(123 days)
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No
The summary does not mention AI, ML, or related terms, and the description of the device's function focuses on standard electro-physiological data analysis.
No
The device is described as an aid for hearing assessment and for determining the presence or absence of a Cortical Auditory Evoked Potential and the audibility of tones, which are diagnostic or assessment functions, not therapeutic.
Yes
The device aids in hearing assessment and audiologists can use the acquired information to diagnose a hearing loss.
Unknown
The provided text describes the intended use and indications for use of the HEARLab device, but it lacks a "Device Description" section. Without a description of the device's components and how it functions, it is impossible to determine if it is solely software or includes hardware. The mention of "evoking an auditory response and recording, analyzing, and displaying the resulting human electro-physiological data" suggests interaction with the patient, which could involve hardware components for stimulation and data acquisition.
Based on the provided information, the HEARLab device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The HEARLab device is described as evoking and recording electro-physiological data from the human body (auditory responses). It does not analyze biological samples like blood, urine, or tissue.
- The intended use is for hearing assessment based on physiological responses. The device measures the body's electrical response to auditory stimuli, which is a physiological measurement, not an analysis of a biological sample.
Therefore, the HEARLab device falls under the category of a medical device that interacts directly with the patient's body to collect physiological data, rather than an IVD which analyzes samples taken from the body.
N/A
Intended Use / Indications for Use
The HEARLab device is intended for use in evoking an auditory response and recording, analyzing, and displaying the resulting human electro-physiological data as an aid for hearing assessment used in conjunction with other clinical devices (such as an audiometer or an auditory brainstem response device).
Healthcare professionals trained in auditory evoked potentials can use HEARLab in order to determine whether the Cortical Auditory Evoked Potential (CAEP) is absent or present in humans from infants who are 42 weeks gestational through adults when stimulated with speech tokens presented in the sound field. This test can be performed on unaided subjects wearing hearing instruments. However, it is not meant to be used on subjects with cochlear implants.
These professionals can also use HEARLab to determine audibility of unaided frequency-specific tones presented to adults using CAEP. Only audiologists should use information acquired by HEARLab in diagnosing a hearing loss or in verifying the effectiveness of a hearing aid.
Product codes
GWJ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
from infants who are 42 weeks gestational through adults
Intended User / Care Setting
Healthcare professionals trained in auditory evoked potentials; audiologists
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/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-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
April 5, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Frye Electronics, Inc. % Ms. Kristina Frye ISO Coordinator 9826 S.W. Tigard Street Tigard, OR 97223
Re: K123701
Trade/Device Name: HEARLab ACA Regulation Number: 21 CFR 882.1900 Regulation Name: Evoked Response Auditory Stimulator Regulatory Class: Class II Product Code: GWJ Dated: February 18, 2013 Received: March 5, 2013
Dear Ms. Frye:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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Page 2 - Ms. Kristina Frye
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Eric ADMann
for 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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Statement of Indications for Use
510(k) Number: K123701
Device Name: HEARLab ACA
Indications for Use:
The HEARLab device is intended for use in evoking an auditory response and recording, analyzing, and displaying the resulting human electro-physiological data as an aid for hearing assessment used in conjunction with other clinical devices (such as an audiometer or an auditory brainstem response device).
Healthcare professionals trained in auditory evoked potentials can use HEARLab in order to determine whether the Cortical Auditory Evoked Potential (CAEP) is absent or present in humans from infants who are 42 weeks gestational through adults when stimulated with speech tokens presented in the sound field. This test can be performed on unaided subjects wearing hearing instruments. However, it is not meant to be used on subjects with cochlear implants.
These professionals can also use HEARLab to determine audibility of unaided frequency-specific tones presented to adults using CAEP. Only audiologists should use information acquired by HEARLab in diagnosing a hearing loss or in verifying the effectiveness of a hearing aid.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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