(86 days)
Vivosonic NeuroScreen™ is indicated for use in the recording and analysis of human auditory brainstem response data necessary for the screening for hearing loss. The Vivosonic NeuroScreen M is indicated for newborns and infants from 34 weeks gestational age to 6 months.
Not Found
I am sorry, but the provided text is a 510(k) summary from the FDA for the Vivosonic NeuroScreen™ Infant Hearing Screener. It outlines the regulatory approval process and includes the indications for use.
However, it does not contain any information about the acceptance criteria, the specific study conducted to prove device performance, sample sizes, data provenance, ground truth establishment, or any comparative effectiveness studies.
Therefore, I cannot fulfill your request for this information based on the provided text.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Vivosonic, Inc. APR - 4 2008 c/o Amjad Rana Manager Quality Assurance and Regulatory Affairs 120-5525 Eglinton Avenue West Toronto, ON M9C 5K5 Canada
Re: K080060
Trade/Device Name: NeuroScreen™ Infant Hearing Screener Regulation Number: 21 CFR 882.1900 Regulation Name: Evoked response auditory stimulator Regulatory Class: Class II Product Code: GWJ Dated: January 7, 2008 Received: January 9, 2008
Dear Mr. Rana:
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. Iisting 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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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M.B. Egolman, m.d.
Malvina B. Evdelman, 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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080060
Indications for Use
510(k) Number (if known): Device Name: Vivosonic NeuroScreen™ Indications for Use:
Vivosonic NeuroScreen™ is indicated for use in the recording and analysis of human auditory brainstem response data necessary for the screening for hearing loss. The Vivosonic NeuroScreen M is indicated for newborns and infants from 34 weeks gestational age to 6 months.
Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Per 21 CFR Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Vann Sorker
(Division Sign-Off) Division of Ochthalmic Ear, Nose and Throat Devises
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).