(141 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other indication of AI/ML use.
No
The device aids in detecting hearing loss and lesions and provides data for diagnosis, rather than directly treating a condition.
Yes
The intended use explicitly states that the device provides information for the "diagnosis of auditory and hearing-related disorders."
Unknown
The provided text only describes the intended use of the device, which is an ABR system. ABR systems typically involve hardware components (electrodes, amplifiers, stimulators) to acquire physiological data. Without a device description, it's impossible to determine if this specific system is software-only or includes hardware.
Based on the provided information, it is highly likely that the AURIS I and AURIS II ABR Systems are not IVD (In Vitro Diagnostic) devices.
Here's why:
- Intended Use: The intended use clearly states that the device "tests for auditory evoked potentials as an aid in detecting hearing loss and lesions in auditory pathways" and is used for "recording and analysis of human physiological data necessary for the diagnosis of auditory and hearing-related disorders." This describes a device that interacts directly with the patient's body to measure physiological responses, not a device that analyzes samples taken from the body (like blood, urine, or tissue).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, etc.)
- Detecting specific analytes or biomarkers
- Performing chemical, immunological, or molecular tests
In summary, the AURIS I and AURIS II ABR Systems appear to be a diagnostic device that measures physiological responses directly from the patient, which is characteristic of a medical device, but not an IVD.
N/A
Intended Use / Indications for Use
The AURIS I and AURIS II ABR Systems provide information regarding the functional integrity of the peripheral and central auditory system. It tests for auditory evoked potentials as an aid in detecting hearing loss and lesions in auditory pathways. It is intended for use in the recording and analysis of human physiological data necessary for the diagnosis of auditory and hearing-related disorders.
Product codes
GWJ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral and central auditory system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
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.
Not Found
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
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
Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal features a stylized image of a person with their head tilted back and arms outstretched. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 82001
Managing Director Synapsys, Inc. 150-10 132nd Avenue Jamaica, New York 11434
Re: K012415
Mr. Julien Chaussy
Trade/Device Name: Auris AEP Regulation Number: 882.1900 Regulation Name: Evoked response auditory stimulator Regulatory Class: II Product Code: GWJ Dated: September 19, 2001 Received: September 24, 2001
Dear Mr. Chaussy:
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.
1
Page 2 - Mr. Julien Chaussy
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Stypt Rhodes
Celia M. Witten, Ph.D., M.D.
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| 510(k) Number (if known): | 1 | 10 1011 ' | ||||
|---|---|---|---|---|---|---|
| Device Name: | ATIRIS ARR | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Comments of Acres of Acres of Canadian Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children Comments |
Indications For Use:
The AURIS I and AURIS II ABR Systems provide information regarding the functional integrity of the peripheral and central auditory system. It tests for auditory evoked potentials as an aid in detecting hearing loss and lesions in auditory pathways. It is ittended for use in the recording and analysis of human physiological data necessary for the diagnosis of auditory and hearing-related disorders.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number K012415
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use