(45 days)
The device use would be indicated in those cases where vocal fold contact information is considered helpful in evaluating physiologically normal speakers for research purposes or clinically in cases of vocal fold pathologies.
Electroglottograph
This document is a 510(k) clearance letter from the FDA for an Electroglottograph device (K990240). It primarily addresses the regulatory approval process and the intended use of the device.
Based on the provided text, there is no information available regarding acceptance criteria, performance studies, or details about the validation of the device beyond its substantial equivalence to a legally marketed predicate device.
The letter states: "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 legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."
This indicates that Kay Elemetrics, Corp. did not provide- or was not required to provide- extensive clinical or performance study data for this 510(k) submission. Instead, the device was cleared based on its substantial equivalence to a device already on the market before 1976. Therefore, all the specific information requested in your prompt (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth, training set information) is not present in the provided document.
To obtain such information, one would typically need to review the full 510(k) submission summary or other regulatory documents that may have been filed by the manufacturer, which are not included here.
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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of three human profiles facing right, with flowing lines suggesting movement or progress.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 1 1999
William D. Harbeson Director of Research and Development Kay Elemetrics, Corp. 2 Bridgewater LN. Lincoln Park, NJ 07035
Re:
K990240 Electroglottograph Dated: January 20, 1999 Received: January 25, 1999 Regulatory class: II 21 CFR 874.1325/Procode: 77 KLX
Dear Mr. Harbeson:
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 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). 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 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 Quality System Regulation (QS) 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 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 requlation 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/cdrh/dsma/dsmamain.html".
Sincerely yours,
Capt. Daniel C. Schultz, M.D.
Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K990240 510(k) Number
Device Name: Electroglottograph
Indications For Use:
The device use would be indicated in those cases where vocal fold contact information is considered helpful in evaluating physiologically normal speakers for research purposes or clinically in cases of vocal fold pathologies.
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Segmon
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological D 240 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use (Option Format 1-2-96)
§ 874.1325 Electroglottograph.
(a)
Identification. An electroglottograph is an AC-powered device that employs a pair of electrodes that are placed in contact with the skin on both sides of the larynx and held in place by a collar. It is intended to measure the electrical impedance of the larynx to aid in assessing the degree of closure of the vocal cords, confirm larygeal diagnosis, aid behavioral treatment of voice disorders, and aid research concerning the laryngeal mechanism.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.