(77 days)
Not Found
No
The summary does not mention AI, ML, or related terms, nor does it describe functionalities typically associated with these technologies in this context (e.g., automated interpretation of complex signals beyond standard algorithms).
No.
The device is used for screening individuals for hearing loss, which is a diagnostic purpose, not a therapeutic one.
Yes
Explanation: The device is used to screen individuals for hearing loss, which is a diagnostic purpose. It evaluates hearing function using Otoacoustic Emissions and Auditory Brainstem Response tests.
No
The device description explicitly states "This device is essentially the Audioscreener OAE+ABR unit with additional software...", indicating it includes a hardware unit in addition to the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Audioscreener OAE+ABR is used to evaluate hearing function by measuring responses from the ear (Otoacoustic Emissions and Auditory Brainstem Response). This is a direct measurement of a physiological response, not an analysis of a specimen taken from the body.
- Intended Use: The intended use describes screening individuals for hearing loss based on these physiological responses.
Therefore, the device falls under the category of a diagnostic device that interacts directly with the patient's body, rather than an in vitro diagnostic device that analyzes samples.
N/A
Intended Use / Indications for Use
The Audioscreener OAE+ABR may be used for patients of all ages, from newborn infants through adults. The Distortion Product Otoacoustic Emissions, Transient Evoked Otoacoustic Emissions, and Auditory Brainstem Response tests are indicated for use in screening individuals for hearing loss for whom behavioral audiometric responses are deemed to be unreliable, such as in infants, young children, and uncooperative or cognitively impaired adults.
Product codes (comma separated list FDA assigned to the subject device)
EWO, GWJ
Device Description
The Audioscreener OAE+ABR is a Otoacoustic Emissions and Audiotory Brainstem Response testing device to be used in the evaluation of hearing function. This device is essentially the Audioscreener OAE+ABR unit with additional software required to perform a Transient Evoked OAE in addition to the Distortion Product OAE test.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
all ages, from newborn infants through adults
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.
Kedly Audioscreener OAE+ABR (K001058)
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
§ 874.1050 Audiometer.
(a)
Identification. An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.(b)
Classification. Class II. Except for the otoacoustic emission device, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, if it is in compliance with American National Standard Institute S3.6-1996, “Specification for Audiometers,” and subject to the limitations in § 874.9.
0
KO 24205
Premarket Notification [510(k)] Summary MAR 0 7 2003
SUBMITTED BY: Everest Biomedical Instruments Co. 16690 Swingley Ridge Rd. Suite 140 Chesterfield. MO 63017 V: 636-519-7770 F: 636-519-7991
CONTACT PERSON: Randall J. Krohn
DATE OF PREPARATION December 19, 2002
TRADE NAME: AUDIOscreener OAE+ABR
COMMON NAME: Otoacoustic Emissions Test Instrument / Evoked Response Auditory Stimulator
CLASSIFICATION NAME: Audiometer (per 21 CFR section 874.1050) Panel 77 Product Code EWO
Evoked Response Auditory Stimulator (per 21 CFR section 882.1900) Panel 84 Product Code GWJ
PREDICATE DEVICES: Kedly Audioscreener OAE+ABR (K001058)
DEVICE DESCRIPTION:
The Audioscreener OAE+ABR is a Otoacoustic Emissions and Audiotory Brainstem Response testing device to be used in the evaluation of hearing function. This device is essentially the Audioscreener OAE+ABR unit with additional software required to perform a Transient Evoked OAE in addition to the Distortion Product OAE test.
INTENDED USE:
The Audioscreener OAE+ABR may be used for patients of all ages, from newborn infants through adults. The Distortion Product Otoacoustic Emissions, Transient Evoked Otoacoustic Emissions, and Auditory Brainstem Response tests are indicated for use in screening individuals for hearing loss for whom behavioral audiometric responses are deemed to be unreliable, such as in infants, young children, and uncooperative or cognitively impaired adults.
1
TECHNOLOGICAL CHARACTERISTICS:
The Audioscreener OAE+ABR is similar in its intended use to predicate devices and existing methodologies. In addition, the device complies with the following safety and performance standards as applicable to its classification:
UL 2601-1 Medical Electrical Equipment Part 1: General Requirements for Safety 18 ed. 1997-10
CSA 22.2 No. 601.1 Medical Electrical Equipment Part 1: General Requirements for Safety-M90
IEC60601-1-2 Medical Electrical Equipment Part 1: General Requirements for Safety 2. Collateral Standard: Electromagnetic Compatibility - Requirements and Tests 1st ed. 1993-04
ANSI S3.6 Specification for Audiometers (sections 4-10 as applicable) 1996
IEC 60601-2-40 Particular Requirements for the Safety of Electromyographs and Evoked Response Equipment (1998-02)
FDA Electroencephalograph Devices Guidance for 510(k) Content Draft Document Version 1.0 November 3, 1997
IEC 645-3 Audiometers Part 3: Auditory Test Signals of Short Duration for Audiometric and Neuro-Otological Purposes (1994-10)
IEC 60601-2-26 Particular Requirements for the Safety of Electroencephalographs (1994-04)
2
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle head facing right, composed of three curved lines that suggest depth and dimension. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
MAR 0 7 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Everest Biomedical Instruments Co. c/o Randall J. Krohn VP Engineering - Neuro Products 16690 Swingley Ridge Rd Suite 140 Chesterfield, MO 63017
Re: K024205
Trade/Device Name: AUDIOscreener OAE+ABR Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: Class II Product Code: EWO Dated: December 19, 2002 Received: December 20, 2002
Dear Mr. Krohn:
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 - Randall J. Krohn
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 (301) 594-4613. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A. halyi Rosenthal
A. Ralph Rosenthal, 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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Page 1 of 1
510(k) Number (if known):
Audioscreener OAE+ABR Device Name:
Indications for Use:
The Audioscreener OAE+ABR may be used for patients of all ages, from newborn infants through adults. The Distortion Product Otoacoustic Emissions, Transient Evoked Otoacoustic Emissions, and Auditory Brainstem Response tests are indicated for use in screening individuals for hearing loss for whom behavioral audiometric responses are deemed to be unreliable, such as in infants, young children, and uncooperative or cognitively impaired adults.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE)
Veena Abrol
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K024305
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) |
(Optional Format 3-10-98)