(259 days)
No
The device description focuses on the hardware components of an X-ray unit and its basic control functions. There is no mention of AI/ML in the intended use, device description, or performance studies.
No.
This device is an X-ray unit intended for diagnostic purposes (intra-oral radiographic exams), not for therapeutic treatment.
Yes
The device is an X-ray unit explicitly intended for "intra-oral radiographic exams for diagnostic purposes related to anatomy of teeth and adjacent oral structures." It produces images that are then used for diagnosis, making it a diagnostic device.
No
The device description clearly lists multiple hardware components, including an X-ray control unit, wall plate, pantograph arm, X-ray source assembly, and collimator cone.
Based on the provided information, the x-mind dc (and Owandy-RX DC) device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The x-mind dc is an X-ray unit. Its function is to generate X-rays that pass through the patient's body to create an image of internal structures (teeth and adjacent oral structures).
- Intended Use: The intended use is for "intra-oral radiographic exams for diagnostic purposes related to anatomy of teeth and adjacent oral structures." This involves imaging the patient directly, not analyzing samples taken from the patient.
- Device Description: The description details the components of an X-ray machine (control unit, arm, tubehead, collimator cone), all of which are involved in generating and directing X-rays towards the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any processes typically associated with in vitro testing.
Therefore, the x-mind dc is a medical imaging device, specifically an X-ray unit, and does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
x-mind dc (and Owandy-RX DC under trademark Owandy Radiology) is an X-ray unit, in particular extraoral source of X-rays, intended for intra-oral radiographic exams for diagnostic purposes related to anatomy of teeth and adjacent oral structures both on adult and pediatric patients, using specific x-ray detectors (chemical films, phosphor plates or digital x-ray sensors) that are not part of the device.
The device is operated and used by dentists, radiologists and other legally qualified health care professionals.
Product codes
EHD
Device Description
x-mind dc consists of the following parts:
- 1 X-ray control unit (timer)
- 2 Wall plate and horizontal bracket
- 3 Pantograph type arm (scissor arm)
- 4 X-ray source assembly (tubehead)
- 5 Collimator cone (Beam Limiting Device)
The timer is the control panel used to manage the exposure settings and to safely use the tubehead. It allows easy and clear selection, with the help of clear and visible signals, of the exposure settings, perform personal settings and display alarms of the device in case of incorrect operation or eventual failures.
The horizontal bracket it is available in 3 different lengths and represents the support for the scissor arm. The pantograph arm, being adjustable in height and depth, allows the precise positioning of the tubehead. The tubehead of the device contains the X-ray tube, the high voltage board and the high frequency generator. It is the component of the device which emits the X-rays.
The collimator cone represents the part of the device in contact with the patient and it allows the correct focal spot to skin distance, ensures the dimension, direction and centering of the X-ray beam.
x-mind dc can be used with conventional chemical films (D, E, F speed films), phosphor plates (PSP), RVG digital detectors (CCD or CMOS).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
anatomy of teeth and adjacent oral structures
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
dentists, radiologists and other legally qualified health care professionals.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical test performed on the subject device:
- Electrical Safety, Electromagnetic Compatibility (EMC) and Performance
The device complies with:
- . IEC 60601-1:2005 + AMD1:2012
- IEC 60601-1-2:2014 .
- IEC TR 60601-4-2:2016 ●
- IEC 60601-1-3:2008 + AMD1:2013 ●
- IEC 60601-1-6:2010 + AMD1:2013 ●
- IEC 60601-2-65:2012 + AMD1:2017 ●
- IEC 62366-1:2015 + AMD1:2020
- ANSI/AAMI ES60601-1:2012 ●
- CAN/CSA-C22.2 N. 60601-1:14
- ETSI EN 300 220-2 v.3.2.1
- ETSI EN 301 489-3 v.2.1.2 ●
- CFR Title 47 Part 15 Subpart C Intentional Radiators 15.231 .
- 21 CFR §1020.30 Diagnostic x-ray systems and their major components. .
- 21 CFR §1020.31 Radiographic equipment ●
-
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a Moderate Level of Concern. The software complies with IEC 62304:2006+AMD1:2015. -
Biocompatibility testing
The biocompatibility evaluation for x-mind dc was conducted in accordance with ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process.
Bench testing was performed to characterize device performance and resultant image quality when device is used/integrated with cleared x-ray receptor(s) meeting recommended specifications. Sample clinical images, evaluated by a clinical expert, demonstrated diagnostic quality output when device is integrated with recommended cleared x-ray receptor(s). The performance was demonstrated to be substantially equivalent to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
December 28, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue and "ADMINISTRATION" in a smaller font size.
de Götzen S.r.l. Fabio Lissandrello Quality Assurance and Regulatory Affairs Manager Strada Provinciale Busto-Cassano 3 Fagnano Olona, Varese 21054 Italy
Re: K231055
Trade/Device Name: x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral Source X-Ray System Regulatory Class: Class II Product Code: EHD Dated: November 29, 2023 Received: November 29, 2023
Dear Fabio Lissandrello:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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,
Gabriela M. Digitally signed for by Gabriela M. Rodal -S Rodal -S
Lu Jiang, Ph.D. Assistant Director DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K231055
Device Name
x-mind dc (under trademark Acteon) Owandy-RX DC (under trademark Owandy Radiology)
Indications for Use (Describe)
x-mind dc (and Owandy-RX DC under trademark Owandy Radiology) is an X-ray unit, in particular extraoral source of X-rays, intended for intra-oral radiographic exams for diagnostic purposes related to anatomy of teeth and adjacent oral structures both on adult and pediatric patients, using specific x-ray detectors (chemical films, phosphor plates or digital xray sensors) that are not part of the device.
The device is operated and used by dentists, radiologists and other legally qualified health care professionals.
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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3
Image /page/3/Picture/0 description: The image shows the logo for Acteon. The logo consists of a blue triangular shape on the left and the word "acteon" in gray letters on the right. The triangular shape is made up of three smaller triangles that are connected at the corners.
510(k) Summary
The summary of this 510(k) is being submitted in accordance with the requirements of 21 CFR Part 807.92.
SUBMITTER l.
Name | de Götzen S.r.l. |
---|---|
Address | Strada Provinciale Busto-Cassano 3, 21054 Fagnano Olona (VA), Italy |
Telephone | +39 0331 376760 |
Contact Person | Fabio Lissandrello – fabio.lissandrello@acteongroup.com |
Date Prepared | November 29th, 2023 |
II. PROPOSED DEVICE
| Name of Device | x-mind dc (under trademark Acteon)
Owandy-RX DC (under trademark Owandy Radiology) |
|----------------------|---------------------------------------------------------------------------------------|
| Common or Usual Name | Unit, x-ray, extraoral with timer |
| Classification Name | Extraoral source X-ray system |
| Regulation Number | 21 CFR 872.1800 |
| Product Code | EHD |
| Regulatory Class | II |
PREDICATE DEVICE AND REFERENCE DEVICE III.
PREDICATE DEVICE | |
---|---|
510(k) Number | K130109 |
Clearance date | August 1st, 2013 |
Device Name | Endograph DC |
Applicant | Villa Sistemi Medicali S.p.A. |
Classification Name | Extraoral source X-ray system |
Regulation Number | 21 CFR 872.1800 |
Product Code | EHD |
Regulatory Class | II |
REFERENCE DEVICE | |
---|---|
510(k) Number | K042260 |
Clearance date | September 7th, 2004 |
Device Name | PHOT-X II, MODEL 303 |
Applicant | Takara Belmont USA, Inc. |
Classification Name | Extraoral source X-ray system |
| Rev. 2
17/11/2023 | x-mind dc Abbreviated 510(k) - K231055 | Page 1 of 8 |
---|---|---|
---------------------- | ---------------------------------------- | ------------- |
4
Image /page/4/Picture/0 description: The image shows the logo for Acteon. The logo consists of a blue triangle-like shape on the left and the word "acteon" in gray on the right. The triangle-like shape is made up of three smaller triangles, with the top triangle pointing upwards and the bottom two triangles pointing downwards.
Regulation Number | 21 CFR 872.1800 |
---|---|
Product Code | EHD |
Regulatory Class | II |
DEVICE DESCRIPTION IV.
NOTE: In the following, all the references to x-mind dc are applicable also to Owandy-RX DC under trademark Owandy Radiology.
x-mind dc consists of the following parts:
- 1 X-ray control unit (timer)
- 2 Wall plate and horizontal bracket
- 3 Pantograph type arm (scissor arm)
- 4 X-ray source assembly (tubehead)
- 5 Collimator cone (Beam Limiting Device)
Image /page/4/Figure/12 description: The image shows a dental X-ray machine with several labeled components. The control panel, labeled as '1', is mounted on the wall. An arm, labeled '2', extends from the control panel to support the X-ray head, which is labeled '4'. A vertical support, labeled '3', connects the arm to the X-ray head, and a cylindrical component, labeled '5', is located at the bottom of the X-ray head.
The timer is the control panel used to manage the exposure settings and to safely use the tubehead. It allows easy and clear selection, with the help of clear and visible signals, of the exposure settings, perform personal settings and display alarms of the device in case of incorrect operation or eventual failures.
The horizontal bracket it is available in 3 different lengths and represents the support for the scissor arm. The pantograph arm, being adjustable in height and depth, allows the precise positioning of the tubehead. The tubehead of the device contains the X-ray tube, the high voltage board and the high frequency generator. It is the component of the device which emits the X-rays.
The collimator cone represents the part of the device in contact with the patient and it allows the correct focal spot to skin distance, ensures the dimension, direction and centering of the X-ray beam.
x-mind dc can be used with conventional chemical films (D, E, F speed films), phosphor plates (PSP), RVG digital detectors (CCD or CMOS).
| Rev. 2
17/11/2023 | x-mind dc Abbreviated 510(k) - K231055 | Page 2 of 8 |
---|---|---|
---------------------- | ---------------------------------------- | ------------- |
5
Image /page/5/Picture/0 description: The image shows the logo for Acteon. The logo consists of a blue triangle-like shape on the left and the word "acteon" in gray on the right. The triangle-like shape is made up of three smaller triangles, and the word "acteon" is in lowercase letters.
INDICATIONS FOR USE V.
x-mind dc (and Owandy-RX DC under trademark Owandy Radiology) is an X-ray unit, in particular extraoral source of X-rays, intended for intra-oral radiographic exams for diagnostic purposes related to anatomy of teeth and adjacent oral structures both on adult and pediatric patients, using specific x-ray detectors (chemical films, phosphor plates or digital x-ray sensors) that are not part of the device.
The device is operated and used by dentists, radiologists and other legally qualified health care professionals.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE VI. DEVICE
NOTE: In the following, all the references to x-mind dc are applicable also to Owandy-RX DC under trademark Owandy Radiology.
Description | Subject Device | Predicate Device | Comparison |
---|---|---|---|
Name | x-mind dc | Endograph DC | N/A |
Manufacturer | de Götzen S.r.l. | Villa Sistemi Medicali S.p.A. | N/A |
510(k) number | TBD | K130109 | N/A |
Intended Use / Indications for Use | x-mind dc is an X-ray unit, | ||
in particular extraoral | |||
source of X-rays, | |||
intended for intra-oral | |||
radiographic exams for | |||
diagnostic purposes | |||
related to anatomy of | |||
teeth and adjacent oral | |||
structures both on adult | |||
and pediatric patients, | |||
using specific x-ray | |||
detectors (chemical | |||
films, phosphor plates or | |||
digital x-ray sensors) that | |||
are not part of the device. | |||
The device is operated | |||
and used by dentists, | |||
radiologists and other | |||
legally qualified health | |||
care professionals. | 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. | Equivalent |
| Rev. 2
17/11/2023 | x-mind dc Abbreviated 510(k) - K231055 | Page 3 of 8 |
---|---|---|
---------------------- | ---------------------------------------- | ------------- |
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Image /page/6/Picture/0 description: The image shows the logo for Acteon. The logo consists of a stylized blue triangle on the left and the word "acteon" in dark gray on the right. The triangle is made up of three curved shapes that come together to form a triangle.
x-mind dc 510(k) Number K231055 -Summary
Device technical data | |||
---|---|---|---|
Type of | |||
power | |||
supply | Single phase alternate | Single phase alternate | Same |
Nominal voltage | 230 V | ||
115 V | 110 ÷ 240 V | Different | |
Line | |||
voltage | |||
regulation | ≤ 3% | ≤ 3% | Same |
Maximum | |||
voltage | |||
variation | ±10% | ±10% | Same |
Nominal current | 5,2 A @ 230 V | ||
9,5 A @ 115 V | 2,4 A @ 240 V | ||
5,4 A @ 110 V | Different | ||
Frequency | 50/60 Hz | 50/60 Hz | Same |
Adsorbed power | 1,2 kVA @ 230 V | ||
1,1 kVA @ 115 V | 570 VA @ 240 V | ||
582 VA @ 110 V | Different | ||
Max. apparent line | |||
resistance | 0,5 Ω @ 230 V | ||
0,2 Ω @ 115 V | 0,8 Ω (181-264 V) | ||
0,4 Ω (99-180 V) | Different | ||
Protection | |||
against | |||
electrical | |||
shock | |||
(insulation class) | Class I | Class I | Same |
Degree | |||
of | |||
protection against | |||
electrical | |||
shock | |||
(applied part) | Type B | Type B | Same |
Generator type | High frequency, constant | ||
potential (DC) | High frequency, constant | ||
potential (DC) | Same | ||
Nominal | |||
anode | |||
voltage | 60 / 70 kV | 60 / 65 / 70 kV | Similar |
Nominal | |||
anode | |||
current | 4 / 8 mA | 6 mA | Different |
Exposure time | 0,020 s ÷ 3,2 s (23 steps) | 0,01 s ÷ 2,0 s (36 steps) | Different |
Focal spot size | 0,7 mm | 0,4 mm | Different |
Anode material | Tungsten | Tungsten | Same |
Total filtration at 70 | |||
kV | 2,4 mm Al | ≥ 2,5 mm Al | Similar |
Half value | |||
layer | |||
(HVL) at 70 kV | 2,2 mm Al | > 2 mm Al | Similar |
Leakage radiation |