and effectiveness wbt nlv name interacoustics a/s ...titan, imp440 wbt premarket notification...

Titan, IMP440 WBT Premarket Notification Submission 510(k)

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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

IMP440 WBTSUBMITTER INFORMATION NlV 2 9 2012Company Name Interacoustics A/SCompany Address Drejervaenget 8

AssensDK-561 0Denmark

Company Phone +45 6371 3555Company Fax +45 6371 3522Company e-mail [email protected] Person Erik Nielsen,

Director, Quality and Regulatory AffairsDate Summary Prepared June. 21 2012

DEVICE IDENTIFICATIONTrade Name TitanCommon Name Audiometric equipment.Classification Name Tester, Auditory ImpedanceI

Evoked response auditory stimulatorProduct Code ETY / GWJPanel Ear Nose & Throat / NeurologyDevice Class Class 11

SUBSTANTIAL EQUIVALENCE (TITAN WITH 1MP440)Predicate Device Titan with IMP440Manufacturer I nteracoustics510(k) No. K083861Date Cleared 04/09/2006

SUBSTANTIAL EQUIVALENCE (MIMOSA HEARID)Predicate Device HEARID WIDEBAND MIDDLE EAR POWER ANALYZERManufacturer MIMOSA ACOUSTICS, INC510(k) No. K053216Date Cleared 02/10/2006

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Description of deviceThe instrument is audiometric equipment used for measuring aural acousticimpedance and admittance (According to ANSI S3.39).

The Titan is a platform with multi functions depending of licensing. The licensefunction for this submission is IMP440 (IMP) for measurement of aural acousticimpedance and admittance.

The Titan IMP test is intended to change the air pressure in the external auditorycanal and measure and graph the mobility characteristics of the tympanic membraneto evaluate the functional condition of the middle ear. The IMP test function is alreadycleared by FDA 510(k) premarket notification K083861 (04/09/2009)

The instrument is a diagnostic/clinical instrument (as defined in 1EC60645-5), butprovides 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/IMP44O). Themeasurements are controlled by the handheld unit.

A connection box (shoulder box) enables different types of accessories to beconnected to the platform

The Titan platform can connect to PC software via a Bluetooth connection.

Indications for UseThe Titan Impedance System is an electroacoustic test instrument that producescontrolled levels of test tones and signals intended for use in conduction diagnostichearing evaluations and assisting in the diagnosis of possible otologic disorders. Itfeatures tympanometry and acoustic reflexes.

The Titan Impedance System measures various acoustic properties of the ear, namelypower reflectance, power absorption, transmittance, reflectance group delay, complexacoustic impedance and admittance, and equivalent ear canal volume. These measuresallow 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 levelof education. The device should not be used without the necessary knowledge and trainingto understand its use and how results should be interpreted.

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Technological CharacteristicsTitan consists of a handheld unit named Titan, Titan Cradle and PC software (TitanSuite, Titan modules/ Titan Applications). The measurements are controlled by thehandheld unit. A license system makes it possible within each configuration to selectwhich functionality the user wants to be incorporated in the system.

A connection box (shoulder box) enables different types of accessories to beconnected 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 earcanal. The probe presents a calibrated tone or click sound into the ear canal and byrecording the intensity and phase of the remaining tone or click in the ear canal it canbe derived how much of the sound is absorbed by or transferred into the ear. Mostcommon measures are:

- A tympanogram, in which the compliance/absorbance is measured as functionof the presented frequencies and pressure in the ear canal;

- An acoustic reflex, in which the compliance/absorbance is measured over timeas function of the presented frequencies while an acoustic activator is presented thatabove certain intensity is expected to cause a contraction of the stapedius musclewhich in return is expected to cause a change in the compliance/absorbance of theear.

The levels of the tonal and click sounds are to be calibrated in an artificial earaccording to peak to peak equivalent signal level principles in JEC 60645-3

Titan with IMP440 WBT is IEC 60645-5/ANSI S3.39, Type 1 (Diagnostic/Clinical)acoustic impedance instrument

Section 05 p. 4 - 110leading diagnostic solutions


Comparison table for Titan with IMP440 and Titan IMP440 WBT

Description Titan with IMP440 'Titan with I1MP440 WBIT Equivalence

Indications for use The Titan Impedance System is an The Titan Impedance System is an Sameelectroacoustic test instrument that electroacoustic test instrument thatproduces controlled levels of test produces controlled levels of test tones The firsttones and signals intended for use in and signals intended for use in paragraph forconduction diagnostic hearing conduction diagnostic hearing Titan IMP440evaluations and assisting in the evaluations and assisting in the WBT isdiagnosis of possible otologic diagnosis of possible otologic disorders. identical withdisorders. It features tympanometry It features tympanometry and acoustic the previousand acoustic reflexes. reflexes. version of the

Ttan withThe Titan Impedance System measures IMP440various acoustic properties of the ear,namely power reflectance, power The addition ofabsorption, transmittance, reflectance subsequentgroup delay, complex acoustic paragraphsimpedance and admittance, and is the subjectequivalent ear canal volume. These of this 510(k)measures allow the evaluation of thefunctional condition of the middle andouter ear.

The Titan Impedance System is suitablefor all populations including new-borninfants.

The Titan Impedance System is to beused by trained personnel only such asaudiologists, ENT surgeons, doctors,hearing healthcare professionals orpersonnel with a similar level ofeducation. The device should not beused without the necessary knowledgeand training to understand its use andhow results should be interpreted.

Target population The devices are suitable for all The devices are suitable for all Samepopulations including new-born populations including new-born infantsinfants

Intended user The devices are to be used by The devices are to be used by trained Same*trained personnel only. personnel only.

Section 05 p. 5-l 11-leading diagnostic solutions

Titan, IMP440 WBT Premnarket Notification Submission 510(k)

Comparison table for Titan with IMP440 WBT and Mimosa HeariD

HeariD (Predicate) Titan IMP440 WBT CommentsType Audiometric equipment Audiometric equipment SameIndications for use The intended use of the The Titan Impedance System Same

HearlD-wbMEPA Middle Ear is an electroacoustic testPower Analyzer is to instrument that produces The first paragraph forcharacterize the middle ear controlled levels of test tones Titan IMP440 WBIT isstatus and to assist in and signals intended for use identical with thediagnosing middle ear in conduction diagnostic previous version of thepathologies, hearing evaluations and Titan with IMP440The HearlD-wbMEPA system assisting in the diagnosis ofmeasures various acoustic possible otologic disorders. It Paragraph 2, 3 and 4 forproperties of the ear, namely features tympanometry and Titan IMP440 WBT arepower reflectance, power acoustic reflexes. identical with paragraphabsorption, transmittance, 2 for the predicatereflectance group delay, The Titan Impedance System device.complex acoustic impedance measures various acousticand admittance, and properties of the ear, namely The 3Cd paragraph for theequivalent ear canal volume, power reflectance, power predicate device is just aThese measures allow the absorption, transmittance, listing of variants ofevaluation of the functional reflectance group delay, devices and has beencondition of the middle and complex acoustic impedlance omitted in theouter ear. The devices are and admittance, and comparisonsuitable for all populations equivalent ear canal volume.including new-born infants. These measures allow theThe devices are to be used by evaluation of the functionaltrained personnel only. condition of the middle andThe HearID system comes in outer ear.two versions: HearlD-b-wbMEPA, and HearID e- The Titan Impedance SystemwbMEPA, where the difference is suitable for all populationsis the variation of the including new-born infants.hardware platform.

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.

Target population The devices are suitable for all The devices are suitable for Samepopulations including new- all populations including new-born infants born infants

Intended user The devices are to be used by The devices are to be used by Sametrained personnel only. trained personnel only. ____________

Safety standard lEG 60601-1 (assumed) IEC 60601-1 Same._____________________I______ It is assumed that the

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_______________HeariD (Predicate) Titan IMP440 WBT Commentspredicate device compliesas it at least is CE marked-

EMC standlard IEC 60601-1-2 (assumed) IEC 60601-1-2 Same.It is assumed that thepredicate device compliesas it at least is CE marked

Performance standard Unknown IEC 60645-S / ANSI 53.39 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 - 80dlB SPL 90/94dB11 peSPL =Substantial equivalent70/74 dB SPL The intensity range is

fixed but inside the rangeas the HeardIO. Thevariable range forHeardlo 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 These parameters are notcomparable, as the range

21, 5 Hz (Click sample time) for the predicate device isc for pure tone, and the

fixed sample time forTitan is fixed for thebroadband click

Stimuli Chirp Chirp (Frequency linearized Substantial equivalentclick)

Pure Tone Not relevant

Artefact rejection Present Present Substantial equivalent.Titan IMP440 WBT has an

___________________ __________________________artefact rejection system,_

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HeariD (Predicate) Titan IMP440 WBT Commentsto remove responsescontaminated with noiseor noise artefacts.HearD has equivalentartefact rejection systemto minimize noisymeasurements.

Real time display of Present No real time presentation. Different.signal and noise -The Titan IMP440 WBT

does not have real timedisplay of signal andnoise. Titan I1MP440 WBThas a real time display ofmeasurement dataduring acquisition. Wetrust that such "qualityindicator" is irrelevantbecause themeasurement time is soshort that an indicatorcannot be monitoredwith any benefit. Afterthe test has finished,accepted and rejectedsample ratio can beviewed.

Normative data Present Present The functionality issubstantial equivalent.Both systems havenormative data present inthe user interface toindicate normal middleear function.Normative data areacquired individually foreach system and is basedon different databases.The Titan IMP440 WBTnormative data is basedon [11, [2]. The HearIDnorm data is based on

_________________other data.Reflectance Area Index Present Present Substantial equivalent.for enhanced Titan IMP440 WBIT uses adiagnosis shaded area indicating

normative region ineither 10/90 percentilesor 5/95 percentiles forevaluating measurementresults. Identical withnormative data above

Customizable Present Present Equivalent. -

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_______________HeariD (Predicate) Titan IMP440 WBT Commentsmeasurement Users can change theprotocols. sequence of

measurements to havetest protocols fit fordiagnostic and clinicalpurposes.

Customizable-display Present Present Substantial equivalent.parameters. The user can change how

many and how graphs arepresented on the display.Graphs may differ but theintended purpose is thesame.

Otitis media with Present Present The functionality iseffusion examples substantial equivalent.

For Titan IMP440 WBTthese are sketchedexamples of curvecharacteristics based onmeasurements [4]

MeasurementsPower 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 IMP440WET.Refer to PowerAbsorbance

Acoustic Present Present Equivalent. (ANSI S3.39Impedance Quantities used for

measurement of auralacoustic impedance andacoustic admittance)

_________________Acoustic Impedance is

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HeariD (Predicate) Titan IMP440 WBT Comments

calculated from thereflectance. Acousticimpedance calculatedusing Titan IMP440 WBTis similar to acousticsimpedance calculated insingle tone based TitanIMP440.

Acoustic Resistance Present Present Equivalent. (ANSI S3.39Quantities used formeasurement of auralacoustic impedance andacoustic admittance)Acoustic Resistance is thereal part of the complexvalued Acoustic

_________________impedance.

Acoustic Present Present Equivalent. (ANSI S3.39Reactance Quantities used for

measurement of auralacoustic impedance andacoustic admittance)Acoustic Reactance is theimaginary part of thecomplex valued Acoustic

________________________________________impedance.

Acoustic Admittance Present Present Equivalent. (ANSI 53.39Quantities used formeasurement of auralacoustic impedance andacoustic admittance)Acoustic Admittance isthe reciprocal of theAcoustic Impedance.

Acoustic Present Present Equivalent. (ANSI S3.39Conductance Quantities used for

measurement of auralacoustic impedance andacoustic admittance)Acoustic Conductance isthe real part of thecomplex valued AcousticAdmittance.

Acoustic Susceptance Present Present Equivalent. (ANSI 53.39Quantities used formeasurement of auralacoustic impedance andacoustic admittance)Acoustic Susceptance isthe imaginary part of thecomplex valued AcousticAdmittance.

Equivalent Volume Present IPresent Equivalent. (ANSI S3.39

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HearID'(Predicate) Titan IMP440 WBIT CommentsClause 5.11)Equivalent volume iscalculated from AcousticAdmittance and isproportional to with thefollowing relation:Equivalent Volume

f

*Acoustic Admittance

Wideband absorbance tympanometry using pressure sweeps: System development and results on adultswith normal hearing, Liu et al., i. Acoust. Soc. Am., Vol. 124, No. 6, page 3708-3719[2]Sound-Conduction Effects on Distortion-Product Otoacoustic Emission Screening Outcomes in NewbornInfants: Test Performance of Wideband Acoustic Transfer Functions and 1-kHz Tympanometry, Sandford etal., Ear & Hearing, vol. 30, no. 6, 635-652[3]

Comparison of Wideband Energy Reflectance Obtained With Reflwin Interacoustics & Mimosa AcousticsShahnaz, N., & Shaw. J. School of Audiology & Speech Sciences, University of British Columbia, Vancouver,BC, Canada[4]Acoustic Immittance Measures, Basic and Advanced PracticeLisa Hunter, PhD), CCC-A, FAAA, Navid Shahnaz, PhD), Aud. (C)

Test summaryThe Titan was tested according to current standards for IMP (impedance audiometry) andwas found to conform to the standards. No clinical tests were performed, but based on thefulfillment of the international standards for IMP, and the comparison to predicate deviceswe trust the device is safe and effective.

ConclusionWe have compared the intended use and performance characteristics with the predicatedevices. The Titan IMP440 WBT was tested according to current standards and thedifferences found between the devices were related to functionality, not in relation to safetyand efficiency. The Titan conforms to the current standards.

The Titan with IMP440 WBT was found to be substantially equivalent to the predicatedevices in technological characteristics and indications for use.

Section 05 p. 11-l - n ea o sileading diagnostic solutions

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

4 Food and Drug Adminitration10903 New Hamrpshire AvenueDocumrent Control Center - W066-0609

Noveber29, 012Silver Spring, MID 20993-002

Interacoustics A/S% Mr. Erik NielsenDirector, Quality and Regulatory AffairsDrejervaenget 8AssensDK-5 610, Denmark

Re: K121847Trade/Device Name: Titan with IMP440 WBTRegulation Number: 21 CFR 874.1090Regulation Name: Auditory impedance testerRegulatory Class: Class 11Product Code: ETY, GWJDated: October 19, 2012Received: October 22, 2012

Dear Mr. Nielsen:

We have reviewed your Section 5 10(k) premarket notification of intent to market the devicereferenced above and have determined the device is substantially equivalent (for the indicationsfor use stated in the enclosure) to legally marketed predicate devices marketed in interstatecommerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or todevices 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 ofdevices, good manufacturing practice, labeling, and prohibitions against misbranding andadulteration. Please note: CDRH does not evaluate information related to contract liabilitywarranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class 11 (Special Controls) or class III (PMA),it may be subject to additional controls. Existing major regulations.affecting your device can befound in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA maypublish further announcements concerning your device in the Federal Regzister.

Please be advised that FDA's issuance of a substantial equivalence determination does not meanthat FDA has made a determination that your device complies with other requirements of the Actor any Federal statutes and regulations administered by other Federal agencies. You must

Mr. Erik Nielsen

comply with all the Act's requirements, including, but not limited to: registration and listing (21CFR Part 807); labeling (21 CER Part 801); medical device reporting (reporting of medicaldevice-related adverse events) (21 CER 803); good manufacturing practice requirements as setforth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronicproduct radiation control provisions (Sections 531-542 of the Act); 21 CER 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), pleasego to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOfflces/ucml 1I5809.htm forthe Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, pleasenote the regulation entitled; "Misbranding by reference to premarket notification" (2lCER Part807.97). For questions regarding the reporting of adverse events under the MDR regulation (21CER Part 803), please go tohttp://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH' s Officeof Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from theDivision of Small Manufacturers, International and Consumer Assistance at its toll-free number(800) 638-2041 or (301) 796-7100 or at its Internet addresshttp)://www.fda.Qzov/MedicalDevices/ResourcesforYouindustry/default.htm.

Sincerely yours,

Eric A. rvjhnnMalvina B. Eydelman, M.D.DirectorDivision of Ophthalmic and Ear, Nose and

Throat DevicesOffice of Device EvaluationCenter for Devices and Radiological Health

Enclosure

Titan, IMP440 WBT' Premarket Notification Submission 510(k)

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 producescontrolled levels of test tones and signals intended for use in conduction diagnostichearing evaluations and assisting in the diagnosis of possible otologic disorders. Itfeatures tympanometry and acoustic reflexes.

The Titan Impedance System measures various acoustic properties of the ear, namelypower reflectance, power absorption, transmittance, reflectance group delay, complexacoustic impedance and admittance, and equivalent ear canal volume. These measuresallow 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 levelof education. The device should not be used without the necessary knowledge and trainingto understand its use and how results should be interpreted.

Prescription Use ---_X__ AND/OR Over-The-Counter Use ___

(Part 21 CFR 801 Su~bpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)ritin s

Division of ophthalmic, NeuroogiCal and Far, pesrito 21C e0.19

Nose and Throat Devices

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