(30 days)
No
The document describes a dental X-ray system and its image processing capabilities, but there is no mention of AI or ML technology being used.
No.
The device is an extraoral dental X-ray system intended for diagnosis, not treatment, of diseases.
Yes
The device is explicitly stated to be "intended to produce X-rays for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures." The term "diagnosis" directly indicates a diagnostic purpose.
No
The device is described as an "extraoral source dental X-ray system," which is a hardware device. While it includes software programs for imaging, it is fundamentally a physical X-ray machine.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to produce X-rays for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. This is a diagnostic imaging device, not a device used to examine specimens derived from the human body.
- Device Description: The description focuses on the X-ray system and its imaging programs for capturing images of anatomical structures.
- Input Imaging Modality: The input is X-ray, which is an external imaging modality, not a method for analyzing biological samples.
- Anatomical Site: The anatomical sites are parts of the human body (teeth, jaw, skull, etc.), not biological specimens.
IVD devices are used to examine specimens such as blood, urine, or tissue to provide information for diagnosis, monitoring, or treatment. This device operates by generating X-rays to create images of internal structures, which is a different category of medical device.
N/A
Intended Use / Indications for Use
The Orthophos PLUS DS / PLUS DS Ceph is an extraoral source dental X-ray system intended to produce X-rays for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.
Product codes
90 MUH
Device Description
The Orthophos PLUS DS / PLUS DS Ceph contains 26 factory installed programs that allow for comprehensive imaging of the entire maxillofacial region. These include panoramic exposures of the teeth, maxillary sinuses and temporal mandibular joints, transverse exposures of the maxillary and mandibular molar, canine and anterior areas, and cephalometric exposures of the skull. This Special 510(k) is being submitted to add the transverse slice imaging programs to the panoramic and cephalometric imaging programs previously described in K972312.
Mentions image processing
The transverse slice exposures generated by the Orthophos PLUS DS / PLUS DS Ceph are processed into digital images by the SIDEXIS Digital Radiography Processing System, while the transverse slice exposures generated by the Orthophos 5 / PLUS / CD are processed into film images.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
teeth, jaw, oral structures, maxillofacial region, maxillary sinuses, temporal mandibular joints, skull
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A hazard analysis, validation testing, and Declaration of Conformity to Design Controls were submitted to support the substantial equivalence of the modified Orthophos system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
K013650
DEC 0 6 2001
Special 510(k) Summary for Orthophos PLUS DS / PLUS DS Ceph
SPONSOR 1.
Sirona Dental Systems GmbH Fabrikstraße 31 D-64625 Bensheim Germany
Contact Person: Fritz Kolle 49 6251 16 3294 Telephone:
Date Prepared: November 5, 2001
2. DEVICE NAME
Orthophos PLUS DS / PLUS DS Ceph Proprietary Name: Common/Usual Name: Dental panoramic and cephalometric X-ray system Extraoral source dental X-ray system Classification Name:
PREDICATE DEVICE 3.
Orthophos DS / DS Ceph (K972312) Orthophos 5 / PLUS / CD (K983057)
INTENDED USE 4.
The Orthophos PLUS DS / PLUS DS Ceph is an extraoral source dental X-ray system intended to produce X-rays for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.
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5. DEVICE DESCRIPTION
The Orthophos PLUS DS / PLUS DS Ceph contains 26 factory installed programs that allow for comprehensive imaging of the entire maxillofacial region. These include panoramic exposures of the teeth, maxillary sinuses and temporal mandibular joints, transverse exposures of the maxillary and mandibular molar, canine and anterior areas, and cephalometric exposures of the skull. This Special 510(k) is being submitted to add the transverse slice imaging programs to the panoramic and cephalometric imaging programs previously described in K972312.
BASIS FOR SUBSTANTIAL EQUIVALENCE 6.
The Orthophos PLUS DS / PLUS DS Ceph that is the subject of this 510(k) premarket notification is a modification of the Orthophos DS / DS Ceph that was previously cleared for marketing under K972312. The modified device has the same intended use and principles of operation as the original device, as well as substantially equivalent technical specifications. The main difference is the addition of the transverse slice imaging capability, which is the same technology as previously reviewed for the Orthophos 5 / PLUS / CD under K983057. The transverse slice exposures generated by the Orthophos PLUS DS / PLUS DS Ceph are processed into digital images by the SIDEXIS Digital Radiography Processing System, while the transverse slice exposures generated by the Orthophos 5 / PLUS / CD are processed into film images. A hazard analysis, validation testing, and Declaration of Conformity to Design Controls were submitted to support the substantial equivalence of the modified Orthophos system.
November 5, 2001
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing the wings and body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 6 2001
Sirona Dental Systems, Inc. % Ms. Sheila M. Hemeion-Heyer Medical Device Consultants 49 Plain Street NORTH ATTLEBORO MA 02760 Re: K013650
Trade/Device Name: Orthophos PLUS DS/PLUS DS Ceph Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 90 MUH Dated: November 5, 2001 Received: November 6, 2001
Dear Ms. Hemeion-Heyer:
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 either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your 510(k) premarket I mis letter will anow you to orgin nastantial equivalence of your device to a legally marketed nontication. This I Drice results in 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), please IT you desire specific advice to: your ae of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Other of Compinanted as (2007 oation" (21 CFR Part 807.97). Other general information on by recence to promation nearly be obtained from the Division of Small Manufacturers, your responsional and Consumer 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,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: Orthophos PLUS DS / PLUS DS Ceph
Indications For Use:
The Orthophos PLUS DS / PLUS DS Ceph is an extraoral source dental panoramic The Ottaopilor L L & D & L C . L System intended to produce X-rays for dental and Optional copiadoneers
radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Symons
(Division Sign-O Division of Reprodu and Radiological De 510(k) Number
Prescription Use
(Per 21 CFR 801.109) ✓
OR
Over-The-Counter Use _
(Optional Format 1-2-96)
November 5, 2001