(87 days)
The CCA-220 Audiometer is an air-conduction audiometer designed to provide automatic hearing testing. A series of tones is presented by the CCA-220 through a Telephonics TDH-39 headset. The test subject then presses a hand switch to indicate to the CCA-200 that the tone has been heard. The CCA-220 proceeds with the hearing testing, and records the subject's responses. The resultant test data are available to print on an integral printer or to store in the CCA-220's hard drive.
The CCA-220 has an integral computer which provides all of the capabilities of the instrument. The instrument's display panel shows the setup and control screens that are used to perform. the test functions. The instrument is based on an integral PC compatible computer with a Pentitura processor, running the operating system of Microsoft Windows 95. Control of the CCA-220 is handled by selecting the desired test elements on the touch screen monitor. The instrument also incorporates an internal printer for printing test results. The CCA-220 has a range of options for both computer interfacing and automatic testing, such as error detection and multilingual voice instruction. These options are selected using the setup screen on the touch-screen monitor.
The provided text is a 510(k) premarket notification letter and the "Indications for Use" statement for the CCA-220 Audiometer. It describes the device's function and intended use but does not contain any information about acceptance criteria, study details, or performance metrics.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval and the device's general capabilities, not on clinical performance studies or specific acceptance criteria.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 9 1998
David P. Mayou Treasure Benson Medical Instruments Co. 3144 Nicollet Avenue South #150 Minneapolis, MN 55404
Re:
K982441 CCA-220 Dated: July 10, 1998 Received: July 14, 1998 Regulatory class: II 21 CFR 874.1050/Procode: 77 EWO
Dear Mr. Mayou:
We have reviewed your Section $10(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for usestated 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 Federal 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 equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Ouality System Regulation (OS) for Medical Devices: General regulation (2) 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.
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 vitro 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/cdrb/dsmaldsmamain.html".
Sincerely yours,
William Yi
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number (if known): | K952441 |
|---|---|
| Device Name: | CCA-220 |
Indications For Use:
The CCA-220 Audiometer is an air-conduction audiometer designed to provide automatic hearing testing. A series of tones is presented by the CCA-220 through a Telephonics TDH-39 headset. The test subject then presses a hand switch to indicate to the CCA-200 that the tone has been heard. The CCA-220 proceeds with the hearing testing, and records the subject's responses. The resultant test data are available to print on an integral printer or to store in the CCA-220's hard drive.
The CCA-220 has an integral computer which provides all of the capabilities of the instrument. The instrument's display panel shows the setup and control screens that are used to perform. the test functions. The instrument is based on an integral PC compatible computer with a Pentitura processor, running the operating system of Microsoft Windows 95. Control of the CCA-220 is handled by selecting the desired test elements on the touch screen monitor. The instrument also incorporates an internal printer for printing test results.
The CCA-220 has a range of options for both computer interfacing and automatic testing, such as error detection and multilingual voice instruction. These options are selected using the setup screen on the touch-screen monitor.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_i/ (Per 21 CFR 801.109)
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Over-The-Counter Use_
(Optional Format 1-2-96)
Vorid A. Sygmm
(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological De 510(k) Number
§ 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.