(84 days)
The Pilot Test and Detective audiometers are both manual single channel pure tone air conduction audiometers used to test the hearing thresholds of children.
The Pilot Test audiometer has the additional capability of using speech testing using "select picture" audiometry with Spondee word lists.
The Detective audiometer has the additional capability to perform automatic pure-tone audiometry.
manual single channel pure tone air conduction audiometers
This document is a 510(k) clearance letter from the FDA for two audiometers, "Pilot Test" and "Detective." It primarily addresses the regulatory approval of the devices based on substantial equivalence to existing predicate devices.
The document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory approval notice, not a technical performance report or a clinical study summary.
Therefore, requested information regarding device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance results cannot be extracted from this document.
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Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 3 2006
Maico-Diagnostics c/o Mr. Daniel Eggan 7625 Golden Triangle Drive Eden Prairie, MN 55344
Re: K060883
Trade/Device Name: "Pilot Test" or "Detective" Audiometers Regulation Number: 21 CFR 874.1050 Regulatory Class: Class II Product Code: EWO, GWJ Dated: March 29, 2006 Received: April 03, 2006
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
M.B. Egelston MD
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section A
Indications for Use Statement
Applicant: Maico-Diagnostics
510(k) Number (if known):
Device Name: Pilot Test, or Detective Audiometers
Indications For Use:
The Pilot Test and Detective audiometers are both manual single channel pure tone air conduction audiometers used to test the hearing thresholds of children.
KO60883
The Pilot Test audiometer has the additional capability of using speech testing using "select picture" audiometry with Spondee word lists.
The Detective audiometer has the additional capability to perform automatic pure-tone audiometry.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE
Prescription Use
(Per 21 CFR 801.109)
(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises
KO60883 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.