(58 days)
Orthopantomograph® OP100 and Orthoceph® OC100 are intended to be used for producing diagnostic images of the surface of the dental arch and lateral images of the skull and lateral images of dentition, TM-joints using linear tomographic method.
Not Found
I apologize, but the provided text from the FDA 510(k) letters (K973642) for the Orthopantomograph® OP100 and Orthoceph® OC100 does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria.
The letters primarily cover the following:
- Approval of the 510(k) submission: Stating that the devices are substantially equivalent to pre-amendment devices.
- Regulatory classification: Class II, 21 CFR 872.1800/Procode: 90 EHD.
- General controls provisions: Annual registration, device listing, GMP, labeling, and prohibitions against misbranding and adulteration.
- Contact information for further questions.
- Indications for Use: Orthopantomograph® OP100 and Orthoceph® OC100 are intended to be used for producing diagnostic images of the dental arch, TM-joints, and lateral images using a linear tomographic method.
To answer your specific questions about acceptance criteria and performance studies, I would need a different type of document, such as:
- A Clinical Study Report
- A Performance Test Report
- The Pre-market Notification (510(k)) Summary (which often contains more detail on performance data if it was required for substantial equivalence)
- The Device's own technical specifications or validation documents
Without such information, I cannot provide details on the study design, acceptance criteria, or performance results.
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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 features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 21 1997
RISTO Mynttinen Regulatory Affairs Intstrumentarium Corporation Imaging Division P.O. Box 20 FIN-04301 Tuusula, Finland
Re:
K973642 Orthopantomograph® OP100 and Orthoceph® OC100 Dated: September 18, 1997 Received: September 24, 1997 Regulatory class: II 21 CFR 872.1800/Procode: 90 EHD
Dear Mr. Mynttinen:
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 Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 (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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 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 question 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 Yim
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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Image /page/1/Picture/0 description: The image contains the words INSTRUMENTARIUM and imaging. The word INSTRUMENTARIUM is in a smaller font and is above the word imaging. To the left of the words is a black graphic that looks like a stylized letter N.
October 28, 1997
K973642 5 10(k) Number:
l Devic : Name:
ﻢ. ﻭﻣ
Orthopantomograph® OP100 and Orthoceph® OC100
ndic: tions For Use: Orthopantomograph® OP100 and Orthoceph® OC100 are intended to be Onlopantomograph - Of 100 and Chination, Then interest of dentition, TM-joints used for producing diagnostion it af race of the of the surfall and lateral images of dental arch using linear tomographic method. _______
Instrumentarium Corp. Imaging Division
Risto Mynttinen
Regulatory Affairs
(Division Sign-Off)
( = colon of Reproductive, Abdominal, ENT,
and Radiological Devices and Radiological Devices,
510(k) Number K973642
ﮨﮯ Prescription Use. "er 21 CFR 801.109)
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.