(45 days)
The Integrity V500 with DPOAE and TEOAE test options 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.
DPOAE and TEOAE tests do not measure hearing per se, but measure 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 Integrity V500 with ABR/ASSR options is indicated for auditory evoked potential testing as an aid in detecting hearing loss and lesions in the auditory pathway.
Not Found
This is a 510(k) premarket notification for the Vivosonic Integrity Model V500, a device for measuring otoacoustic emissions (DPOAE and TEOAE Test Option) and auditory evoked potentials (ABR/ASSR Test Option). This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The 510(k) process is a pre-market submission demonstrating that the device is substantially equivalent to a legally marketed predicate device. It typically focuses on comparing the new device's technological characteristics, indications for use, and performance to a predicate device already on the market, rather than presenting a novel study to establish performance against pre-defined acceptance criteria (as might be seen in a de novo classification or PMA pathway).
Therefore, I cannot extract the requested information from the provided text because it is not present. The document focuses on regulatory approval based on substantial equivalence to a predicate device.
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Public Health Service
JAN 2 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Vivosonic, Inc. c/o Entela, Inc. Mr. N. E. Devine, Jr. 3033 Madison Ave. SE Grand Rapids, MI 49548
Re: K043396
Trade/Device Name: Integrity, Model V500 Regulation Number: 21 CFR 882.1900 Regulation Name: Biomicroscopes Regulatory Class: Class II Product Code: GWJ; EWO Dated: January 13, 2005 Received: January 14, 2005
Dear Mr. Devine:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 9 ro(ts) prematice is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the cherosure) to regally manet date of the Medical Device Amendments, or to a commerce prior to May 20, 1770, the excentions of the Federal Food, Drug. devices that have been reclassined in acceraation of a premarket approval application (PMA). and Cosment Act (Act) that do not require subject to the general controls provisions of the Act. The I bu may, merciole, market the do res, color connects for annual registration, listing of general controls provisions of the revelopment of the 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 Inay be subject to such additions, 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 I least of advised that I DT 8 issume of the your device complies with other requirements of the Act that I Dr Hab intatutes and regulations administered by other Federal agencies. You must or any I edetail 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 CI It Fart 6077, laboring (21 CFR Part 820); and if applicable, the clectronic 10.11 in the quand of of trol provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 – Mr. N. E. Devine, Jr.
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 halpi 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
Enclosure
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Indications for Use
510(k) Number (if known): Koy 3396
Device Name: INTEGRITY V500
Indications for Use:
DPOAE and TEOAE Test Option
The Integrity V500 with DPOAE and TEOAE test options 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.
DPOAE and TEOAE tests do not measure hearing per se, but measure 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.
ABR/ASSR Test Option
The Integrity V500 with ABR/ASSR options is indicated for auditory evoked potential testing as an aid in detecting hearing loss and lesions in the auditory pathway.
The Integrity V500 is a prescription device. The labeling, instructions and user operations are designed for trained professionals.
Prescription Use: Yes (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use: No (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)
Page 1 of 1
(Posted November 13, 2003)
n of Ophthalm Nose and Throat Dev
510(k) Number
§ 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).