(176 days)
X-MIND prime 3D (and I-MAX 3D under trademark Owandy Radiology) is an extra-oral dental panoramic and CBCT (aka CBVT) X-ray unit to take either two dimensional (panoramic, TMJ and sinus exams) or three dimensional radiographic exams of teeth, jaw and oral structures. The models with cephalometric arm will be able to take two dimensional cranial cephalometric exams in different projections and the wrist exam (Carpus) dedicated to the evaluation of the bone growth.
Two dimensional images are taken using the narrow beam technique. Three dimensional exams are taken using cone shaped X-ray beam technique; both of them are well known techniques.
The device is operated and used by dentists, radiologists and other legally qualified health care professionals, i.e. Prescription Use (Part 21 CFR 801 Subpart D).
The target patient population includes adults and pediatric patients from 7 years old [~27 kg (59.5 lb); 125 cm (49.2 in) standing height].
Anyway, the sustainability to X-ray exposure must be evaluated by surgeons, dentists and qualified and authorized physicians.
X-MIND prime 3D is an X-ray device for the radiographic analysis of the maxillo-facial complex. X-MIND prime 3D performs 2D Panoramic, Half-panoramic, Low dose Panoramic, Frontal dentition, Ortho Rad Panoramic, Bitewing Bilateral, Bitewing Right, 2D Sinus and 2D TMJ, 3D Dentition with multiple available FOV centered in different areas of the maxillo-facial complex (Full Dentition, Maxillary Jaw, Mandibular Jaw, Maxillary Teeth, Mandibular Teeth), 3D Sinus, 3D TMJ, AP and LL cephalometric exams, Carpus exam.
X-MIND prime 3D system can be used with the following type of patient:
- . Patient population: the target patient population includes adults and pediatric patients from 7 years old [~25 kq (55 lb); 125 cm (49.2 in) standing height]. Anyway, the sustainability to X-ray exposure must be evaluated by surgeons, dentists and qualified and authorized physicians
- Patient status: .
- self-sufficient patient (the patient can autonomously place himself as requested by · the physician)
- . non self-sufficient patient (the patient is assisted by medical personnel)
- in any case the patient must be conscious, not anaesthetized and not incapacitated
- . Nationality: multiple.
The reason of the present submission is the introduction of a significative change on X-MIND prime 3D device (listing number D342123 and FDA clearance K180601).
This significant change mostly consists in the addition of the cephalometric arm to X-MIND prime 3D.
This document is a 510(k) summary for the X-MIND prime 3D dental X-ray system. It primarily focuses on demonstrating substantial equivalence to predicate devices, particularly K180601 (X-MIND prime 3D) and K181297 (DENTIOIII Series).
The document does not contain information related to acceptance criteria for an AI-powered device, nor does it detail a study proving such a device meets acceptance criteria. The device described is a medical imaging hardware system, not an AI or software-only diagnostic aid.
Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, data provenance, expert establishing ground truth, adjudication methods, MRMC studies, standalone performance, or how ground truth was established, as this information is not present within the provided text for an AI-powered device.
The document primarily focuses on:
- Device Description: X-MIND prime 3D (and I-MAX 3D) is an extra-oral dental panoramic and CBCT X-ray unit, with a new version including a cephalometric arm. It performs 2D panoramic, TMJ, sinus exams, and 3D radiographic exams of teeth, jaw, and oral structures. The cephalometric arm adds 2D cranial cephalometric exams and wrist exams for bone growth evaluation.
- Intended Use: Used by dentists, radiologists, and other legally qualified healthcare professionals for prescription use, targeting adults and pediatric patients from 7 years old.
- Comparison to Predicate Devices: Detailed tables comparing the proposed device to its primary predicate (X-MIND prime 3D, K180601, manufactured by de Götzen S.r.l. – ACTEON Group) and an additional predicate (DENTIOIII Series, K181297, manufactured by HDX WILL CORP.) regarding features, examination programs, technical characteristics, and software functions.
- Performance Data and Testing Evidence: This section mentions only Electrical safety and EMC testing conducted by an NRTL to verify compliance with general requirements for medical electrical equipment, usability, and electromagnetic compatibility. It lists various IEC, ANSI/AAMI, and ISO standards to which the device complies. It also states compliance with 21 CFR §1020.30, §1020.31, and §1020.33 related to performance standards for ionizing radiation emitting products.
In summary, none of the requested information pertains to an AI component or a study evaluating AI performance within this 510(k) summary.
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November 18, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
de Gotzen S.r.l. % Dario Bandiera Quality Assurance and Regulatory Affairs Manager Via Roma, 45 Olgiate Olona. Varese 21057 ITALY
Re: K201382
Trade/Device Name: X-MIND prime 3D (under trademark Acteon) I-MAX 3D (under trademark Owandy Radiology) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: OAS, MUH Dated: October 8, 2020 Received: October 13, 2020
Dear Dario Bandiera:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201382
Device Name
X-MIND prime 3D (under trademark Acteon) I-MAX 3D (under trademark Owandy Radiology)
Indications for Use (Describe)
X-MIND prime 3D (and I-MAX 3D under trademark Owandy Radiology) is an extra-oral dental panoramic and CBCT (aka CBVT) X-ray unit to take either two dimensional (panoramic, TMI and sinus exams) or three dimensional radiographic exams of teeth, jaw and oral structures. The models with cephalometric arm will be able to take two dimensional cranial cephalometric exams in different projections and the wrist exam (Carpus) dedicated to the evaluation of the bone growth.
Two dimensional images are taken using the narrow beam technique. Three dimensional exams are taken using cone shaped X-ray beam technique; both of them are well known techniques.
The device is operated and used by dentists, radiologists and other legally qualified health care professionals, i.e. Prescription Use (Part 21 CFR 801 Subpart D).
The target patient population includes adults and pediatric patients from 7 years old [~27 kg (59.5 lb); 125 cm (49.2 in) standing height].
Anyway, the sustainability to X-ray exposure must be evaluated by surgeons, dentists and qualified and authorized physicians.
| 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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| Via Roma, 45 |
|---|
| -------------- |
21057 Olgiate Olona (VA)
X-MIND prime 3D
VOL. 004
001_Summary
510(k) Summary
Index
| I. | SUBMITTER | 2 |
|---|---|---|
| II. | PROPOSED DEVICE | 2 |
| III. | PREDICATE DEVICES | 2 |
| IV. | DEVICE DESCRIPTION | 3 |
| V. | INDICATIONS FOR USE | 9 |
| VI. | COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATEDEVICES | 9 |
| VII. | PERFORMANCE DATA AND TESTING EVIDENCE. | 21 |
| VIII | CONCLUSION | 23 |
| Rev. n. 2 | VOL. 004 | |
|---|---|---|
| 08/10/2020 | X-MIND prime 3D 510(k) Abbreviated | Page 1 of 23 |
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VOL. 004
510(k) Summary
The summary of this 510(k) is being submitted in accordance with the requirements of 21 CFR Part 807.92.
I. SUBMITTER
| Owner's name: | de Götzen S.r.l. – ACTEON Group |
|---|---|
| Address: | via Roma, 45 – 21057 Olgiate Olona (VA), Italy |
| Tel: | +39 0331 376760 |
| Fax: | +39 0331 376763 |
| Contact person: | Dario Bandiera – dario.bandiera@acteongroup.com |
| Date: | September 15th, 2020 |
Table 1: Submitter information
PROPOSED DEVICE II.
| Name of the device: | X-MIND prime 3D (under trademark Acteon)I-MAX 3D (under trademark Owandy Radiology) |
|---|---|
| Common or Usual name: | Dental panoramic, cephalometric and CBCT X-ray system |
| Classification name: | Computed tomography X-ray system (21 CFR 892.1750) |
| Regulatory class: | II |
| Product Code: | OAS |
Table 2: Proposed device information
PREDICATE DEVICES III.
Legally marketed devices to which equivalence is claimed is:
| PRIMARY PREDICATE DEVICE | |
|---|---|
| Device name | X-MIND prime 3D |
| Manufacturer | de Götzen S.r.l. – ACTEON Group |
| Device product code | OAS |
| Regulation number | 892.1750 |
| Regulation name | Computed tomography x-ray system |
| Clearance date | November 2nd, 2018 |
| 510(k) number | K180601 |
Table 3: Primary predicate device information
| Rev. n. 2 | X-MIND prime 3D 510(k) Abbreviated | VOL. 004 |
|---|---|---|
| 08/10/2020 | Page 2 of 23 |
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VOL. 004
Via Roma, 45 21057 Olgiate Olona (VA) 510(k) Summary
ADDITIONAL PREDICATE DEVICE Device name DENTIOIII Series (DENTIOIII, DENTIOIII-S) Manufacturer HDX WILL CORP. Device product code MUH Requlation number 872.1800 Extraoral source x-ray system Requlation name Clearance date November 21st, 2018 510(k) number K181297
Table 4: Additional predicate device information
DEVICE DESCRIPTION IV.
NOTE: In the following, all the reference to X-MIND prime 3D are applicable also to I-MAX 3D under trademark Owandy Radiology
X-MIND prime 3D is an X-ray device for the radiographic analysis of the maxillo-facial complex. X-MIND prime 3D performs 2D Panoramic, Half-panoramic, Low dose Panoramic, Frontal dentition, Ortho Rad Panoramic, Bitewing Bilateral, Bitewing Right, 2D Sinus and 2D TMJ, 3D Dentition with multiple available FOV centered in different areas of the maxillo-facial complex (Full Dentition, Maxillary Jaw, Mandibular Jaw, Maxillary Teeth, Mandibular Teeth), 3D Sinus, 3D TMJ, AP and LL cephalometric exams, Carpus exam.
X-MIND prime 3D system can be used with the following type of patient:
- . Patient population: the target patient population includes adults and pediatric patients from 7 years old [~25 kq (55 lb); 125 cm (49.2 in) standing height]. Anyway, the sustainability to X-ray exposure must be evaluated by surgeons, dentists and qualified and authorized physicians
- Patient status: .
- self-sufficient patient (the patient can autonomously place himself as requested by · the physician)
- . non self-sufficient patient (the patient is assisted by medical personnel)
- in any case the patient must be conscious, not anaesthetized and not incapacitated
- . Nationality: multiple.
OVERVIEW OF THE DEVICE
The reason of the present submission is the introduction of a significative change on X-MIND prime 3D device (listing number D342123 and FDA clearance K180601).
This significant change mostly consists in the addition of the cephalometric arm to X-MIND prime 3D, as shown in overview figure below:
| Rev. n. 2 | X-MIND prime 3D 510(k) Abbreviated | VOL. 004 |
|---|---|---|
| 08/10/2020 | Page 3 of 23 |
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Image /page/6/Picture/0 description: The image shows a document with the title "X-MIND prime 3D 510(k) Summary". The document also includes the volume number "VOL. 004" and the summary number "001_Summary". The document also includes the address "Via Roma, 45 21057 Olgiate Olona (VA)" and the ACTEON logo.
Image /page/6/Figure/1 description: The image shows two X-MIND prime 3D machines, one without a CEPH arm and one with a CEPH arm. Both machines have several labeled parts, including the base, the arm, and the head. The machine with the CEPH arm has additional labeled parts related to the CEPH arm, such as the sensor and the support.
Figure 1: overview of the scanner in the configurations without and with the cephalometric arm
| 1 | Control panel | The control panel provides an intuitive overview of the systemand hold the keys to move up and down the column, turn on andoff the positioning lasers and reset the device to the start examposition.Image: Control Panel |
|---|---|---|
| 2 | Detector group | It contains the PAN/ CBCT detector for use in generatingradiographic images of the maxillo-facial region. The samedetector is used to acquire 2D panoramic and CBCT exams. |
| 3 | Fixed arm | It supports the rotating arm. |
| 4 | Telescopic Column | The telescopic column supports and moves the entire structure ofthe medical device.In the version without CEPH arm it is fixed to the wall without anyfootrest; |
| X-MIND prime 3D device consists of the following parts: | |||||||
|---|---|---|---|---|---|---|---|
| -- | -- | -- | -- | -- | -- | --------------------------------------------------------- | -- |
| Rev. n. 2 | X-MIND prime 3D 510(k) Abbreviated | VOL. 004 |
|---|---|---|
| 08/10/2020 | Page 4 of 23 |
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VOL. 004
001_Summary
Via Roma, 45 21057 Olgiate Olona (VA) 510(k) Summary
| in the version with CEPH arm it is fixed to the wall and resting onthe floor. | |||
|---|---|---|---|
| 5 | Patient handgrip | Handgrips held by the patient during the exam. | |
| 6 | Patient support | The patient support allows to stabilise and immobilise the patient.It is equipped with tools to position the patient head to fit thepatient's anatomy to the Field of View (FOV). | |
| 7 | X-ray generator | The X-ray assembly is the source of the X-ray beam during theexams. The beam is modelled by a collimator; the electroniccontrol ensures precision and accuracy of selected loading factors(kVp and anodic current). The tubehead aluminium additionalfiltration fits the CFR 21 part 1020.30 and remove low-energyionising radiations, obtaining suitable radiation quality whilereducing the dose absorbed by the patient. | |
| 8 | Rotating arm | The rotating arm supports detectors and X-ray generator. This isthe rotating part of the medical device, which moves around thepatient during the image acquisition phase of panoramic / 3Dexams. | |
| 9 | CEPH arm | In the version of X-MIND prime 3D with cephalometric arm, itallows the execution of cephalometric exams: radiographicimages of the patient skull in LL and AP views and of the patient'swrist to evaluate the bone growth (using the carpus plateprovided with the cephalometric function). | |
| 10 | CEPH craniostat | The craniostat is the patient positioning aiming device (composedby ear and nasion rest) for the cephalometric exams. | |
| 11 | CEPH 2ry collimator | The CEPH 2ry collimator is translating during X-Rays in sync withCEPH detector and 1ry collimator (to collimate on CEPH detectorthe X-Ray beam emerging from the generator). | |
| 12 | CEPH detector | The CEPH detector is translating during X-Rays in sync with CEPH2ry collimator and 1ry collimator (to generate radiographic imagesof the patient skull in LL and AP views and of the patient's wrist. |
Table 5: X-MIND prime 3D parts
| Rev. n. 2 | X-MIND prime 3D 510(k) Abbreviated | VOL. 004 |
|---|---|---|
| 08/10/2020 | Page 5 of 23 |
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Via Roma, 45 21057 Olgiate Olona (VA)
510(k) Summary
EQUIPMENT CONFIGURATIONS
X-MIND prime 3D can be sold in these different configurations:
PAN / CBCT
In this configuration, X-MIND prime 3D is equipped only with the PAN/CBCT detector which allows to acquire both panoramic and CBCT exams.
PAN / CBCT / CEPH
The equipment can carry out the panoramic, 3D and cephalometric exams.
The device is equipped with a PAV/CBCT detector which allows to acquire both panoramic and CBCT exams.
On the cephalometric arm, a dedicated CEPH detector allows the acquisition of the cephalometric exams.
LIST OF EXAMS
X-MIND prime 3D is a complete panoramic X-ray system that can perform the followinq exams:
2D examination programs
- . Standard Panoramic exam
- TM| closed and open mouth: 4 slices are taken in the same image (left/right condyle, open/close . mouth). Condyles are examined in lateral projection
- TMJ single phase .
- Sinus P/A projection: one P/A projection, where both the maxillary sinuses are represented. ●
- . Half Panoramic (left/right): panoramic acquired only on the right or left side of the mouth
- Ortho Rad Panoramic: panoramic projection limited to the dentition, obtained with X-ray beam . constantly perpendicular to the arch. It allows to reduce superimposition of adjacent teeth and to improve visualization of possible interproximal caries
- . Frontal Dentition: panoramic limited to the frontal dentition (canine to canine), that allows to improve the detail definition on incisors
- Low Dose Panoramic: panoramic with reduced angle of rotation to exclude the ascending ramus . from the image. The result is a panoramic limited to the dentition area using a reduced patient dose
- Bitewing (Left/Right/Left and Right): the left or right projection allows the examination of lateral . dentition (from eighth to fourth approximately), with optimized trajectory of rotating arm for a higher orthogonality of the x-ray beam on the adjacent teeth, to improve visualization of possible interproximal caries. Left and Right Bitewing projection performs both Bitewing views in sequence,
| Rev. n. 2 | X-MIND prime 3D 510(k) Abbreviated | VOL. 004 |
|---|---|---|
| 08/10/2020 | Page 6 of 23 |
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Via Roma, 45 21057 Olgiate Olona (VA)
joining them on the same image
3D examination programs
- . 3D Full Dentition (FOV 85 x 93 mm): 3D exam of the full dentition
- . 3D Single Jaw (FOV 85 x 50 mm): 3D exam of a single dental arc with two different FOV positions: Maxillary, Mandibular
- 3D Mandibular Teeth (FOV 50 x 50 mm): 3D exam of a reduced part of the mandibular dentition, with five different FOV positions: Frontal, Premolars (right/left) and Molars (right/left)
- 3D Maxillary Teeth (FOV 50 x 50 mm): 3D exam of a reduced part of the maxillary dentition, with . five different FOV positions: Frontal, Premolars (right/left) and Molars (right/left)
- 3D TM| (FOV 85 x 93 mm): 3D exam of the temporomandibular joint with two different FOV . positions (right/left)
- . 3D Sinus (FOV 85 x 93 mm): 3D exam of the maxillary sinuses area
Cephalometric examination programs
- Cephalometric L-L projections (with formats 18x24, 24x24, 30x24 and 18x18, 24x18, 30x18): exam . of the skull acquired in lateral projection. The selection between HS High Speed and HD High Definition is available.
- . Cephalometric A-P projections (with formats 24x24 and 24x18): exam of the skull acquired in frontal position. The selection between HS High Speed and HD High Definition is available.
- . Carpus Projection (with format 18x24): exam specifically intended for evaluating the state of calcification and the patient's bone growth trend. The exam is available only in HD High Definition mode.
For each exam it is possible to select patient type (Adult or Child) and the patient size (small, medium, large) to allow the automatic selection of the preset exposure parameters. Otherwise, the user has the possibility to select the exposure parameters manually, with a high voltage ranging between 60 and 86 kV in 2 kV steps, and with the anodic current ranging from 2 mA to 12.5 mA with R20 scale steps.
PRINCIPLES OF OPERATION
The X-ray generator and the detector (PAN/CBCT, CEPH) are the most important parts of the X-MIND prime 3D device and allow the acquisition of the radiographic images of the maxillofacial complex. The PAN/CBCT detector and the X-ray source are mounted on the rotating arm of the device, while the CEPH detector is mounted on the cephalometric arm.
| Rev. n. 2 | X-MIND prime 3D 510(k) Abbreviated | VOL. 004 |
|---|---|---|
| 08/10/2020 | Page 7 of 23 |
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001_Summary
510(k) Summary
Via Roma, 45 21057 Olgiate Olona (VA)
During the panoramic and CBCT exams, the rotating arm rotates up to 200° (depending on the selected exams) around the patient's head, and the detector acquires a set of radiographic images. A collimator ensures an efficient use of the radiation, minimising the exposed area only on the anatomical region of interest.
The raw images are processed to obtain a 2D image (panoramic) or 3D reconstruction of the target volume.
In order to acquire the cephalometric exams, the CEPH detector performs a horizontal linear scanning of the skull, while the focus is kept in a fixed position, quaranteeing the same projection geometry as if using a film. The X-ray source is automatically aligned to digital sensor. The use of a secondary collimator on the cephalometric arm ensures the minimum level of radiation to the patient limiting the size of the fan shaped beam to the target region of interest. A digital filter is automatically applied to lateral cephalometric images to enhance the visibility of soft tissues profile while preserving the bone structures.
| Rev. n. 2 | X-MIND prime 3D 510(k) Abbreviated | VOL. 004 |
|---|---|---|
| 08/10/2020 | Page 8 of 23 |
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21057 Olgiate Olona (VA)
Via Roma, 45
X-MIND prime 3D
510(k) Summary
V. INDICATIONS FOR USE
X-MIND prime 3D (and I-MAX 3D under trademark Owandy Radiology) is an extra-oral dental panoramic and CBCT (aka CBVT) X-ray unit to take either two dimensional (panoramic, TM) and sinus exams) or three dimensional radiographic exams of teeth, jaw and oral structures. The models with cephalometric arm will be able to take two dimensional cranial cephalometric exams in different projections and the wrist exam (Carpus) dedicated to the evaluation of the bone growth.
Two dimensional images are taken using the narrow beam technique. Three dimensional exams are taken using cone shaped X-ray beam technique; both of them are well known techniques.
The device is operated and used by dentists, radiologists and other legally qualified health care professionals, i.e. Prescription Use (Part 21 CFR 801 Subpart D).
The target patient population includes adults and pediatric from 7 years old [~27 kg (59.5 lb); 125 cm (49.2 in) standing height].
Anyway, the sustainability to X-ray exposure must be evaluated by surgeons, dentists and qualified and authorized physicians.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE VI. DEVICES
NOTE: In the following, all the reference to X-MIND prime 3D are applicable also to I-MAX 3D under trademark Owandy Radiology
| Rev. n. 2 | X-MIND prime 3D 510(k) Abbreviated | VOL. 004 |
|---|---|---|
| 08/10/2020 | Page 9 of 23 |
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ACTIFO
X-MIND prime 3D
VOL. 004
001_Summary
Via Roma, 45 21057 Olgiate Olona (VA)
| Proposed device:X-MIND prime 3D | Primary predicate device:Rotograph Prime 3D | Additional predicatedevice:DENTIOIII series(DENTIOIII, DENTIOIII-S) | |
|---|---|---|---|
| IntendedUse | X-MIND prime 3D is anextra-oral dentalpanoramic and CBCT (akaCBVT) X-ray unit to takeeither two dimensional(panoramic, TMJ and sinusexams) or threedimensional radiographicexams of teeth, jaw andoral structures. The modelswith cephalometric arm willbe able to take twodimensional cranialcephalometric exams indifferent projections andthe wrist exam (Carpus)dedicated to the evaluationof the bone growth. | Rotograph Prime 3D is anextra-oral dentalpanoramic and CBCT (akaCBVT) X-ray unit to takeeither two dimensional(panoramic, TMJ and sinusexams) or threedimensional radiographicexams of teeth, jaw andoral structures. | The DENTIOIII series isintended for dentalradiographic examinationof the teeth andtemporomandibular joints,specifically for panoramicand cephalometricexaminations. It is to beused only by dentalpractitioners and/orradiologists |
| Rev. n. 2 | VOL. 004 | |
|---|---|---|
| 08/10/2020 | X-MIND prime 3D 510(k) Abbreviated | Page 10 of 23 |
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VOL. 004
001_Summary
Via Roma, 45 21057 Olgiate Olona (VA) 510(k) Summary
| Proposed device:X-MIND prime 3D | Primary predicate device:Rotograph Prime 3D | Additional predicatedevice:DENTIOIII series(DENTIOIII, DENTIOIII-S) |
|---|---|---|
| Two dimensional imagesare taken using the narrowbeam technique. Threedimensional exams aretaken using cone shaped X-ray beam technique; bothof them are well knowntechniques.The device is operated andused by dentists,radiologists and otherlegally qualified health careprofessionals, i.e.Prescription Use (Part 21CFR 801 Subpart D).The target patientpopulation includes adultsand pediatric patients from7 years old [~27 kg (59.5 lb);125 cm (49.2 in) standingheight].Anyway, the sustainabilityto X-ray exposure must beevaluated by surgeons,dentists and qualified andauthorized physicians. | Two dimensional imagesare taken using the narrowbeam technique. Threedimensional exams aretaken using cone shaped X-ray beam technique; bothof them are well knowntechniques.The device is operated andused by dentists,radiologists and otherlegally qualified health careprofessionals.It can be used with bothpediatric and adultpatients. |
Table 6: Comparison of the intended use among proposed and predicate devices.
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Image /page/14/Picture/12 description: The image shows the logo for Acteon. The logo features the word "ACTEON" in bold, sans-serif font. A blue swoosh design is located to the left of the word, adding a visual element to the logo. The logo is simple and modern in design.
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Detailed comparison of similarities and differences
The following table highlights the existing similarities for 2D and 3D exams between the proposed device and the primary predicate device.
| Proposed device:X-MIND prime 3D | Primary predicate device:X-MIND prime 3D(Rotograph Prime 3D) | |
|---|---|---|
| 2D Examination programs | ||
| Panoramic exam | Yes | Yes |
| Ortho Rad Panoramic | Yes | Yes |
| Segmented Panoramic (Halfpanoramic, frontal dentition,bitewings) | Yes | Yes |
| Low dose panoramic | Yes | Yes |
| TMJ Closed/Open mouth | Yes | Yes |
| TMJ single phase | Yes | Yes |
| Sinus | Yes | Yes |
| 2D Exam characteristics | ||
| Magnification (Panoramic) | 1.28 constant | 1.28 constant |
| Source to image distance | 520 mm | 520 mm |
| Panoramic max image size | equivalent to 15x30 cm film | equivalent to 15x30 cm film |
| Adult panoramic scan time | 14 s | 14 s |
| Child panoramic exam withshorter scan time than adultpanoramic exam | 12.8 s | 12.8 s |
| Rev. n. 2 | X-MIND prime 3D 510(k) Abbreviated | VOL. 004 |
|---|---|---|
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| Proposed device:X-MIND prime 3D | Primary predicate device:X-MIND prime 3D(Rotograph Prime 3D) | |
|---|---|---|
| 3D examination programs | ||
| 3D Full dentition | Yes | Yes |
| 3D TMJ Left | Yes | Yes |
| 3D TMJ Right | Yes | Yes |
| 3D Sinus | Yes | Yes |
| 3D Single Jaw(maxillary / mandibular) | Yes | Yes |
| 3D teeth only (maxillary /mandibular) | Yes | Yes |
| 3D High resolution mode | Yes | Yes |
| 3D exam characteristics |
| 3D exam characteristics | ||
|---|---|---|
| X-ray beam | Cone Beam | Cone Beam |
| Acquisition trajectory | Single 200 degree rotation(except for 3D TMJ)Single 180 degree rotation(for 3D TMJ) | Single 200 degree rotation(except for 3D TMJ)Single 180 degree rotation (for3D TMJ) |
| Rotation time | 20 s (except for 3D TMJ)18 s (for 3D TMJ) | 20 s (except for 3D TMJ)18 s (for 3D TMJ) |
| X-ray emission method | Pulsed | Pulsed |
| Reconstruction algorithm | Feldkamp with the option ofMAR (Metal Artifact Removal) | Feldkamp with the option ofMAR (Metal Artifact Removal) |
| Rev. n. 2 | X-MIND prime 3D 510(k) Abbreviated | VOL. 004 |
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| Proposed device:X-MIND prime 3D | Primary predicate device:X-MIND prime 3D(Rotograph Prime 3D) | |
|---|---|---|
| Magnification | 1.37 | 1.37 |
| Source to image distance | 520 mm | 520 mm |
| X-ray emission time | 6.2 - 7 s | 6.2 - 7 s |
| Biggest FOV (Ø x H) mm (3Ddentition, 3D TMJs, 3D sinus) | 85 mm x 93 mm | 85 mm x 93 mm |
| Size of acquired voxel (isotropic) | 175 µm | 175 µm |
| Size of acquired voxel in Highresolution mode (isotropic),available on Other FOVs | 87.5 µm | 87.5 µm |
| 2D/3D imaging detector | ||
| Technology | CMOS flat panel with CesiumIodide (CsI) scintillator screen | CMOS flat panel with CesiumIodide (CsI) scintillator screen |
| Sensor active area (Height xWidth) | 144 x 118.6 mm | 144 x 118.6 mm |
| Pixel size | 120 µm x 120 µm | 120 µm x 120 µm |
| Bit depth | 16 bit | 16 bit |
| Number of sensor pixels | 1200 x 988 | 1200 x 988 |
| Generator/tubecharacteristics | ||
| X-ray generator | High frequency | High frequency |
| Focal spot value | 0.5 mm (IEC 60336) | 0.5 mm (IEC 60336) |
| Rev. n. 2 | X-MIND prime 3D 510(k) Abbreviated | VOL. 004 |
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| Proposed device:X-MIND prime 3D | Primary predicate device:X-MIND prime 3D(Rotograph Prime 3D) | |
|---|---|---|
| Anode type | Fixed | Fixed |
| X-ray exposure time control | Automatic - pre-programmedMicroprocessor Controlled | Automatic – pre-programmedMicroprocessor Controlled |
| Independent kV-mA regulation | Yes | Yes |
| DAP Software | Yes | Yes |
| kV Range | 60 - 86 kV step 2kV | 60 - 86 kV step 2kV |
| Total filtration | ≥ 2.5 mm Al eq | ≥ 2.5 mm Al eq |
| mA range | 2 - 12.5 mA | 2 - 12.5 mA |
| Collimator | Automatic | Automatic |
| Patient positioning forpanoramic and 3D exams | ||
| 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, head strip | Temple clamps, bite block, chinsupport, head strip |
| Focal layer adjustment(prognatism compensation) | Electronic, three positions, nopatient movement | Electronic, three positions, nopatient movement |
| Patient positioning orientationvs the operator | Face to face | Face to face |
| Rev. n. 2 | X-MIND prime 3D 510(k) Abbreviated | VOL. 004 |
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| Proposed device:X-MIND prime 3D | Primary predicate device:X-MIND prime 3D(Rotograph Prime 3D) | |
|---|---|---|
| Height of chin support from thefloor | 978-1678 mm | 975-1635 mm |
| User interface | ||
| Real time visualization | Yes | Yes |
| PC connection | Two dedicated Giga-Ethernetchannels: one for the machinecommunication and for theceph detector, the seconddedicated to the PAN/3Ddetector | Ethernet for the machinecommunication + point to pointdedicated giga-ethernet for thedetector |
| User interface | Onboard keyboard and virtualcontrol panel (on PC) | Onboard keyboard and virtualcontrol panel (on PC) |
| Software | ||
| System architecture | Based on multiple CPUsconnected via Can Bus plusEthernet connection to PC | Based on multiple CPUsconnected via Can Bus plusEthernet connection to PC. |
| Rev. n. 2 | X-MIND prime 3D 510(k) Abbreviated | VOL. 004 |
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| Proposed device:X-MIND prime 3D | Primary predicate device:X-MIND prime 3D(Rotograph Prime 3D) | |
|---|---|---|
| Firmware functions(of Control Processing Units) forcontrolling movements andimageacquisition/synchronization | Firmware functions aredesigned to manage thepanoramic/3D version andthe cephalometric option.Some differences in thefirmware functions arerelated to the management ofthe added cephalometricoption. Some additionaldifferences are related tospecific hardware solutions ordifferent microprocessorsfrom the Primary PredicateDevice. | Firmware functions aredesigned to manage thefollowing configuration:panoramic/3D version |
| X-ray generator board firmwarefunctions | X-ray parameters (kV, mA,pulsed / continuous emission)management, X-ray start andstop, errors control.Can Bus communication. | X-ray parameters (kV, mA,pulsed / continuous emission)management, X-ray start andstop, errors control.Can Bus communication. |
| Communication protocolbetween the computer andControlling Processing Unitboard. | Proprietary TCP/IP protocol | Proprietary TCP/IP protocol |
| Software functions (on PC) | Graphical user interface (GUI)to control the machine,TCP/IP communication, imageacquisition and correction;image reconstruction. | Graphical user interface (GUI)to control the machine, TCP/IPcommunication, imageacquisition and correction;image reconstruction |
| Rev. n. 2 | X-MIND prime 3D 510(k) Abbreviated | VOL. 004 |
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| Proposed device:X-MIND prime 3D | Primary predicate device:X-MIND prime 3D(Rotograph Prime 3D) | |
|---|---|---|
| Image acquisition | Integration of the specificdetector manufacturer SDK;PC memory and disk spacemanagement and control. | Integration of the specificdetector manufacturer SDK; PCmemory and disk spacemanagement and control. |
| Image correction (defect map,offset and flat field) | Correction functions fordetector are designed byActeon / Owandy. Offsetcorrection is done beforeeach acquisition | Correction functions fordetector are designed byActeon / Owandy. Offsetcorrection is done beforeeach acquisition |
| 2D examination programs' finalimage | The frames acquired by theFlat panel detector in areamode after the corrections,are elaborated with a shiftand add procedure to formthe final image. Thisprocedure applies tocephalometric images too | The frames acquired by the Flatpanel detector in area mode areafter the correction, areelaborated with a shift and addprocedure to form the finalimage |
| 2D examination programs'image pre-processing | GUI provides basic image pre-processing capabilities thatthe user can enable ordisable. By default they aredisabled. This procedureapplies to cephalometricimages too | GUI provides basic image pre-processing capabilities that theuser can enable or disable. Bydefault they are disabled. |
| Rev. n. 2 | X-MIND prime 3D 510(k) Abbreviated | VOL. 004 |
|---|---|---|
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| Proposed device:X-MIND prime 3D | Primary predicate device:X-MIND prime 3D(Rotograph Prime 3D) | |
|---|---|---|
| 3D examination imagereconstruction | The frames acquired by theFlat panel detector in areamode after the correction, areelaborated with a Feldkampalgorithm -and eventuallywith the MAR algorithm- toget a set of axial slices; then adicom header is added toeach slice file. Dicom datasetis then saved to disk fortransfer to externalvisualization/processingprograms.The 3D reconstruction is doneusing PC GPU or CPU. | The frames acquired by the Flatpanel detector in area modeafter the correction, areelaborated with a Feldkampalgorithm -and eventually withthe MAR algorithm- to get a setof axial slices; then a dicomheader is added to each slicefile. Dicom dataset is thensaved to disk for transfer toexternalvisualization/processingprograms.The 3D reconstruction is doneusing PC CPU. |
| Installation | ||
| Telescopic column | Yes | Yes |
| Power supply voltage | 110-240 V, 50/60 Hz | 110-240 V, 50/60 Hz |
| Current rating | 14 A | 14.5 A |
Table 7: Comparison between the proposed and the primary predicate device.
| Rev. n. 2 | X-MIND prime 3D 510(k) Abbreviated | VOL. 004 |
|---|---|---|
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510(k) Summary
The following table is focused on the comparison about the cephalometric exams between the proposed device and the additional predicate device.
| Proposed device:X-MIND prime 3D | Additional predicate device:DENTIOIII series (DENTIOIII,DENTIOIII-S) | |
|---|---|---|
| Cephalometric imagingdetector | ||
| Detector model | Xineos-2301 | Xineos-2301 |
| Manufacturer | Teledyne DALSA | Teledyne DALSA |
| Technology | CMOS flat panel with CesiumIodide (CsI) scintillator screen | CMOS flat panel with CesiumIodide (CsI) scintillator screen |
| Sensor active area (Height xWidth) | 228 mm x 6.7 mm | 228 mm x 7.0 mm |
| Pixel size | 99 $\mu$ m x 99 $\mu$ m | 99 $\mu$ m x 99 $\mu$ m |
| Bit depth | 14 bit | 14 bit |
| Number of sensor pixels | 2304 x 68 | 2305 x 68 |
| MTF | 65% at 1 lp/mm | 65% at 1 lp/mm |
| DQE | 57% at 1 lp/mm | 57% at 1 lp/mm |
| Cephalometric examinationprograms | ||
| Exam time | Max 15.1 s (HD) / min 4.4 s(HS) | Max 8.2 s (Normal) / 4.2 s (Fast) |
| Frontal (AP/PA) projection | Yes | Yes |
| Lateral (LL) projection | Yes | Yes |
| Rev. n. 2 | X-MIND prime 3D 510(k) Abbreviated | VOL. 004 |
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Additional predicate device: Proposed device: DENTIOIII series (DENTIOIII, X-MIND prime 3D DENTIOIII-S) Carpus Yes Yes Mechanical characteristics 1735 mm (single detector type) 1650 mm Source to image distance 1729 mm (dual detector type) Floor-Wall or Floor mount Type of installation Floor mount Weight (wall mount version) 123 kg 160 kg 2229.5 mm x 1851 mm x 1205 Dimensions (wall mount 2309 mm x 1953 mm x 1222 version) mm mm
Table 8: Comparison between the proposed and the additional predicate device.
The differences between the proposed device and the predicate devices do not raise new questions of safety and effectiveness.
VII. PERFORMANCE DATA AND TESTING EVIDENCE
The following performance data are provided in support of the substantial equivalence determination.
Electrical safety and EMC testing were conducted on X-MIND prime 3D. The performance tests were conducted by a Nationally Recognized Testing Laboratory (NRTL) in order to verify:
- compliance with general requirements for basic safety and essential performance of medical electrical equipment and dental extra-oral X-ray equipment
- . compliance with usability requirements
- . compliance with electromagnetic compatibility requirements.
The following table shows the standards to which X-MIND prime 3D complies, compared to those related primary predicated device X-MIND prime 3D:
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Image /page/24/Picture/0 description: The image shows the logo for Acteon. The logo consists of the word "ACTEON" in bold, black letters. A blue curved line is located to the left of the word, starting below the "A" and extending upwards and to the left.
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| Applied standards | Proposed device:X-MIND prime 3D | Primary predicate device:X-MIND prime 3D(Rotograph Prime 3D) |
|---|---|---|
| IEC 60601-1: 2005 + CORR. 1(2006) + CORR. 2 (2007) | IEC 60601-1: 2005 + CORR. 1(2006) + CORR. 2 (2007) | |
| IEC 60601-1-2:2014 | IEC 60601-1-2:2007 | |
| IEC 60601-1-3:2013 | IEC 60601-1-3:2008 | |
| IEC 60601-2-63:2017 | IEC 60601-2-63:2012 | |
| IEC 62304:2015 | IEC 62304:2006 | |
| ES60601-1: 2005/(R)2012 andA1:2012 | ANSI/AAMI ES60601-1: 2005 /A2:2010 | |
| CAN/CSA-C22.2 No. 60601-1:08 | CAN/CSA-C22.2 No. 60601-1:08 | |
| IEC 60601-1-6:2013 | IEC 60601-1-6:2010 | |
| IEC 62366-1:2015 | IEC 62366:2007 | |
| ISO 10993-1:2010 | ISO 10993-1:2010 | |
| ISO 10993-2:2006 | ISO 10993-2:2006 | |
| ISO 10993-5:2009 | ISO 10993-5:2009 | |
| ISO 10993-10:2010 | ISO 10993-10:2010 | |
| ISO 10993-12:2012 | ISO 10993-12:2012 |
X-MIND prime 3D has been tested according to approved verification protocols to assure its conformity to the following parts of USA Code of Federal Regulations relating to PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS USA:
21 CFR §1020.30 Diagnostic x-ray systems and their major components.
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Image /page/25/Picture/0 description: The image shows the logo for Acteon, which is a stylized wordmark with a blue swoosh above the letters. Below the logo is the text "Via Roma, 45" followed by "21057 Olgiate Olona (VA)". This text likely represents the address of the company or a location associated with Acteon. The address is located in Italy.
510(k) Summary
001_Summary
510(k) Summary
21 CFR §1020.31 Radiographic equipment.
21 CFR §1020.33 Computed tomography (CT) equipment.
CONCLUSION VIII.
X-MIND prime 3D has the same indication for use as the predicate devices. It performs the same functions in the same environment as the predicate devices. It is based on well-known technology. It shares the same technological characteristics as the predicate devices. Minor technological differences do not raise any new questions regarding safety or effectiveness of the device, so it is as safe as effective as the predicate devices.
| Rev. n. 2 | X-MIND prime 3D 510(k) Abbreviated | VOL. 004 |
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§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.