(29 days)
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No
The description focuses on standard OAE measurement technology and does not mention AI or ML.
No
The device is used for testing cochlear function and measuring otoacoustic emissions, which are diagnostic purposes, not therapeutic.
Yes
The device "ER36 Series OAE Test System" is indicated for "testing of cochlear function" and its purpose is to identify individuals with hearing impairment. This aligns with the definition of a diagnostic device, which is used to identify or detect a disease, condition, or physiological state.
No
The device description explicitly states it is a "battery powered, hand-held microprocessor-controlled instrument" with a physical probe and cable, indicating it includes significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body. They are used to detect diseases, conditions, or infections.
- Device Function: The ER36 Series OAE Test System measures otoacoustic emissions by directing sounds into the ear canal and detecting the resulting low-level sounds produced by the cochlea. This is a physical measurement of a physiological response within the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use is to test cochlear function by measuring OAEs, which is a direct assessment of a bodily function, not the analysis of a biological sample.
Therefore, the ER36 Series OAE Test System falls under the category of a medical device used for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ER36 Series OAE Test System is indicated for testing of cochlear function in infants, children, and adults by measuring otoacoustic emissions (OAEs). The OAEs are generated by a series of clicks or tones that are directed into the ear canal. Otoacoustic emissions are low level audio frequency sounds that are produced by the cochlea as part of the normal hearing process.
Product codes
EWO
Device Description
The ER36 Series OAE Test System is a battery powered, hand-held microprocessor-controlled instrument designed to measure otoacoustic emissions. The ER36 is connected by a 1 meter, thin flexible cable to the ER36 MicroProbe OAE Test Probe (Ear Probe). The Ear Probe incorporates a field replaceable Probe Tip (9-lumen tube) that is inserted and acoustically sealed to the test ear canal with a compliant ear tip. The ER36 provides otoacoustic emissions measurements by two methods: distortion product otoacoustic emissions (DPOAE), and transient-evoked otoacoustic emissions (TEOAE). The OAEs are generated by a series of clicks or tones that are directed into the ear canal. Otoacoustic emissions are low level audio-frequency sounds that are produced by the cochlea as part of the normal hearing process.
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
Ear canal
Indicated Patient Age Range
Infants, children, and adults
Intended User / Care Setting
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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)
Design verification activities were performed to ensure the modified device was substantially equivalent to the predicate device and that it met performance specifications; this testing was performed on the basis of the risk analysis and per device design controls.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a traditional symbol of medicine, with three intertwined snakes and a staff. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Etymotic Research, Inc. % Ms. Meaghan Bailey Senior Director, Medical Devices NSF Health Sciences Medical Devices 2001 Pennsylvania Ave. NW, Suite 950 Washington, DC 20006
Re: K150491
Trade/Device Name: Er36 Series Oae Test System Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: Class II Product Code: EWO Dated: February 25, 2015 Received: February 25, 2015
Dear Ms. Bailey:
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.
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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); medical device 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Deborah L. Falls -S
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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Indications for Use
510(k) Number (if known) K150491
Device Name ER36 Series OAE Test System
Indications for Use (Describe)
The ER36 Series OAE Test System is indicated for testing of cochlear function in infants, children, and adults by measuring otoacoustic emissions (OAEs). The OAEs are generated by a series of clicks or tones that are directed into the ear canal. Otoacoustic emissions are low level audio frequency sounds that are produced by the cochlea as part of the normal hearing process.
A vailable evidence suggests that otoacoustic emissions are generated by the cochlea's outer hair cells and that the presence of OAE's is an indication that the outer hair cells are vidence indicates that these emissions normally occur with normal hearing, or at most, mild hearing loss (usually 30-40dB HL). The majority of hearingimpaired individuals will be identified by a simple OAE test.
Type of Use (Select one or both, as applicable)> Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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| I. SUBMITTER | |
|---|---|
| Company Name: | Etymotic Research, Inc. |
| 61 Martin Lane | |
| Elk Grove Village, IL 60007 | |
| Tel: (847) 228-0006 | |
| Fax: (847) 228-6836 | |
| Contact Person: | Meaghan Bailey, Senior Director, NSF Health Sciences |
| Date Prepared: | February 25, 2015 |
| II. DEVICE | |
| Trade Name: | ER36 Series OAE Test System |
| Common Name: | Audiometer, Otoacoustic Emissions Device |
| Classification Name: | Class II Audiometer |
| Device Classification: | Class II, 21 CFR 874.1050 |
| III. PREDICATE DEVICE | |
| Predicate Devices: | ERO•SCAN TM OAE Test System (K010165) |
| Etymotic Research, Inc. | |
| Class II, 21 CFR 874.1050 |
Purpose of the Special 510(k) Premarket Notification: The ER36 is a modification of its predicate device.
IV. DEVICE DESCRIPTION
Device Description: The ER36 Series OAE Test System is a battery powered, hand-held microprocessor-controlled instrument designed to measure otoacoustic emissions. The ER36 is connected by a 1 meter, thin flexible cable to the ER36 MicroProbe OAE Test Probe (Ear Probe). The Ear Probe incorporates a field replaceable Probe Tip (9-lumen tube) that is inserted and acoustically sealed to the test ear canal with a compliant ear tip. The ER36 provides otoacoustic emissions measurements by two methods: distortion product otoacoustic emissions (DPOAE), and transient-evoked otoacoustic emissions (TEOAE). The OAEs are generated by a series of clicks or tones that are directed into the ear canal. Otoacoustic emissions are low level audio-frequency sounds that are produced by the cochlea as part of the normal hearing process.
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Modifications and enhancements from the prior device version (ER34) includes updated electronic components removal of the device internal probe, change in ergonomics and the patient/user interface (i.e., LED/LCD display, ear probe housing material, and switch change), change in the dimensions of the controller housing, battery power change (Lithium-Ion rechargeable single cell), addition of a Bluetooth wireless printing option, and addition of a USB computer connection.
V. INDICATIONS FOR USE
| Intended Use: | The ER36 is a test instrument that measures otoacoustic
emissions in infants, children, and adults. |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: | The ER36 Series is indicated for testing of cochlear
function in infants, children and adults by measuring
otoacoustic emissions (OAEs). The OAEs are generated by
a series of clicks that are directed into the ear canal.
Otoacoustic emissions are low level audio-frequency
sounds that are produced by the cochlea as part of the
normal-hearing process. Available evidence suggests that
otoacoustic emissions are generated by the cochlea's outer
hair cells and that the presence of OAEs is an indication
that the outer hair cells are viable. Clinical evidence
indicates that these emissions normally occur with normal
hearing, or at most, mild hearing loss (usually 30-40 dB
HL). The majority of hearing-impaired individuals will be
identified by a simple OAE test. |
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The product has the same intended use, indications for use, and principle of operation as the ERO•SCANTM OAE Test System (K010165). Modifications to the device do not raise new or different questions of safety or effectiveness for the device's intended use. The results of risk analysis and design verification and validation activities provide evidence that the device is as safe and effective as its predicate. This evidence therefore demonstrates that the ER36 is substantially equivalent to its predicate device, ERO®SCANTM OAE Test System.
VII. PERFORMANCE DATA
The risk analysis method used to assess the impact of the modifications was ISO 14971:2007. According to the results of the risk analysis, the residual risks of the device were deemed acceptable in relation to device benefits. Design verification activities were performed to ensure the modified device was substantially equivalent to the predicate device and that it met performance specifications; this testing was performed on the basis of the risk analysis and per device design controls.
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Conclusion: The ER36 utilizes the same technology and has the same indications for use as the cited predicate device (21 CFR 807.92(a)(3)), and is therefore substantially equivalent.