(55 days)
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No
The description details a computer-controlled audiometer that follows a standard, pre-defined algorithm (Modified Hughson-Westlake method) based on user input. There is no mention of learning, adaptation, or complex pattern recognition characteristic of AI/ML. The technology described is a traditional automated system.
No
The device is described as an audiometer for automatic hearing testing, not for treating hearing issues. Its primary function is diagnostic, not therapeutic.
Yes
The device is an audiometer, which is used for automatic hearing testing to assess an individual's hearing ability. Hearing tests are diagnostic procedures.
No
The device description explicitly states that the CCA-200 is an "air conduction audiometer" that presents tones through a "TDH-39 headset" and receives input from a "hand switch." These are physical hardware components that are part of the device, even though it is controlled by software on a separate computer.
Based on the provided text, the CCA-200 Computer Controlled Audiometer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is performed outside of the living body ("in vitro").
- CCA-200 Function: The CCA-200 is an audiometer. Its function is to test a person's hearing by presenting tones and recording their responses. This is a direct interaction with the patient's sensory system and does not involve the analysis of biological specimens.
The description clearly states the device's purpose is "automatic hearing testing" and involves presenting tones through a headset to a "test subject" who indicates when they have heard the tone. This is a functional test of hearing, not an analysis of a biological sample.
N/A
Intended Use / Indications for Use
The CCA-200 Computer Controlled Audiometer is an air conduction audiometer designed to provide automatic hearing testing. A series of tones is presented by the CCA-200 through a TDH-39 headset to the test subject. The test subject then presses a hand switch to indicate Lo the CCA-200 that the tone bas been heard. The CCA-200 proceeds with the hearing test using the Modified Hughson-Westlake method of hearing testing, and records the subject's responses, The resultant data are available to print on an external printer connected to the control computer or to store in the computer.
The CCA-200 can perform its function only on command from a control computer. The computer monitor displays the setup and control screens that are used to perform the Lest functions. An IRM compatible computer with a 486DX2-50 or proceessor, running Windows 95 or Windows NT, is required. Control of the CCA-200 is handled through the RS232 serial port. The computer is not included with the CCA-200.
The CCA-200 is designed for use in test environments where multiple automatic hearing tests are controlled from a single computer. The CCA-200 has a range of options for both computer interfacing and automatic testing, such as multilingual voice instructions. These options are selected using a setup screen on the computer.
Product codes
77 EWO
Device Description
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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
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Indicated Patient Age Range
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Intended User / Care Setting
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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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES · USA
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 5 1998
David P. Mayou Vice-President Benson Medical Instruments Company 2344 Nicollet Avenue, Suite 150 Minneapolis, MN 55404
Re:
K981439 CCA-200 (Computer Controlled Audiometer Dated: March 19, 1998 Received: April 21, 1998 Regulatory class: II 21 CFR 874.1050/Procode: 77 EWO
Dear Mr. Mayou:
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 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 Rederal Food, Drug, and Cosmetic Act (Act). 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 (Premarket Approval), 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 895. A substantially equivaliation assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) 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 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 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 and additionally 809.10 for in vitto diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/odrh/dsmaldsmam.html".
Sincerely yours,
Lillian Yin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductiv Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
of 1 Parc
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device I ame:_ CCA-200
Indicatic is For Use:
The CCA-200 Computer Controlled Audiometer is an air conduction audiometer designed to provide automatic hearing testing. A series of tones is presented by the CCA-200 through a TDH-39 headset to the test subject. The test subject then presses a hand switch to indicate Lo the CCA-200 that the tone bas been heard. The CCA-200 proceeds with the hearing test using the Modified Hughson-Westlake method of hearing testing, and records the subject's responses, The resultant data are available to print on an external printer connected to the control computer or to store in the computer.
The CCA-200 can perform its function only on command from a control computer. The computer monitor displays the setup and control screens that are used to perform the Lest functions. An IRM compatible computer with a 486DX2-50 or proceessor, running Windows 95 or Windows NT, is required. Control of the CCA-200 is handled through the RS232 serial port. The computer is not included with the CCA-200.
The CCA-200 is designed for use in test environments where multiple automatic hearing tests are controlled from a single computer. The CCA-200 has a range of options for both computer interfacing and automatic testing, such as multilingual voice instructions. These options are selected using a setup screen on the computer.
(PLE VSE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NERDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | ||
|---|---|---|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | ||
| 510(k) Number | K981439 | |
| OR | Over-The-Counter Use |
Prescript on Use (Pet 21 ( FR 801.109)
The former the may be the many of the may be the may be the
OR
Over-The-Counter Use
(Optional Format 1-2-96)