(197 days)
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.
Endograph DC is an extraoral source x-ray unit. Endograph DC is dedicated to intraoral radiography in which the x-ray source is placed outside the mouth of the patient while the image detector (film or digital detector) is placed inside the mouth. The image detector is not part of Endograph DC system, so it is not part of this submission.
The provided text describes a 510(k) summary for the "Endograph DC" device, which is an extraoral source x-ray unit for dental radiography. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific performance-based acceptance criteria through an independent clinical trial or extensive standalone performance evaluation.
Here's a breakdown based on the provided input:
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A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics in a table. The rationale for substantial equivalence is based on the device having the same indication for use and similar technological characteristics as the predicate device (ViVi S.r.l. Ergon-X HF, K120318). Minor technological differences are stated to "not raise any new questions regarding safety or effectiveness."Acceptance Criteria Reported Device Performance Indication for Use Equivalence Endograph DC has the same indication for use as the predicate device. Technological Equivalence Endograph DC shares the same technological characteristics as the predicate device. Minor differences do not raise new safety or effectiveness concerns. Safety Standards Compliance The device has been tested for compliance to IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for Safety, and its derivatives. Software Development & Validation Software development follows documented processes for design, verification, and validation testing. Final device validation and risk assessment conducted. -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not mention a specific "test set" or data directly related to a study proving performance against acceptance criteria. The evaluation presented is a regulatory submission for substantial equivalence. The "testing" mentioned refers to compliance with safety standards (IEC 60601-1) rather than a clinical performance study with a test set of images or patients. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no clinical performance study with a test set requiring expert ground truth establishment is described. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical performance study with a test set requiring adjudication is described. -
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
No MRMC comparative effectiveness study is mentioned. The device is an X-ray unit, not an AI-powered diagnostic tool, so the concept of human readers improving with AI assistance is not relevant in this context. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes an X-ray unit, which is a medical imaging device/hardware. It does not describe an algorithm or software requiring standalone performance testing in the sense of an AI model's diagnostic accuracy. The safety and effectiveness information focuses on compliance with general medical electrical equipment standards and quality system processes for software development and risk assessment. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The evidence provided is based on technical specifications, adherence to standards, and comparison to a predicate device, not on a ground truth derived from clinical data for diagnostic accuracy. -
The sample size for the training set
Not applicable. The device is an X-ray unit, not a machine learning model that requires a training set. -
How the ground truth for the training set was established
Not applicable, as there is no training set for a machine learning model.
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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.
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.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: | Walter SchneiderVilla Radiology Systems91 Willenbrock Rd. B-1Oxford, CT, 06478ph 203 2628836e-mail walter@villaus.com | |
| 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:• ViVi S.r.l. Ergon-X HF (K120318), | |
| Product Description: | Endograph DC is an extraoral source x-ray unit.Endograph DC is dedicated to intraoral radiography in which the x-ray source is placed outsidethe mouth of the patient while the image detector (film or digital detector) is placed inside themouth.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 diagnosisof 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 SubstantialEquivalence: | Endograph DC has the same indication for use as the predicate device. It shares the sametechnological characteristics as the predicate device. Minor technological differences do not raiseany new questions regarding safety or effectiveness of the device. |
|---|---|
| Safety and EffectivenessInformation: | The device labeling contains operating instructions for safe and effective use of Endograph DC.The software development for this device follows documented processes for software design,verification and validation testing. Final device validation and risk assessment has beenconducted, to identify potential design hazards that could cause an error or injury based on theuse of this device. Appropriate steps have been taken to control all identified risks. The device hasbeen tested for compliance to IEC 60601-1 Medical Electrical Equipment Part 1: GeneralRequirements for Safety, and its derivatives |
| Conclusion: | Endograph DC performs the same functions in the same environment as the predicate device. Itshares the same technology as the predicate device. It is based on well known technology. It is assafe and effective as the predicate device. We believe it does not introduce any new potentialsafety 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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)
(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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§ 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.