INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME)
Device Facts
| Record ID | K070696 |
|---|---|
| Device Name | INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME) |
| Applicant | Interacoustics A/S |
| Product Code | GWJ · Neurology |
| Decision Date | Jun 29, 2007 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.1900 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
The Interacoustics ASSR is indicated for use in the recording and analysis of human physiological data used for the diagnosis of auditory and hearing-related functions. The Interacoustics ASSR can be used as either simple screening device if used as part of a group of I audionettic tests. It is exceptionally useful in testing individuals for whom behavioural audiometric results are deemed unreliable; this would include infants, young children, cognitively impaired or uncooperative adults. It allows for the estimation of hearing threshold at various frequencies, through the use of ASSR (Auditory Steady-State Response) test protocols. It is designed to be used by individuals who are trained in the performance and interpretation of evoked potentials such as audiologists and physicians. The results of the test will be used by trained hearing health care professionals to make recommendations regarding appropriate intervention strategies.
Device Story
System comprises general hardware platform (ERA) and ASSR software installed in Eclipse cabinet. Device records and analyzes human physiological data to estimate hearing thresholds via Auditory Steady-State Response (ASSR) protocols. Operated by audiologists or physicians in clinical settings. Software runs on connected PC, communicating with hardware via USB. System uses license-based functionality selection. Test results and reports are generated by software; database stores patient information and results. Healthcare providers use output to determine hearing thresholds and guide clinical intervention strategies. Benefits include objective hearing assessment for patients unable to perform behavioral audiometry.
Clinical Evidence
No clinical data provided. Performance data indicated that the system meets all specified requirements and is substantially equivalent to the predicate device.
Technological Characteristics
Hardware platform (ERA) with modular software (ASSR). Connectivity via USB to PC. System utilizes license-based feature activation. Designed for audiometric and ABR testing functions. Cabinet-based form factor (Eclipse).
Indications for Use
Indicated for recording/analysis of human physiological data for diagnosis of auditory/hearing functions. Suitable for infants, young children, cognitively impaired, or uncooperative adults where behavioral audiometry is unreliable. Used for estimating hearing thresholds at various frequencies via ASSR protocols.
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
- Bio-logic Master Evoked Response System (K021895)
Related Devices
- K031051 — SMARTEP-ASSR, MODEL M811007 · Intelligent Hearing Systems · Feb 20, 2004
- K073626 — BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM · Bio-Logic Systems Corp. · Feb 5, 2008
- K021895 — BIO-LOGIC MASTER EVOKED RESPONSE SYSTEM · Bio-Logic Systems Corp. · Jul 1, 2002
- K141524 — NEURO-AUDIO · Teleemg, LLC USA · Mar 12, 2015
- K193033 — GSI Audera Pro · Grason Stadler · Apr 24, 2020
Submission Summary (Full Text)
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K070696
Interacoustics
Interacoustics ASSR -- Eclipse System 510k Notification
Author Hanne Nielsen
Revision 1
JUN 2 9 2007
## 510(K) SUMMAREY OF SAFETY AND EFFECTIVENESS Interacoustics ASSR, Eclipse System
### SUBMITTER INFORMATION
| A | Company Name: | Interacoustics A/S |
|---|--------------------------------|--------------------------------------------------------|
| B | Company Address: | Drejervaenget 8<br>Assens, DK-5610, Denmark |
| C | Company Phone:<br>Company Fax: | +45 6371 3555<br>+45 6371 3522 |
| D | Contact Person: | Hanne Nielsen<br>Quality Manager<br>Interacoustics A/S |
| E | Date Summary Prepared: | 28/02/2007 |
## DEVICE IDENTIFICATION
| A | Generic Device Name: | Evoked Response Auditory Stimulator |
|---|-------------------------|-------------------------------------------------------|
| B | Trade/proprietary Name: | Interacoustics ASSR, Eclipse System (cabinet<br>name) |
| C | Classification: | Class II |
| D | Product Code: | GWJ |
## SUBSTANTIAL EQUIVALENCE
| Predicate Device | Manufacture | 510(k) No. | Date Cleared |
|--------------------------------------------|---------------------------|------------|--------------|
| Bio-logic Master Evoked<br>Response System | Bio-logic Systems<br>Corp | K021895 | 07/01/2002 |
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Interacoustics ASSR -- Eclipse System 510k Notification
Author Hanne Nielsen
Image /page/1/Picture/2 description: The image shows the Interacoustics logo. The logo features the word "Interacoustics" in a bold, sans-serif font, enclosed within an oval shape that resembles a globe. The globe is represented by curved lines that suggest latitude and longitude, giving the logo a global or international feel.
Revision 1
### DEVICE DESCRIPTION
This system consists of a general hardware platform (ERA) and a software platform (ASSR). This may be installed into any external cabinet as required for proper use of the system. For this application the external cabinet used is the Eclipse. Other cabinets will be released in the future using the same hardware platform (ERA) and will allow software interchange ability between cabinets.
As stated before this device is based on a general hardware platform (ERA) which is designed to be able to perform different audiometric and ABR testing functions. This module has been previously approved per 510k #K052562, functions may be added to this platform in the future, each module will be re-applied for at that time.
A license system makes it possible to select which functionality the user wants to be incorporated in the system.
The specific functionality of the system is controlled by the ASSR software. This software is installed on the connected PC and the system uses a USB connection between the PC and the hardware
Test results and reports are formatted and printed by the ASSR software. A database containing test results and other patient information can be located and shared on the PC,
#### INTENDED USE
The Interacoustics ASSR is indicated for use in the recording and analysis of human physiological data used for the diagnosis of auditory and hearing-related functions.
It allows for the estimation of hearing threshold at various frequencies, through the use of ASSR (Auditory Steady-State Response) test protocols. It is designed to be used as a diagnostic test procedure by individuals who are trained in the performance and interpretation of evoked potentials such as audiologists and physicians. The results of the test will be used by trained hearing health care professionals to make recommendations regarding appropriate intervention strategies.
#### TECHNOLOGICAL CHARACTERISTICS
A comparison of the technological characteristics of the Interacoustics ASSR - Eclipse System and the predicate device has been performed. The results of this comparison demonstrate that the Interacoustics ASSR – Eclipse System is equivalent to the marketed predicate device.
Date OG/Q2/2007
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Interacoustics ASSR – Eclipse System 510k Notification
Author Hanne Nielsen
Image /page/2/Picture/2 description: The image shows a logo with the word "Interacoustics" written in a stylized font. The word is placed inside an oval shape that resembles a globe, with lines representing the longitudes and latitudes. The logo appears to be a simple, black-and-white design.
Revision 1
1
# PERFORMANCE DATA
The performance data indicated that the Interacoustics ASSR – Eclipse System meets all specified requirements, and is substantially equivalent to the predicate device.
Date 06/03/2007
. .
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The text is in all caps and is relatively small compared to the eagle symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
# JUN 2 9 2007
Interacoustics A/S c/o Mr. Daniel Egan Manager of Quality and Regulatory Compliance 7625 Golden Triangle Drive Eden Prairie, MN 55344
Re: K070696
Trade/Device Name: Interacoustics ASSR, Eclipse System (Cabinet Name) Regulation Number: 21 CFR 882.1900 Regulation Name: Evoked response auditory stimulator Regulatory Class: Class II Product Code: GWJ Dated: May 22, 2007 Received: May 23, 2007
Dear Mr. Egan:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.
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Page 2 - Mr. Daniel Egan
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely yours,
M.B. Egelman Simud
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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#### Indications for Use Statement
Applicant: Interacoustics A/S 070696
510(k) Number (if known):
Device Name: Interacoustics ASSR
Indications For Use:
The Interacoustics ASSR is indicated for use in the recording and analysis of human physiological data used for the diagnosis of auditory and hearing-related functions.
The Interacoustics ASSR can be used as either simple screening device if used as part of a group of I audionettic tests. It is exceptionally useful in testing individuals for whom behavioural audiometric results are deemed unreliable; this would include infants, young children, cognitively impaired or uncooperative adults. It allows for the estimation of hearing threshold at various frequencies, through the use of ASSR (Auditory Steady-State Response) test protocols. It is designed to be used by individuals who are trained in the performance and interpretation of evoked potentials such as audiologists and physicians. The results of the test will be used by trained hearing health care professionals to make recommendations regarding appropriate intervention strategies.
Prescription Use (Part 21 CFR 801 Subpart D)
> Prescription Use (Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page of
(Per 21 CFR 801.109)
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k)
510(k) Number K070696
