(160 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the processing as using "statistics".
No
The device is used for the recording and analysis of physiological data to diagnose auditory and hearing-related disorders, not to treat them.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for "recording and automated analysis of human physiological data... necessary for the diagnosis of auditory and hearing-related disorders."
No
The device description explicitly states it is a "handheld device" that uses an "OAE probe" with "speakers" and a "microphone" to measure physiological responses. While it contains a "self-contained firmware (software) module," it is clearly integrated with and dependent on hardware components for its function.
Based on the provided information, the Type 1077 device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens from the human body. The description of the Type 1077 device clearly states that it records and analyzes human physiological data (auditory brainstem responses and otoacoustic emissions) by interacting directly with the patient's ear canal. It does not analyze samples like blood, urine, or tissue.
- The device description focuses on the interaction with the patient's ear and the measurement of physiological responses. The process involves inserting a probe into the ear canal, playing sounds, and measuring the patient's response via a microphone. This is a direct physiological measurement, not an in vitro analysis of a biological specimen.
- The intended use is for recording and analyzing physiological data for the diagnosis of auditory disorders. This aligns with the definition of a medical device used for diagnosis, but not specifically an IVD.
Therefore, the Type 1077 device is a medical device used for diagnostic purposes, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Type 1077 device is indicated for use in the recording and automated analysis of human physiological data (screening auditory brainstem responses and/or otoacoustic emissions) necessary for the diagnosis of auditory and hearing-related disorders.
Distortion Product Otoacoustic Emissions and Transient Evoked Otoacoustic Emissions: The Type 1077 DPOAE module and TEOAE module can be used for patients of all ages, from children to adults, including infants and geriatric patients. It is especially indicated for use in testing individuals for whom behavioral audiometric results are deemed unreliable, such as infants, young children, and cognitively impaired adults.
Auditory Brainstem Response: The Type 1077 ABR module is especially intended for infants from 34 weeks (gestational age) up to 6 months of age.
When the device is used to screen infants. they should be asleep or in a quiet state at the time of screening. The device is intended for use by audiologists. ENT's and other healthcare professionals..
Product codes (comma separated list FDA assigned to the subject device)
GWJ
Device Description
The device is identical to our own device described in K122067. Only the indications for use has changed. The age range has been expanded. Different models of the device are capable of the following list of tests: AccuScreen TE for TEOAE (Transiently Evoked Otoacoustic Emissions), AccuScreen DP for DPOAE (Distortion Product Otoacoustic Emissions), AccuScreen TE/DP for TEOAE and DPOAE, AccuScreen ABR for ABR (Auditory Brainstem Response), AccuScreen ABR/TE for ABR and TEOAE, AccuScreen ABR/DP for ABR and DPOAE, AccuScreen ABR/TE/DP for ABR, TEOAE and DPOAE.
The measurement application is controlled from a self-contained firmware (software) module installed in the handheld device. The firmware module can be configured to allow different OAE measurement types (DPOAE and/or TEOAE) by a license key stored in the device.
For automated OAE measurements, the handheld device uses an OAE probe, designed and manufactured by PATH Medical GmbH. The OAE probe has been granted marketing clearance by the FDA following the submission of a 510(k) (K100661). The OAE probe is fitted with an ear-tip (constructed of biocompatible material) and inserted in the ear canal of the patient. The AccuScreen device plays stimulus sounds in the ear canal via small speakers in the OAE probe. The AccuScreen device measures the patient's response to the stimulus sounds via a microphone in the probe. The measured response is processed by the AccuScreen device using statistics to help deter or not a hearing loss may be present.
When the OAE measurement is a DPOAE measurement, the stimulus signal is composed of two pure tone signals, each presented by a speaker in the OAE measurement is a TEOAE measurement, the stimulus signal is a series of broadband clicks presented by one speaker in the OAE probe.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear canal
Indicated Patient Age Range
Patients of all ages, from children to adults, including infants and geriatric patients for DPOAE and TEOAE modules. Infants from 34 weeks (gestational age) up to 6 months of age.
Intended User / Care Setting
Audiologists, ENT's and other healthcare professionals.
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)
Clinical testing was performed to confirm that the Type 1077 can produce valid results in patients of all age groups and performed in a comparable manner to the predicate Echo-Screen, Fischer-Zoth Audiologic Systems K013977. Subjects were tested on Type 1077 and again on the Echo-Screen. The goal was to test and compare a minimum of 16 ears per age group. Overall 130 ears were tested and compared, with overall DPOAE agreement of 93.8% and TEOAE agreement of 91.5%.
Number of ears recommended: 20 per age group for 6 mo-9 y, 10-19 y, 20-39 y, 40-59 y, >59 y, totaling 100.
Achieved/tested: 26 (6 mo-9 y), 22 (10-19 y), 30 (20-39 y), 36 (40-59 y), 16 (>59 y), totaling 130.
DPOAE agreement: 26/26 (100.0 %) for 6 mo-9 y, 22/22 (100.0 %) for 10-19 y, 30/30 (100.0 %) for 20-39 y, 33/36 (91.7 %) for 40-59 y, 11/16 (68.8 %) for >59 y, totaling 122/130 (93.8 %).
TEOAE agreement: 26/26 (100.0 %) for 6 mo-9 y, 22/22 (100.0 %) for 10-19 y, 30/30 (100.0 %) for 20-39 y, 30/36 (83.3 %) for 40-59 y, 11/16 (68.8 %) for >59 y, totaling 119/130 (91.5 %).
After identifying that there were some discrepant results between our device and the predicate device. (40-59 y & >59 y age groups) we used a diagnostic OAE device to re-test all test subjects for which there was not a match between the Type 1077 and predicate device. Our intent was to determine which of the two devices (Type 1077 or Predicate) provided the correct result. After performing the diagnostic OAE testing, we discovered that the predicate device was found to have provided incorrect results in 11 of the 19 cases. Overall the results showed that the Type 1077 performed in a comparable manner to the Echo-Screen on the expanded patient population shown in the revised indications for use.
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
§ 882.1900 Evoked response auditory stimulator.
(a)
Identification. An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.(b)
Classification. Class II (performance standards).
0
510(K) Summary, 510(k) K132957 Submitter: GN Otometrics A/S Hoerskaetten 9 Taastrup, DENMARK DK-2630 Registration number: 9612197 (US) Phone: (612) 865-7862 Contact: Tom Riniker, Director RA/OA triniker@gnotometrics.com Date Prepared: February 20, 2014
Identification of the Device:
Proprietary-Trade Name: MADSEN AccuScreen Type 1077 Classification Name: Stimulator, Auditory, Evoked Response Common/Usual Name: Auditory Evoked Response Stimulator. Product code: GWJ Classification Panel: Neurology Device Class: Class II FDA CFR Section: FDA 21CFR 882.1900
Equivalent legally marketed devices:
| Predicate Devices | ||||
|---|---|---|---|---|
| Product Name: | Echo-Screen T, TA, TD, TDA, TC | Type 1077 AccuScreen | ||
| 510(k) Number: | ||||
| K013977 | ||||
| K122067 | ||||
| Classification Name: | Stimulator, Auditory, Evoked | Stimulator, Auditory, Evoked | ||
| Response | Response | |||
| FDA CFR Section: | FDA 21CFR 882.1900 | FDA 21CFR 882.1900 | ||
| Device Product Code: | GWJ | GWJ | ||
| Manufacturer Name: | Fischer-Zoth Audiologic Systems | GN Otometrics |
Description of the Device: The device is identical to our own device described in K122067. Only the indications for use has changed. The age range has been expanded. Different models of the device are capable of the following list of tests:
| Device type | Test types |
|---|---|
| AccuScreen TE | TEOAE (Transiently Evoked Otoacoustic Emissions) |
| AccuScreen DP | DPOAE (Distortion Product Otoacoustic Emissions) |
| AccuScreen TE/DP | TEOAE and DPOAE |
| AccuScreen ABR | ABR (Auditory Brainstem Response) |
| AccuScreen ABR/TE | ABR and TEOAE |
| AccuScreen ABR/DP | ABR and DPOAE |
| AccuScreen ABR/TE/DP | ABR, TEOAE and DPOAE |
The measurement application is controlled from a self-contained firmware (software) module installed in the handheld device. The firmware module can be configured to allow different OAE measurement types (DPOAE and/or TEOAE) by a license key stored in the device.
For automated OAE measurements, the handheld device uses an OAE probe, designed and manufactured by PATH Medical GmbH. The OAE probe has been granted marketing clearance by the
1
FDA following the submission of a 510(k) (K100661). The OAE probe is fitted with an ear-tip (constructed of biocompatible material) and inserted in the ear canal of the patient. The AccuScreen device plays stimulus sounds in the ear canal via small speakers in the OAE probe. The AccuScreen device measures the patient's response to the stimulus sounds via a microphone in the probe. The measured response is processed by the AccuScreen device using statistics to help deter or not a hearing loss may be present.
When the OAE measurement is a DPOAE measurement, the stimulus signal is composed of two pure tone signals, each presented by a speaker in the OAE measurement is a TEOAE measurement, the stimulus signal is a series of broadband clicks presented by one speaker in the OAE probe.
While the device has not changed from our 2012 510(k) submission K122067, the target population has been expanded as described in the indications statement directly below:
Indications for Use:
The Type 1077 device is indicated for use in the recording and automated analysis of human physiological data (screening auditory brainstem responses and/or otoacoustic emissions) necessary for the diagnosis of auditory and hearing-related disorders.
Distortion Product Otoacoustic Emissions and Transient Evoked Otoacoustic Emissions: The Type 1077 DPOAE module and TEOAE module can be used for patients of all ages, from children to adults, including infants and geriatric patients. It is especially indicated for use in testing individuals for whom behavioral audiometric results are deemed unreliable, such as infants, young children, and cognitively impaired adults.
Auditory Brainstem Response:
The Type 1077 ABR module is especially intended for infants from 34 weeks (gestational age) up to 6 months of age.
When the device is used to screen infants. they should be asleep or in a quiet state at the time of screening. The device is intended for use by audiologists. ENT's and other healthcare professionals..
Safety and Effectiveness, comparison to predicate device has the same indications for use as the predicate device K013977and employs similar technology to accomplish the same tasks. The device is identical to our product described in K122067 except for the indications statement. We have expanded the subject population to include persons of all ages. A detailed comparison table is provided below.
2
Substantial Equivalence Chart
.
| | Echo-Screen T, TA, TD,
TDA, TC, Fischer-Zoth
Audiologic Systems
K013977 | MADSEN AccuScreen Type
1077 K122067 | MADSEN AccuScreen Type
1077 |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use: | The Fischer-Zoth Audiologic
Systems model family Echo-
Screen T consisting of Echo-
screen T, Echo-Screen TA,
Echo-Screen TD, Echo-Screen
TDA and Echo-Screen TC are
based upon Otoacoustic
Emissions (OAE) and Auditory
Brainstem Response (ABR)
technology. The device is
intended to screen hearing for
newborns through adults,
including geriatric patients. The
device does not measure
hearing per se, but helps to
determine whether or not a
hearing loss may be present.
The "Echo-Screen T" product
family consists of handheld,
automated OAE and ABR
based hearing screening
systems which are easy to use.
The measurement flow is menu
guided and the evaluation is
based upon signal statistics.
The "Echo-Screen T" devices
are intended to be used by
trained personnel in a medical
or school environment. The
"Echo-Screen T" models are
not intended for fitting assistive
listening devices such as
hearing aids or cochlear
implants. | AccuScreen is a portable
instrument used to screen infants
for hearing loss. The instrument
uses the Distortion Product
Otoacoustic Emissions (DPOAE),
Transient Evoked Otoacoustic
Emissions (TEOAE) and
Auditory Brainstem Response
(ABR) technologies. The
instrument is intended for
screening infants from 34 weeks
(gestational age) up to 6 months
of age that are well enough to be
ready for discharge from the
hospital. Infants should be asleep
or in a quiet state at the time of
screening. AccuScreen is
intended for use by audiologists,
ENTs and other health care
professionals. | The Type 1077 device is indicated
for use in the recording and
automated analysis of human
physiological data (screening
auditory brainstem responses and/or
otoacoustic emissions) necessary for
the diagnosis of auditory and hearing-
related disorders.
Distortion Product Otoacoustic
Emissions and Transient Evoked
Otoacoustic Emissions:
The Type 1077 DPOAE module and
TEOAE module can be used for
patients of all ages, from children to
adults, including infants and geriatric
patients. It is especially indicated for
use in testing individuals for whom
behavioral audiometric results are
deemed unreliable, such as infants,
young children, and cognitively
impaired adults.
Auditory Brainstem Response:
The Type 1077 ABR module is
especially intended for infants from
34 weeks (gestational age) up to 6
months of age.
When the device is used to screen
infants, they should be asleep or in a
quiet state at the time of screening.
The device is intended for use by
audiologists, ENT's and other
healthcare professionals. |
| Config-
uration | Hand held battery operated,
rechargeable battery | Hand held battery operated,
rechargeable battery | Hand held battery operated,
rechargeable battery |
| | Echo-Screen T, TA, TD,
TDA, TC, Fischer-Zoth
Audiologic Systems
K013977 | MADSEN AccuScreen Type
1077 K122067 | MADSEN AccuScreen Type
1077 |
| Photo | Image: Echo-Screen T, TA, TD, TDA, TC, Fischer-Zoth Audiologic Systems K013977 | Image: MADSEN AccuScreen Type 1077 K122067 | Image: MADSEN AccuScreen Type 1077 |
| Tests
Performed | DPOAE, TEOAE, ABR | SAME | SAME as MADSEN AccuScreen
Type 1077 K122067 |
| Weight | Echo-Screen including
battery pack and probe: 550g
(1.2 lbs) | 240 g (8.5 oz) excluding
battery
280 g (9.9 oz) including
battery | SAME as MADSEN AccuScreen
Type 1077 K122067 |
| Size | Echo-Screen incl. battery
pack: 230 x 95 x 53 mm
(9.06 x 3.74 x 2.09 inches) | 202 x 73 x 30 mm (8 x 2.8 x
1.2 inches) | SAME as MADSEN AccuScreen
Type 1077 K122067 |
| Battery | 6V 1500mAh NiMH,
exchangeable | Rechargeable Li-ion 3.7
V/1800 mAh (6.7 Wh), fully
charged | SAME as MADSEN AccuScreen
Type 1077 K122067 |
| Operating
time | > 10 hrs with fully charged
battery | 8 hours of continuous use
(based on a typical use
scenario. Actual use can
influence the battery life
time.) | SAME as MADSEN AccuScreen
Type 1077 K122067 |
| Display | 128 x 64 dot graphic LCD
w/ switchable backlight | Color, TFT, touch screen,
Dimensions: 89.4 mm (3.5
inches) Resolution: 240 x 320
pixels Backlight type: LED,
adjustable | SAME as MADSEN AccuScreen
Type 1077 K122067 |
| Data
memory | 128 kB built-in flash
memory, unlimited storage
time | Patient memory capacity:
Max. 250 patients
Test memory capacity: Min.
500 tests | SAME as MADSEN AccuScreen
Type 1077 K122067 |
| Interfaces | RS232 up to 115 kbps,
infrared (optional
modem feature available) | IR data transmission to
docking station - USB
interface from docking station | SAME as MADSEN AccuScreen
Type 1077 K122067 |
3
្រឡូ
,
র প্র
网站
19 - 16 ン (2) 2017 12:00 13:00 10:00 10:00 10:00 10:00 10:00 10:00 10:00 10:00 10:00 10:00 10:00 10:00 10:00 10:00 10:00 10:00 10:00 10:00 10:00 10:00 10:00 10:00 10:00 10:00 10:00
4
| | Echo-Screen T, TA, TD,
TDA, TC, Fischer-Zoth
Audiologic Systems
K013977 | MADSEN AccuScreen Type
1077 K122067 | MADSEN AccuScreen Type
1077 |
|---------------------|----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|
| Safety
standards | EN 60601-1 + A1 + A2
EN 60601-1-2 EN 60601-2-
26 EN 60601-2-40 | • EN 60601-1, Internally
Powered, Type BF, IPXO
• U2601-1; CAN/CSA-C22.2
NO 601.1-90,
• IEC 60601-2-26
• IEC 60601-2-40
EMC: EN 60601-1-2 | SAME as MADSEN AccuScreen
Type 1077 K122067 |
Summary of non-clinical testing: (Performed in K122067): Standards testing demonstrated compliance with the safety standards in the table above, as well as:
ISO 10993-5 Biological Evaluation of Medical Devices: Tests for Cytotoxicity
ISO 10993-10 Biological Evaluation f Medical Devices: Tests for Irritation and delayed-type hypersensitivity ISO 10993-1 Biological Evaluation of Medical Devices: Evaluation and Testing
ISO 10993-12 Biological Evaluation of Medical Devices: Sample Preparation and Reference Materials
Bench testing also demonstrated compliance with system hardware and software specifications. A revised risk analysis was also conducted.
Summary of clinical testing: Clinical testing was performed to confirm that the Type 1077 can produce valid results in patients of all age groups and performed in a comparable manner to the predicate Echo-Screen, Fischer-Zoth Audiologic Systems K013977. Subjects were tested on Type 1077 and again on the Echo-Screen. The goal was to test and compare a minimum of 16 ears per age group. Overall 130 ears were tested and compared, with overall DPOAE agreement of 93.8% and TEOAE agreement of 91.5%. The results are shown below.
| Age | 6 mo-9 y | 10-19 y | 20-39 y | 40-59 y | >59 y | Total |
|---|---|---|---|---|---|---|
| Number of ears | ||||||
| recommended | 20 | 20 | 20 | 20 | 20 | 100 |
| Achieved/tested | 26 | 22 | 30 | 36 | 16 | 130 |
| DPOAE | ||||||
| agreement | 26/26 | |||||
| (100.0 %) | 22/22 | |||||
| (100.0 %) | 30/30 | |||||
| (100.0 %) | 33/36 | |||||
| (91.7 %) | 11/16 | |||||
| (68.8 %) | 122/130 | |||||
| (93.8 %) | ||||||
| TEOAE | ||||||
| agreement | 26/26 | |||||
| (100.0 %) | 22/22 | |||||
| (100.0 %) | 30/30 | |||||
| (100.0 %) | 30/36 | |||||
| (83.3 %) | 11/16 | |||||
| (68.8 %) | 119/130 | |||||
| (91.5 %) |
After identifying that there were some discrepant results between our device and the predicate device. (40-59 y & >59 y age groups) we used a diagnostic OAE device to re-test all test subjects for which there was not a match between the Type 1077 and predicate device. Our intent was to determine which of the two devices (Type 1077 or Predicate) provided the correct result. After performing the diagnostic OAE testing, we discovered that the predicate device was found to have provided incorrect results in 11 of the 19 cases. Overall the results showed that the Type 1077 performed in a comparable manner to the Echo-Screen on the expanded patient population shown in the revised indications for use.
Conclusion: After analyzing bench testing, safety, EMC, software, and clinical validation testing we conclude that the MADSEN AccuScreen Type 1077 (with expanded indications for use) is as safe and effective as the predicate device, and has essentially the same technological characteristics, thus rendering it substantially equivalent to the predicate devices.
5
Public Health Service
Food and Drug Administmlion 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MID 20993-002
February 27, 2014
GN Otometrics A/S c/o Daniel Kamm, P.E. 8870 Ravello Ct. Naples. FL 34114
Re: K132957
Trade/Device Name: Madsen accuscreen type 1077 Regulation Number: 21 CFR 882.1900 Regulation Name: Evoked Response Auditory Stimulator Regulatory Class: Class II Product Code: GWJ Dated: January 20, 2014 Received: January 28, 2014
Dear Mr. Kamm:
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. Ilisting 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 (sec above) into cither 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.
6
Page 2 - Daniel Kamm, P.E.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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 -S
· for 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
7
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K132957
Device Name
MADSEN AccuScreen Type 1077
Indications for Use (Describe)
The Type 1077 device is indicated for use in the recording and automated analysis of human physiological data (screening auditory brainstem responses and/or otoacoustic emissions) necessary for the diagnosis of auditory and hearing-related disorders.
Distortion Product Otoacoustic Emissions and Transient Evoked Otoacoustic Emissions:
The Type 1077 DPOAE module and TEOAE module can be used for patients of all ages, from children to adults, including infants and geriatric patients. It is especially indicated for use in testing individuals for whom behavioral results are deemed unreliable, such as infants, young children, and cognitively impaired adults.
Auditory Brainstem Response:
The Type 1077 ABR module is especially intents from 34 weeks (gestational age) up to 6 months of age.
When the device is used to screen infants, they should be asleep or in a quiet state at the time of screening. The device is intended for use by audiologists, ENT's and other healthcare professionals.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
| FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | Digitally signed by Shuchen Peng -S
DN: c=US, o=U.S. Government, ou=HHS, ou=FDA,
ou=People, cn=Shuchen Peng -S,
0.9.2342.19200300.100.1.1=1300399622 .
Date: 2014.02.27 15:53:15 -05'00'
Shuchen Peng -S |
| -------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
8
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