Soltus 500

K192936 · Sedecal., Sa. · IZL · Nov 15, 2019 · Radiology

Device Facts

• Record ID: K192936
• Device Name: Soltus 500
• Applicant: Sedecal., Sa.
• Product Code: IZL · Radiology
• Decision Date: Nov 15, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1720
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography

Device Story

Mobile digital X-ray system; battery-powered; motorized movement. Inputs: X-ray exposure parameters; patient data via barcode scanner. Operation: Physician/technician positions unit; captures images using Canon flat panel detectors; processes via embedded control computer. Features: Distributed Antenna System (DAS) for optimized Wi-Fi communication with detectors; Enhanced Work Flow (EWF) via secondary embedded computer for RIS/PACS connectivity. Outputs: Diagnostic radiographic images displayed on integrated touch screen; DAP dosimetry data. Used in clinical settings for bedside/point-of-care imaging. Healthcare providers use images for diagnostic decision-making; benefits include improved mobility and workflow efficiency in hospital environments.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing and verification of system performance. Digital receptor panels previously cleared by FDA.

Technological Characteristics

Mobile X-ray system; 20-50 kW generator; 40-150 kV range. Components: Ralco R108 collimator; Canon CXDI wireless flat panel detectors. Connectivity: Wi-Fi (via DAS), Ethernet, USB, Infrared. Power: Battery/AC. Software: Canon CXDI-NE control software. Standards: IEC 60601-1, 60601-1-2, 60601-1-3, 60601-2-54, 60601-2-28, 60601-1-6, IEC 62304.

Indications for Use

Indicated for adult and pediatric patients requiring diagnostic radiographic imaging of the skull, spine, chest, abdomen, and extremities. Contraindicated for mammography.

Regulatory Classification

Identification

A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Battery Mobile X-ray Unit PhoeniX (K192011)

Reference Devices

• Digital Radiography CXDI-401C Wireless (K133693)
• Digital Radiography CXDI-701C Wireless (K131106)
• Digital Radiography CXDI-801C Wireless (K131106)
• Digital Radiography CXDI-710C Wireless (K170332)
• Digital Radiography CXDI-410C Wireless (K171270)
• CXDI Control Software (K133693, K131106, K170332, K171270)

Submission Summary (Full Text)

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November 15, 2019

Sedecal., SA. % Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES, FLORIDA 34114

Re: K192936

Trade/Device Name: Soltus 500 Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile X-Ray System Regulatory Class: Class II Product Code: IZL, MOB Dated: October 17, 2019 Received: October 18, 2019

Dear Daniel Kamm:

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

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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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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) K192936

Device Name Soltus 500

#### Indications for Use (Describe)

Intended for use by a qualified/trained doctor or technician on both adult and pediatic subjects for taking diagnostic radiographic exposures of the skull, spinal column, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography

Type of Use (Select one or both, as applicable)

| <span style="font-size: 10pt;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|--------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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## 510(k) Summary: 510(k) Number K192936

Image /page/3/Picture/2 description: The image is a teal-colored logo with the word "SEDECAL" in white letters. To the left of the word is a white icon of a person sitting at a desk. The logo is enclosed in a rounded rectangle with a white border.

SEDECAL SA C/ Pelaya, 9 - 13, Pol. Ind. Río de Janeiro 28110 Algete, Madrid España (Spain) Tel .- [phone] Fax.- [phone] [e-mail] Date Prepared: July 10, 2019 Contact: Mª Luisa Gómez de Agüero, Quality and Regulatory Manager

- 1) Identification of the Device: Trade/Device Name: Soltus 500 Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Codes: IZL, MQB.
- Common/Usual Name: Digital Mobile Diagnostic X-Ray System
- 2) Equivalent legally marketed device: K192011 Trade/Device Name: Battery Mobile X-ray Unit PhoeniX Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Codes: IZL, MQB. Common/Usual Name: Digital Mobile Diagnostic X-Ray System
- 3) Reference devices: Digital Flat Panel Detectors (FDA 510K Cleared) Trade/Device Name: Digital Radiography CXDI-401C Wireless (K133693), Digital Radiography CXDI-701C Wireless (K131106), Digital Radiography CXDI-801C Wireless (K131106), Digital Radiography CXDI-710C Wireless (K170332), Digital Radiography CXDI-710C Wireless (K170332), Digital Radiography CXDI-410C Wireless (K171270), CXDI Control Software (K133693, K131106, K170332, K171270) Regulation Number: 21 CFR 892. 1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB
- 4) Indications for Use: Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.

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## 5) Description of the Device:

The Soltus 500 Mobile Digital X-Ray System, Model 10501, ("Mobile X-Ray System") is the same as the predicate mobile PhoeniX with 2 additional features, (i) Distributed Antenna System (DAS), and (ii) Enhanced Work Flow (EWF).

The Mobile X-Ray System has motorized movement and full battery operation. It contains a touch screen that operates as a control console. The Mobile X-Ray System supports various Canon flat panel detectors (Digital Radiography CXDI) supplied with the unit. (See (3) reference devices, above).

The Mobile X-Ray System additionally supports

- Ethernet communication
- Wireless Wi-Fi communications (with digital detectors and remote hand switch).
- Video Output to display EWF (Enhanced Work Flow) computer on Mobile x-ray unit monitor
- USB ports.
- Infrared data communication for registering the Wireless Detector
- Barcode scanner to register patient information. ●
- Dosimetry for Dose Area Product (DAP).
- Card reader to control access to the unit

New features:

- i) Distributed Antenna System (DAS) The Distributed Antenna system improves upon the antenna that is in the predicate device. It consists of a series of antennas to optimize the Wi-Fi communication between the wireless flat Panel detector and the wireless access point.
- ii) Enhanced Work Flow (EWF)

The Enhance Work Flow functionality allows the user to connect to the hospitals RIS and PACS system via a second computer embedded in the Mobile X-Ray Unit

### 6) Substantial Equivalence Chart

| Characteristic | Predicate: K192011, Trade/Device Name:<br>Battery Mobile X-ray Unit PhoeniX | Soltus 500 |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Indications for<br>Use: | Intended for use by a qualified/trained doctor<br>or technician on both adult and pediatric<br>subjects for taking diagnostic radiographic<br>exposures of the skull, spinal column, chest,<br>abdomen, extremities, and other body parts.<br>Applications can be performed with the<br>patient sitting, standing, or lying in the prone<br>or supine position. Not for mammography | SAME |
| Configuration | Mobile System with digital x-ray panel and<br>image acquisition computer | SAME |
| Characteristic | Predicate: K192011, Trade/Device Name:<br>Battery Mobile X-ray Unit Phoenix | Soltus 500 |
| X-ray<br>Generator(s) | kW rating: 20 kW, 32 kW, 40 kW and 50 kW.<br>kV range: from 40 kV to 150 kV in 1 kV steps.<br>mA range: from 10 mA to 630 mA / 640 mA /<br>650 mA. | SAME |
| Collimator | Ralco R108 DHHS | SAME |
| Photos | Phoenix® Mobile<br>Image: Phoenix Mobile X-ray | Soltus 500<br>Image: Soltus 500 X-ray |
| Digital X-ray<br>Panel Supplied | CANON CXDI-401C Wireless<br>CANON CXDI-701C Wireless<br>CANON CXDI-801C Wireless<br>CANON CXDI-710C Wireless<br>CANON CXDI-810C Wireless<br>CANON CXDI-410C Wireless | SAME |
| Software | Canon control software CXDI-NE | SAME |
| Panel Interface | Ethernet or Wi-Fi wireless | SAME |
| Meets US<br>Performance<br>Standard | YES 21 CFR 1020.30 | SAME |
| Computer | One control computer | One computer with two motherboards<br>(control PC, Enhanced Work Flow (EWF) |
| Power Source | Input transformer with 7 input voltage taps<br>(100 / 110 / 120 /, 127 / 220 / 230 / 240 V~).<br>AC 20 amp and Batteries | SAME |
| Wireless<br>Antennas | One single internal antenna | Distributed Antenna System (DAS) |

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- 7) The technological characteristics, including design, materials, composition, and energy source, are substantially the same, so there are no issues impacting safety and effectiveness. Safety and Effectiveness, comparison to predicate device. The results of bench testing indicates that the new device is as safe and effective as the predicate device. Proper system operation is fully verified upon installation. We verified that the modified combination of components worked properly and produced diagnostic quality images as good as our predicate generator/panel combination.
- 8) Summary of non-clinical testing: Systems covering all generator/panel combinations were assembled and tested and found to be operating properly. In addition to the testing performed on the predicate, the modifications received bench testing and safety testing was updated. Firmware was validated according to the FDA Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005. Because the system uses Wi-Fi and Ethernet, we observed the recommendations contained in the FDA Guidance Document: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff Document Issued on: October 2, 2014. The digital panel software employed was already reviewed by FDA in K190368. The Soltus 500 Battery Mobile X-Ray Units have been tested to be in compliance with the following
- a) IEC 60601-1:2005+A1:2012 (Edition 3.1)
- b) IEC 60601-1-2:2014 (Edition 4.0)

International Standards:

- c) IEC 60601-1-3:2008+A1:2013 (Edition 2.1)
- d) IEC 60601-2-54:2009+A1:2015 (Edition 1.1)
- e) IEC 60601-2-28:2010 (Edition 2.0)
- IEC 60601-1-6:2010 + A1:2013 (Edition 3.1) f)
- g) IEC 62304:2006 + A1:2016 (Edition 1.1)
- 9) Summary of clinical testing: Clinical testing was not required to establish substantial equivalence because all digital x-ray receptor panels have had previous FDA clearance.
- 10) Conclusion: After analyzing bench and clinical tests, it is the conclusion of Sedecal SA. that the new Soltus 500 Digital Diagnostic Mobile X-Ray Systems are as safe and effective as the predicate device, have few technological differences, and has the same indications for use, thus rendering it substantially equivalent to the predicate device.