-Panoramic adult or child exams, with 3 sizes and 3 tvpes of biting for a total of 18 combinations with automatic parameter selection; with manual selection, it is possible to select a high voltage between 60kV and 70kV, in 2kV steps and anodic current from 2 mA to 7.1 mA in the R20 scale steps.
-Sinus mode to take exams of the paranasal sinuses with front projection (postero/anterior);
-TMJ (closed/open mouth) exams in lateral projection.

XP (Extended Projection Package) optional function allows to carry out the following additional exams:

-Right or left half-panoramic, to be used when the patient is known to have a problem only on one side of the arch, in order to reduce radiation;
-Low dose Panoramic, which reduces the dose radiated by excluding the TMJ's ascending rami from the radiograph;
Frontal dentition, for a radiograph of the front part (roughly from canine to canine); -
-Ortho Rad Panoramic which reduces teeth overlap, thereby improving the diagnosis of interproximal decay:
Bitewing left or right for lateral dentition (generally from eighth to fourth) with a trajectory that reduces teeth overlap;
-Bilateral Bitewing (left and right), which sequentially performs both bitewings, showing them on the same image.

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). In particular, Rotograph Prime is equipped with a PAN sensor: it is suitable for Panoramic-type imaging, all Panoramic, i.e. all images with about 14cm-high field; all Panoramic. TMJ, and Sinus images belong to this type.

AI/ML Overview

This document describes the Rotograph Prime and I-MAX extra-oral dental panoramic X-ray units and compares them to a predicate device, the Rotograph EVO D, to demonstrate substantial equivalence for FDA 510(k) clearance.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a quantitative sense for image quality or clinical performance metrics. Instead, it relies on the comparison to a predicate device (Rotograph EVO D) and conformance with recognized international standards for safety and performance. The primary acceptance criterion for the premarket notification appears to be demonstrating substantial equivalence to the predicate device, meaning the new device is as safe and effective.

The provided tables mainly focus on comparing technical specifications and features. The key "performance" aspect is image quality, which is addressed through a comparative study.

Acceptance Criterion (Implicit)	Reported Device Performance (as per document)
Image Quality Equivalence to Predicate Device	"The equivalence of the image quality of panoramic radiographies of the subject device has been assessed with image comparison tests." (Specific metrics or results not detailed in this summary, but a separate annex titled "7_Image_Quality_Comparison" is mentioned as having been supplied)
Conformance with International Standards for Safety and Essential Performance (examples of key standards)	Conforms to: - IEC 60601-1: General requirements for basic safety and essential performance - IEC 60601-1-2: Electromagnetic compatibility - IEC 60601-1-3: Radiation Protection in Diagnostic X-Ray Equipment - IEC 60601-2-63: Particular requirements for dental extra-oral X-ray equipment - IEC 62304: Medical device software - ANSI/AAMI ES60601-1: General Requirements - CAN/CSA-C22.2 No. 60601-1: General requirements for basic safety and essential performance - IEC 60601-1-6: Usability - IEC 62366: Usability engineering - ISO 10993: Biological evaluation of medical devices (Parts 2, 5, 10, 12)
Software Validation (Moderate Level of Concern)	"The software validation activities were performed in accordance with the FDA Guidance, 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices' (May 11, 2005)." Device software is classified as "Moderate Level of Concern."
Device not introducing new questions of safety or effectiveness (based on technological differences)	"The review of the technological differences...shows that they are due only to technological evolution and removal of not needed functions and/or version so they do not raise any new questions regarding safety or effectiveness..."
Biocompatibility of patient-contacting components	"All parts in contact with patient have been assessed according to ISO 10993."
Electrical safety, EMC/EMI, and Performance Testing (general categories)	"Electrical safety, EMC/EMI testing, biocompatibility consideration, performance and image quality testing, verification and validation testing were performed to support the substantial equivalence determination." (Specific results not detailed in this summary but mentioned as provided in test reports).
Total Filtration compliance	"Due to the reduced kV range, the total filtration has been reduced maintaining the compliance with 21CFR 1020.30."

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document mentions "image comparison tests" and refers to "annex 7_Image_Quality_Comparison" for details. However, it does not explicitly state the number of images or cases used in these image comparison tests within the provided text.
Data Provenance: Not explicitly stated. Given the manufacturer is based in Italy (Villa Sistemi Medicali S.p.A.), and the predicate device is also from the same manufacturer, it's highly probable the data was generated in Europe, possibly Italy. The document indicates it's a premarket submission for a new device, implying it would involve newly acquired images for testing, making it somewhat "prospective" in the context of comparing a new device against an existing one, although the images themselves might be taken from a test phantom or patient data collected specifically for the comparison. It is not explicitly stated whether it uses patient data or phantom data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This information is not provided in the document. The document refers to "image comparison tests" but does not detail how ground truth was established, who participated, or their qualifications.

4. Adjudication Method for the Test Set

This information is 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

MRMC Study: No, this document describes an X-ray imaging device, not an AI software. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not applicable and was not performed.
Effect Size: Not applicable.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, this document describes an X-ray imaging device, which is a physical hardware product. Therefore, a standalone algorithm-only performance study is not applicable. The image quality comparison is likely testing the device's ability to produce diagnostically equivalent images to the predicate, irrespective of an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document mentions "image comparison tests" to assess "equivalence of the image quality." It does not specify the type of ground truth used for these images. It's common in such comparisons for technical performance (e.g., resolution, contrast, artifact levels) to be assessed against expected values or by visual comparison by experts. It is possible a gold standard phantom or reference images were used, but this is not explicitly stated.

8. The Sample Size for the Training Set

This information is not applicable as the device is an X-ray hardware system, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set was Established

This information is not applicable for the same reason as point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles connected by flowing lines.

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

July 6, 2017

VILLA SISTEMI MEDICALI S.P.A. PAOLO SANTIN QA MANAGER VIA DELLE AZALEE 3 BUCCINASCO I-20090 IT

Re: K162190

Trade/Device Name: Rotograph Prime (under Trade Mark Villa Sistemi Medicali), I-max (under Trade Mark Owandy Radiology) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: June 5, 2017 Received: June 8, 2017

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 (see 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael D. O'Hara For

Robert A. Ochs, Ph.D. 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) K162190

Device Name

Rotograph Prime (under Trade Mark Villa Sistemi Medicali), I-MAX (under Trade Mark Owandy Radiology)

Indications for Use (Describe)

Rotograph Prime and I-MAX are extra-oral dental panoramic X-ray units to radiograph teeth, jaw and oral structures.

The devices are operated and used by dentists, radiologists and other legally qualified health care professionals.

They can be used with both pediatric and adult patients.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image is a logo for Villa. The logo consists of a blue square with a white letter "N" inside. Below the square is the word "VILLA" in white, block letters. The letter "N" is stylized with a sharp, angular design.

510(k) Summary - rev. 1

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)ITALYPhone: +39 02 488591Registration # 8021091
Contact Person:	Paolo Casagrande SantinQA ManagerPhone: +39 02 48859 239Fax: +39 02 48859 303Email: p.casagrande@villasm.com
Designated Agent:	Ernesto FilizzolaVilla Radiology Systems91 Willenbrock Rd. B-1Oxford, CT, 06478ph 203 2628836e-mail ernesto@villaus.com
Date Prepared:	June 27, 2017
Device Name:	Rotograph Prime (under trade mark Villa Sistemi Medicali)I-MAX (under Trade mark Owandy Radiology as Private Labeler)
Device Type:	System, x-ray, extraoral source, digital
Regulation Number:	21 CFR 872.1800
Regulation Name:	Extraoral Source X-Ray System
Regulatory Class:	Class II
Product Code:	MUH
Predicate Device:	The Rotograph Prime (and I-MAX under trade mark Owandy Radiology) is comparedwith the following predicate device:
	Villa Sistemi Medicali Rotograph EVO D (K090749)- Regulation Number: 21 CFR 872.1800- Regulation Name: Extraoral Source X-Ray System- Regulatory Class: Class II- Product Code: MUH

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Product Description: Rotograph Prime (and I-MAX under trade mark Owandy Radiology) is a complete panoramic X-ray system. The basic version performs:

-Panoramic adult or child exams, with 3 sizes and 3 tvpes of biting for a total of 18 combinations with automatic parameter selection; with manual selection, it is possible to select a high voltage between 60kV and 70kV, in 2kV steps and anodic current from 2 mA to 7.1 mA in the R20 scale steps.
-Sinus mode to take exams of the paranasal sinuses with front projection (postero/anterior);
-TMJ (closed/open mouth) exams in lateral projection.

XP (Extended Projection Package) optional function allows to carry out the following additional exams:

-Right or left half-panoramic, to be used when the patient is known to have a problem only on one side of the arch, in order to reduce radiation;
-Low dose Panoramic, which reduces the dose radiated by excluding the TMJ's ascending rami from the radiograph;
Frontal dentition, for a radiograph of the front part (roughly from canine to canine); -
-Ortho Rad Panoramic which reduces teeth overlap, thereby improving the diagnosis of interproximal decay:
Bitewing left or right for lateral dentition (generally from eighth to fourth) with a trajectory that reduces teeth overlap;
-Bilateral Bitewing (left and right), which sequentially performs both bitewings, showing them on the same image.

146x6 mm

3072x128

-Detector type:
FFT-CCD area image sensor

48 um (96 um in 2X2 binning mode)

Sensible area (HxL) PAN Sensor: -
-Pixel dimension:
-Number of pixels:
-Spatial resolution:
4 lp/mm
-Sensor cover attenuation equivalent: < 0.4 mm Al eq.

Installation mode

The x-ray system is sold only in a wall mounted version.

Accessories and components

The device can be equipped with different accessories to fulfill different diagnostic needs, such as standard chin support with bite stick, chin support for edentulous patients and Xray push button with extensible cable.

The device contains the following materials and/or components:

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-Tube-head: dielectric oil, copper, iron, aluminum, glass, tungsten.
-Collimator: lead
Other parts of the device: non-biodegradable plastic materials, metal materials, printed circuits, iron-plastic materials, lead

The patient contacting components are:

temple support rods
chin supports
bite sticks
handles

Chin supports and bite sticks are unchanged from predicate device. Handles and temple support rods are specific for the subject device.

All parts in contact with patient have been assessed according to ISO 10993.

Contact duration is in the range of seconds to few minute and contact type is surfacecontacting.

Indication for Use: Rotograph Prime (and I-MAX under trade mark Owandy Radiology) is an extra-oral dental panoramic X-ray unit to radiograph teeth, jaw and oral structures. The device is operated and used by dentists, radiologists and other legally qualified health care professionals. It can be used with both pediatric and adult patients.

Rationale for Substantial Equivalence

Here below a summing up the main features of the proposed and predicate devices in order to point out the significant similarities and differences.

Rotograph Prime (and I-MAX under trade mark Owandy Radiology) is based on a well-known technology and it has the same indication for use as the predicate device as reported here below.

	Villa Sistemi Medicali - Rotograph PrimeandOwandy Radiology - I-MAX510(k) number tbd	Villa Sistemi MedicaliRotograph EVO D510(k) number K090749
Intended Use	Rotograph Prime is an extra-oral dental panoramicX-ray unit to radiograph teeth, jaw and oralstructures.The device is operated and used by dentists,radiologists and other legally qualified health careprofessionals.It can be used with both pediatric and adultpatients.	Extraoral source x-ray system, which areintended for dental radiographic examination ofthe teeth, jaw, and oral structures, specificallyfor panoramic examinations and implantologyand for TMJ studies and cephalometry

Rotograph Prime (and I-MAX under trade mark Owandy Radiology) has the same functions in the same environment as the predicate device. In particular, the proposed devices perform the same exams for the examination of teeth, jaw and oral structures, as the Rotograph EVO D device.

The proposed devices also use a high frequency x-ray generator with the same x-ray exposure time control and focal spot value of the predicate device.

In the subject devices, patient positioning is assured through two laser pointers that allow to locate the reference planes, as in Rotograph EVO D predicate device.

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Image /page/6/Picture/0 description: The image features a logo with a stylized white letter 'N' set against a blue square background. Below the square, the word 'VILLA' is written in white, bold letters. The logo appears clean and modern, with a simple color scheme.

The subject device detector is exactly the same model as the detector. The equivalence of the image quality of panoramic radiographies of the subject device has been assessed with image comparison tests.

For all these reasons, Rotograph Prime (and I-MAX under trade mark Owandy Radiology) share the fundamental technological characteristics as the predicate device, even if there are some minor differences, not affecting the safety and effectiveness, between the subject and predicate devices.

The following tables list the similarities and the differences between the subject device (Rotograph Prime under trade mark Villa Sistemi Medicali and I-MAX under trade mark Owandy Radiology) and the predicate device (Rotograph EVO D, manufactured by Villa Sistemi Medicali and cleared by FDA with 510(k) number K090749).

	Villa Sistemi Medicali - Rotograph PrimeandOwandy Radiology - I-MAX510(k) number K162190	Villa Sistemi MedicaliRotograph EVO D510(k) number K090749
Versions
Digital	YES	YES
Exam projections
Pan	YES	YES
Improved orthogonalitydentition	YES	YES
Segmented Pan	YES	YES
Frontal dentition	YES	YES
Low dose panoramic	YES	YES
TMJ	YES	YES
Sinus	YES	YES
Size of pixel (acquired)	96 μm	96 μm
Magnification (PAN)	1,23 constant	1,23 constant
Source to image distance	500 mm	500 mm
Panoramic max image size	equivalent to 15x30 cm film	equivalent to 15x30 cm film
	Villa Sistemi Medicali - Rotograph PrimeandOwandy Radiology - I-MAX510(k) number K162190	Villa Sistemi MedicaliRotograph EVO D510(k) number K090749
Standard PAN image resolution	1536 x 2805 pixels	1536 x 2805 pixels
Dynamic (acquisition)	12 bit	12 bit
Generator / tube
X-ray generator	High frequency	High frequency
Focal spot value	0.5 mm (IEC 60336)	0.5 mm (IEC 60336)
Anode type	fixed	fixed
X-ray exposure time control	Automatic - pre-programmed MicroprocessorControlled	Automatic - pre-programmed MicroprocessorControlled
Independent kV-mA regulation	YES	YES
DAP Software	YES	YES
Patient positioning
Height adjustment	motorized	motorized
Positioning lights	2 laser pointers	2 laser pointers
Patient position	standing	standing
Patient positioning tools	temple clamps, bite block, chin support	temple clamps, bite block, chin support
Focal layer adjustment(prognatism compensation)	Electronic, three positions, no patient movement	Electronic, three positions, no patientmovement
User interface
Real time visualization	YES	YES
PC connection	Ethernet	Ethernet
Installation
Telescopic column	YES	YES
Power supply voltage	110-120 V, 50/60 Hz	110-120 V, 50/60 Hz
	Villa Sistemi Medicali - Rotograph PrimeandOwandy Radiology - I-MAX510(k) number K162190	Villa Sistemi MedicaliRotograph EVO D510(k) number K090749
Versions
Analog	NO	YES
Exam projections
Ceph	NO	YES
Adult PAN scan time	14.4 sec	13.8 sec
Child PAN scan time	13.3 sec	13.8 sec
Generator / tube
kV Range	60-70 kV step 2kV	60-86 kV step 2kV
mA range	2-7.1 mA	6-10 mA
Total filtration	2.0 mm Al eq	2.5 mm Al eq
Collimator	Fixed	Automatic
Patient positioning
Height of chin support	975-1635 mm	920-1755 mm
Patient positioning orientation	face to face	lateral with adjustable mirror
User interface
On board user interface	keyboard and virtual control panel	keyboard and O-LED display
Installation
Type of installation	wall mount	floor mount
Current rating	7 A	15 A
Weight (wall mount version)	62 kg	157 kg
Dimensions (wall mount version)	1107 x 953 mm	1260 x 1040 mm

Similarities

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Image /page/8/Picture/0 description: The image features a logo with a stylized white letter 'N' on a blue square background. Below the square, the word 'VILLA' is written in white, block letters. The overall design is simple and modern, with a clear contrast between the white elements and the blue background.

Differences

See the next paragraph "Detailed description of the differences" for additional information and details about each difference between subject and predicate device.

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Detailed description of the differences

As detailed described on the following paragraphs, all the differences do not affect the safety and effectiveness of the subject devices.

Versions .

The Predicate device is available also in analog version (using film-screen combination as image receptor). The subject device is available only in digital version (using the same digital detector as the predicate device). This choice has been driven by the current market and technology trend. Analog extraoral dental units have substantially disappeared from the market in the last 5 years.

. Exam projections

Ceph

The predicate device includes, as an option, also cephalometric examination of the skull. The subject device doesn't include cephalometric exams. The reason is that the device is dedicated to a market segment in which doctors don't need this exam. The fact that this function is not offered has no impact on the performance of the other available projections neither introduces differences vs pan-only version of the predicate device. The subject device is therefore equivalent to the pan-only version of the predicate device.

Adult Pan Scan time

During panoramic exams, the machine has to perform movements according to the selected exam specific trajectory; the exam scan time is the time taken by the machine to complete these movements. The panoramic exam trajectory implemented in the subject device is slightly slower from the one on the predicate device in order to adapt to the small geometric differences between the units; for this reason the scan time is increased of about 4%.

Cihild Pan Scan time

Due the fact that on the subject device the scan time has been slightly increased, it has been implemented a PAN exam specific for children with a reduced scan time.

In fact, the trajectory of child panoramic exam movements is shorter and dedicated to child patients giving a dose reduction vs. the adult exam. This trajectory has been already used on previous Villa panoramic units. It doesn't require different instructions of patient positioning respect to the adult exam.

Generator / tube ●

kV Range and mA range

The radiological parameters ranges have been optimized for the exam projections (on subject device ceph exams that requires higher dose is not present) and receptor type (on subject device film version that requires higher dose is not present) available on the subject device.

Total filtration

Due to the reduced kV range, the total filtration has been reduced maintaining the compliance with 21CFR 1020.30

Collimator

Due to the absence of the ceph exams, only one collimator slot is needed on the subject device. This collimator slot corresponds to the predicate devices for the exam projections available on the subject device.

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Patient positioning ●

Height of chin support

The Height range of chin support has been reduced based on the following assumption: 975mm correspond to the height of the chin of a 7 years old child, according to the Dreyfuss Tables and 1635mm correspond to the height of the chin of a man of about 190cm of height. According to the Dreyfuss tables this cover about 99% of the adult population.

Patient Positioning orientation

A difference has been introduced in the patient orientation with respect to the machine and operator. In the predicate device, the patient is facing the column; in order for the operator to have visibility of the patient's face, a mirror is present on the column. In the subject device the patient is facing to the equipment, making it possible for the operator to have a direct face visibility of the patient, therefore improving the positioning accuracy and patient's confidence.

. User interface

The user interface of the subject device is made by a keyboard on the machine to drive movements and lasers plus a virtual control panel on PC to select exams and their parameters. The user interface of the predicate device is on board but its digital version has also a virtual control panel on the PC with which exams and their parameters can be selected. The reason of this difference is related to the fact that the subject device, being only digital, always requires a PC so the on board keyboard could be removed while the predicate device needed the on-board keyboard for exam selection for the analog version that doesn't require a PC to work.

Installation .

Type of installation

The weight reduction of the subject device respect to the predicate device made it possible to produce a fully wall-mounted version which leaves the floor space free from support structures and more comfortable for the patient, especially in case of particular needs, such as wheelchairs.

Current rating

Due to the different radiological parameters ranges respect to the current rating of the subject device is also reduced

Weight (wall mount version)

Due to the absence of analoq version and cephalometric device, and thanks to the use of light-weight materials and optimized components design, the weight of subject device has been significantly reduced compared to the predicate device. The weight reduction doesn't affect the robustness of the device

Dimensions (wall mount version)

Due to the optimized components design, the dimension of subject device has been reduced compared to the predicate device

Regarding software ●

The elimination of the analog (film) version, the cephalometric option and the automatic contributed to the simplification both of the overall electronic and of the software architecture. The changes to the virtual control panel on PC - to select exams and their parameters - are limited just only to the cosmetic graphics elements. No other significant change is present in the software.

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The review of the technological differences between the subject device and the predicate device shows that they are due only to technological evolution and removal of not needed functions and/or version so they do not raise any new questions regarding safety or effectiveness of the Rotograph Prime (and I-MAX under trade mark Owandy Radiology). Basing on the above considerations, we can conclude that the Rotograph Prime (and I-MAX under trade mark Owandy Radiology) is as safe and effective as the predicate device.

PERFORMANCE DATA AND TESTING EVIDENCE:

Electrical safety, EMC/EMI testing, biocompatibility consideration, performance and image quality testing, verification and validation testing were performed to support the substantial equivalence determination. All standards applied were FDA recognized international standards. The software validation activities were performed in accordance with the FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained

in Medical Devices" (May 11, 2005). The device software is considered a "Moderate Level of Concern".

Rotograph Prime has been designed to be in conformity with the following international standards:

-IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007): Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
-IEC 60601-1-2:2007: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
-IEC 60601-1-3:2008: Medical electrical equipment - Part 1-3: General Requirements for Radiation Protection in Diagnostic X-Ray Equipment
-IEC 60601-2-63:2012: Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
-IEC 62304:2006: Medical device software - Software life-cycle processes
-ANSI/AAMI ES60601-1: 2005 / A2:2010 - Medical electrical equipment, Part 1: General Requirements
CAN/CSA-C22.2 No. 60601-1:08: Medical electrical equipment Part 1: General requirements for basic safety and essential performance
-IEC 60601-1-6:2010: Medical electrical equipment - Part 1-6: General requirements for safety - Collateral Standard: Usability
-IEC 62366:2007: Medical devices - Application of usability engineering to medical devices
-ISO 10993-2:2006: Biological evaluation of medical devices- part 2: animal welfare requirements
-ISO 10993-5:2009: Biological evaluation of medical devices- part 5: tests for in vitro cytotoxicity
-ISO 10993-10:2010: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
-ISO 10993-12:2012: Biological evaluation of medical devices- part 12: sample preparation and reference materials

In the submission are provided all the test reports including test protocol, methods, pass/fail criteria, and results in conformity with the standards here above.

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A risk analysis was performed to analyze the hazards associated with the changes.

Non-clinical considerations according to FDA Guidance "Guidance for the submissions of 510(k)'s for Solid State Xray Imaging Devices" were performed in order to assess the image quality and the relevant analysis has been supplied (see annex 7_Image_Quality_Comparison).

The intended use of the proposed device is the same of the predicate device. Concerning Conclusion: the technical characteristics, it has been demonstrated that Rotograph Prime (and I-MAX under trade mark Owandy Radiology) does not introduce innovative aspects and does not arise different considerations regarding the safety and the relevant risks linked to the device. Despite some minor technological differences, Rotograph Prime (and I-MAX under trade mark Owandy Radiology) can be considered as safe and as effective as the predicate device and therefore substantially equivalent to the predicate Rotograph EVO D.

Regulation Number and Section

§ 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.