(108 days)
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.
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,
The Interacoustics ASSR, Eclipse System is based on substantial equivalence to a predicate device, the Bio-logic Master Evoked Response System (K021895). The submission states that the device meets "all specified requirements" for performance, which indicates that it has been evaluated against certain acceptance criteria. However, the specific quantitative acceptance criteria are not explicitly detailed in the provided document.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Equivalence to Predicate Device (K021895) in recording and analysis of human physiological data for diagnosis of auditory and hearing-related functions. | "The performance data indicated that the Interacoustics ASSR – Eclipse System meets all specified requirements, and is substantially equivalent to the predicate device." |
| Indicated for estimating hearing threshold at various frequencies using ASSR test protocols. | The device is described as allowing for "the estimation of hearing threshold at various frequencies, through the use of ASSR (Auditory Steady-State Response) test protocols." |
| Designed for use by trained individuals (audiologists and physicians), for whom behavioral audiometric results are unreliable (e.g., infants, young children, cognitively impaired adults). | "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." It is "exceptionally useful in testing individuals for whom behavioural audiometric results are deemed unreliable." |
| Proper functioning of hardware (ERA) and software (ASSR) platform. | The system consists of a general hardware platform (ERA) and a software platform (ASSR), and its specific functionality is controlled by the ASSR software. The ERA module was previously approved per 510k #K052562. |
Study Details
The provided 510(k) summary does not contain detailed information about a specific study with sample sizes, data provenance, expert qualifications, or adjudication methods. The primary method for demonstrating device performance and meeting acceptance criteria appears to be a comparison of technological characteristics and a declaration of substantial equivalence to a predicate device.
Here's what can be extracted based on the input:
- Sample size used for the test set and the data provenance: Not specified. The document only states that "The performance data indicated that the Interacoustics ASSR – Eclipse System meets all specified requirements, and is substantially equivalent to the predicate device." This implies that some form of testing or comparison was performed, but the details of the test set are not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified. Given that the submission relies on substantial equivalence and mentions "performance data" without detailing study specifics, there's no information about expert involvement in establishing a ground truth for a test set.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not specified.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable/Not specified. This device is an "Evoked Response Auditory Stimulator" and does not appear to involve AI or human "readers" in the context of image interpretation or similar tasks where MRMC studies are typically conducted. Its function is to record and analyze physiological data.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not explicitly stated as a separate standalone study. The device itself is described as a system (hardware and software) that records and analyzes data, and it is "designed to be used... by individuals who are trained in the performance and interpretation of evoked potentials." This implies a human-in-the-loop for interpretation and recommendations, but it does not specify a standalone algorithm performance study.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not specified.
- The sample size for the training set: Not applicable/Not specified. The device's approval is based on substantial equivalence, not on a machine learning model developed and validated with separate training and test sets in the typical sense.
- How the ground truth for the training set was established: Not applicable/Not specified.
Summary of Study Information:
The 510(k) submission for the Interacoustics ASSR, Eclipse System, relies on the concept of substantial equivalence to an existing predicate device (Bio-logic Master Evoked Response System, K021895). The document explicitly states: "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." And "The performance data indicated that the Interacoustics ASSR – Eclipse System meets all specified requirements, and is substantially equivalent to the predicate device."
Such submissions typically include engineering verification and validation testing to ensure the new device performs as intended and is safe and effective when compared to the predicate, but the detailed methodology, sample sizes, and expert adjudications of these tests are not present in the provided summary. The stated "performance data" presumably refers to these types of internal verification and validation activities rather than a large-scale clinical trial or comparative effectiveness study as might be seen for novel technologies or AI devices.
{0}------------------------------------------------
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 8Assens, DK-5610, Denmark |
| C | Company Phone:Company Fax: | +45 6371 3555+45 6371 3522 |
| D | Contact Person: | Hanne NielsenQuality ManagerInteracoustics 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 (cabinetname) |
| C | Classification: | Class II |
| D | Product Code: | GWJ |
SUBSTANTIAL EQUIVALENCE
| Predicate Device | Manufacture | 510(k) No. | Date Cleared |
|---|---|---|---|
| Bio-logic Master EvokedResponse System | Bio-logic SystemsCorp | K021895 | 07/01/2002 |
{1}------------------------------------------------
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
{2}------------------------------------------------
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
. .
{3}------------------------------------------------
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.
{4}------------------------------------------------
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
{5}------------------------------------------------
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
§ 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).