ENDOGRAPH DC

K130109 · Villa Sistemi Medicali S.P.A. · EHD · Aug 1, 2013 · Dental

Device Facts

• Record ID: K130109
• Device Name: ENDOGRAPH DC
• Applicant: Villa Sistemi Medicali S.P.A.
• Product Code: EHD · Dental
• Decision Date: Aug 1, 2013
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.1800
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Endograph DC is an extraoral source x-ray unit for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The device is to be operated and used by dentists, radiologists and other legally qualified health care professionals. It can be used with both pediatric and adult patients.

Device Story

Endograph DC is an extraoral dental X-ray unit; source placed outside patient mouth; image detector (film or digital) placed inside mouth. Device generates X-ray beams for radiographic imaging of teeth, jaw, and oral structures. Operated by dentists, radiologists, or qualified healthcare professionals in clinical settings. Output is X-ray exposure for diagnostic imaging; assists clinicians in identifying dental/oral pathologies. Benefits include diagnostic visualization of oral structures to inform clinical decision-making.

Clinical Evidence

No clinical data. Safety and effectiveness established through bench testing, including compliance with IEC 60601-1 (General Requirements for Safety), software verification/validation, and risk assessment.

Technological Characteristics

Extraoral dental X-ray unit. Operates as an X-ray source. Complies with IEC 60601-1 standards. Software-controlled operation.

Indications for Use

Indicated for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures in pediatric and adult patients. To be used by dentists, radiologists, and qualified healthcare professionals.

Regulatory Classification

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.

Predicate Devices

• ViVi S.r.l. Ergon-X HF (K120318)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a logo with a stylized letter 'V' at the top, which appears to be formed by two intersecting lines. Below the 'V', the word 'VILLA' is printed in a bold, sans-serif font. Underneath 'VILLA', the words 'SISTEMI MEDICALI' are stacked, also in a sans-serif font, but with a slightly distressed or aged appearance. The overall design is simple and modern, with a focus on the company name and a clean visual aesthetic.

K130109

## 510(k) Summary or 510(k) Statement

## 510 (k) Summary

This summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92.

| 510(k) Number: | | |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Submitter: | Villa Sistemi Medicali S.p.A.<br>via delle Azalee 3<br>20090 Buccinasco (MI)<br>ITALY<br>Registration # 8021091 | |
| Contact Person: | Paolo Casagrande Santin<br>QA Manager<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] | |
| Designated Agent: | Walter Schneider<br>Villa Radiology Systems<br>91 Willenbrock Rd. B-1<br>Oxford, CT, 06478<br>ph 203 2628836<br>e-mail [e-mail] | |
| Date Prepared: | July 12, 2013 | |
| Trade Name: | Endograph DC | |
| Common Name: | Extra oral source X-ray unit | |
| Classification Name: | 872.1800 Unit, x-ray, extraoral with timer | |
| Class: | II | |
| Product Code: | EHD | |
| Predicate Device: | The Endograph DC is compared with the following predicate device:<br>• ViVi S.r.l. Ergon-X HF (K120318), | |
| Product Description: | Endograph DC is an extraoral source x-ray unit.<br>Endograph DC is dedicated to intraoral radiography in which the x-ray source is placed outside<br>the mouth of the patient while the image detector (film or digital detector) is placed inside the<br>mouth.<br>The image detector is not part of Endograph DC system, so it is not part of this submission. | |
| Indication for Use: | Endograph DC is an extraoral source x-ray unit for dental radiographic examination and diagnosis<br>of diseases of the teeth, jaw, and oral structures. The device is to be operated and used by | |

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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" 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.

dentists, radiologists and other legally qualified health care professionals. It can be used with both pediatric and adult patients.

| Rationale for Substantial<br>Equivalence: | Endograph DC has the same indication for use as the predicate device. It shares the same<br>technological characteristics as the predicate device. Minor technological differences do not raise<br>any new questions regarding safety or effectiveness of the device. |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Safety and Effectiveness<br>Information: | The device labeling contains operating instructions for safe and effective use of Endograph DC.<br>The software development for this device follows documented processes for software design,<br>verification and validation testing. Final device validation and risk assessment has been<br>conducted, to identify potential design hazards that could cause an error or injury based on the<br>use of this device. Appropriate steps have been taken to control all identified risks. The device has<br>been tested for compliance to IEC 60601-1 Medical Electrical Equipment Part 1: General<br>Requirements for Safety, and its derivatives |
| Conclusion: | Endograph DC performs the same functions in the same environment as the predicate device. It<br>shares the same technology as the predicate device. It is based on well known technology. It is as<br>safe and effective as the predicate device. We believe it does not introduce any new potential<br>safety risks and is substantially equivalent to the predicate device. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 1, 2013

Villa Sistemi Medicali, S.p.a. % Mr. Paolo Casagrande Santin Via Delle Azalee, 3 20090 Buccinasco (MI) ITALY

Re: K130109

Trade/Device Name: Endograph DC Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: EHD Dated: July 12, 2013 Received: July 24, 2013

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 note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (sec 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); 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.

Image /page/2/Picture/12 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the circle is a stylized image of an eagle, with its wings spread. The eagle is facing to the right.

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## Page 2 - Mr. Santin

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K130109

Endograph DC Device Name:

Indications for Use:

Endograph DC is an extraoral source x-ray unit for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The device is to be operated and used by dentists, radiologists and other legally qualified health care professionals. It can be used with both pediatric and adult patients.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

K130109 510(k) _______________________________________________________________________________________________________________________________________________________________________

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