(27 days)
The Vivo 200 DPS VivoScan™ Version 2.0 is indicated for use when it is necessary for a trained health care professional (for example an Audiologist) to measure or determine cochlear function by measuring, recording and displaying otoacoustic emissions. This device does not measure hearing, but helps to determine whether or not a hearing loss may be present, requiring further evaluation.
The Vivo 200 DPS VivoScan™ Version 2.0 does not measure hearing per se, but measures whether or not the cochlear hair cells are functioning. This device does not determine hearing levels, but allows the operator to establish specific pass or refer criteria.
The Vivo 200 DPS VivoScan™ Version 2.0 is indicated for patients of all ages from newborn through adults, to and including geriatic patients. The otoacoustic emissions test 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 Vivo 200 DPS VivoScan™ Version 2.0 is a prescription device. The labeling instructions and user operations are designed for trained professionals.
Vivo 200 DPS™ Version 2.0 is a diagnostic system that assists clinical professionals in the assessment and screening of cochlear function. The device includes a probe with a disposable tip that fits in the patient's ear canal. The probe contains a tiny speaker for stimulating the patient's ear with sound and a microphone for receiving low-volume otoacoustic emissions (OAEs).
The probe is connected to a probe adaptor circuit that generates the acoustic stimuli and amplifies the OAE responses. The probe adaptor circuit initiates stimulus delivery under the control of a dedicated notebook computer. The notebook computer reads the response from the probe adaptor and processes the signal digitally to measure and detect the OAE signal level, estimate the noise and display the results.
The Vivo 200 DPS™ Version 2.0 probe adaptor is capable of producing stimuli and eliciting Transient Evoked OAEs (TEOAEs) and Distortion Product OAEs (DPOAEs). TEOAEs are produced by the cochlea in response to short duration click sounds. DPOAEs are produced in response to two continuous pure tones that are close to each other in frequency.
The Vivo 200 DPS™ Version 2.0 software contains digital signal processing algorithms for measuring and detecting responses to both types of OAEs. The DPOAE and TEOAE responses are acquired and detected using the same probe. probe adaptor circuit and computer interface. The stimuli for both types of OAEs use the same probe, amplification circuitry and computer interface but utilize different modules in the probe adaptor circuit to generate their respective waveforms.
Software running on the notebook computer under the Windows XP™ operating system incorporates a graphical user interface that allows the user to configure the OAE test protocol, initiate and stop the test, print, save and review test results, and store patient information.
The provided document, K033108, is a 510(k) Summary for the Vivo 200 DPS VivoScan™ Version 2.0 OAE Audiometer. It primarily focuses on demonstrating substantial equivalence to a previously marketed device rather than providing detailed acceptance criteria and a comprehensive study report with specific performance metrics.
Based on the information provided in the document, here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state specific, quantifiable acceptance criteria (e.g., minimum sensitivity, specificity, accuracy, or specific response levels) for the Vivo 200 DPS VivoScan™ Version 2.0. The primary "performance" discussed is its substantial equivalence to a predicate device.
The main change in this version is the addition of Transient Evoked Otoacoustic Emissions (TEOAE) functionality. The "Software algorithm" comparison parameter notes:
| Comparison Parameter | Difference |
|---|---|
| Software algorithm | The propriety code in the VIVO 200DPS Version 2.0 uses averaging and Fast Fourier Transform (FFT) to process Transient Evoked Otoacoustic Emissions (TEOAE). |
This indicates the method used for TEOAE processing, but not its performance against a specific criterion. The document also states that the device "is designed to meet the EN 60601 series of standards for electromagnetic (EMI) and electrical safety," which are safety and electrical performance standards, not diagnostic performance acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not provide details about a specific test set, its sample size, data provenance, or study type (retrospective/prospective) for evaluating the diagnostic performance of the Vivo 200 DPS VivoScan™ Version 2.0. The submission is a 510(k) for substantial equivalence, which often relies on demonstrating that the new device does not raise new questions of safety and effectiveness compared to a predicate device, sometimes without new clinical studies if the changes are minor.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Since no specific test set or study validating diagnostic performance is detailed, there is no information provided on the number or qualifications of experts used to establish ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Given the lack of a detailed performance study with a test set, no adjudication method is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The document does not mention any MRMC comparative effectiveness study or any AI component that would assist human readers. The device is described as a diagnostic system that assists clinical professionals by measuring, recording, and displaying otoacoustic emissions, implying it's a measurement tool rather than an AI-assisted diagnostic aid in the modern sense.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
While the device includes "digital signal processing algorithms" for measuring and detecting responses, the document does not describe a standalone performance study of these algorithms in isolation (i.e., algorithm only without human-in-the-loop performance as a diagnostic tool). The device is intended for use by a "trained health care professional."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Since no specific performance study with a test set is described, the type of ground truth used is not mentioned.
8. The sample size for the training set
The document does not describe a training set sample size. This type of information is typically related to machine learning models, which are not explicitly detailed as a primary component of this device beyond "digital signal processing algorithms."
9. How the ground truth for the training set was established
As no training set is described, how ground truth for a training set was established is not provided.
Summary of what is present in the document:
The 510(k) summary primarily asserts substantial equivalence to a predicate device, noting the addition of TEOAE functionality using digital signal processing algorithms (averaging and FFT). It defines the device's intended use and patient population. It does not provide details of clinical studies, performance metrics, acceptance criteria, or ground truth establishment typically found in submissions with novel diagnostic algorithms requiring such validation. The focus is on demonstrating that the updated device is safe and effective in a manner similar to its predecessor.
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OCT 2 7 2003
| 510(k) SUMMARY |
|---|
| ---------------- |
TRADE NAME OF DEVICE(S):
COMMON NAME:
CLASSIFICATION:
Vivo 200 DPS VivoScan™ Version 2.0 OAE Audiometer.
Otoacoustic Emissions Test Instrument.
The Vivo 200 DPS VivoScan™ Version 2.0 is Class II Medical Device (21CFR874.1050, Procode: EWO).
COMPANY NAME and ADDRESS:
Vivosonic Inc. 56 Aberfoyle Crescent, Suite 620 Toronto, ON Canada M8X 2W4
(877)-255-7685
(416)-231-2289
CONTACT PERSON:
Yuri Sokolov, PhD, President & CEO
TELEPHONE NUMBER:
FAX:
DESCRIPTION OF DEVICE:
Vivo 200 DPS™ Version 2.0 is a diagnostic system that assists clinical professionals in the assessment and screening of cochlear function. The device includes a probe with a disposable tip that fits in the patient's ear canal. The probe contains a tiny speaker for stimulating the patient's ear with sound and a microphone for receiving low-volume otoacoustic emissions (OAEs).
The probe is connected to a probe adaptor circuit that generates the acoustic stimuli and amplifies the OAE responses. The probe adaptor circuit initiates stimulus delivery under the control of a dedicated notebook computer. The notebook computer reads the response from the probe adaptor and processes the signal digitally to measure and detect the OAE signal level, estimate the noise and display the results.
The Vivo 200 DPS™ Version 2.0 probe adaptor is capable of producing stimuli and eliciting Transient Evoked OAEs (TEOAEs) and Distortion Product OAEs (DPOAEs). TEOAEs are produced by the cochlea in response to short duration click sounds. DPOAEs are produced in response to two continuous pure tones that are close to each other in frequency.
The Vivo 200 DPS™ Version 2.0 software contains digital signal processing algorithms for measuring and detecting responses to both types of OAEs. The DPOAE and TEOAE responses are acquired and detected using the same probe. probe adaptor circuit and computer interface. The stimuli for both types of OAEs use the same probe, amplification circuitry and computer interface but utilize different modules in the probe adaptor circuit to generate their respective waveforms.
Software running on the notebook computer under the Windows XP™ operating
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system incorporates a graphical user interface that allows the user to configure the OAE test protocol, initiate and stop the test, print, save and review test results, and store patient information.
INDICATION FOR USE:
The Vivo 200 DPS VivoScan™ Version 2.0 is indicated for use when it is necessary for a trained health care professional (for example an Audiologist) to measure or determine cochlear function by measuring, recording and displaying otoacoustic emissions. This device does not measure hearing, but helps to determine whether or not a hearing loss may be present, requiring further evaluation.
The Vivo 200 DPS VivoScan™ Version 2.0 does not measure hearing per se, but measures whether or not the cochlear hair cells are functioning. This device does not determine hearing levels, but allows the operator to establish specific pass or refer criteria.
The Vivo 200 DPS VivoScan™ Version 2.0 is indicated for patients of all ages from newborn through adults, to and including geriatric patients. The otoacoustic emissions test 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 Vivo 200 DPS VivoScan™ Version 2.0 is a prescription device. The labeling instructions and user operations are designed for trained professionals.
ELECTRICAL SAFETY: The Vivo DPS VivoScan Version 2.0 is designed to meet the EN 60601 series of standards for electromagnetic (EMI) and electrical safety required for Medical Electrical Equipment.
Substantial Equivalence Comparison
The Vivo 200 DPS™ Version 2.0 device is substantially equivalent to our currently marketed Vivo 200 DPS™ OAE Audiometer.
| Comparison Parameter | Difference |
|---|---|
| Intended use | Essentially the same. |
| Patient population | No difference |
| Patient connection and connectionsites | No difference |
| Hardware configuration | No difference |
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| Software algorithm | The propriety code in the VIVO 200DPS Version 2.0uses averaging and Fast Fourier Transform (FFT) toprocess Transient Evoked Otoacoustic Emissions(TEOAE)1. |
|---|---|
| User Manual | The User Manual has been updated and revised toprovide information and use instructions for the TEOAEmeasurement capability. |
| Safety Characteristics | There is no difference in patient connection and isolation. |
1 Transient Evoked Otoacoustic Emissions (TEOAE) functionality was added to the Vivo 200 DPS™ Version 2.0. TEOAEs are OAEs produced in response to a short duration sound. These short-duration stimuli may be tone bursts or clicks.
Date Summary Prepared:
October 7, 2003
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, with three parallel lines forming the head and shoulders. The figure is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.
Public Health Service
OCT 27 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Vivosonic Inc. Yuri Sokolov, Ph.D. President & CEO 56 Aberfoyle Crescent, Suite 620 Toronto, ON Canada M8X 2W4
Re: K033108
Trade/Device Name: Vivo 200 DPS VivoScan™ Version 2.0 OAE Audiometer Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: Class II Product Code: EWO Dated: September 29, 2003 Received: September 30, 2003
Dear Dr. Sokolov:
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 - Yuri Sokolov, Ph.D
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. Paiz Korenthal
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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K033108/A'
Page 1 of 1
510(k) Number (if known): __ K033108
Vivo 200 DPS VivoScan™ Version 2.0 Device Name:
Indications For Use:
The Vivo 200 DPS VivoScan™ Version 2.0 is indicated for use when it is necessary for a trained health care professional (for example an Audiologist) to measure or determine cochlear function by measuring, recording and displaying otoacoustic emissions. This device does not measure hearing, but helps to determine whether or not a hearing loss may be present, requiring further evaluation.
The Vivo 200 DPS VivoScan™ Version 2.0 does not measure hearing per se, but measures whether or not the cochlear hair cells are functioning. This device does not determine heaning levels, but allows the operator to establish specific pass or refer criteria.
The Vivo 200 DPS VivoScan™ Version 2.0 is indicated for patients of all ages from newborn through adults, to and including geriatic patients. The otoacoustic emissions test 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 Vivo 200 DPS VivoScan™ Version 2.0 is a prescription device. The labeling instructions and user operations are designed for trained professionals.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
JRC
(Division Sign-Off) Division of Ophthalmic Nose and Threat O
510(k) Number K033108
(Optional Format 3-10-98)
§ 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.