(310 days)
The Orthopantomograph® OP300 dental panoramic, cephalometric and cone beam computed tomography x-ray device is intended for dental radiographic examinations of teeth, jaw and TMJ areas by producing conventional 2D x-ray images as well as x-ray projection images of an examined volume for the reconstruction of a 3D view. The device must only be operated and used by dentists and other legally qualified professionals.
Orthopantomograph® OP300 is an extraoral source dental x-ray device, which produces conventional digital 2D panoramic, cephalometric and TMJ x-ray images as well as digital x-ray projection images taken during cone beam rotations around a patient's head. The projection images are reconstructed to be viewed in 3D by a 3D viewing software. The name Orthopantomograph® OP300 is used when the device can produce panoramic, TMJ and optionally 3D images. The name Orthoceph® OC300 is used when the cephalometric option for cephalometric x-ray images is added to the device. Furthermore, the device can be equipped with the Volumetric Tomography device (K063773).
The provided text is a 510(k) summary for the Orthopantomograph® OP300, a dental X-ray device. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study that proves the device meets specific acceptance criteria in terms of performance metrics like sensitivity or specificity.
Therefore, the requested information regarding acceptance criteria, reported performance, sample sizes, expert qualifications, and adjudication methods for a specific study proving device performance against acceptance criteria is not present in the provided text. The document primarily identifies the device, its intended use, technological characteristics, and claims substantial equivalence to predicate devices.
Here's a breakdown of why each specific piece of information cannot be extracted:
- 1. A table of acceptance criteria and the reported device performance: The document does not define specific performance acceptance criteria for the new device (e.g., minimum diagnostic accuracy, image quality scores). It doesn't report any direct performance metrics for the Orthopantomograph® OP300 in a study.
- 2. Sample size used for the test set and the data provenance: There is no mention of a test set, studies, or clinical data.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: As no test set or study is described, this information is not available.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable as no test set or study is described.
- 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This document is for an X-ray device, not an AI-powered diagnostic tool, and no MRMC studies or AI involvement are mentioned.
- 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an AI algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth is mentioned as no study is described.
- 8. The sample size for the training set: Not applicable as this is not an AI algorithm or a study involving a training set.
- 9. How the ground truth for the training set was established: Not applicable for the same reasons as above.
In summary, the provided 510(k) summary (K093683) for the Orthopantomograph® OP300 is a regulatory document focused on establishing substantial equivalence based on intended use and technological characteristics rather than providing detailed clinical study results with performance metrics and acceptance criteria.
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Image /page/0/Picture/1 description: The image shows the word "INSTRUMENTARIUM" in a simple, sans-serif font. To the left of the word is a logo that appears to be a stylized "i" inside of a circle. The text and logo are black against a white background. The image is clear and easy to read.
510(k) Summary
OCT - 6 2010
Date:
April 29., 2010
The name of the 510(k) owner:
Instrumentarium Dental, PaloDEx Group Oy Nahkelantie 160 04300 Tuusula, Finland
Tel: +358 10 270 2000 Fax: +358 9 851 4048
Contact person: Mr. Matti Tulikoura, Tel +358 400 609 507
United States Sales Representative (U.S. Designated agent):
INSTRUMENTARIUM DENTAL INC. 1245 W. Canal Street, Milwaukee, Wisconsin 53233, USA
Tel: +1 414 747 1030, 800 558 6120 Fax: +1 414 481 8665
Contact Person: Mr. Frank Kashinski, Tel +1 414 747 6315
Trade name:
Orthopantomograph® OP300
Common name:
Dental panoramic, cephalometric and cone beam computed tomography x-ray device
Classification name:
System, x-ray, extraoral source, digital (21 CFR 872.1800, product code MUH)
Predicate device:
Planmeca Promax 3D (K060328), SCANORA® 3D (K073350) and Veraviewepocs 3D (K073696).
Description:
Orthopantomograph® OP300 is an extraoral source dental x-ray device, which produces conventional digital 2D panoramic, cephalometric and TMJ x-ray images as well as digital x-ray projection images taken during cone beam rotations around a patient's head. The projection images are reconstructed to be viewed in 3D by a 3D viewing software. The name Orthopantomograph® OP300 is used when the device can produce panoramic, TMJ and optionally 3D images. The name Orthoceph® OC300 is used when the cephalometric option for cephalometric x-ray images is added to the device. Furthermore, the device can be equipped with the Volumetric Tomography device (K063773).
Instrumentarium Dental
Nahkelantie 160, 04300 Tuusula Finland Street address: P.O. Box 20, F1-04301 Tuusula, Finland Postal adoress: +358 10 270 2000 Tel. +358 10 270 2230 Fax
Bank
SWIFT Nordea Bank NDEAFIHH Account: F19015963000046864
PaloDEx Group Oy. Tuusula, FINLAND Business ID 1981046-8 FI19810468 VAT
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Image /page/1/Picture/0 description: The image shows the word "INSTRUMENTARIUM" in a simple, sans-serif font. To the left of the word is a logo that appears to be a stylized letter "i" inside of a circle. The logo is black and white, with the "i" being white and the rest of the circle being black. The text is all in uppercase letters.
Image /page/1/Picture/1 description: The image shows a black and white drawing of a diagonal line. The line is thick and appears to be drawn with a marker or pen. There is also a small dot and a short vertical line near the top right of the image.
Intended use:
The Orthopantomograph® OP300 dental panoramic, cephalometric and cone beam computed tomography x-ray device is intended for dental radiographic examinations of teeth, jaw and TMJ areas by producing conventional 2D x-ray images as well as xray projection images of an examined volume for the reconstruction of a 3D view. The device must only be operated and used by dentists and other legally qualified professionals.
Technological characteristics:
The Orthopantomograph® OP300 is similar to the predicate devices Planmeca Promax 3D & Soredex Scanora 3D and otherwise similar to the Morita Veraviewepocs 3D predicate device by offering options for conventional cephalometric x-ray images and cone beam 3D images using pulsing and continuous power mode.
Substantial Equivalence:
We consider Orthopantomograph® OP300 is as safe and effective as the prodicate devices.
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Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by a series of curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
OCT 0 6 2010
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Matti Tulikoura Regulatory Manager Instrumentarium Dental, PaloDEx Group OY Nahkelantie 160, Tuusula 04300 FINLAND
Re: K093683
Trade/Device Name: Orthopantomograph® OP300 .. Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system -------Regulatory Class: II Product Code: MUH Dated: September 3, 2010 Received: September 8, 2010
Dear Mr. Tulikoura:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
signature
David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the word "INSTRUMENTARIUM" in all capital letters. To the left of the word is a logo. The logo is a circle with a white swan-like figure inside of it, surrounded by a black background.
Indications for Use
510(k) Number (if known): JK 093683
Device Name: Orthopantomograph® OP300
Indications for Use:
The Orthopantomograph® OP300 dental panoramic, cephalometric and cone beam computed tomography x-ray device is intended for dental radiographic examinations of teeth, jaw and TMJ areas by producing conventional 2D x-ray images as well as x-ray projection images of an examined volume for the reconstruction of a 3D view. The device must only be operated and used by dentists and other legally qualified professionals.
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 Dovice Evaluation (ODE) () ( ) ( ) ( ) ( )
Mr. L. O'Hern for David C. Brown
(Division Sign-Off)
610K K093683
Instrumentarium Dental Street address: Nahkelantie 160, 04300 Tuusula Finland Postal address: P.O. Box 20, Fl-04301 Tuusula, Finfand +358 45 7882 2000 l el +358 45 7802 2506
Bank
SWIFT Nordea Bank NDEAFIHH
Account: F19015963000046864 PaloDEx Group Oy, Tuusula, FINLAND
Business ID 1981046-8 VAT F:19810468
§ 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.