(59 days)
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.
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).
The provided text is a 510(k) summary for the Rotograph EVO and Rotograph EVO D dental panoramic and cephalometric units. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain the specific information required to complete a table of acceptance criteria, reported device performance, or details of a study proving the device meets acceptance criteria.
The document states:
- Safety and Effectiveness Information: "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."
- 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."
This indicates that a validation study was conducted, likely assessing the device's technical performance against a set of predetermined criteria, but the details of these criteria, the study's methodology, results (acceptance criteria met), sample sizes, ground truth establishment, or expert involvement are not included in this 510(k) summary. The summary focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed performance study.
Therefore, I cannot provide most of the requested information based solely on the provided text.
Here's what can be inferred or explicitly stated from the document, with many fields left as "Not provided in the document":
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the document (Likely technical specifications related to image quality, radiation dose, mechanical performance, software reliability, and safety standards like IEC 60601-1) | Not provided in the document (Stated to be "as safe and effective as the predicate devices" and that validation testing was conducted) |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not provided in the document.
- Data provenance: Not provided in the document. (The device is manufactured in Italy, so testing data might originate there, but this is not specified.)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not provided in the document.
4. Adjudication method for the test set
- Not provided in the document.
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
- Not applicable/Not provided. The device is an X-ray imaging system, not an AI-powered diagnostic aid for human readers. The document refers to "software development" and "validation testing" but does not mention AI.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is an X-ray imaging device, not purely an algorithm. Its performance typically refers to the quality and consistency of the images it produces.
7. The type of ground truth used
- Not explicitly stated. For an imaging device, ground truth for performance validation typically involves comparing images against established quality metrics, phantom studies, or potentially clinical correlation, but this is not detailed.
8. The sample size for the training set
- Not applicable/Not provided. The document describes a "software development" and "validation testing" process, suggesting traditional software engineering and testing for device functionality rather than an AI model requiring a training set.
9. How the ground truth for the training set was established
- Not applicable/Not provided.
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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.
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KC90749
Page 1 of 2
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 320090 Buccinasco (MI)ITALYRegistration # 8021091 |
|---|---|
| Contact Person: | Paolo Casagrande SantinQA ManagerPhone: +39 02 48859 239Fax: +39 02 48859 303Email: p.casagrande@villasm.com |
| Designated Agent: | Bill KosteckiDel Medical ImagingQA/RA ManagerRegistration # 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 eitherfilms and cassettes (Rotograph EVO) or digital imaging (Rotograph EVO D). Both models canbe equipped with a cephalostat. The device can be equipped with accessories to fulfil differentdiagnostic needs. In digital configuration (Rotograph EVO D) the images are acquired by a CCDsensor and are displayed on a monitor, and image manipulation, archiving andcommunication 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, areextraoral source x-ray systems, which are intended for dental radiographic examination of theteeth, jaw, and oral structures, specifically for panoramic examinations and implantology andfor TMJ studies and cephalometry. |
| Rationale for SubstantialEquivalence: | Rotograph EVO and Rotograph EVO D have the same indication for use as the predicatedevices. They share the same technological characteristics as the predicate devices. Minortechnological differences do not raise any new questions regarding safety or effectiveness ofthe 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.
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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
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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 |
Page 1 of 1
§ 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.