TITAN

{0}------------------------------------------------ Premarket Notification Submission 510(k) # MAY - 5 2011 ### 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS Titan Titan with DPOAE440 Titan with ABRIS440 SUBMITTER INFORMATION Company Name Company Address Company Phone Company Fax Company e-mail Contact Person Date Summary Prepared DEVICE IDENTIFICATION Trade Name Common Name Classification Name Product Code Panel Device Class Interacoustics A/S Drejervaenget 8 Assens, DK-5610, Denmark +45 6371 3555 +45 6371 3522 info@interacoustics.com Erik Nielsen, Director, Quality and Regulatory Affairs Apr. 28 2011 Titan Audiometric equipment Otoacoustic emission device, Evoked response auditory stimulator and measurements EWO / GWJ Ear Nose & Throat / Neurology Class II SUBSTANTIAL EQUIVALENCE (TITAN WITH DPOAE440) Predicate Device DPOAE20 (Eclipse) Manufacturer Interacoustics 510(k) No. KOROS39 Date Cleared 05/30/2006 SUBSTANTIAL EQUIVALENCE (TITAN WITH ABRIS440) Predicate Device Maico MB 11 Manufacturer MAICO 510(k) No. K082035 Date Cleared 01/29/2009 Section 05 p. 2 - 10 , • Image /page/0/Picture/15 description: The image shows the Interacoustics logo. The logo consists of a globe-like icon on the left, followed by the word "Interacoustics" in bold, white letters. A registered trademark symbol is present to the right of the word. Below the logo, there is a tagline that is difficult to read due to its small size and resolution. {1}------------------------------------------------ ### Device Description The instrument is audiometric equipment used for testing middle ear, inner ear and brainstem abnormalities. The Titan is a combination of: - Audiometric device for measurement of aural acoustic impedance (IMP) (Cleared . under K083861) - Audiometric device for measurement of otoacoustic emissions (OAE) . - Audiometric device for measurement of auditory brainstem responses (ABR) ● The Titan can have one of three functions depending on license: The Titan IMP test is intended to change the air pressure in the external auditory canal and measure and graph the mobility characteristics of the tympanic membrane to evaluate the functional condition of the middle ear. The Titan OAE test generates an acoustic stimulus in the ear canal at a moderate intensity level. The stimulus vibrates a thin membrane in the cochlear, and activates the outer hair cells located on the membrane. This activation is propagated back through the middle ear as sound into the ear canal. Microphone(s) detects OAE-related sounds. The Titan ABR test produces a short acoustic stimulus and measures via cutaneous electrodes the auditory evoked potentials from the inner ear, the auditory nerve and the brainstem. The test uses an automatic detection algorithm to determine if an ABR is evoked in response to the short acoustic stimulus. The output of the device is either PASS (ABR detected) or REFER (ABR is not detected). The Titan with DPOAE440 is intended as clinical audiometer. The Titan with ABRIS440 is intended as a screener audiometer. #### Indications for Use The Titan with DPOAE440 is intended for use in the audiologic evaluation and documentation of ear disorders using Distortion Product Otoacoustic Emissions. The target population for Titan with DPOAE440 includes all ages. The Titan with ABRIS440 is intended for use in the audiologic evaluation and documentation of ear and nerve disorders using auditory evoked potentials from the inner ear, the auditory nerve and the brainstem. The target population for Titan with ABRIS440 is newborns. K103760 Section 05 p. 3 - 10 Image /page/1/Picture/18 description: The image shows the logo for Interacoustics. The logo features a stylized globe on the left, followed by the word "Interacoustics" in a bold, sans-serif font. The logo is set against a black background. leading diagnostic solutions {2}------------------------------------------------ ## Technological Characteristics Titan consists of a handheld unit named Titan, Titan Cradle and PC software (Titan Suite, Titan modules/ Titan Applications). The measurements are controlled by the handheld unit. A license system makes it possible within each configuration to select which functionality the user wants to be incorporated in the system. A connection box (shoulder box) enables different types of accessories to be connected to the platform (depending on the module) The Titan platform can connect to PC software via a Bluetooth connection. Image /page/2/Picture/6 description: The image shows a sequence of handwritten alphanumeric characters. The characters are "K103760" and are written in a simple, slightly slanted font. The characters are all connected, and the overall impression is that of a quickly written note. Section 05 p. 4 - 10 Image /page/2/Picture/8 description: The image shows the Interacoustics logo. The logo consists of a globe-like symbol on the left and the word "Interacoustics" in bold, white letters on a black background. Below the logo, there is a tagline that reads "leading diagnostic solutions". {3}------------------------------------------------ | Description | Maico, MB 11 | Titan with ABRIS 440 | Equivalence | |-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for use | The Maico MB 11 with<br>BERAphone and the MB 11<br>Standard are intended to<br>generate evoked auditory<br>brainstem response (ABR) -<br>based measurements for<br>newborn hearing screening,<br>providing a PASS/REFER result. | The Titan with ABRIS440 is<br>intended for use in the audiologic<br>evaluation and documentation of<br>ear and nerve disorders using<br>auditory evoked potentials from<br>the inner ear, the auditory nerve<br>and the brainstem. | Similar<br>The wording<br>is just a little<br>different | | Target population | Newborns | Newborns | Same | | Intended user | The User does not require special<br>technical skills or interpretation<br>of the results. | The User does not require special<br>technical skills or interpretation of<br>the results. | Same | | Anatomical sites | Examination of Ear and hearing<br>nerves | Examination of Ear and hearing<br>nerves | Same | | Safety standards | IEC 60601-1 | IEC 60601-1 | Same | | Performance<br>standard | IEC 60645-7 (Type 2) | IEC 60645-7 (Type 2) | Same | | Device Type | Screening device<br>(PASS/REFER) result | Screening device<br>(PASS/REFER) result | Same | | System<br>Configuration | 1 -channel ABR system operated<br>through a base unit connected<br>via a USB port to any standard<br>computer (Laptop Computer<br>recommended) | 1 -channel ABR system operated<br>through a handheld base unit. The<br>base unit can be operated stand<br>alone or PC controlled through USB<br>or Bluetooth. | Similar The<br>only different<br>is that Titan<br>can work as<br>stand alone | | Display information<br>, | Testing sequence along with<br>current EEG parameters (number<br>of sweeps, number of artifacts,<br>SNR, and artifact rejection<br>system setting) | PASS/REFER status, indicated with<br>value between 0 and 100% where<br>100% indicates a pass. EEG peak or<br>RMS value, rejection status,<br>residual noise and what<br>transducer(s) are detected. | Similar<br>Some minor<br>differences in<br>displayed<br>information | | Electrode quality<br>check | YES | YES | Same | | Impedance Test<br>(Quality control) | Indicator in three levels.<br>Red: above 10kOhm<br>Yellow: between 10 & 8kOhm<br>Green: below 8kOhm | Before recording:<br>Electrode impedance is measured if<br>they are above 10kOhm, below 10<br>kOhm or below 3 kOhm. | Similar<br>The<br>difference in<br>the mid range<br>is due to<br>measurement<br>frequencies | | Description | Maico, MB 11 | Titan with ABRIS 440 | Equivalence | | | | | and has<br>influence on<br>the results.<br>The Titan may<br>require a little<br>more<br>carefulness<br>while placing<br>electrodes. | | Binaural screening | YES | YES | Same | | Pre-amplifier<br>channels | 1 | 1 | Same | | Stimulus | Chirps | Chirps | Same<br>Please refer<br>to<br>comparison<br>between MB-<br>11 and<br>ABRIS440 in<br>attachment<br>12-E | | Pre-amplifier Gain | 86 dB | 64 dB | Similar<br>Depends on<br>amplifier<br>characteristics<br>as CMMR and<br>SN ratio. Have<br>no influence<br>on measuring<br>results. | | Filtering | HW HP 30Hz filters of 1st order | Two HW HP filters of 1st order:<br>Cut-off frequencies 7Hz and 45Hz | Similar<br>Both look at<br>frequencies<br>above 80Hz<br>and at that<br>frequency the<br>response<br>from the two<br>filters are<br>identical. The<br>basic purpose<br>of the filters | | Description | Maico, MB 11 | Titan with ABRIS 440 | Equivalence | | | | | are to<br>eliminate DC<br>components | | Masking | None | None | Same | | Transducers | BERAphone<br>TDH39<br>EAR 3A Insert phones | Titan Probe<br>TDH39<br>EAR 3A Insert phones | Similar<br>The Titan<br>probe is a<br>dedicated<br>probe for<br>Titan as the<br>BERAphone is<br>a dedicated<br>probe for MB<br>11 | | Stimulus rate | 92.5/s | 90/s | Similar | | Screening level | 35dBHL | 35dBHL | Same | | Screening<br>measurement | 180 seconds | 180 seconds | Same | . ## Comparison Titan with ABRIS440 and predicate device K103760 Section 05 p. 5 - 10 . (1) Interacoustics® toading dlagnostic solullans {4}------------------------------------------------ ﺮ Section 05 p. 6 - 10 Image /page/4/Picture/4 description: The image shows the Interacoustics logo. The logo consists of a globe-like icon on the left, followed by the word "Interacoustics" in a bold, sans-serif font. Below the word, there is a tagline that reads "leading diagnostic solutions" in a smaller font. The logo is set against a black background. {5}------------------------------------------------ Premarket Notification Submission 510(k) K103760 Section 05 p. 7 - 10 Image /page/5/Picture/5 description: The image shows the Interacoustics logo. The logo consists of a globe-like icon on the left, followed by the word "Interacoustics" in bold, white letters on a black background. Below the logo, the words "leading diagnostic solutions" are written in a smaller font. {6}------------------------------------------------ | | DPOAE20 (Predicate) | DPOAE440 (New) | Comments | |------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for use | The Interacoustics DPOAE20 system is for use in the audiologic evaluation and documentation of ear disorders using Distortion Product Otoacoustic Emission tone stimuli. The presence of Otoacoustic emissions suggests normal outer hair cell function within cochlea, which in turn suggests normal hearing. OAEs are recorded using an OAE probe which is placed in the ear canal. The OAE response from the ear is recorded and processed by the Eclipse and the DPOAE2O software and then displayed on the computer screen for evaluation. | The Titan with DPOAE440 is intended for use in the diagnostic audiologic evaluation and documentation of ear disorders using Distortion Product Otoacoustic Emissions. | Similar<br>The wording is just a little different | | Target population | The patient group includes all ages | The patient group includes all ages | Same | | Intended user | Ear, Nose, and Throat doctors, Neurology specialists, Audiologist and other health- professionals concerned with measuring auditory functions. | The Titan is designed to be used only by skilled personnel such as audiologists, ENT surgeons, and doctors, hearing healthcare professionals or personnel with similar level of education. The device should not be used without the necessary knowledge and training to understand its use and how results should be interpreted. | Same | | Evaluation method | DPOAE | DPOAE | Same | | Safety standard | IEC 60601-1 | IEC 60601-1 | Same | | EMC standard | IEC 60601-1-2 | IEC 60601-1-2 | Same | | Performance standard | IEC 60645-6 (Type 2) | IEC 60645-6 (Type 2) | Same | | | DPOAE20 (Predicate) | DPOAE440 (New) | Comments | | Test signals | IEC 60645-1/ANSI S3.6 , IEC<br>60645-3 | IEC 60645-1/ANSI S3.6 , IEC<br>60645-3 | Same | | Stimulus: | | | | | Frequency Range | 500-8000 Hz | 500 to 10000 Hz | Similar<br>The DPOAE has an<br>extended range. This is<br>a technical<br>improvement due to<br>better technology and<br>probes. | | Frequency Step | 50 Hz | 25 Hz | Similar<br>A technical better<br>resolution is possible<br>due to better<br>technology. | | Level | 30-75 dB SPL ( 70 dB above<br>6kHz) | 30 to 80 dB SPL (75 dB SPL<br>for 6kHz and 65 dB SPL for<br>8kHz and 10kHz) | Similar<br>The DPOAE has an<br>extended range. This is<br>a technical<br>improvement due to<br>better technique and<br>probes. | | Level Step | 1 dB SPL | 1 dB SPL | Same | | Transducer | Dedicated<br>DPOAE20/TEOAE25 probe | Dedicated<br>IOW Probe | Similar<br>New transducer due to<br>the hardware design of<br>Titan is different from<br>DPOAE20 hardware.<br>The transducer has the<br>same characteristics as<br>the predicate. The<br>transducer is not new<br>compared to the<br>previous version of<br>Titan cleared under<br>K083861 | | Probe detection | None | Auto detection | Different<br>The probe unit has<br>build-in memory for all<br>probe relevant<br>calibration values. | | Recording | | | | | Analysis time | Minimum 2 sec to unlimited<br>test time. | Minimum 2 seconds to<br>unlimited time | | | A/D Resolution | 16 bit, 7.3 Hz resolution | 24 bit, 5.38 Hz resolution | Similar<br>Better resolution due<br>to better technology | | | DPOAE20 (Predicate) | DPOAE440 (New) | Comments | | Artifact Reject System | -30 -> +30 dB SPL or off. | -30 to +30 dB SPL or off | Same | | Stimulus Tolerance | Adjustable between 1 and 10 dB | Adjustable between 1 and 10 dB | Same | | SNR Criteria | Adjustable between 1 and 20 dB | Adjustable between 3 and 25 dB | Similar<br>The limits has be<br>adjusted to better fit to<br>real world practice.<br>This givers higher<br>evidence for response.<br>(1 dB is in fact too<br>small to use as criteria) | | Probe check window | 256 points frequency<br>response of the ear canal<br>due to a click stimulus<br>presented with a rate of 100<br>Hz at 80 dB SPL | 1024 points frequency<br>response of the ear canal<br>due to a click stimulus | Similar<br>Better resolution due<br>to better technology<br>used | | DP-Response<br>window | 4096 points frequency<br>response | 4096 points frequency<br>response | Same | | Display | | | | | General Display gain | Applicable during testing | Applicable during testing | Same | | Display | Stimulus level and type | Stimulus level and type,<br>Basic and advanced view | Similar<br>A simpler (basic) view<br>has been introduces | | Database | | | | | | Supported by Interacoustics<br>OtoAccess™ database. | Supported by<br>Interacoustics OtoAccess™<br>database. | Same | | | Operating under NOAH is<br>possible, using IA<br>NOAHLink. | Operating under NOAH is<br>possible, using IA<br>NOAHLink. | Same | #### - : - ı Image /page/6/Picture/4 description: The image shows a sequence of handwritten characters, which appear to be alphanumeric. The sequence reads 'K103760'. The characters are written in a simple, clear style, with each digit and letter easily distinguishable. The writing is in black against a white background. Section 05 p. 8 - 10 :・ Image /page/6/Picture/6 description: The image shows the logo for Interacoustics, a company that provides leading diagnostic solutions. The logo consists of a stylized globe on the left, followed by the company name in bold, white letters on a black background. Below the company name is the tagline "leading diagnostic solutions" in a smaller font. {7}------------------------------------------------ Section 05 p. 9 - 10 Image /page/7/Picture/4 description: The image shows the logo for Interacoustics, a company that provides diagnostic solutions. The logo consists of a globe-like icon and the company name in a bold, sans-serif font. Below the company name is the tagline "leading diagnostic solutions" in a smaller font. {8}------------------------------------------------ ### Premarket Notification Submission 510(k) #### Test summary The Titan was tested according to current standards for OAE and ABR and was found to conform to the standards. No clinical tests were performed, but based on the fulfillment of the international standards for OAE and ABR, and the comparison to predicate devices we believe the device is safe and effective. ### Conclusion We have compared the intended use and performance characteristics with the predicate devices. The Titan was tested according to current standards and the differences found between the devices were related to functionality, not in relation to safety and efficiency. The Titan conforms to the current standards. The Titan with DPOAE440 and Titan with ABRIS440 were found to be substantially equivalent to the predicate devices in technological characteristics and indications for use. Section 05 p. 10 - 10 Image /page/8/Picture/9 description: The image shows the logo for Interacoustics. The logo consists of a globe-like icon on the left and the word "Interacoustics" in a bold, sans-serif font on the right. The background is black, and the text and icon are white. Image /page/8/Picture/10 description: The image shows a sequence of characters that appear to be handwritten. The characters are 'K103760', with each digit and letter clearly distinguishable. The handwriting style is casual, with some characters slightly slanted and connected. {9}------------------------------------------------ Image /page/9/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room ~WO66-G609 Silver Spring, MD 20993-0002 Interacoustics A/S c/o Erik Nielsen Director, Quality and Regulatory Affairs Drejervaenget 8 Assens, DK-5610 Denmark MAY - 5 2011 Re: K103760 Trade/Device Name: · Titan with ABRIS440 and Titan with DPOAE440 Regulation Number: 21 CFR 882.1900 Regulation Name: Evoked Response Auditory Stimulator Regulatory Class: Class II Product Code: GWJ, EWO Dated: April 7, 2011 Received: April 12, 2011 Dear Mr. Nielsen: 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. 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 {10}------------------------------------------------ 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/CDRH0ffices/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/ReportalProblem/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 yours, Rithm, h 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 {11}------------------------------------------------ 103760 Premarket Notification Submission 510(k) ## Indications for Use Applicant: Interacoustics A/S 510(k) Number (if known): K103760 Device Name: Titan with DPOAE440, Titan with ABRIS440 #### Indications for Use: The Titan with DPOAE440 is intended for use in the audiologic evaluation and documentation of ear disorders using Distortion Product Otoacoustic Emissions. The target population for Titan with DPOAE440 includes all ages. The Titan with ABRIS440 is intended for use in the audiologic evaluation and documentation of ear and nerve disorders using auditory evoked potentials from the inner ear, the auditory nerve and the brainstem. The target population for Titan with ABRIS440 is newborns. Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR (Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices K103760 510(k) Number Image /page/11/Picture/17 description: The image shows the Interacoustics logo. The logo consists of a globe-like icon on the left and the word "Interacoustics" in bold, white letters on a black background. Below the logo, there is a tagline that reads "leading diagnostic solutions" in a smaller font size.