MB 11

K011746 · Maico Diagnostic GmbH · GWJ · Aug 24, 2001 · Neurology

Device Facts

• Record ID: K011746
• Device Name: MB 11
• Applicant: Maico Diagnostic GmbH
• Product Code: GWJ · Neurology
• Decision Date: Aug 24, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1900
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Maico MB 11 is intended to generate evoked auditory brainstem response (ABR) - based measurements for both child and newborn hearing screening ..

Device Story

The Maico MB 11 is an auditory brainstem response (ABR) screening device used for newborns and children. It captures physiological electrical signals in response to auditory stimuli. The device processes these signals to determine hearing status, providing automated screening results to clinicians. It is intended for use in clinical settings to facilitate early detection of hearing impairment. The output assists healthcare providers in identifying patients requiring further diagnostic evaluation.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of device specifications and intended use.

Technological Characteristics

Auditory brainstem response (ABR) measurement system. Device utilizes signal processing to generate and analyze evoked potentials. Form factor designed for clinical screening environments.

Indications for Use

Indicated for hearing screening in newborns and children using evoked auditory brainstem response (ABR) measurements.

Regulatory Classification

Identification

An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 4 2001

Maico Diagnostic GmbH c/o Mr. Daniel Eggan Manager of Regulatory Affairs/Quality Assurance Maico Diagnostics 9675 West 76th Street Eden Prairie, Minnesota 55344

Re: K011746

Trade/Device Name: MB 11 Regulation Number: 882.1900 Regulatory Class: II Product Code: GWJ Dated: May 25, 2001 Received: June 5, 2001

Dear Mr. Eggan:

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 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 private that, 20, 1978, 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 Cosmotions 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations ( remailer in provide 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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Mr. Daniel Eggan

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 nontication. The I Drivination 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 CFF Part 801 and IT you desire specific acvice for your as ic devices), please contact the Office of Compliance at additionally 607.10 for m This alaguestions on the promotion and advertising of your device, [phone]. Trudinonally, for questions of [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsionals and Consumer Assistance at its toll-free number [phone] or Manufacturers Internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".

Sincerely yours,

Mark n Milkersa

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Section A

## Indications for Use Statement

Ver/ 3 - 4/24/96

Applicant(s): Maico-Diagnostic GmbH(manufacturer), and Maico-Diagnostics (distributor) ﻠ 510(k) Number (if known): K (11746

Device Name: Maico MB 11 or MB 11

Indications For Use:

The Maico MB 11 is intended to generate evoked auditory brainstem response (ABR) - based measurements for both child and newborn hearing screening ..

(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)

L. Mark N. Milliken

Division of General, Restorative and Neurological Devices

510(k) Number K011746