CLARUJUST

K092089 · Audigence, Inc. · EWO · Mar 10, 2010 · Ear, Nose, Throat

Device Facts

• Record ID: K092089
• Device Name: CLARUJUST
• Applicant: Audigence, Inc.
• Product Code: EWO · Ear, Nose, Throat
• Decision Date: Mar 10, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Clarujust™ is an automated testing software accessory for ANSI S3.6 speech audiometers. Clarujust™ is indicated for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. This device is intended to be used by trained medical professional for patients over 18 without cognitive difficulties.

Device Story

Clarujust™ is an automated software accessory for ANSI S3.6 speech audiometers. It functions as an add-on to existing audiometric hardware to facilitate diagnostic hearing evaluations. Operated by trained medical professionals in clinical settings, the software automates the testing process to assist in diagnosing potential otologic disorders. By standardizing the administration of speech audiometry, the device aims to improve the consistency and efficiency of hearing assessments, ultimately supporting clinicians in making informed diagnostic decisions for adult patients.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software accessory for ANSI S3.6 speech audiometers. Operates as an automated testing platform. Connectivity via integration with standard speech audiometry hardware. No specific materials or energy sources listed as it is a software-based accessory.

Indications for Use

Indicated for diagnostic hearing evaluations and assisting in the diagnosis of otologic disorders in patients over 18 years of age without cognitive difficulties. No contraindications.

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

Audigence, Inc. % Craig Pagan C2C Development, LLC 1050 W. NASA Blvd, Suite 154 Melbourne, FL 32901

MAR 1 0 2010

Re: K092089

Trade/Device Name: Audigence Clarujust™ Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: Class II Product Code: EWO Dated: February 12, 2010 Received: February 18, 2010

Dear Mr. Craig Pagan:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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Page 2 - Mr. Craig Pagan

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,

Q. A. Thomson Jr.

Malvina B. Eydelman, M.L 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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## INDICATIONS FOR USE STATEMENT

510(k) Number: K092089

Clarujust™ Device Name:

## INDICATIONS:

Clarujust™ is an automated testing software accessory for ANSI S3.6 speech audiometers. Clarujust™ is indicated for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. This device is intended to be used by trained medical professional for patients over 18 without cognitive difficulties.

## CONTRAINDICATIONS:

None

> Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

AS

(Division Sign-Off) Division of Ophthatmic, Neurological and Ear, Nose and Throat Devices

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510(k) Number K092089