(59 days)
Not Found
No
The description focuses on conventional x-ray technology and digital imaging acquisition and display, with no mention of AI or ML algorithms for image processing or analysis.
No
The device is described as an "x-ray imaging system" intended for "dental radiographic examination," which is a diagnostic purpose, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" states that the system is for "dental radiographic examination" and can be used for "implantology" and "TMJ studies and cephalometry," all of which are diagnostic procedures. The "Device Description" also mentions that the device can be equipped with accessories to "fulfil different diagnostic needs."
No
The device description explicitly states it is a "panoramic x-ray imaging system" and a "conventional panoramic x-ray system utilizing either films and cassettes or digital imaging," indicating it is a hardware device that produces X-ray images. While it includes digital components and image processing, it is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The Rotograph EVO and Rotograph EVO D are extraoral source x-ray systems. They generate x-rays that pass through the patient's body to create images of internal structures. This is an in vivo process (occurring within a living organism), not an in vitro process (occurring outside of a living organism).
- Intended Use: The intended use clearly states it's for "dental radiographic examination of the teeth, jaw, and oral structures." This involves imaging the patient directly.
The information provided describes a medical imaging device, not a device that analyzes biological samples.
N/A
Intended Use / Indications for Use
Rotograph EVO and Rotograph EVO D, panoramic x-ray imaging systems with cephalostat, are extraoral source x-ray systems, which are intended for dental radiographic examination of the teeth, jaw, and oral structures, specifically for panoramic examinations and implantology and for TMJ studies and cephalometry.
Product codes
EHD, MUH
Device Description
Rotograph EVO and Rotograph EVO D are conventional panoramic x-ray system utilizing either films and cassettes (Rotograph EVO) or digital imaging (Rotograph EVO D). Both models can be equipped with a cephalostat. The device can be equipped with accessories to fulfil different diagnostic needs. In digital configuration (Rotograph EVO D) the images are acquired by a CCD sensor and are displayed on a monitor, and image manipulation, archiving and communication are performed via a computer (not included in the device).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
teeth, jaw, and oral structures
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)
The software development for this device follows documented processes for software design, verification and validation testing, Final device validation (see Appendix C) and risk assessment has been conducted, to identify potential design hazards that could cause an error or injury based on the use of this device. Appropriate steps have been taken to control all identified risks. The device has been tested for compliance to IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for Safety. and its derivatives
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K002432, K002432, K041120, K062403
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
Image /page/0/Picture/0 description: The image shows a logo for Villa Sistemi Medicali. The logo consists of a black square with a stylized white "V" inside. Below the square, the word "VILLA" is printed in a sans-serif font, followed by "SISTEMI" and "MEDICALI" stacked below each other, also in sans-serif font. The logo appears to be for a medical systems company.
.
KC90749
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MAY 18 2009
510(k) Summary or 510(k) Statement
י
510 (k) Summary
This summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92.
| Submitter. | Villa Sistemi Medicali S.p.A.
via delle Azalee 3
20090 Buccinasco (MI)
ITALY
Registration # 8021091 |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Paolo Casagrande Santin
QA Manager
Phone: +39 02 48859 239
Fax: +39 02 48859 303
Email: p.casagrande@villasm.com |
| Designated Agent: | Bill Kostecki
Del Medical Imaging
QA/RA Manager
Registration # 9027610 |
| Date Prepared: | March 16, 2009 |
| Trade Name: | Rotograph EVO and Rotograph EVO D |
| Common Name: | Dental panoramic and cephalometric unit |
| Classification Name: | 872.1800 Unit, X-Ray, Extraoral With Timer |
| Predicate Devices: | The Rotograph EVO and Rotograph EVO D are compared with the following predicate devices: |
| | • Villa Sistemi Medicali Strato X - model Strato 2000 (K002432), |
| | • Villa Sistemi Medicali Strato X - model Strato 2000 Digital (K002432), |
| | • AFP/Owandy EVApan Digital/K1VSM2000 dental panoramic sensor (K041120), |
| | • Owandy IMAX CEPH digital X-ray sensor (K062403). |
| Product Description: | Rotograph EVO and Rotograph EVO D are conventional panoramic x-ray system utilizing either
films and cassettes (Rotograph EVO) or digital imaging (Rotograph EVO D). Both models can
be equipped with a cephalostat. The device can be equipped with accessories to fulfil different
diagnostic needs. In digital configuration (Rotograph EVO D) the images are acquired by a CCD
sensor and are displayed on a monitor, and image manipulation, archiving and
communication are performed via a computer (not included in the device). |
| Indication for Use: | Rotograph EVO and Rotograph EVO D, panoramic x-ray imaging systems with cephalostat, are
extraoral source x-ray systems, which are intended for dental radiographic examination of the
teeth, jaw, and oral structures, specifically for panoramic examinations and implantology and
for TMJ studies and cephalometry. |
| Rationale for Substantial
Equivalence: | Rotograph EVO and Rotograph EVO D have the same indication for use as the predicate
devices. They share the same technological characteristics as the predicate devices. Minor
technological differences do not raise any new questions regarding safety or effectiveness of
the devices. |
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Image /page/1/Picture/0 description: The image shows a logo for Villa Sistemi Medicali. The logo consists of a stylized letter "V" above the words "VILLA," "SISTEMI," and "MEDICALI," stacked vertically. The logo is in black and white, with the letter "V" and the text appearing in white against a black background.
Safety and Effectiveness Information:
The device labeling contains operating instructions for safe and effective use of Rotograph EVO and Rotograph EVO D. The software development for this device follows documented processes for software design, verification and validation testing, Final device validation (see Appendix C) and risk assessment has been conducted, to identify potential design hazards that could cause an error or injury based on the use of this device. Appropriate steps have been taken to control all identified risks. The device has been tested for compliance to IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for Safety. and its derivatives
Conclusion:
Rotograph EVO and Rotograph EVO D perform the same functions in the same environment as the predicate devices. They share the same technology as the predicate devices. They are based on well known technology. They are as safe and effective as the predicate devices. We believe they do not introduce any new potential safety risks and are substantially equivalent to the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
MAY 18 2009
Food and Drug. Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Paolo Casagrande Santin Quality Assurance Manager Villa Sistemi Medicali S.p.A. Via delle Azalee 3 Buccinasco MI 20090 ITALY
Re: K090749 .
Trade/Device Name: Rotograph EVO and Rotograph EVO D Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: EHD and MUH Dated: March 16, 2009 Received: March 20, 2009
Dear Mr. Santin:
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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
ﺰ ﺗ
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Image /page/4/Picture/0 description: The image is a logo for Villa Sistemi Medicali. The logo is black and white and features a stylized letter "V" above the words "VILLA" and "SISTEMI MEDICALI". The letter "V" is white and is set against a black background. The words "VILLA" and "SISTEMI MEDICALI" are also white and are set against a black background.
Indications for Use Statement
Indications for Use
510(k) Number (if known): K090749
Device Name: Rotograph EVO and Rotograph EVO D
Indications for Use:
Rotograph EVO and Rotograph EVO D, panoramic x-ray imaging system with cephalostat, are extraoral source x-ray system, which are intended for dental radiographic examination of the teeth, jaw, and oral structures, specifically for panoramic examinations and implantology and for TMJ studies and cephalometry.
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 Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K090749 |
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