(58 days)
The Rotograph Plus as manufactured by Villa Sistemi Medicali S.p.A of Milan, Italy is intended to be used as an extra oral radiological device for the examination of the human dentition and related anatomy as well as craniostatic examinations. They are to be used for Panoramic and Cephalometric Radiology as it is applied to dental diagnosis in dentistry.
This product is manufactured by the Villa Sistemi Medicali company of Milan, Italy and is classified as a class II device. It is intended to be used as a dental extra oral x-ray device for the panoramic and cephalometric examination of the human anatomy as it applies to dentistry.
The provided text is a 510(k) summary for the ROTOGRAPH PLUS dental extra oral x-ray device. It states that the device is "substantially equivalent" to a predicate device (Belmont X-Caliber unit).
However, the document does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance studies, or how ground truth was established.
The document only states:
- Product Name: ROTOGRAPH PLUS
- Manufacturer: Villa Sistemi Medicali S.p.A. (Milan, Italy)
- Intended Use: Dental extra oral x-ray device for panoramic and cephalometric examination of human anatomy as it applies to dentistry, including human dentition, related anatomy, and craniostatic examinations.
- Regulatory Class: Class II (procode 90 EHD)
- Standards: Manufactured under guidelines of FDA/DHHS performance standards for radiation emitting devices, 21 CFR Subchapter J, and International Standard IEC 601.1 and 601.2.7.
- Substantial Equivalence: Deemed substantially equivalent to the Belmont X-Caliber unit.
- Safety and Effectiveness: "The manufacturer further warrants that this device is safe and effective for its intended use."
Since the document is a 510(k) summary claiming substantial equivalence, it typically relies on the predicate device's performance demonstration rather than providing new, detailed performance study data for the new device. A 510(k) often focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring a full, standalone clinical trial with specific performance metrics as might be seen for a PMA.
Therefore, for the information requested:
- A table of acceptance criteria and the reported device performance: Not provided in the document. The document primarily focuses on regulatory compliance and substantial equivalence to a predicate device.
- Sample size used for the test set and the data provenance: Not provided in the document.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided in the document.
- Adjudication method for the test set: Not provided in the document.
- 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: Not applicable. This device is an X-ray machine, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an X-ray machine, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided in the document.
- The sample size for the training set: Not applicable. This device is an X-ray machine, not an AI model that requires a training set.
- How the ground truth for the training set was established: Not applicable.
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K9'112768
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OCT -- 8 1997
510 ( k) SUMMARY FOR
Product name: ROTOGRAPH PLUS
This product is manufactured by the Villa Sistemi Medicali company of Milan, Italy and is classified as a class II device. It is intended to be used as a dental extra oral x-ray device for the panoramic and cephalometric examination of the human anatomy as it applies to dentistry.
This product is manufactured under the guidelines of the FDA/DHHS performance standards as it applies to radiation emitting devices and 21 CFR Subchapter J and the International Standard IEC 601.1 and 601.2.7. This product is substantially equivalent to the Belmont X-Caliber unit as marketed in the United States. The manufacturer further warrants that this device is safe and effective for its intended use.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
- 8 1997
Re:
Al Sosa President Chicago X-Ray System Inc. 219 Mayer Avenue Wheeling, IL 60090
K972968 Rotograph Plus System Software Dated: August 8, 1997 Received: August 11, 1997 Regulatory class: II 21 CFR 872.1800/Procode: 90 EHD
Dear Mr. Sosa:
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 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, 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 requirement, as set forth in the Quality System Regulation (OS) 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 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.
hĩ tiêu Yui
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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CHICAGO X SYSTEMS IN
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219 Mayer Avenue Wheeling, IL 60090 Pho: 847-459-3889 FAX: 847-459-9214 chicagox-ray@worldnet.att.net
Friday, August 08, 1997
510 (K) Number ( if known):
Device name: ROTOGRAPH PLUS
INDICATIONS FOR USE:
The Rotograph Plus as manufactured by Villa Sistemi Medicali S.p.A of Milan, Italy is intended to be used as an extra oral radiological device for the examination of the human dentition and related anatomy as well as craniostatic examinations. They are to be used for Panoramic and Cephalometric Radiology as it is applied to dental diagnosis in dentistry.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Edward G. Seyson
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
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§ 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.