(157 days)
The Titan Impedance System is an electroacoustic test instrument that produces controlled levels of test tones and signals intended for use in conduction diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. It features tympanometry and acoustic reflexes.
The Titan Impedance System measures various acoustic properties of the ear, namely power reflectance, power absorption, transmittance, reflectance group delay, complex acoustic impedance and admittance, and equivalent ear canal volume. These measures allow the evaluation of the functional condition of the middle and outer ear.
The Titan Impedance System is suitable for all populations including new-born infants.
The Titan Impedance System is to be used by trained personnel only such as audiologists, ENT surgeons, doctors, hearing healthcare professionals or personnel with a 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.
The instrument is audiometric equipment used for measuring aural acoustic impedance and admittance (According to ANSI S3.39).
The Titan is a platform with multi functions depending of licensing. The license function for this submission is IMP440 (IMP) for measurement of aural acoustic impedance and admittance.
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 IMP test function is already cleared by FDA 510(k) premarket notification K083861 (04/09/2009)
The instrument is a diagnostic/clinical instrument (as defined in IEC60645-5), but provides normative data for guidance.
Titan consists of a handheld unit named Titan, Titan Cradle (cleared by FDA 510(k) premarket notification K083861) and PC software (Titan Suite/IMP440). The measurements are controlled by the handheld unit.
A connection box (shoulder box) enables different types of accessories to be connected to the platform
The Titan platform can connect to PC software via a Bluetooth connection.
The Interacoustics Titan IMP440 WBT is an electroacoustic test instrument intended for diagnostic hearing evaluations and assisting in the diagnosis of otologic disorders. It measures various acoustic properties of the ear, including power reflectance, power absorption, transmittance, reflectance group delay, complex acoustic impedance and admittance, and equivalent ear canal volume.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than detailing specific numeric acceptance criteria for performance metrics. The comparison table (on pages 3-5 of the original document) primarily highlights similarities and differences in technical characteristics and functionalities between the Titan IMP440 WBT and its predicate devices (Titan with IMP440 and MIMOSA HEARID).
Implicit Acceptance Criteria (based on substantial equivalence):
| Feature/Measure | Acceptance Criteria (Substantial Equivalence) | Reported Device Performance (Titan IMP440 WBT) |
|---|---|---|
| Indications for Use | "Same" as predicate devices (Titan IMP440 and MIMOSA HEARID): Conduct diagnostic hearing evaluations, assist in diagnosing otologic disorders, perform tympanometry and acoustic reflexes, measure various acoustic properties of the ear (power reflectance, absorption, transmittance, delay, impedance, admittance, ear canal volume). | Meets: Identical intended use as the previous Titan IMP440, with additional paragraphs matching the predicate MIMOSA HEARID regarding specific acoustic property measurements, suitability for all populations (including newborns), and use by trained personnel. |
| Target Population | "Same" as predicate devices: All populations, including newborn infants. | Meets: Suitable for all populations, including newborn infants. |
| Intended User | "Same" as predicate devices: Trained personnel (audiologists, ENT surgeons, doctors, hearing healthcare professionals). | Meets: To be used by trained personnel only. |
| Safety Standard | Compliance with IEC 60601-1 (assumed for predicate). | Meets: Complies with IEC 60601-1. |
| EMC Standard | Compliance with IEC 60601-1-2 (assumed for predicate). | Meets: Complies with IEC 60601-1-2. |
| Performance Standard | Unknown for MIMOSA HEARID, but expectation of compliance with state-of-the-art standards. | Meets: Complies with IEC 60645-5 / ANSI S3.39 (Type 1 Diagnostic/Clinical). |
| Frequency Range | Functionally equivalent to 200-6000 Hz of MIMOSA HEARID, ensuring no negative impact on safety or effectiveness. | Meets (Substantially Equivalent): 250-8000 Hz. Justified that expanded range (due to better transducers) does not influence safety or effectiveness. |
| Intensity Range | Functionally equivalent to 0-80 dB SPL of MIMOSA HEARID, ensuring no negative impact on safety or effectiveness. | Meets (Substantially Equivalent): 90/94 dB peSPL = 70/74 dB SPL (fixed). Justified that fixed range is within predicate device's variable range and does not impact safety/effectiveness for WBT (wideband tympanometry) as pure tone stimulation is not relevant. |
| Stimuli | Functionally equivalent to Chirp/Pure Tone of MIMOSA HEARID. | Meets (Substantially Equivalent): Chirp (Frequency linearized click). Pure Tone is not relevant for this WBT function. |
| Artefact Rejection | Presence of an artefact rejection system. | Meets (Substantially Equivalent): Present, described as removing responses contaminated with noise or noise artifacts, similar to the predicate's equivalent system. |
| Normative Data | Presence of normative data. | Meets (Substantially Equivalent): Present, used to indicate normal middle ear function in the user interface. Based on referenced studies [1, 2]. |
| Reflectance Area Index | Presence of a system for enhanced diagnosis via reflectance area index. | Meets (Substantially Equivalent): Uses shaded area (10/90 or 5/95 percentiles) indicating normative region. Identical functionality to normative data display. |
| Measurement Protocols | Customizable measurement protocols. | Meets: Users can change the sequence of measurements to fit diagnostic and clinical purposes. |
| Customizable Display Parameters | Customizable display of graphs/parameters. | Meets (Substantially Equivalent): Users can change how many graphs are presented, with the intended purpose being the same as the predicate. |
| Otitis Media Examples | Presence of examples for Otitis Media with Effusion. | Meets (Substantially Equivalent): Sketched examples of curve characteristics based on measurements [4]. |
| Measures (Power Reflectance, Absorption, Transmittance, Acoustic Impedance, Resistance, Reactance, Admittance, Conductance, Susceptance, Equivalent Volume) | Presence of these specific acoustic measurements as defined by ANSI S3.39. | Meets (Substantially Equivalent): All listed measures are present, often explicitly stated as equivalent or directly derived from each other (e.g., reflectance to absorbance), and align with ANSI S3.39 definitions of these quantities. Power absorbance is plotted, noting its identity to power transmittance. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "No clinical tests were performed" (page 9) for the Titan IMP440 WBT device in this 510(k) submission. Therefore, there is no test set sample size mentioned, nor any data provenance (country of origin, retrospective/prospective). The assessment relies on compliance with international standards and comparison to predicate devices' performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Given that no clinical tests were performed, no experts were used to establish ground truth for a test set as part of this specific submission.
4. Adjudication Method for the Test Set
Since no clinical tests and no test set were used, there was no adjudication method applied for this submission.
5. Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The submission solely focuses on demonstrating substantial equivalence through technical comparisons and compliance with standards, not on human reader performance improvement with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
No standalone (algorithm only) performance study was conducted that would typically involve a test set. Instead, the device's functional performance was verified through compliance with recognized standards (IEC 60645-5 / ANSI S3.39) and comparison against the technical specifications of predicate devices.
7. Type of Ground Truth Used
For the newly submitted device, no direct ground truth (e.g., pathology, outcomes data) was established for its own performance. The grounds for acceptance criteria are:
- Compliance with international standards: IEC 60601-1, IEC 60601-1-2, IEC 60645-5 / ANSI S3.39.
- Substantial equivalence to predicate devices: The functionality and performance characteristics of the Titan IMP440 WBT were compared to the cleared Titan IMP440 and MIMOSA HEARID. The assumption is that if it is substantially equivalent and meets standards, it is safe and effective.
The normative data included in the device (mentioned as "present" in the comparison table) are based on published research [1, 2], which would inherently have involved clinical studies to establish their "ground truth" (e.g., healthy ear function). However, this is for the normative data itself, not for a direct performance study of the Titan IMP440 WBT in this submission.
8. Sample Size for the Training Set
As the device described is a medical instrument for measurement and diagnosis (not an AI algorithm that "learns" from data in a conventional sense), the concept of a "training set" is not applicable in the way it is for machine learning algorithms. The device's functionality is engineered based on established acoustic principles and standards. The "normative data" could be considered analogous to a statistical reference for interpretation rather than a training set for an algorithm. However, the sample sizes for the studies used to generate these normative data [1, 2] are not provided in this excerpt, though they would have been part of the original research.
9. How the Ground Truth for the Training Set Was Established
Again, the concept of a "training set ground truth" is not directly applicable. If considering the normative data as an analogous reference, its "ground truth" would have been established through the research studies it was based on (e.g., "adults with normal hearing" [1], and "newborn infants" [2]). These studies would have involved clinical assessments to define "normal" (or the specific conditions being studied). However, the details of these ground truth establishments are beyond the scope of this 510(k) summary, referring instead to external academic publications.
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Titan, IMP440 WBT
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
Titan IMP440 WBT
Interacoustics A/S
Drejervaenget 8
SUBMITTER INFORMATION Company Name Company Address
NOV 2-9 2012
Company Phone Company Fax Company e-mail Contact Person
Assens DK-5610 Denmark +45 6371 3555 +45 6371 3522 info@interacoustics.com Erik Nielsen. Director, Quality and Regulatory Affairs June. 21 2012
Date Summary Prepared
DEVICE IDENTIFICATION Trade Name Common Name Classification Name
Product Code Panel Device Class
Titan Audiometric equipment. Tester, Auditory Impedance / Evoked response auditory stimulator ETY / GWJ Ear Nose & Throat / Neurology Class II
SUBSTANTIAL EQUIVALENCE (TITAN WITH IMP440)
Predicate Device Manufacturer 510(k) No. Date Cleared
Titan with IMP440 Interacoustics K083861 04/09/2006
SUBSTANTIAL EQUIVALENCE (MIMOSA HEARID)
Predicate Device Manufacturer 510(k) No. Date Cleared
HEARID WIDEBAND MIDDLE EAR POWER ANALYZER MIMOSA ACOUSTICS, INC K053216 02/10/2006
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Description of device
The instrument is audiometric equipment used for measuring aural acoustic impedance and admittance (According to ANSI S3.39).
The Titan is a platform with multi functions depending of licensing. The license function for this submission is IMP440 (IMP) for measurement of aural acoustic impedance and admittance.
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 IMP test function is already cleared by FDA 510(k) premarket notification K083861 (04/09/2009)
The instrument is a diagnostic/clinical instrument (as defined in IEC60645-5), but provides normative data for guidance.
Titan consists of a handheld unit named Titan, Titan Cradle (cleared by FDA 510(k) premarket notification K083861) and PC software (Titan Suite/IMP440). The measurements are controlled by the handheld unit.
A connection box (shoulder box) enables different types of accessories to be connected to the platform
The Titan platform can connect to PC software via a Bluetooth connection.
Indications for Use
The Titan Impedance System is an electroacoustic test instrument that produces controlled levels of test tones and signals intended for use in conduction diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. It features tympanometry and acoustic reflexes.
The Titan Impedance System measures various acoustic properties of the ear, namely power reflectance, power absorption, transmittance, reflectance group delay, complex acoustic impedance and admittance, and equivalent ear canal volume. These measures allow the evaluation of the functional condition of the middle and outer ear.
The Titan Impedance System is suitable for all populations including new-born infants.
The Titan Impedance System is to be used by trained personnel only such as audiologists, ENT surgeons, doctors, healthcare professionals or personnel with a 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.
Section 05 p. 3 - 11
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leading diagnostic solutions
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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.
For measuring acoustic properties of the middle ear a probe is placed into the ear canal. The probe presents a calibrated tone or click sound into the ear canal and by recording the intensity and phase of the remaining tone or click in the ear canal it can be derived how much of the sound is absorbed by or transferred into the ear. Most common measures are:
-
A tympanogram, in which the compliance/absorbance is measured as function of the presented frequencies and pressure in the ear canal;
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An acoustic reflex, in which the compliance/absorbance is measured over time as function of the presented frequencies while an acoustic activator is presented that above certain intensity is expected to cause a contraction of the stapedius muscle which in return is expected to cause a change in the compliance/absorbance of the ear.
The levels of the tonal and click sounds are to be calibrated in an artificial ear according to peak to peak equivalent signal level principles in IEC 60645-3
Titan with IMP440 WBT is IEC 60645-5/ANSI S3.39, Type 1 (Diagnostic/Clinical) acoustic impedance instrument
Section 05 p. 4 - 11
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leading diagnostic solutions
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| Description | Titan with IMP440 | Titan with IMP440 WBT | Equivalence |
|---|---|---|---|
| Indications for use | The Titan Impedance System is an electroacoustic test instrument that produces controlled levels of test tones and signals intended for use in conduction diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. It features tympanometry and acoustic reflexes. | The Titan Impedance System is an electroacoustic test instrument that produces controlled levels of test tones and signals intended for use in conduction diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. It features tympanometry and acoustic reflexes.The Titan Impedance System measures various acoustic properties of the ear, namely power reflectance, power absorption, transmittance, reflectance group delay, complex acoustic impedance and admittance, and equivalent ear canal volume. These measures allow the evaluation of the functional condition of the middle and outer ear.The Titan Impedance System is suitable for all populations including new-born infants.The Titan Impedance System is to be used by trained personnel only such as audiologists, ENT surgeons, doctors, hearing healthcare professionals or personnel with a 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. | SameThe first paragraph for Titan IMP440 WBT is identical with the previous version of the Titan with IMP440The addition of subsequent paragraphs is the subject of this 510(k) |
| Target population | The devices are suitable for all populations including new-born infants | The devices are suitable for all populations including new-born infants | Same |
| Intended user | The devices are to be used by trained personnel only | The devices are to be used by trained personnel only | Same |
Comparison table for Titan with IMP440 and Titan IMP440 WBT
Section 05 p. 5 - 11
leading diagnostic solutions
Inte
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| Type | HearID (Predicate) | Titan IMP440 WBT | Comments |
|---|---|---|---|
| Audiometric equipment | Audiometric equipment | Same | |
| Indications for use | The intended use of theHearID-wbMEPA Middle EarPower Analyzer is tocharacterize the middle earstatus and to assist indiagnosing middle earpathologies.The HearID-wbMEPA systemmeasures various acousticproperties of the ear, namelypower reflectance, powerabsorption, transmittance,reflectance group delay,complex acoustic impedanceand admittance, andequivalent ear canal volume.These measures allow theevaluation of the functionalcondition of the middle andouter ear. The devices aresuitable for all populationsincluding new-born infants.The devices are to be used bytrained personnel only.The HearID system comes intwo versions: HearID-b-wbMEPA, and HearID e-wbMEPA, where the differenceis the variation of thehardware platform. | The Titan Impedance Systemis an electroacoustic testinstrument that producescontrolled levels of test tonesand signals intended for usein conduction diagnostichearing evaluations andassisting in the diagnosis ofpossible otologic disorders. Itfeatures tympanometry andacoustic reflexes.The Titan Impedance Systemmeasures various acousticproperties of the ear, namelypower reflectance, powerabsorption, transmittance,reflectance group delay,complex acoustic impedanceand admittance, andequivalent ear canal volume.These measures allow theevaluation of the functionalcondition of the middle andouter ear.The Titan Impedance Systemis suitable for all populationsincluding new-born infants.The Titan Impedance Systemis to be used by trainedpersonnel only such asaudiologists, ENT surgeons,doctors, hearing healthcareprofessionals or personnelwith a similar level ofeducation. The device shouldnot be used without thenecessary knowledge andtraining to understand its useand how results should beinterpreted. | SameThe first paragraph forTitan IMP440 WBT isidentical with theprevious version of theTitan with IMP440Paragraph 2, 3 and 4 forTitan IMP440 WBT areidentical with paragraph2 for the predicatedevice.The 3rd paragraph for thepredicate device is just alisting of variants ofdevices and has beenomitted in thecomparison |
| Target population | The devices are suitable for allpopulations including new-born infants | The devices are suitable forall populations including new-born infants | Same |
| Intended user | The devices are to be used bytrained personnel only. | The devices are to be used bytrained personnel only. | Same |
| Safety standard | IEC 60601-1 (assumed) | IEC 60601-1 | Same. |
| HearID (Predicate) | Titan IMP440 WBT | Comments | |
| EMC standard | IEC 60601-1-2 (assumed) | IEC 60601-1-2 | predicate device compliesas it at least is CE markedSame.It is assumed that thepredicate device compliesas it at least is CE marked |
| Performance standard | Unknown | IEC 60645-5 / ANSI S3.39 | The Titan IMP440 WBTcomplies with currentstate of the art standards.It is unknown if thepredicate devicecomplies. |
| Frequency Range | 200-6000 Hz | 250-8000Hz | Substantial equivalentTitan system use bettertransducers so thefrequency range can beexpanded to 8kHz. Wetrust that this does notinfluence the safety oreffectiveness of thesystem |
| Intensity Range | 0 - 80dB SPL | 90/94 dB peSPL =70/74 dB SPL | Substantial equivalentThe intensity range isfixed but inside the rangeas the HeardID. Thevariable range forHeardID is used for puretone stimulation and thisis not relevant for theTitan WBT. We trust thatwhen the range is insidethe predicate device wecan declare equivalencefor safety andeffectiveness. |
| Sample time | 0.1 - 10 seconds per point | 21, 5 Hz (Click sample time) | These parameters are notcomparable, as the rangefor the predicate device isfor pure tone, and thefixed sample time forTitan is fixed for thebroadband click |
| Stimuli | ChirpPure Tone | Chirp (Frequency linearizedclick)Not relevant | Substantial equivalent |
| Artefact rejection | Present | Present | Substantial equivalent.Titan IMP440 WBT has anartefact rejection system |
| HearID (Predicate) | Titan IMP440 WBT | Comments | |
| to remove responses contaminated with noise or noise artefacts. HearID has equivalent artefact rejection system to minimize noisy measurements. | |||
| Real time display of signal and noise | Present | No real time presentation. | Different. The Titan IMP440 WBT does not have real time display of signal and noise. Titan IMP440 WBT has a real time display of measurement data during acquisition. We trust that such "quality indicator" is irrelevant because the measurement time is so short that an indicator cannot be monitored with any benefit. After the test has finished, accepted and rejected sample ratio can be viewed. |
| Normative data | Present | Present | The functionality is substantial equivalent. Both systems have normative data present in the user interface to indicate normal middle ear function. Normative data are acquired individually for each system and is based on different databases. The Titan IMP440 WBT normative data is based on [1], [2]. The HearID norm data is based on other data. |
| Reflectance Area Index for enhanced diagnosis | Present | Present | Substantial equivalent. Titan IMP440 WBT uses a shaded area indicating normative region in either 10/90 percentiles or 5/95 percentiles for evaluating measurement results. Identical with normative data above |
| HearID (Predicate) | Titan IMP440 WBT | Comments | |
| measurementprotocols. | Present | Present | Users can change thesequence ofmeasurements to havetest protocols fit fordiagnostic and clinicalpurposes. |
| Customizable displayparameters. | Present | Present | Substantial equivalent.The user can change howmany and how graphs arepresented on the display.Graphs may differ but theintended purpose is thesame. |
| Otitis media witheffusion examples | Present | Present | The functionality issubstantial equivalent.For Titan IMP440 WBTthese are sketchedexamples of curvecharacteristics based onmeasurements [4] |
| Measurements | |||
| Power Reflectance | Present | Present | Substantial equivalent.Power Reflectance isequal to 1 - PowerAbsorbance.Power absorbance isplotted in Titan IMP440WBT.Refer to PowerAbsorbance |
| Power Absorbance | Present | Present | Equivalent.Power Absorbance tellshow much of the sound isabsorbed by the middleear, that value is identicalto the PowerTransmittance.The equivalency is basedon result from [3] |
| Power Transmittance | Present | Present | Equivalent.Identical to PowerAbsorbance.Power absorbance isplotted in Titan IMP440WBT.Refer to PowerAbsorbance |
| AcousticImpedance | Present | Present | Equivalent. (ANSI S3.39Quantities used formeasurement of auralacoustic impedance andacoustic admittance) |
| HearID (Predicate) | Titan IMP440 WBT | Comments | |
| Acoustic Resistance | Present | Present | calculated from thereflectance. Acousticimpedance calculatedusing Titan IMP440 WBTis similar to acousticsimpedance calculated insingle tone based TitanIMP440. |
| Acoustic Reactance | Present | Present | Equivalent. (ANSI S3.39Quantities used formeasurement of auralacoustic impedance andacoustic admittance)Acoustic Resistance is thereal part of the complexvalued AcousticImpedance. |
| AcousticReactance | Present | Present | Equivalent. (ANSI S3.39Quantities used formeasurement of auralacoustic impedance andacoustic admittance)Acoustic Reactance is theimaginary part of thecomplex valued AcousticImpedance. |
| Acoustic Admittance | Present | Present | Equivalent. (ANSI S3.39Quantities used formeasurement of auralacoustic impedance andacoustic admittance)Acoustic Admittance isthe reciprocal of theAcoustic Impedance. |
| AcousticConductance | Present | Present | Equivalent. (ANSI S3.39Quantities used formeasurement of auralacoustic impedance andacoustic admittance)Acoustic Conductance isthe real part of thecomplex valued AcousticAdmittance. |
| Acoustic Susceptance | Present | Present | Equivalent. (ANSI S3.39Quantities used formeasurement of auralacoustic impedance andacoustic admittance)Acoustic Susceptance isthe imaginary part of thecomplex valued AcousticAdmittance. |
| Equivalent Volume | Present | Present | Equivalent. (ANSI S3.39 |
| HearID (Predicate) | Titan IMP440 WBT | Comments | |
| Clause 5.11) | |||
| Equivalent volume is | |||
| calculated from Acoustic | |||
| Admittance and is | |||
| proportional to with the | |||
| following relation: | |||
| Equivalent Volume | |||
| $= \frac{f}{226}$ | |||
| • Acoustic Admittance |
Comparison table for Titan with IMP440 WBT and Mimosa HearlD
Section 05 p. 6 - 11
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0
Interacoustics®
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Interacoustics®
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Section 05 p. 10 - 11
Image /page/8/Picture/4 description: The image shows the logo for Interacoustics. The logo consists of a stylized globe on the left and the word "Interacoustics" in a bold, sans-serif font on the right. A registration mark is present to the right of the word.
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(1)
Wideband absorbance tympanometry using pressure sweeps: System development and results on adults with normal hearing, Liu et al., J. Acoust. Soc. Am., Vol. 124, No. 6, page 3708-3719
[2]
Sound-Conduction Effects on Distortion-Product Otoacoustic Emission Screening Outcomes in Newborn Infants: Test Performance of Wideband Acoustic Transfer Functions and 1-kHz Tympanometry, Sandford et al., Ear & Hearing, vol. 30, no. 6, 635-652
[3]
Comparison of Wideband Energy Reflectance Obtained With Reflwin Interacoustics & Mimosa Acoustics Shahnaz, N., & Shaw. J. School of Audiology & Speech Sciences, University of British Columbia, Vancouver, BC, Canada
[4]
Acoustic Immittance Measures, Basic and Advanced Practice Lisa Hunter, PhD, CCC-A, FAAA, Navid Shahnaz, PhD, Aud. (C)
Test summary
The Titan was tested according to current standards for IMP (impedance audiometry) and was found to conform to the standards. No clinical tests were performed, but based on the fulfillment of the international standards for IMP, and the comparison to predicate devices we trust the device is safe and effective.
Conclusion
We have compared the intended use and performance characteristics with the predicate devices. The Titan IMP440 WBT 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 IMP440 WBT was found to be substantially equivalent to the predicate devices in technological characteristics and indications for use.
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Section 05 p. 11 - 11
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
November 29, 2012
Interacoustics A/S % Mr. Erik Nielsen Director, Quality and Regulatory Affairs Drejervaenget 8 Assens DK-5610. Denmark
Re: K121847
Trade/Device Name: Titan with IMP440 WBT Regulation Number: 21 CFR 874.1090 Regulation Name: Auditory impedance tester Regulatory Class: Class II Product Code: ETY, GWJ Dated: October 19, 2012 Received: October 22, 2012
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
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Page 2 – Mr. Erik Nielsen
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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Eric A. Mann
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Applicant: Interacoustics A/S
510(k) Number (if known): K121847
Device Name: Titan, IMP440 WBT
Indications for Use:
The Titan Impedance System is an electroacoustic test instrument that produces controlled levels of test tones and signals intended for use in conduction diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. It features tympanometry and acoustic reflexes.
The Titan Impedance System measures various acoustic properties of the ear, namely power reflectance, power absorption, transmittance, reflectance group delay, complex acoustic impedance and admittance, and equivalent ear canal volume. These measures allow the evaluation of the functional condition of the middle and outer ear.
The Titan Impedance System is suitable for all populations including new-born infants.
The Titan Impedance System is to be used by trained personnel only such as audiologists, ENT surgeons, doctors, hearing healthcare professionals or personnel with a 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.
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)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Shulhan Fery
(Division Sign-Off) (Division Sign-Off)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K121847
Prescription Use
(Per 21 CFR 801.109)
Interacoustics®
§ 874.1090 Auditory impedance tester.
(a)
Identification. An auditory impedance tester is a device that 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 device is used to determine abnormalities in the mobility of the tympanic membrane due to stiffness, flaccidity, or the presence of fluid in the middle ear cavity. The device is also used to measure the acoustic reflex threshold from contractions of the stapedial muscle, to monitor healing of tympanic membrane grafts or stapedectomies, or to monitor followup treatment for inflammation of the middle ear.(b)
Classification. Class II (special controls). The device, when it is a tympanometer or auditory impedance tester that complies with FDA-recognized consensus standard ANSI S3.39, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.