(196 days)
The Maico MB 11 with BERAphone and the MB 11 Standard are intended to generate evoked auditory brainstem response (ABR) - based measurements for newborn hearing screening, providing a PASS/REFER result. This does not require special technical skills or interpretation of the results.
Not Found
The provided text is an FDA 510(k) clearance letter for the Maico MB 11 with BERAphone Probe and MB 11 Standard. It states that the device is "substantially equivalent" to legally marketed predicate devices and is intended for newborn hearing screening, providing a PASS/REFER result. However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is solely an FDA clearance letter and does not include the technical details of the device's validation.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
JAN 2 9 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Maico Diagnostics c/o Mr. Daniel Eggan Quality and Regulatory Compliance Manager 7625 Golden Triangle Drive Eden Prairie, MN 55344
Re: K082035
Trade/Device Name: MB11 with BERAphone Probe, MB11 Standard Regulation Number: 21 CFR 882.1900 Regulation Name: Evoked response auditory stimulator Regulatory Class: Class II Product Code: GWJ Dated: January 15, 2009 Received: January 16, 2008
Dear Mr. Eggan:
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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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. Egelston, m.d.
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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Section A
Indications for Use Statement
Applicant(s): Maico-Diagnostics
K082035 510(k) Number (if known):
Device Name: Maico MB 11with BERAphone Probe, MB 11 with BERAphone Probe, or MB 11 Standard
Indications For Use:
The Maico MB 11 with BERAphone and the MB 11 Standard are intended to generate evoked auditory brainstem response (ABR) - based measurements for newborn hearing screening, providing a PASS/REFER result. This does not require special technical skills or interpretation of the results.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
Dlm Doucit
1Divis on Sion-L Division of Ophthalmic and Ear. Nose and Throat Devi
510(k) Number K082035
§ 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).