Who is the manufacturer of MADSEN ACCUSCREEN TYPE 1077?

Gn Otometrics filed the 510(k) submission for MADSEN ACCUSCREEN TYPE 1077 (K132957).

What is the FDA product code for MADSEN ACCUSCREEN TYPE 1077?

GWJ. It is classified under 21 CFR 882.1900 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for MADSEN ACCUSCREEN TYPE 1077?

510(k) clearance (submission type: Traditional).

What are the predicate devices for MADSEN ACCUSCREEN TYPE 1077?

Echo-Screen T, TA, TD, TDA, TC (K013977); Type 1077 AccuScreen (K122067).

Who can help prepare an FDA 510(k) submission like MADSEN ACCUSCREEN TYPE 1077?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MADSEN ACCUSCREEN TYPE 1077

K132957 · Gn Otometrics · GWJ · Feb 27, 2014 · Neurology

Device Facts

Record ID	K132957
Device Name	MADSEN ACCUSCREEN TYPE 1077
Applicant	Gn Otometrics
Product Code	GWJ · Neurology
Decision Date	Feb 27, 2014
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1900
Device Class	Class 2
Attributes	Pediatric

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..

Device Story

Handheld, battery-operated screening device for auditory function; utilizes OAE probe (PATH Medical GmbH) with ear-tip inserted into patient ear canal. Device plays stimulus sounds (broadband clicks for TEOAE; two pure tones for DPOAE) via probe speakers; records patient response via probe microphone. Firmware processes signals using statistical analysis to determine presence of hearing loss. Used by audiologists, ENTs, and healthcare professionals in clinical settings. Output displayed on touch screen; assists clinicians in identifying potential hearing disorders in patients unable to provide reliable behavioral responses. Benefits include objective, automated screening for infants and cognitively impaired populations.

Clinical Evidence

Clinical study compared Type 1077 to predicate Echo-Screen (K013977) across 130 ears in various age groups (6mo-9y to >59y). Primary endpoints were DPOAE and TEOAE agreement. Overall agreement was 93.8% for DPOAE and 91.5% for TEOAE. Discrepant results in older cohorts were adjudicated using a diagnostic OAE device, confirming the subject device's accuracy.

Technological Characteristics

Handheld, battery-operated (3.7V/1800mAh Li-ion). Features 3.5-inch color TFT touch screen. Uses OAE probe with biocompatible ear-tips. Connectivity via IR to docking station with USB interface. Safety standards: EN 60601-1, IEC 60601-2-26, IEC 60601-2-40. Biocompatibility per ISO 10993-5, -10, -1, -12. Software-controlled via internal firmware module.

Indications for Use

Indicated for screening auditory brainstem responses (ABR) and/or otoacoustic emissions (OAE) in humans. DPOAE/TEOAE modules: all ages, including infants, children, adults, and geriatric patients; specifically for those with unreliable behavioral audiometric results (e.g., cognitively impaired). ABR module: infants 34 weeks gestational age to 6 months. Contraindications: infants must be asleep or in a quiet state.

Regulatory Classification

Identification

An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.

Predicate Devices

Echo-Screen T, TA, TD, TDA, TC (K013977)
Type 1077 AccuScreen (K122067)

Submission Summary (Full Text)

{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}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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MADSEN ACCUSCREEN TYPE 1077

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Indications for Use

Device Story

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Technological Characteristics

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MADSEN ACCUSCREEN TYPE 1077

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

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