(157 days)
Not Found
No
The summary describes a standard electroacoustic test instrument for hearing evaluations and does not mention any AI or ML capabilities. The device measures acoustic properties and provides normative data for guidance, which is typical for this type of equipment and does not indicate AI/ML.
No.
The device is described as an "electroacoustic test instrument" intended for "conduction diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders," indicating a diagnostic rather than therapeutic purpose.
Yes
The 'Intended Use / Indications for Use' section states the device is "intended for use in conduction diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders." The 'Device Description' also explicitly calls it a "diagnostic/clinical instrument."
No
The device description explicitly states that the Titan Impedance System consists of a handheld unit, a cradle, and PC software. It also mentions a connection box and accessories. This indicates the presence of significant hardware components beyond just software.
Based on the provided information, the Titan Impedance System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The Titan Impedance System directly interacts with the patient's ear (an anatomical site) to measure acoustic properties. It does not analyze biological samples like blood, urine, or tissue.
- The intended use and device description clearly state it's an electroacoustic test instrument for diagnostic hearing evaluations and assisting in the diagnosis of otologic disorders. This involves measuring physical properties of the ear, not analyzing biological markers in a sample.
- The device is described as audiometric equipment. Audiometry is a field focused on measuring hearing and the function of the auditory system, not on in vitro analysis of biological specimens.
Therefore, the Titan Impedance System falls under the category of a diagnostic medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
ETY, GWJ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear
Indicated Patient Age Range
all populations including new-born infants.
Intended User / Care Setting
trained personnel only such as audiologists, ENT surgeons, doctors, healthcare professionals or personnel with a similar level of education.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
Image /page/0/Picture/18 description: The image is a logo for Interacoustics. The logo consists of a stylized globe on the left and the word "Interacoustics" in a sans-serif font on the right. A registered trademark symbol is located to the right of the word. The logo is white on a black background.
1
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
Image /page/1/Picture/16 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. The globe icon has lines running across it, and the word "Interacoustics" is written in a sans-serif font.
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.
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;
-
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
Image /page/2/Picture/11 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. A registered trademark symbol is present to the right of the word.
leading diagnostic solutions
3
| 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. | Same
The first paragraph for Titan IMP440 WBT is identical with the previous version of the Titan with IMP440
The 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
4
| Type | HearID (Predicate) | Titan IMP440 WBT | Comments |
|---|---|---|---|
| Audiometric equipment | Audiometric equipment | Same | |
| Indications for use | The intended use of the | ||
| HearID-wbMEPA Middle Ear | |||
| Power Analyzer is to | |||
| characterize the middle ear | |||
| status and to assist in | |||
| diagnosing middle ear | |||
| pathologies. | |||
| The HearID-wbMEPA 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 devices are | |||
| suitable for all populations | |||
| including new-born infants. | |||
| The devices are to be used by | |||
| trained personnel only. | |||
| The HearID system comes in | |||
| two versions: HearID-b- | |||
| wbMEPA, and HearID e- | |||
| wbMEPA, where the difference | |||
| is the variation of the | |||
| hardware platform. | 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. | Same
The first paragraph for
Titan IMP440 WBT is
identical with the
previous version of the
Titan with IMP440
Paragraph 2, 3 and 4 for
Titan IMP440 WBT are
identical with paragraph
2 for the predicate
device.
The 3rd paragraph for the
predicate device is just a
listing of variants of
devices and has been
omitted in the
comparison |
| 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 |
| 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 complies
as it at least is CE marked
Same.
It is assumed that the
predicate device complies
as it at least is CE marked |
| Performance standard | Unknown | IEC 60645-5 / ANSI S3.39 | The Titan IMP440 WBT
complies with current
state of the art standards.
It is unknown if the
predicate device
complies. |
| Frequency Range | 200-6000 Hz | 250-8000Hz | Substantial equivalent
Titan system use better
transducers so the
frequency range can be
expanded to 8kHz. We
trust that this does not
influence the safety or
effectiveness of the
system |
| Intensity Range | 0 - 80dB SPL | 90/94 dB peSPL =
70/74 dB SPL | Substantial equivalent
The intensity range is
fixed but inside the range
as the HeardID. The
variable range for
HeardID is used for pure
tone stimulation and this
is not relevant for the
Titan WBT. We trust that
when the range is inside
the predicate device we
can declare equivalence
for safety and
effectiveness. |
| Sample time | 0.1 - 10 seconds per point | 21, 5 Hz (Click sample time) | These parameters are not
comparable, as the range
for the predicate device is
for pure tone, and the
fixed sample time for
Titan is fixed for the
broadband click |
| Stimuli | Chirp
Pure Tone | Chirp (Frequency linearized
click)
Not relevant | Substantial equivalent |
| Artefact rejection | Present | Present | Substantial equivalent.
Titan IMP440 WBT has an
artefact 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 |
| measurement
protocols. | Present | Present | Users can change the
sequence of
measurements to have
test protocols fit for
diagnostic and clinical
purposes. |
| Customizable display
parameters. | Present | Present | Substantial equivalent.
The user can change how
many and how graphs are
presented on the display.
Graphs may differ but the
intended purpose is the
same. |
| Otitis media with
effusion examples | Present | Present | The functionality is
substantial equivalent.
For Titan IMP440 WBT
these are sketched
examples of curve
characteristics based on
measurements [4] |
| Measurements | | | |
| Power Reflectance | Present | Present | Substantial equivalent.
Power Reflectance is
equal to 1 - Power
Absorbance.
Power absorbance is
plotted in Titan IMP440
WBT.
Refer to Power
Absorbance |
| Power Absorbance | Present | Present | Equivalent.
Power Absorbance tells
how much of the sound is
absorbed by the middle
ear, that value is identical
to the Power
Transmittance.
The equivalency is based
on result from [3] |
| Power Transmittance | Present | Present | Equivalent.
Identical to Power
Absorbance.
Power absorbance is
plotted in Titan IMP440
WBT.
Refer to Power
Absorbance |
| Acoustic
Impedance | Present | Present | Equivalent. (ANSI S3.39
Quantities used for
measurement of aural
acoustic impedance and
acoustic admittance) |
| | HearID (Predicate) | Titan IMP440 WBT | Comments |
| Acoustic Resistance | Present | Present | calculated from the
reflectance. Acoustic
impedance calculated
using Titan IMP440 WBT
is similar to acoustics
impedance calculated in
single tone based Titan
IMP440. |
| Acoustic Reactance | Present | Present | Equivalent. (ANSI S3.39
Quantities used for
measurement of aural
acoustic impedance and
acoustic admittance)
Acoustic Resistance is the
real part of the complex
valued Acoustic
Impedance. |
| Acoustic
Reactance | Present | Present | Equivalent. (ANSI S3.39
Quantities used for
measurement of aural
acoustic impedance and
acoustic admittance)
Acoustic Reactance is the
imaginary part of the
complex valued Acoustic
Impedance. |
| Acoustic Admittance | Present | Present | Equivalent. (ANSI S3.39
Quantities used for
measurement of aural
acoustic impedance and
acoustic admittance)
Acoustic Admittance is
the reciprocal of the
Acoustic Impedance. |
| Acoustic
Conductance | Present | Present | Equivalent. (ANSI S3.39
Quantities used for
measurement of aural
acoustic impedance and
acoustic admittance)
Acoustic Conductance is
the real part of the
complex valued Acoustic
Admittance. |
| Acoustic Susceptance | Present | Present | Equivalent. (ANSI S3.39
Quantities used for
measurement of aural
acoustic impedance and
acoustic admittance)
Acoustic Susceptance is
the imaginary part of the
complex valued Acoustic
Admittance. |
| 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
Image /page/4/Picture/5 description: The image shows the logo for Interacoustics, a company that provides leading diagnostic solutions. The logo is in white text on a black background. The word "Interacoustics" is in a large, bold font, and the words "leading diagnostic solutions" are in a smaller font below. There is a globe icon to the left of the word "Interacoustics".
5
0
Interacoustics®
6
Image /page/6/Picture/4 description: The image is a logo for Interacoustics. The logo features the company name in a bold, sans-serif font, with the "®" symbol next to it. To the left of the company name is a circular graphic with lines running across it. The background of the logo is black, and the text and graphic are white.
7
Interacoustics®
8
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.
9
(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.
Image /page/9/Picture/18 description: The image shows the logo for Interacoustics. The logo consists of a globe-like icon on the left, followed by the word "Interacoustics" in a bold, sans-serif font. A registered trademark symbol is located in the upper right corner of the logo. The logo is white against a black background.
Section 05 p. 11 - 11
10
Image /page/10/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
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
11
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
12
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)
Page 1 of 1
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®