(60 days)
The OS1000 serie is software controlled diagnostic panoramic dental x-ray equipment for producing high quality images of dentition with multiple orbit, TMJ, sinus. Cross section radiography is also possible. Theses models can be applied widely to not only orthodontic, prothesis, oral surgery, implant treatment, but also ortorhinolaryngology, orthodontics.
The OS1000 is a Panoramic and Tomographic unit. The OS1000E is only a Panoramic unit. The OS1000C is a Panoramic, Tomographic and Cephalometric unit. The OS1000EC is only a Panoramic and Cephalometric unit.
The input describes a 510(k) notice for the Trophy Radiologie Panoramic Orthoslice OS1000 series, which are dental X-ray devices. However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
The document is a standard FDA 510(k) clearance letter and the "Indications for Use" statement from the manufacturer. These documents typically confirm that a device is substantially equivalent to a legally marketed predicate device but do not detail the specific studies, metrics, or performance data used to demonstrate that equivalence.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 5 1999
Marie-Pierre Labat-Camy Regulatory Affairs Manager Trophy Radiologie 4 rue F. Pelloutier Croissy Beaubourg 77437 Marne la Vallee Cedex, 2 FRANCE
Re:
K991455 Panoramic Orthoslice OS1000 series: OS1000, OS1000E, OS1000EC, OS1000P and OS1000EP Dated: April 12, 1999 Received: April 26, 1999 Regulatory Class: II 21 CFR 872.1800/Procode: 90 EHD
Dear Ms. Marie-Pierre Labat-Camy:
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 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 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 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/dsma/dsmamain.html".
Sincerely yours,
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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510 (k) NOTIFICATION
Image /page/1/Picture/1 description: The image shows the logo for Trophy REX Group. The logo features a stylized letter 't' with a circle on its upper right side. Below the 't' is the word "trophy" in a bold, sans-serif font. Underneath "trophy" is the text "REX Group", with "REX" in a bolder font than "Group".
510 (k) Number :
Device Name : OrthoSlice OS1000, OS1000E, OS1000C, OS1000EC
Indication For Use :
The OS1000 serie is software controlled diagnostic panoramic dental x-ray equipment for producing high quality images of dentition with multiple orbit, TMJ, sinus. Cross section radiography is also possible.
Theses models can be applied widely to not only orthodontic, prothesis, oral surgery, implant treatment, but also ortorhinolaryngology, orthodontics.
The OS1000 is a Panoramic and Tomographic unit. The OS1000E is only a Panoramic unit
The OS1000C is a Panoramic, Tomographic and Cephalometric unit. The OS1000EC is only a Panoramic and Cephalometric unit
( PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED )
Concurence of CDRH, Office of Device Evaluation (ODE)
Daniel h. Symm
Division Sign Off
Division Sign-Off Division of Reproductive, Abdominal, ENT, and Radiological De 510(k) Number
Prescription Use
( Per 21 CFR 801.109 )
Or
Over-The-Counter Use_ ( Optional Format 1-2-96)
§ 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.