditory and hearing-related disorders. The device is especially indicated for use in the screening of infants to determine hearing loss. Sites appropriate for use include the well-baby nursery, neonatal intensive care unit (NICU), mother's bedside, outpatient clinic, audiologist's office, or doctor's office. The device is simple to operate. It does not require special technical skills or interpretation of results by the device operator. Basic training with the device is sufficient to learn how to operate it: The SmartScreener-Plus2 device can be used for patients of all ages, from children to adults, including infants and geriatric patients. It is especially indicated for use in testing individuals for whom behavioral audiometric results are deemed unreliable, such as infants, young children, and cognitively impaired or uncooperative adults. The possible anatomical sites of contact are the patient's ear, ear canal, and/or external skin surrounding the ear (with the contact object being a sound delivery eartip, headphone cushion, or an acoustic ear coupler such as a circumaural ear cup, intra-aural ear bud, or supra-aural ear patch), the patient's head (with the contact object being a bone vibrator), and the patient's head, nape of the neck and shoulder (with the contact object being electrodes that are capable of measuring bio-potentials). The SmartScreener-Plus2 device is for prescription use. #### Comparison with Predicate Device: Comparisons of technological characteristics of the SmartScreener-Plus2 with the predicate devices (Bio-logic ABaer Cub with integrated OAE and ABR functions and the Intelligent Hearing Systems SmartEP-ASSR) are given in the table below: | Parameter for Comparison | Predicate Device<br>Bio-logic ABaer Cub with integrated<br>OAE and ABR functions (K021801) | Predicate Device<br>IHS SmartEP-ASSR<br>(K031051) | Similarity or<br>Difference to<br>Predicate Devices | |--------------------------|--------------------------------------------------------------------------------------------|---------------------------------------------------|-----------------------------------------------------| | Target Population | Patients of all ages. | Same. | Same. | | Where Used | Clinical setting. | Same. | Same. | | Anatomical Sites | Scalp, ear and other skin sites. | Same. | Same. | | Sterility | None required. | Same. | Same. | | Biocompatibility | Completely biocompatible. | Same. | Same. | {2}------------------------------------------------ | Design | Main hardware unit (housing<br>circuitry, supplies, and equipment)<br>connected to (1) patient cables and<br>transducers and (2) a portable<br>computer (with installed testing<br>software). | Same. | Same. | |---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|-------------------------------------| | Components/<br>Materials | Main hardware unit, transducers,<br>acoustic couplers, electrodes, cables,<br>computer, printer and cart. | Same. | Same. | | Human Factors | Simple, easy-to-follow instructions<br>and software user interface. | Same. | Same. | | Standards. | None known. | Same. | Same. | | Energy Used and/or<br>Delivered | Stimulation of auditory system. | Same. | Same. | | Chemical Safety | No chemicals are involved in the use<br>of this device. | Same. | Same. | | Mechanical Safety | No mechanical parts in contact with<br>patient. | Same. | Same. | | Electrical Safety | Meets IEC60601-1, UL2601-1,<br>CSA-C22.2 No. 601.1, AAMI.ES1,<br>and CE Mark. | Meets EN60601-1,<br>EN60601-1-2,<br>EN60601-2-40,<br>EN55011,<br>EN61000-3-2,<br>EN61000-3-3, and<br>CE Mark. | Same as SmartEP-<br>ASSR (K031051). | | Thermal Safety | Device is not thermal in nature. | Same. | Same. | ### Substantial Equivalence: Based on the information presented here, the SmartScreener-Plus2 device is substantially equivalent to the Bio-logic ABaer Cub with Integrated OAE and ABR and the Intelligent Hearing Systems SmartEP-ASSR devices. #### Performance Testing: This submission includes a comparison table of specifications for both the SmartScreener-Plus2 device and the predicate devices. The SmartScreener-Plus2 device specifications were verified and validated. ### Conclusions: Based on the information presented in this submission, the SmartScreener-Plus2 device is as safe and effective as the identified predicate devices, the Bio-logic ABaer Cub with integrated OAE and ABR and the Intelligent Hearing Systems SmartEP-ASSR. {3}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with outstretched wings, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is simple and iconic, representing the HHS's mission to protect the health of all Americans. #### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Intelligent Hearing Systems % Edward Miskiel, Ph.D. President & CEO 6860 SW 81 51 Street Miami, Florida 33143 JUL - 7 2009 Re: K090579 Trade/Device Name: SmartScreener-Plus2 Regulation Number: 21 CFR 882.1900 Regulation Name: Auditory Evoked Response Stimulator Regulatory Class: Class II Product Code: GWJ, EWO Dated: June 18, 2009 Received: June 24, 2009 Dear Dr. Miskiel: We have reviewed vour 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. 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. 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 devicerelated 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. {4}------------------------------------------------ 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, MAJ. R. E. H. M.D. 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}------------------------------------------------ # Indications for Use 510(k) Number: K090579 Device Name: SmartScreener-Plus2 Indications For Use: The SmartScreener-Plus2 device is indicated for use in the recording and automated analysis of human physiological data (auditory brainstem responses and/or otoacoustic emissions) necessary for the diagnosis of auditory and hearingrelated disorders. The device is especially indicated for use in the screening of infants to determine hearing loss. Sites appropriate for use include the well-baby nursery, neonatal intensive care unit (NICU), mother's bedside, outpatient clinic, audiologist's office, or doctor's office. The device is simple to operate. It does not require special technical skills or interpretation of results by the device operator. Basic training with the device is sufficient to learn how to operate it. The SmartScreener-Plus2 device can be used for patients of all ages, from children to adults, including infants and geriatric patients. It is especially indicated for use in testing individuals for whom behavioral audiometric results are deemed unreliable, such as infants, young children, and cognitively impaired or uncooperative adults. The possible anatomical sites of contact are the patient's ear, ear canal, and/or external skin surrounding the ear (with the contact object being a sound delivery eartip, headphone cushion, or an acoustic ear coupler such as a circumaural ear cup, intra-aural ear bud, or supra-aural ear patch), the patient's head (with the contact object being a bone vibrator), and the patient's head, nape of the neck and shoulder (with the contact object being electrodes that are capable of measuring biopotentials). The SmartScreener-Plus2 device is for prescription use. 510(k) Number : Prescription Use _______X (Part 21 CFR 801 Subpart D) AND/OR (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | (Division Sign-Off) | | |-----------------------------------------------|--| | Division of Ophthalmic, Neurological and Ear, | | | Nose and Throat Devices | | Page 1 of 1K090579