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, 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 Description

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.

AI/ML Overview

The provided text is a 510(k) Summary for the Soltus 500 mobile X-ray system. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove meeting specific acceptance criteria for performance metrics typically associated with AI/CADe devices.

Therefore, many of the requested elements for acceptance criteria and study details (like sample size for test/training sets, expert qualifications, adjudication methods, effect size of human readers with AI, ground truth details) are not applicable or findable in this type of submission.

Here's a breakdown based on the information available in the provided text:

1. A table of acceptance criteria and the reported device performance

The document doesn't present specific performance metrics or acceptance criteria in the typical sense of an AI/CADe device. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to a predicate device and compliance with relevant safety and performance standards.

Acceptance Criteria (Implied)	Reported Device Performance
Safety and Effectiveness (equivalent to predicate)	"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.""The Soltus 500 Battery Mobile X-Ray Units have been tested to be in compliance with the following International Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-54, IEC 60601-2-28, IEC 60601-1-6, IEC 62304."
Technological Characteristics (substantially the same)	See the "Substantial Equivalence Chart" (Page 4-5) which details that most characteristics (Indications for Use, Configuration, X-ray Generator(s), Collimator, Digital X-ray Panel Supplied, Software, Panel Interface, Meets US Performance Standard, Power Source) are "SAME" as the predicate K192011. The differences (Computer, Wireless Antennas) are described as improvements (EWF, DAS) that do not impact safety or effectiveness.
Firmware and Cybersecurity Validation	"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."
Diagnostic Quality Images	"produced diagnostic quality images as good as our predicate generator/panel combination."
Compliance with relevant standards	IEC 60601-1:2005+A1:2012 (Edition 3.1)IEC 60601-1-2:2014 (Edition 4.0)IEC 60601-1-3:2008+A1:2013 (Edition 2.1)IEC 60601-2-54:2009+A1:2015 (Edition 1.1)IEC 60601-2-28:2010 (Edition 2.0)IEC 60601-1-6:2010 + A1:2013 (Edition 3.1)IEC 62304:2006 + A1:2016 (Edition 1.1)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable/Not provided. This device is a mobile X-ray system, not an AI/CADe device that performs diagnostic analysis on images. The evaluation primarily involved bench testing of the hardware and software components, and comparison to the predicate device. Clinical testing was explicitly stated as "not required."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not provided. No clinical ground truth was established as clinical testing was not required.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided. No adjudication method was used as no clinical test set requiring ground truth was established.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This was not an AI/CADe device, and therefore no MRMC study was performed.

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

Not applicable. This device is an X-ray imaging system, not a diagnostic algorithm.

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

Not applicable/Not provided. No clinical ground truth was used for evaluation. The "ground truth" for the device's functionality was based on engineering specifications, performance standards, and comparison to the predicate device's established performance, verified through bench testing.

8. The sample size for the training set

Not applicable/Not provided. This is a hardware system, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable/Not provided. This is a hardware system; there is no training set or ground truth in this context.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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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 .- +34 91 6280544 Fax.- +34 91 6280574 mlgomez@sedecal.com 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
1. 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
1. 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
1. 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 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:Battery Mobile X-ray Unit PhoeniX	Soltus 500
Indications forUse:	Intended for use by a qualified/trained doctoror technician on both adult and pediatricsubjects for taking diagnostic radiographicexposures of the skull, spinal column, chest,abdomen, extremities, and other body parts.Applications can be performed with thepatient sitting, standing, or lying in the proneor supine position. Not for mammography	SAME
Configuration	Mobile System with digital x-ray panel andimage acquisition computer	SAME
Characteristic	Predicate: K192011, Trade/Device Name:Battery Mobile X-ray Unit Phoenix	Soltus 500
X-rayGenerator(s)	kW rating: 20 kW, 32 kW, 40 kW and 50 kW.kV range: from 40 kV to 150 kV in 1 kV steps.mA range: from 10 mA to 630 mA / 640 mA /650 mA.	SAME
Collimator	Ralco R108 DHHS	SAME
Photos	Phoenix® MobileImage: Phoenix Mobile X-ray	Soltus 500Image: Soltus 500 X-ray
Digital X-rayPanel Supplied	CANON CXDI-401C WirelessCANON CXDI-701C WirelessCANON CXDI-801C WirelessCANON CXDI-710C WirelessCANON CXDI-810C WirelessCANON CXDI-410C Wireless	SAME
Software	Canon control software CXDI-NE	SAME
Panel Interface	Ethernet or Wi-Fi wireless	SAME
Meets USPerformanceStandard	YES 21 CFR 1020.30	SAME
Computer	One control computer	One computer with two motherboards(control PC, Enhanced Work Flow (EWF)
Power Source	Input transformer with 7 input voltage taps(100 / 110 / 120 /, 127 / 220 / 230 / 240 V~).AC 20 amp and Batteries	SAME
WirelessAntennas	One single internal antenna	Distributed Antenna System (DAS)

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1. 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.
1. 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)
1. 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.
1. 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.

Regulation Number and Section

§ 892.1720 Mobile x-ray system.

(a)
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.(b)
Classification. Class II.