MA61, MA62, MA63 FAMILY OF PORTABLE AUDIOMETERS

K092244 · Diagnostic Group, LLC · EWO · Mar 1, 2010 · Ear, Nose, Throat

Device Facts

• Record ID: K092244
• Device Name: MA61, MA62, MA63 FAMILY OF PORTABLE AUDIOMETERS
• Applicant: Diagnostic Group, LLC
• Product Code: EWO · Ear, Nose, Throat
• Decision Date: Mar 1, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1050
• Device Class: Class 2

Intended Use

The MA61, MA62, and MA63, family of audiometers are a portable line of devices ranging from a one and a half channel, to a full two-channel, air, bone, and speech audiometer. These audiometers are used to screen, test, and diagnose hearing loss.

Device Story

MA61, MA62, and MA63 are portable audiometers; range from 1.5 to 2-channel configurations. Devices perform air, bone, and speech audiometry to screen, test, and diagnose hearing loss. Operated by clinicians in clinical settings. Devices generate auditory stimuli; output used by clinicians to assess patient hearing thresholds and diagnose auditory impairment.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Portable audiometer family; 1.5 to 2-channel architecture; supports air, bone, and speech audiometry. Class II device (21 CFR 874.1050).

Indications for Use

Indicated for screening, testing, and diagnosing hearing loss in patients requiring audiometric evaluation.

Regulatory Classification

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.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

MAR - 1 2010

Diagnostic Group, LLC DBA - Maico Diagnostics c/o Mr. Daniel Eggan 7625 Golden Triangle Drive Eden Prairie, MN 55344

Re: K092244/S001

Trade/Device Name:MA61, MA62, MA63 Family of Portable Audiometers Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: Class II Product Code: EWO Dated: January 11, 2010 Received: January 12, 2010

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device

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Page 2 - Mr. Daniel Egan

related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Rihannof

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neuroloical, and Ear, Nose, Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K092244

## Section A

## Indications for Use Statement

## Applicant(s): Diagnostic Group LLC, dba: Maico Diagnostics

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name(s): Maico MA61, MA62, and MA63 Indications For Use:

The MA61, MA62, and MA63, family of audiometers are a portable line of devices ranging from a one and a half channel, to a full two-channel, air, bone, and speech audiometer. These audiometers are used to screen, test, and diagnose hearing loss.

Prescription Use × (Part 21 CFR 801 Subpart D)

510(k) Number_

AND/OR

Over-The-Counter Use (21 CFR 801 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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| (Division Sign-Off) | | (Per 21 CFR 801.109) | Page 1 of |
| Division of Ophthalmic, Neurological and Ear, | | | |
| Nose and Throat Devices | | | |
| 510/k) Number | K092244 | | |