(244 days)
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Not Found
No
The summary does not mention AI, ML, or related terms, and the description focuses on automated testing software for audiometers.
No
The device is described as an "automated testing software accessory" used for "conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders." This indicates a diagnostic purpose, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section states that Clarujust™ is "indicated for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders."
Yes
The device is explicitly described as "automated testing software accessory" and does not mention any accompanying hardware components that are part of the device itself. It functions as an accessory to existing hardware (ANSI S3.6 speech audiometers) but is presented as a software product.
Based on the provided information, Clarujust™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Clarujust™'s Function: Clarujust™ is described as an automated testing software accessory for speech audiometers. It's used to conduct diagnostic hearing evaluations by testing a patient's response to sounds, not by analyzing biological specimens.
- Intended Use: The intended use clearly states it's for "conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders," which is a functional assessment of hearing, not an in vitro analysis.
Therefore, Clarujust™ falls under the category of a diagnostic device used for functional testing, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
EWO
Device Description
Clarujust™ is an automated testing software accessory for ANSI S3.6 speech audiometers.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
patients over 18
Intended User / Care Setting
trained medical professional
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 874.1050 Audiometer.
(a)
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.(b)
Classification. Class II. Except for the otoacoustic emission device, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, if it is in compliance with American National Standard Institute S3.6-1996, “Specification for Audiometers,” and subject to the limitations in § 874.9.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with stylized wings and tail feathers. The logo is black and white.
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 (800) 638-2041 or (301) 796-7100 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
2
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