x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology)

K231055 · De Götzen S.R.L. · EHD · Dec 28, 2023 · Dental

Device Facts

• Record ID: K231055
• Device Name: x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology)
• Applicant: De Götzen S.R.L.
• Product Code: EHD · Dental
• Decision Date: Dec 28, 2023
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.1800
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

Extraoral X-ray unit for dental imaging; consists of control timer, wall/bracket mount, pantograph arm, tubehead, and collimator cone. Operates by emitting X-rays through a high-frequency constant potential (DC) generator. Used in dental clinics by dentists/radiologists. Input: manual selection of exposure settings via control panel. Output: X-ray beam directed at patient anatomy; captured by external detectors (film, phosphor plates, or digital sensors). Healthcare providers use resulting images for diagnostic assessment of teeth and oral structures. Benefits include precise positioning via adjustable arm and diagnostic-quality imaging for dental treatment planning.

Clinical Evidence

Bench testing only. Performance validated through electrical safety, EMC, and performance testing per IEC 60601-1, 60601-1-2, 60601-1-3, 60601-2-65, and 21 CFR 1020.30/31. Biocompatibility evaluated per ISO 10993-1. Sample clinical images were reviewed by a clinical expert to confirm diagnostic quality when integrated with cleared receptors.

Technological Characteristics

Extraoral dental X-ray system; high-frequency constant potential (DC) generator; tungsten anode; 0.7 mm focal spot; 60/70 kV anode voltage. Class I, Type B applied part. Connectivity includes cabled/wireless exposure switch. Software-controlled timer. Sterilization not applicable (non-invasive). Complies with IEC 60601-1, 60601-1-2, 60601-1-3, 60601-2-65, and 21 CFR 1020.30/31.

Indications for Use

Indicated for intra-oral radiographic exams of teeth and adjacent oral structures in adult and pediatric patients. Used by dentists, radiologists, and qualified healthcare professionals.

Regulatory Classification

Identification

An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.

Predicate Devices

• Endograph DC (K130109)

Reference Devices

• PHOT-X II, MODEL 303 (K042260)

Submission Summary (Full Text)

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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).

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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 ([e-mail]) or phone [phone] 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

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# 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) | |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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 | [phone] |
| Contact Person | Fabio Lissandrello – [e-mail] |
| Date Prepared | November 29th, 2023 |

#### II. PROPOSED DEVICE

| Name of Device | x-mind dc (under trademark Acteon)<br>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<br>17/11/2023 | x-mind dc Abbreviated 510(k) - K231055 | Page 1 of 8 |
|----------------------|----------------------------------------|-------------|
|----------------------|----------------------------------------|-------------|

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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<br>17/11/2023 | x-mind dc Abbreviated 510(k) - K231055 | Page 2 of 8 |
|----------------------|----------------------------------------|-------------|
|----------------------|----------------------------------------|-------------|

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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,<br>in particular extraoral<br>source of X-rays,<br>intended for intra-oral<br>radiographic exams for<br>diagnostic purposes<br>related to anatomy of<br>teeth and adjacent oral<br>structures both on adult<br>and pediatric patients,<br>using specific x-ray<br>detectors (chemical<br>films, phosphor plates or<br>digital x-ray sensors) that<br>are not part of the device.<br>The device is operated<br>and used by dentists,<br>radiologists and other<br>legally qualified health<br>care professionals. | Endograph DC is an<br>extraoral source x-ray<br>unit for dental<br>radiographic<br>examination and<br>diagnosis of diseases of<br>the teeth, jaw, and oral<br>structures. The device is<br>to be operated and used<br>by dentists, radiologists<br>and other legally<br>qualified health care<br>professionals. It can be<br>used with both pediatric<br>and adult patients. | Equivalent |

| Rev. 2<br>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<br>power<br>supply | Single phase alternate | Single phase alternate | Same |
| Nominal voltage | 230 V<br>115 V | 110 ÷ 240 V | Different |
| Line<br>voltage<br>regulation | ≤ 3% | ≤ 3% | Same |
| Maximum<br>voltage<br>variation | ±10% | ±10% | Same |
| Nominal current | 5,2 A @ 230 V<br>9,5 A @ 115 V | 2,4 A @ 240 V<br>5,4 A @ 110 V | Different |
| Frequency | 50/60 Hz | 50/60 Hz | Same |
| Adsorbed power | 1,2 kVA @ 230 V<br>1,1 kVA @ 115 V | 570 VA @ 240 V<br>582 VA @ 110 V | Different |
| Max. apparent line<br>resistance | 0,5 Ω @ 230 V<br>0,2 Ω @ 115 V | 0,8 Ω (181-264 V)<br>0,4 Ω (99-180 V) | Different |
| Protection<br>against<br>electrical<br>shock<br>(insulation class) | Class I | Class I | Same |
| Degree<br>of<br>protection against<br>electrical<br>shock<br>(applied part) | Type B | Type B | Same |
| Generator type | High frequency, constant<br>potential (DC) | High frequency, constant<br>potential (DC) | Same |
| Nominal<br>anode<br>voltage | 60 / 70 kV | 60 / 65 / 70 kV | Similar |
| Nominal<br>anode<br>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<br>kV | 2,4 mm Al | ≥ 2,5 mm Al | Similar |
| Half value<br>layer<br>(HVL) at 70 kV | 2,2 mm Al | > 2 mm Al | Similar |
| Leakage radiation | < 0,25 mGy/h | < 0,25 mGy/h | Same |
| Focal length (SSD) | 20 cm (short cone)<br>31 cm (long cone,<br>rectangular cone) | 20 cm<br>30 cm with optional<br>collimator cone | Similar |

| Rev. 2<br>17/11/2023 | x-mind dc Abbreviated 510(k) - K231055 | Page 4 of 8 |
|----------------------|----------------------------------------|-------------|
|----------------------|----------------------------------------|-------------|

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Image /page/7/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, with the bottom triangle being slightly smaller than the other two.

| X-ray<br>exposure<br>button | Cabled or wireless<br>exposure switch | Cabled or wireless<br>exposure switch | Same |
|-----------------------------|------------------------------------------|------------------------------------------|-----------------------------------------------------------------|
| Exposure modes | Preset loading factors or<br>manual mode | Preset loading factors or<br>manual mode | Same |
| Image receptor type | Film, phosphor plate,<br>digital sensor | Film, phosphor plate,<br>digital sensor | Same |
| Patient type | Adult and child | Adult and child | Same |
| Installation | Wall mount<br>Mobile<br>Chair<br>Ceiling | Wall mount<br>Mobile | Similar (more installation<br>option for the subject<br>device) |

Both the subject and predicate device are X-ray equipment for dental intra-oral X-ray imaging, particularly they are extra-oral sources of X-rays intended to be used for producing diagnostic X-ray images of the teeth and adjacent oral structures.

Both devices are intended to be used by dentists, radiologists and other legally qualified health care professionals, and can be used both on adult and pediatric patients.

The type of X-ray detectors used for producing the X-ray images is clearly stated in the intended used of the subject device, the same kind of detectors is used also with the predicate device to obtain the radiographic exams.

Although worded differently, there are no differences between the subject device and the predicate device with respect to indications and intended use.

The subject and the predicate device are intra-oral X-ray units which use a high frequency constant potential (DC) generator for producing the X-rays, and some differences exist under the electrical data characteristics. These differences are just due to the different design specifications of the power supply board, which do not raise issue of safety and effectiveness. Both devices have been tested with the same performance testing and comply with the general requirements for basic safety and essential performance of medical electrical equipment and dental intra-oral X-ray equipment and have the same classification for the protection against the electrical shock.

The differences related to the tubehead characteristics are due to the different design specifications of the X-ray generation system, however both devices conform to the same safety and performance standards.

The above-mentioned differences between the proposed device and the predicate device do not raise new questions of safety and effectiveness.

| Rev. 2 | x-mind dc Abbreviated 510(k) - K231055 | Page 5 of 8 |
|------------|----------------------------------------|-------------|
| 17/11/2023 | | |

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Image /page/8/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 arranged to form a larger triangle.

#### VII. PERFORMANCE DATA

The performance of the subject device and the predicate device have been validated using the same or updated versions of the testing methods.

| Applied standards | | |
|------------------------------------------------------------------|------------------------------------------------------------------------|-----------------|
| Subject Device: x-mind dc | Predicate Device: Endograph DC | Comparison |
| IEC 60601-1:2005 + AMD1:2012 | IEC 60601 1: 2005 + Corr.1 (2006) +<br>Corr.2 (2007) | Updated version |
| IEC 60601-1-2:2014 | IEC 60601-1-2:2014 | Same |
| IEC TR 60601-4-2:2016 | - | |
| IEC 60601-1-3:2008 + AMD1:2013 | IEC 60601-1-3:2008 | Updated version |
| IEC 60601-1-6:2010 + AMD1:2013 | IEC 60601-1-6:2010 | Updated version |
| IEC 60601-2-65:2012 + AMD1:2017 | IEC 60601-2-65:2012 | Updated version |
| IEC 62304:2006 + AMD1:2015 | IEC 62304:2006 + Ac:2008 | Updated version |
| IEC 62366-1:2015 + AMD1:2020 | IEC 62366:2007 | Updated version |
| ANSI/AAMI ES60601-1:2012 | ANSI/AAMI ES60601-1:2005 | Updated version |
| CAN/CSA-C22.2 N. 60601-1:14 | CAN/CSA-C22.2 No 60601-1:08 | Updated version |
| ETSI EN 300 220-2 v.3.2.1 | ETSI EN 300 220-2 v.3.1.1 | Updated version |
| ETSI EN 301 489-3 v.2.1.2 | ETSI EN 301 489-3 v.1.6.1 and Final<br>Draft ETSI EN 301 489-3 v.2.1.1 | Same |
| CFR Title 47 Part 15 Subpart C –<br>Intentional Radiators 15.231 | CFR Title 47 Part 15 Subpart C -<br>Intentional Radiators 15.231 | Same |
| ISO 10993-1:2018 | ISO 10993-1:2009 | Updated version |

The following performance data were provided in support of the substantial equivalence determination. Non-Clinical test performed on the subject device:

1) 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 ●

| Rev. 2 | x-mind dc Abbreviated 510(k) - K231055 | Page 6 of 8 |
|------------|----------------------------------------|-------------|
| 17/11/2023 | | |

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Image /page/9/Picture/0 description: The image shows the logo for Acteon. The logo consists of a blue triangle shape on the left and the word "acteon" in gray letters on the right. The triangle shape is made up of three smaller triangles, with the bottom triangle being slightly curved.

# 2) 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.

# 3) 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.

In addition to this, the tubehead characteristics of the subject device are compared with the ones of a legally marketed reference device:

| Device technical data | Subject Device<br>x-mind dc | Reference Device<br>Phot-X II Model 303 | Comparison |
|-----------------------|--------------------------------------------|--------------------------------------------|------------|
| Generator type | High frequency, constant<br>potential (DC) | High frequency, constant<br>potential (DC) | Same |
| Nominal anode voltage | 60 / 70 kV | 60 / 70 kV | Same |
| Nominal anode current | 4 / 8 mA | 4 / 7 mA | Similar |
| Exposure time | 0,02 s ÷ 3,2 s (23 steps) | 0,01 s ÷ 3,2 s (23 steps) | Similar |
| Anode material | Tungsten | Tungsten | Same |
| Focal spot size | 0,7 mm | 0,7 mm | Same |

Both the subject and the reference devices use a tubehead with the same technology, based on a high frequency constant potential (DC) generator for producing the X-rays. The design characteristics of the tubeheads are equivalent, as well as the selectable exposure time range is basically the same. Also, the X-ray tubes have the same anode material and same focal spot size.

This comparison supports the tubehead performance data of the subject device, which is as safe and effective as the legally marketed reference device.

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.

#### VIII. FDA GUIDANCE DOCUMENTS

The following FDA quidance documents have been used for the 510(k) submission:

- Format for Traditional and Abbreviated 510(k)s, dated September 13, 2019 ●
- The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)], dated July 28, 2014
- . Pediatric Information for X-ray Imaging Device Premarket Notifications, dated November 28, 2017

| Rev. 2 | x-mind dc Abbreviated 510(k) - K231055 | Page 7 of 8 |
|------------|----------------------------------------|-------------|
| 17/11/2023 | | |

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Image /page/10/Picture/0 description: The image shows the logo for Acteon. The logo consists of a blue triangular symbol on the left and the word "acteon" in dark gray on the right. The triangular symbol is made up of three curved shapes that come together to form a triangle.

- Radio Frequency Wireless Technology in Medical Devices, dated August 14, 2013 .
- . Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", dated September 4, 2020
- . Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, dated May 11, 2005
- Electromagnetic Compatibility (EMC) of Medical Devices, dated June 6, 2022

#### IX. CONCLUSION

x-mind dc has the same indication for use as the predicate device. It performs the same functions in the same environment as the predicate device. It is based on a well-known technology for the X-ray generation. It shares the same main technological characteristics as the predicate device. Minor technological differences do not raise any new questions regarding safety or effectiveness of the device, so it is as safe and effective as the predicate device.

| Rev. 2<br>17/11/2023 | x-mind dc Abbreviated 510(k) - K231055 | Page 8 of 8 |
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