(249 days)
The Mitaya aluminum interspaced x_ray grid is a standard style of ... x-ray grid, used in conventional radiography techniques.
X-Ray Grid
The provided text is a 510(k) premarket notification letter from the FDA to William Hague X-Ray Accessory Corporation regarding their "Mitaya Aluminum Interspaced X-Ray Grid" (K964025). This document does not contain any information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, ground truth establishment, or any details related to AI or MRMC studies.
The letter is a regulatory document stating that the FDA has determined the device is substantially equivalent to a legally marketed predicate device for the stated indications for use, and therefore, it can be marketed.
Therefore, I cannot fulfill your request for information about acceptance criteria and a study proving the device meets those criteria based on the provided text. The device described (an X-Ray Grid) is a physical accessory for conventional X-ray machinery, not an AI-powered device, and the document is a regulatory clearance letter, not a study report.
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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
William Hague X-Ray Accessory Corporation 207 Day Street Danielson, CT 06239 ... JUN 1 3 1997 Re: K964025
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Mitaya Aluminum Interspaced X-Ray Grid Dated: May 19, 1997 Received: May 22, 1997 Regulatory class: I 21 CFR 892.1910/Procode: 90 IXJ
Dear Mr. Hague:
参 We have reviewed your Section 510(k) notification of intent to market the device and we have deemnined the device is substantially equivalent for the indications for use stated in interstate commerce prior to May 28, 1976, the enactment date of the Medical 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 equivalient determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 does not affect any obligation you might have under sections 51 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) 594-4591 for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. 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/cdrh/dsmamain.html".
Sincerely yours,
William
Lillian Yin, Ph.D. 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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510(k) Number (if known):__K964025
Device Name:__X-Ray Grid
Indications For Use: The Mitaya aluminum interspaced x_ray grid is a standard style of ... x-ray grid, used in conventional radiography techniques.
It is used by a qualified x-ray technician, operating conventional x-ray machinery
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Concurrence of CDRH, Office of Device Evaluation (ODE)
David L. Segmon
(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological De 510(k) Number
Prescription Use______________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)
OR
Over -- The-Counter Use_______________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 892.1910 Radiographic grid.
(a)
Identification. A radiographic grid is a device that consists of alternating radiolucent and radiopaque strips intended to be placed between the patient and the image receptor to reduce the amount of scattered radiation reaching the image receptor.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.