(24 days)
Not Found
No
The document describes standard signal processing algorithms (Point Optimized Variance Ratio) and software integration, but does not mention AI or ML.
No.
The device is used for diagnosis of auditory conditions by recording and analyzing physiological data, not for treating them.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the product families are "indicated for use in the recording and analysis of human physiological data necessary for the diagnosis of auditory and hearing-related disorders."
No
The device description explicitly states that the product is an "integration of both OAE and ABR screening functions into one portable unit, the ABaer Cub," and that it includes "the same hardware package as the ABaer Cub." It also mentions "electronic hardware" and a "battery-powered, portable hand-held test instrument." This indicates the device is a combination of hardware and software, not software-only.
Based on the provided text, the device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the device is used for "recording and analysis of human physiological data necessary for the diagnosis of auditory and hearing-related disorders." While it doesn't directly analyze a sample in vitro, the data it collects (Otoacoustic Emissions and Evoked Potentials) are physiological measurements taken from the patient's body. The analysis of this data is used to aid in diagnosis.
- Diagnosis: The intended use clearly links the data analysis to the "diagnosis of auditory and hearing-related disorders." This is a key characteristic of IVD devices.
- Physiological Data: The device records and analyzes "human physiological data." While not a traditional biological sample like blood or urine, physiological signals are considered within the scope of IVD devices when used for diagnostic purposes.
While the device description focuses on the hardware and software integration, the intended use is the primary factor in determining if a device is an IVD. The device's function is to collect and analyze physiological data from a patient to aid in the diagnosis of a medical condition, which aligns with the definition of an IVD.
N/A
Intended Use / Indications for Use
The Bio-logic Otoacoustic Emissions (OAE) and Evoked Potential (EP) product families are indicated for use in the recording and analysis of human physiological data necessary for the diagnosis of auditory and hearing-related disorders.
This product, the ABaer Cub with Automated OAE and ABR, like it's predicate devices, the AuDX and the ABaer Cub, is especially indicated for use in the screening of infants to determine hearing loss.
The Bio-logic OAE and EP Systems 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 or uncooperative adults. The use of the Bio-logic OAE and EP families of products is to be performed under the prescription and supervision of a physician or other trained health care professional.
Product codes (comma separated list FDA assigned to the subject device)
EWO, GWJ
Device Description
The Bio-logic Hearing Screening products, including the OAE and ABR test instruments Scout/AuDX and ABaer Cub, are intended to be used for the purpose of testing for hearing loss in patients of all ages, but primarily in infants . The predicate devices referenced above are the latest current products of this type marketed by Bio-logic. This new product, ABaer Cub with OAE, is the integration of both OAE and ABR screening functions into one portable unit, the ABaer Cub, with additional OAE software functions added to the Pocket PC host computer for the ABaer Cub.
The ABaer Cub predicate device performs Evoked Potential screening, recording and analysis functions, provides one channel of data recording, and includes the Point Optimized Variance Ratio (POVR) algorithm for optimizing signal quality, implementing the screening function and enhancing speed of test completion. This new ABaer Cub with OAE device performs these same functions in the same ways, but has the added capability of performing the OAE tests of the Sport/AuDX predicate device, all within the same hardware package as the ABaer Cub.
The Sport/AuDX predicate device can be used in either a stand-alone (AuDX) or host-connected (Sport) mode. The same DSP software is used in both types of box. The primary difference between the two products is that the Sport requires the use of a host computer for user control information and to store and display the data returned from the Sport box. For the AuDX, all user control and display is right at the AuDX box, making this a fully portable test instrument but with limited control and display capability. However, after an AuDX test is completed, it can be connected to a host computer to download test data for display on the host computer screen if desired. This same Sport/AuDX DSP software functionality has been incorporated into the ABaer Cub box. Much of the Sport host computer display software has been incorporated into the ABaer Cub Pocket PC (host computer), resulting in a completely battery-powered, portable hand-held test instrument capable of performing both the Automated OAE and ABR tests. The Sport OAE predicate device uses a desktop or laptop computer instead of the Pocket PC. The electronic hardware is the same as the ABaer Cub hardware used in that predicate device. Because both the Pocket PC and the ABaer Cub unit are battery powered, this significantly improves the portability and usability of the device over that of the Sport OAE predicate device. The ABaer Cub software for control of this device is a combination of the Sport and ABaer Cub predicate device software, with some GUI changes necessary in the Sport OAE software to modify the graphics display for use with the smaller Pocket PC LCD screen. The host software for the Sport/AuDX OAE predicate device is written in the C++ programming language for the Windows 95/98/ME operating system, whereas the host software for the ABaer Cub is written in the C++ programming language for the Windows Pocket PC operating system. Together, these software additions implement the same functionality and perform the same intended use as both predicate devices, but with improved portability and ease-of-use.
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 children to adults, including infants and geriatric patients. especially indicated for use in the screening of infants
Intended User / Care Setting
prescription and supervision of a physician or other trained health care professional.
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.
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
K 021801
Image /page/0/Picture/1 description: The image shows the logo for Bio-logic Systems Corp. The logo is set against a black background. The words "Bio-logic" are in a large, bold, white font, with the registered trademark symbol to the right of the word "logic". Below "Bio-logic" is the text "SYSTEMS CORP" in a smaller, white font.
One Bio-logic Plaza Mundelein, IL 60060-3700 1-800-323-8326 Fax: 847-949-8615 www.bio-logic.com
JUN 2 7 2002
SECTION 2: SUMMARY AND CERTIFICATION
510(K) SUMMARY
Safety and effectiveness information concerning the ABaer Cub with OAE device modification to the Bio-logic Hearing Screening product family is summarized below.
Because this is not a CLASS III device, the special certification defined for this section is not required.
| PREPARED BY: | Bio-logic Systems Corp |
|---|---|
| One Bio-logic Plaza | |
| Mundelein, IL 60060 |
TELEPHONE: (847)-949-5200
CONTACT PERSON: Norman E. Brunner
DATE ON WHICH THE SUMMARY WAS PREPARED: May 24, 2002
NAME OF DEVICE: Bio-logic ABaer Cub with integrated OAE and ABR functions.
COMMON NAME: Audiometer (OAE) and Evoked Response (ABR).
CLASSIFICATION NAME: Audiometer (reference 21CFR 874.1050) and Auditory Evoked Response system (reference 21CFR 882.1900).
PREDICATE DEVICE: The OAE function is substantially equivalent to the Sport/AuDX predicate device (510(k) #K974076) and the ABR function is substantially equivalent to the ABaer Cub predicate device (510(k) #K021215).
DESCRIPTION OF THE DEVICE:
The Bio-logic Hearing Screening products, including the OAE and ABR test instruments Scout/AuDX and ABaer Cub, are intended to be used for the purpose of testing for hearing loss in patients of all ages, but primarily in infants . The predicate devices referenced above are the latest current products of this type marketed by Bio-logic. This new product, ABaer Cub with OAE, is the integration of both OAE and ABR screening functions into one portable unit, the ABaer Cub, with additional OAE software functions added to the Pocket PC host computer for the ABaer Cub.
1
Snecial 510(k): ABaer Cub with OAE
The ABaer Cub predicate device performs Evoked Potential screening, recording and analysis functions, provides one channel of data recording, and includes the Point Optimized Variance Ratio (POVR) algorithm for optimizing signal quality, implementing the screening function and enhancing speed of test completion. This new ABaer Cub with OAE device performs these same functions in the same ways, but has the added capability of performing the OAE tests of the Sport/AuDX predicate device, all within the same hardware package as the ABaer Cub.
The Sport/AuDX predicate device can be used in either a stand-alone (AuDX) or host-connected (Sport) mode. The same DSP software is used in both types of box. The primary difference between the two products is that the Sport requires the use of a host computer for user control information and to store and display the data returned from the Sport box. For the AuDX, all user control and display is right at the AuDX box, making this a fully portable test instrument but with limited control and display capability. However, after an AuDX test is completed, it can be connected to a host computer to download test data for display on the host computer screen if desired. This same Sport/AuDX DSP software functionality has been incorporated into the ABaer Cub box. Much of the Sport host computer display software has been incorporated into the ABaer Cub Pocket PC (host computer), resulting in a completely battery-powered, portable hand-held test instrument capable of performing both the Automated OAE and ABR tests. The Sport OAE predicate device uses a desktop or laptop computer instead of the Pocket PC. The electronic hardware is the same as the ABaer Cub hardware used in that predicate device. Because both the Pocket PC and the ABaer Cub unit are battery powered, this significantly improves the portability and usability of the device over that of the Sport OAE predicate device. The ABaer Cub software for control of this device is a combination of the Sport and ABaer Cub predicate device software, with some GUI changes necessary in the Sport OAE software to modify the graphics display for use with the smaller Pocket PC LCD screen. The host software for the Sport/AuDX OAE predicate device is written in the C++ programming language for the Windows 95/98/ME operating system, whereas the host software for the ABaer Cub is written in the C++ programming language for the Windows Pocket PC operating system. Together, these software additions implement the same functionality and perform the same intended use as both predicate devices, but with improved portability and ease-of-use.
INTENDED USE:
The Bio-logic Otoacoustic Emissions (OAE) and Evoked Potential (EP) product families are indicated for use in the recording and analysis of human physiological data necessary for the diagnosis of auditory and hearing-related disorders.
This product, the ABaer Cub with Automated OAE and ABR, like it's predicate devices, the AuDX and the ABaer Cub, is especially indicated for use in the screening of infants to determine hearing loss.
The Bio-logic OAE and EP Systems 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 or uncooperative adults. The use of the Bio-logic OAE and EP families of products is to be performed under the prescription and supervision of a physician or other trained health care professional.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three overlapping profiles suggesting a sense of community or collaboration. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 7 2002
Bio-logic Systems Corp. c/o Norman E. Brunner Vice-President of Research & Development One Bio-logic Plaza Mundelein, IL 60060-3700
Re: K021801
Trade/Device Name: ABaer Cub with Automated OAE and ABR Regulation Number: 21 CFR 874.1050 & 21 CFR 882.1900 Regulation Name: Audiometer & Auditory Evoked Response System Regulatory Class: Class II Product Code: EWO & GWJ Dated: May 31, 2002 Received: June 3, 2002
Dear Mr. Brunner:
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 – Norman E. Brunner
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) 594-4613. 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,
A. Ralph 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
4
INDICATIONS FOR USE STATEMENT
Not Assigned 510(k) Number (if known):
Device Name: ABaer Cub with Automated OAE and ABR.
Indications For Use:
The Bio-logic Otoacoustic Emissions (OAE) and Evoked Potential (EP) product families are indicated for use in the recording and analysis of human physiological data necessary for the diagnosis of auditory and hearing-related disorders.
This product, the ABaer Cub with Automated OAE and ABR, like it's predicate devices, the AuDX and the ABaer Cub, is especially indicated for use in the screening of infants to determine hearing loss.
The Bio-logic QAE and EP Systems 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 or uncooperative adults. The use of the Biologic OAE and EP families of products is to be performed under the prescription and supervision of other trained health care professional.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ooms K. Kane, M.D.
Prescription Use
(Per 21 CFR 801.109) X
OR
Over-The-Counter Use _
(Optional Format 1-2-96)