(27 days)
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No
The summary describes a system for measuring distortion product otoacoustic emissions (DPOAEs) and does not mention any AI or ML components in its description, intended use, or performance studies.
No
The device is used to determine the presence of cochlear function by measuring distortion product tones, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is described as a "DPOAE Measurement System" intended to "determine the presence of cochlear function" by measuring distortion product tones generated by the cochlea. This falls under the definition of a diagnostic device as it measures and evaluates a bodily function to identify its presence or absence.
No
The device description explicitly states it is a "Measurement system" designed to provide "acoustic stimuli" and perform "rapid clinical measurement and evaluation" of distortion product tones. This implies the presence of hardware components (e.g., a probe, microphone, speaker) to generate stimuli and measure responses, which is inconsistent with a software-only device.
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 taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The CUB®DIS II™ DPOAE Measurement System measures acoustic signals generated by the cochlea within the ear canal. It does not analyze biological samples taken from the body.
- Intended Use: The intended use is to determine the presence of cochlear function by measuring these acoustic signals, not by analyzing a biological sample.
Therefore, the device operates in vivo (within the living body) by interacting with the ear canal and measuring a physiological response, rather than in vitro (in glass) by analyzing a sample outside the body.
N/A
Intended Use / Indications for Use
The intended use of The CUBEDIS II TM DPOAE Measurement System is to determine the presence of cochlear function.
Product codes
77 EWO
Device Description
The CUBEDIS II TM DPOAE Measurement system is designed to provide acoustic stimuli for, and rapid clinical measurement and evaluation of, odd order distortion product tones generated by the cochlea and measured in the ear canal, at the audiometric frequencies (or other frequencies, as desired), between 500 through 8,000 Hz with no known artifacts, a low noise floor system, and a high signal-to-noise ratio.
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 (cochlea)
Indicated Patient Age Range
Not Found
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
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Key Metrics
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Predicate Device(s)
Etymotic Research CUBEDIS TM Oto-acoustic Emission
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
510(k) Summary
MAY 20 1998
PREPARED BY:
Mimosa Acoustics, Inc. 382 Forest Hill Way Mountainside, NJ 07092
Patricia S. Jeng, President
TELEPHONE:
CONTACT PERSON:
DATE ON WHICH THE SUMMARY WAS PREPARED
NAME OF DEVICE:
COMMON NAME:
April 22, 1998
acoustic Emission
(908) 518 0711
CUBEDIS II TM DPOAE Measurement System
Etymotic Research CUBEDIS TM Oto-
Otoacoustic Emissions Test Instrument
PREDICATE DEVICE:
FUNCTION OF DEVICE:
The CUBEDIS II TM DPOAE Measurement system is designed to provide acoustic stimuli for, and rapid clinical measurement and evaluation of, odd order distortion product tones generated by the cochlea and measured in the ear canal, at the audiometric frequencies (or other frequencies, as desired), between 500 through 8,000 Hz with no known artifacts, a low noise floor system, and a high signal-to-noise ratio.
SAFETY:
The Mimosa Acoustic CUBEDIS II TM DPOAE Measurement System is in compliance with the following standards:
EN 55011B Emissions Test EN 60601-1-2 Immunity Test IEC 801-2 Electrostatic Discharge Test IEC 801-3 RF Electromagnetic Field Test IEC 801-4 Fast Transients Test IEC 801-5 Surge Test Standard for Medical Electrical Equipment, Part 1:
General Requirements for Safety - UL 2601-1, Second Edition
1
1
Medical Electrical Equipment, Part 1: ical Electrical Equipment, Part 1.
General Requirements for Safety - CAN/CSA - C22.2 No. 601.1-M90.
COMPARISON of the Mimosa CUB®DIS II TM device to the Etymfic Research CUB®DIS TM unit:
Identical for both products INDICATION FOR USE:
ﻟﺴﻢ
Comaprision between Ariel_ DSP16+ and Mimosa DSP Boards
| | Computer
Software | Computer
Hardware | DSP Board | Probe Driver
&
Microphone
Pre-Amplifier | Acoustic Probe
&
Ear-tips | |
|--|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|----------------|
| | CUBDIS | Data Collections:
DOS in Fortran
Graphic displays
DOS Fortran Package
Signal Processing:
Fortran routines | DSP port
Uses ISA full-size
plug-in slot | Ariel DSP16 Plus
Etymotic Research
ER-10C DPOAE
Probe Driver-Preamp | Etymotic Research
ER-10C DPOAE
Low Noise Probe
&
ER10C14 series ear-tips | |
| | CUBDIS II | Data Collections:
Window95 Visual C++
Graphic displays
Window95 Visual C++
Window95 Visual Basic
Signal Processing:
Same routines as the
Fortran routines in
CUBDIS system. | Uses PCMCIA card
plug-in slot | MA DSP PC Card
(PCMCIA Card) | Mimosa Acoustics
Probe Interface
Cable (PIC)
designed after
ER-10C DPOAE
Probe Driver-Preamp
with Etymotic's help. | Same as above. |
2
| Parameters | Ariel DSP16+ | Mimosa DSP |
|---|---|---|
| Size (Type) | ISA full-size DSP board | PC (PCMCIA) Type II DSP card |
| INPUT | ||
| Measurement Bandwidth | 20 kHz | Same |
| ADC Resolution | 16 bit | Same |
| ADC Differential Nonlinearity | - | $ \pm0.5 $ LSB |
| Instantaneous Dynamic Range - | ||
| Line Inputs | 88 dB | 85 dB |
| Total Harmonic distortion - Line | ||
| Inputs | 0.025 | 0.006 |
| Signal-to-Intermodulation distor- | ||
| tion | - | 90 dB (Typ) |
| Full Scale Input Voltage: | 20 Vpp | 2.9 Vpp |
| OUTPUT | ||
| Measurement Bandwidth | 20 kHz | Same |
| DAC Resolution | 16 bits | Same |
| DAC Differential Nonlinearity | - | $ \pm0.5 $ LSB |
| Total Dynamic Range | 88 dB | 95 dB |
| Total Harmonic Distortion | 0.025 | 0.01% |
| Signal-to-Intermodulation Distor- | ||
| tion | - | 85 dB |
| Full Scale Output Voltage | 20 Vpp | 2.8 Vpp |
Comaprision between Ariel_ DSP16+ and Mimosa DSP Boards
。・
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3
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 0 1998
Patricia S. Jeng President Mimosa Acoustics, Inc. P.O. Box 1111 Mountainside, New Jersey 07092 Re:
The CUB® DIS II ™ DPOAE Measurement System Dated: April 22, 1998 Received: April 23, 1998 Regulatory class: II 21 CFR 874.1050/Procode: 77 EWO
Dear Ms. Jeng:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".
Sincerely yours,
Kiliaith
Lillian Yin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): $9814 6.6 The CUB®DIS II™ DPOAE Measurement System Device Name:
Indications For Use:
1
The intended use of The CUB®DIS II™ DPOAE Measurement System is to determine the presence of cochlear function.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ehrich A. Reppert
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic
Radiological Devices
510(k) Number K981460
Prescription Use (Pcr 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Formal 1-2-96)