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

Device Description

These are redesigned versions of our predicate mobile digital diagnostic xray systems. They feature motorized movement and full battery operation. Various Canon digital Xray panels are supplied with the system. (See list above.) The Mobile X-Ray Unit PhoeniX has a Basic configuration or Advanced configuration. Advanced configurations include:

Second screen on head assembly.
Smooth movements of head assembly.
Telescopic arm in four steps instead three steps for basic configuration.

The Mobile X-Ray unit is provided with touch screen to operate as a control console. The Digital Imaging System is composed by image receptors and application for image acquisition (control console & image processing controller). The Image acquisition software "CANON CXDI Control Software NE" runs on Mobile X-ray unit and it is displayed on touch screen. It is the user interface and compatible digital detectors are listed above. All have FDA Clearance. The Advanced configuration has a second Touch Screen Monitor located on head-assembly.

The PhoeniX Mobile X-Ray Unit is provided with separate battery packs for X-Ray generation and motorized movements of the unit can operate connected to mains or in stand-alone mode, that is, operating without mains being present or unplugged from mains. The unit is connected to mains to charge the batteries; New rating: the input voltage range goes from 100 V~ to 240 V~, 1 phase, 1.1 kVA. New X-ray generator (model SHFM) is mounted on Battery Mobile X-Ray unit PhoeniX. This new X-Ray generator for PhoeniX Mobile X-Ray Unit has a radiogenic unit mounted on headassembly and comprising an X-ray tube with rotating anode and its circuit for high voltage. The electronic and associated software to control the X-ray generation are placed on mobile cart. The Battery Mobile X-Ray Unit PhoeniX is provided with different output powers: 20 kW, 32 kW, 40 kW and 50 kW. There are available two X-ray tube inserts with rotating anode manufactured by CANON ELECTRON TUBES & DEVICES:

New: XRR-3331 insert.
New: E7886 insert.
New: Manual Beam Limiting Device from Ralco, model: R108 F. External interface (controls) and covers are provided by Sedecal. There are two versions of collimator assembly, Basic and Advanced.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a mobile X-ray system named PhoeniX. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study for novel acceptance criteria.

Therefore, many of the requested items (acceptance criteria, specific study details with sample sizes, expert involvement, and ground truth information) are not directly addressed in the provided FDA submission as they would be for a de novo marketing authorization or a more extensive clinical study. The submission relies heavily on non-clinical testing and the prior clearance of its components and predicate devices.

However, I can extract information related to the device's technical specifications and the basis for its substantial equivalence, which implicitly acts as its "acceptance criteria" for regulatory clearance.

Here's an analysis based on the provided text, addressing the points where information is available:

1. Table of Acceptance Criteria (Implicit) and Reported Device Performance

The device is considered acceptable if its performance and specifications are substantially equivalent to the predicate device and meet relevant international standards. The "reported device performance" in this context refers to its technical specifications and compliance with safety standards, rather than clinical performance metrics like sensitivity or specificity.

Acceptance Criteria (Implicitly based on Predicate & Standards)	Reported Device Performance (PhoeniX)
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. (SAME as Predicate)
Configuration:	Mobile System with digital x-ray panel and image acquisition computer. (SAME as Predicate)
kW Rating:	20 kW, 32 kW, 40 kW and 50 kW. (Predicate: 40 kW only)
kV Range:	From 40 kV to 150 kV in 1 kV steps. (SAME as Predicate)
mA Range:	From 10 mA to 630 mA / 640 mA / 650 mA. (Predicate: From 10 mA to 500 mA)
Collimator:	Ralco R108F (Two versions: Basic and Advanced). (Predicate: Ralco R221 DHHS)
Digital X-ray Panels Supplied:	CANON CXDI-401C Wireless, CANON CXDI-701C Wireless, CANON CXDI-801C Wireless. (SAME as Predicate). Plus: CANON CXDI-710C Wireless, CANON CXDI-810C Wireless, CANON CXDI-410C Wireless. (New panels, but all previously FDA cleared).
Software:	Canon control software CXDI-NE. (SAME as Predicate, updated in K190368)
Panel Interface:	Ethernet or Wi-Fi wireless. (SAME as Predicate)
Meets US Performance Standard:	YES 21 CFR 1020.30. (SAME as Predicate)
Power Source:	Universal power supply, from 100 V~ to 240 V~. 1 phase, 1.1 kVA. (Predicate: Input transformer with 7 input voltage taps; AC 20 amp and Batteries)
Safety and Effectiveness:	"The results of bench testing indicate that the new devices are as safe and effective as the predicate devices. 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."
Compliance with International 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). (Compliance affirmed through non-clinical testing)

Regarding the Study Proving Acceptance Criteria:

The "study" in this submission is primarily a non-clinical bench testing and comparative analysis to establish substantial equivalence to a legally marketed predicate device (K161345 RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS).

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not specified in terms of number of images or patients. The non-clinical testing involved "Systems covering all generator/panel combinations were assembled and tested." This suggests testing of device configurations rather than a "test set" of medical images or patient data in the typical sense of an AI/CAD device.
Data Provenance: Not applicable in the context of clinical data for a "test set." The testing是在实验室环境中，使用设备进行物理和功能验证。

3. Number of Experts and Qualifications to Establish Ground Truth:

Not applicable as this was a non-clinical submission for substantial equivalence based on technical specifications and functionality. Clinical trials requiring expert reads for ground truth were not performed.

4. Adjudication Method:

Not applicable as there was no clinical reading study or consensus required for ground truth determination.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. The document states: "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." This device is a mobile X-ray system, not an AI or CAD software that assists human readers.

6. Standalone (Algorithm Only Without Human-in-the-loop) Performance:

Not applicable. This device is an X-ray imaging system, not an algorithm that performs a diagnostic task independently. Its performance is related to image quality, radiation output, mechanical safety, and electrical safety.

7. Type of Ground Truth Used:

Technical Specifications and Compliance with Standards: The "ground truth" for this submission are the established performance characteristics of the predicate device and the specified requirements of relevant international safety and performance standards (e.g., IEC 60601 series, 21 CFR 1020.30). The "truth" is that the device meets these engineering and regulatory benchmarks.
The document mentions that the modified combination of components "produced diagnostic quality images as good as our predicate generator/panel combination," implying an internal assessment of image quality, but no explicit detailed ground truth generation method is described for clinical image interpretation.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set of data. The device's components (X-ray generator, panels, software) are either updates to existing technology or previously cleared devices.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for an AI/ML algorithm.

Summary

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Image /page/0/Picture/0 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 the FDA logo, which 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.

SEDECAL, SA. % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES, FL 34114

Re: K192011

Trade/Device Name: PhoeniX Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL, MOB Dated: July 26, 2019 Received: July 29, 2019

Dear Mr. 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 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

September 25, 2019

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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 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.

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) K192011

Device Name PhoeniX

Indications for Use (Describe)

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 K192011

Image /page/3/Picture/1 description: The image is a logo for SEDECAL. The logo is a teal rounded rectangle with a white border. Inside the rectangle, there is a white icon of a person sitting at a desk on the left and the word "SEDECAL" in white on the right.

SEDECAL SA C/ Pelaya, 9 - 13, Pol. Ind. Río de Janeiro 28110 Algete, Madrid España (Spain) Tel .- +34 91 6280544 Fax.- +34 91 6280574 Date Prepared: July 10, 2019 Contact: Mª Luisa Gómez de Agüero, Quality and Regulatory Manager

1. Identification of the Device: Trade/Device Name: 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. Equivalent legally marketed device: K161345 Trade/Device Name: RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR 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: We employ these cleared devices (K131106, K133693, K170332 and K171270 with software update cleared in K190368) without modification: Trade/Device Name: Canon Digital X-ray Panels CANON CXDI-401C Wireless CANON CXDI-701C Wireless CANON CXDI-801C Wireless CANON CXDI-710C Wireless CANON CXDI-810C Wireless CANON CXDI-410C Wireless 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,

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standing, or lying in the prone or supine position. Not for mammography.

1. Description of the Device: These are redesigned versions of our predicate mobile digital diagnostic xray systems. They feature motorized movement and full battery operation. Various Canon digital Xray panels are supplied with the system. (See list above.) The Mobile X-Ray Unit PhoeniX has a Basic configuration or Advanced configuration. Advanced configurations include:
- Second screen on head assembly.
- Smooth movements of head assembly.
- Telescopic arm in four steps instead three steps for basic configuration.

New: XRR-3331 insert.
New: E7886 insert.
New: Manual Beam Limiting Device from Ralco, model: R108 F. External interface (controls) and covers are provided by Sedecal. There are two versions of collimator assembly, Basic and Advanced.

Image /page/4/Picture/10 description: The image is a comparison of two different models of a medical device, labeled as "Basic" and "Advanced". The "Basic" model features a white box-like structure with a black control panel that has knobs and buttons. The "Advanced" model has a similar white box-like structure, but it is attached to a more complex arm and has a screen with various settings displayed.

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Basic	Advanced
Knobs to adjust the collimator blades.Collimator light push button.Rail system to install external additionalfiltration.Measuring tape to measure the SID.Double laser (optional)Motorized filter (optional)	Knobs to adjust the collimator blades.Collimator light push button.Rail system to install external additional filtration.Measuring tape to measure the SID.Double laser (optional)Motorized filter (optional)Rear knobs to adjust the collimator blades (optional).Additional options selectable with TFT:Variable additional filtration.Collimator blades aperture.

The Battery Mobile X-Ray Unit Phoenix is driven by holding the handlebar with the hands. It is provided to internal sensor (gauges) that control the direction and speed of each wheel depending the force applied by the operator.

New: the handlebar is capacitive handlebar and when operator put his hands-on handlebar the movements are enabled. The height of handlebar is adaptable to improve the user commodity.

Four buttons are provided on the hand grips placed on Head-Assembly. They control the motion of each driving wheel and allow fine positioning adjustment of the patient (movements with low speed because this control is not intended for long displacement).

The Battery Mobile X-Ray unit supports:

Ethernet communication (with hospital and backup cable for digital detectors) ●
. Wireless Wi-Fi communications (with digital detectors and remote hand switch). The wireless communication is supported by Access Point and one single internal antenna.

New: the front panel of Phoenix has a VGA port to display control console on external monitor. New: USB ports.

Infrared data communication for register the Wireless Detector to the Mobile unit by infrared communication. (This operation is done during installation process by service personnel.) Options:

Barcode scanner for register patient information.

Dosimetry for Dose Area Product (DAP).

Tube Arm specifications:

-Counterbalanced tube arm.

Tube arm reach 1220 mm horizontally for both configurations (Advanced option with 4 steps and Basic option with 3 steps).

-Column rotation: ± 317 °.

Maximum SID to floor is 2020 mm for both configurations.
Minimum SID to floor is 530 mm for both configurations.

Mobile Unit:

Weight: the worst configuration 520 kg.

-Size (L x W x H):

Mobile on parking position: 1220 x 540 x 1290 mm. o

Mobile fully extended (Telescopic column & Telescopic arm): 2290 x 1790 x 2230 mm. o

-Frontal anti-collision system.

Motorized unit up to 5,5 km/h.
Motor drive with two independent drive motors, one for each wheel (forward and reverse).

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-Touch screen console:

Main control console: 19 inch. 0
Additionally, second touch screen of 8.4 inch for Advanced configuration 0

8) Substantial Equivalence Chart

Characteristic	Predicate: K161345, Trade/Device Name:RadPRO® Mobile 40kW; RadPRO® Mobile40kW FLEXPLUS, Model SM-40HF-B-D-VIR	Phoenix
Indications forUse:	Intended for use by a qualified/trained doctoror technician on both adult and pediatricsubjects for taking diagnostic radiographicexposures of the skull, spinalcolumn, chest, abdomen, extremities, andother body parts. Applications can beperformed with the patient sitting, standing,or lying in the prone or supine position. Notfor mammography	SAME
Configuration	Mobile System with digital x-ray panel andimage acquisition computer	SAME
X-rayGenerator(s)	kW Rating: 40 kW only.kV range: From 40 kV to 150 kV in 1 kV stepsmA range: From 10 mA to 500 mA	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.
Collimator	Ralco R221 DHHS	Ralco R108F (Two versions, see details above.)
Photos	Image: RadPRO® Mobile	Image: Phoenix Basic
Characteristic	Predicate: K161345, Trade/Device Name:RadPRO® Mobile 40kW; RadPRO® Mobile40kW FLEXPLUS, Model SM-40HF-B-D-VIR	Phoenix
Photos	Image: RadPRO® Mobile Flex Plus	Image: Phoenix Advanced
Digital X-rayPanel Supplied	Canon CXDI 401C Wireless (CSI) K133693Pixel size: 125 μm 3320 × 3408 pixelsCanon CXDI 701C Wireless (CSI) K131106Pixel size: 125 μm 2800 × 3408 pixelsCanon CXDI 801C Wireless (CSI) K131106Pixel size: 125 μm 2800 × 2192 pixels	CANON CXDI-401C Wireless (SAME)CANON CXDI-701C Wireless (SAME)CANON CXDI-801C Wireless (SAME)Plus:CANON CXDI-710C WirelessCANON CXDI-810C WirelessCANON CXDI-410C Wireless
Software	Canon control software CXDI-NE	SAME, updated in K190368
Panel Interface	Ethernet or Wi-Fi wireless	SAME
Meets USPerformanceStandard	YES 21 CFR 1020.30	SAME
Power Source	Input transformer with 7 input voltage taps(100 / 110 / 120 /, 127 / 220 / 230 / 240 V~).AC 20 amp and Batteries	Universal power supply, from 100 V~ to 240V~. 1 phase, 1.1 kVA

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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 indicate that the new devices are as safe and effective as the predicate devices. 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. Firmware was validated according to the FDA Guidance: Guidance for the Content of Premarket

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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 PhoeniX Battery Mobile X-Ray Units have been tested to be in compliance with the following International Standards:

a) IEC 60601-1:2005+A1:2012 (Edition 3.1)
b) IEC 60601-1-2:2014 (Edition 4.0)
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 PhoeniX 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.